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Baricitinib

Phase 3

Atopic Dermatitis | Small molecule | Dermatology |Eli Lilly and Company|Last Updated: Jul 20, 2026

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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials8
Total Enrollment4,792
FDA Designations
No designations recorded
Clinical trial landscape

Baricitinib · 46 trials · 28 indications

Phase 3 23Phase 2 10Phase 1 13
NCT07222332A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)Diabetes Mellitus, Type 1
RECRUITING300 Analytics
NCT07222137A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and AdultsDiabetes Mellitus, Type 1
RECRUITING150 Analytics
NCT05723198A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia AreataAreata Alopecia
RECRUITING595 Analytics
NCT04421027A Study of Baricitinib (LY3009104) in Participants With COVID-19COVID-19
COMPLETED1,525 Analytics
NCT04088396A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)Systemic Juvenile Idiopathic Arthritis
ACTIVE NOT_RECRUITING58 Analytics
NCT04088409A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive UveitisUveitis
ACTIVE NOT_RECRUITING30 Analytics
NCT03899259A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia AreataAlopecia Areata
COMPLETED606 Analytics
NCT03952559A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic DermatitisAtopic Dermatitis
ACTIVE NOT_RECRUITING516 Analytics
NCT03773965A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic ArthritisJuvenile Idiopathic Arthritis
RECRUITING190 Analytics
NCT03773978A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic ArthritisJuvenile Idiopathic Arthritis
COMPLETED220 Analytics
PHASE3RECRUITING
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Diabetes Mellitus, Type 1Unlock trial analytics
PHASE3RECRUITING
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
Diabetes Mellitus, Type 1Unlock trial analytics
PHASE3RECRUITING
A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Areata AlopeciaUnlock trial analytics
PHASE3COMPLETED
A Study of Baricitinib (LY3009104) in Participants With COVID-19
COVID-19Unlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
Systemic Juvenile Idiopathic ArthritisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
UveitisUnlock trial analytics
PHASE3COMPLETED
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
Alopecia AreataUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
Atopic DermatitisUnlock trial analytics
PHASE3RECRUITING
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Juvenile Idiopathic ArthritisUnlock trial analytics
PHASE3COMPLETED
A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Juvenile Idiopathic ArthritisUnlock trial analytics
Study Endpoints
Primary Endpoints
Change from Baseline in C-peptide Area Under the Curve (AUC)
Baseline, Week 52
Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes
Baseline up to approximately 5 years
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20
Week 36
Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO])
Day 1 to Day 28

Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO).

Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2
Day 1 to Day 28

Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.

Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12
Week 12

Percentage of Participants Achieving Adapted PediACR30 Response Criteria

Part A: Percentage of Responders for Baricitinib at Week 24
Week 24

Response was defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline.

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20
Week 36

The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement
Week 16

Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement is presented. The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104
Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

Open label Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.

Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104
Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.

Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Baseline through Week 264

Number of participants with one or more SAEs

Number of Participants with Permanent Investigational Product Discontinuations
Baseline through Week 264

Number of participants with permanent investigational product discontinuations

Time to Disease Flare
Week 12 to Week 44

A disease flare is defined as a worsening of 30% or more in at least three of the six core Paediatric American College of Rheumatology (PedACR) criteria for juvenile rheumatoid arthritis (JIA) and an improvement of 30% or more in no more than one of the criteria. The six PedACR criteria are: 1) the number of active joints, 2) the number of joints with limited range of motion, 3) physician's global assessment of disease activity, 4) parent's global assessment of the participant's overall well-being, 5) physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ) and 6) acute-phase reactant (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]), the ESR measure is only used as an acute phase reactant in the core criteria.

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement
Week 16

The IGA measures investigators global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib)
Week 52

SRI-4 response defined as 1)greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).

Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (Placebo, 2 mg or 4 mg Baricitinib)
Week 16

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1
Weeks 16, 36 and 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
Weeks 16, 36, and 52

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib)
Week 16

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2mg and 4mg Baricitinib)
16 Weeks

The IGA measures the investigator's global assessment of the participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2 mg, or 4 mg Baricitinib)
16 Weeks

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)
Week 12

ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100.

Number of Participants Who Experienced Adverse Events (AEs) or Serious AE
Baseline through 84 Months

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reported at a threshold of 5%. An SAE is an AE from this study that results in any of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, considered significant by the investigator for any other reason A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg
Week 12

ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.

Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
Week 12

ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.

Percent change in albuminuria (UACR)
Baseline, monthly for 6 months
Proportion of patients with resolution of cardiac FDG uptake on PET-CT
From baseline to end of treatment at 16 weeks

Resolution of FDG uptake will be determined by the consensus of two blinded nuclear medicine radiologists, in accordance with current SNMMI and ASNC guidelines

Assess the clinical response across treatment arms after 24 weeks of active treatment.
Immediate-start arm: 24 weeks after baseline visit; Delayed-start arm: 36 weeks after baseline visit

Response (yes/no): where 'response' is defined as 'achieving at least minimal clinical response according to the IMACS criteria at 24 weeks post-active treatment (at 24 weeks in the immediate-start arm and at 36 weeks in the delayed-start arm)'.

Mean and Standard Deviation (SD) of the AGS Scale at 52 Weeks
52 weeks

The primary objective is to determine if the administration of baricitinib to participants with Aicardi-Goutières Syndrome (AGS) results in a change or stability of the AGS scale from baseline to 52 weeks. The AGS scale is a neurologic scale used to evaluate neurologic function of participants under treatment. The scale includes items for head circumference and developmental milestones. A lower score suggests a worse outcome. The range of scores is from 0 (most severe) to 11 (least severe).

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3
Week 36

The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.

Percent Change From Baseline in SALT Score - Phase 3 Open-Label Addendum
Baseline, Week 52

The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100, with lower score indicating better health outcomes.

Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Week 24

Participants were defined as responder as follows using SLEDAI-2K definitions of arthritis and rash. If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint. If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint. If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.

Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
Week 16

The EASI 50, defined as ≥ 50% reduction from baseline in EASI score, assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe.

Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24
Baseline, Week 24

UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to \<50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.

Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
Week 12

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.

Percentage of Participants in the 4 mg and 8 mg Dose Groups Who Achieved an American College of Rheumatology 20 (ACR20) Responder Index Response Baseline Through Week 12 .
12 weeks

ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP) and erythrocyte sedimentation rate (ESR), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) , Patient's Global Assessment of Disease Activity-VAS (PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI), where non-responders were participants who discontinued the study prior to the completion of Part A. Percentage of participants achieving ACR20 response = (number of ACR20 responders) /(number of participants treated) \* 100.

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose
Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose

PK: Cmax of baricitinib after a single oral dose

PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Baricitinib Following a Single Oral Dose
Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose

PK: AUC(0-tlast) of Baricitinib, measured in hour times nanogram per milliliter (ng\*hr/mL)

PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose
Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose

PK: AUC(0-∞) of Baricitinib

Number of Participants With One or More Clinically Significant Event(s)
Baseline through Study Completion (up to Day 20)

Clinically significant events were defined as a moderate to severe adverse event, abnormal clinical sign, or clinical laboratory finding that may pose risk to the well-being of the participant. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib Following Both the Oral and the IV Dose
Predose, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 Hours Postdose

AUC\[0-∞\] is is the area under the concentration verses time curve from zero to infinity, reported as nanograms times hour per milliliter (ng\*h/mL).

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib
Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib
Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
PK: Maximum Concentration (Cmax) of Baricitinib
Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose
PK: Area Under the Concentration Curve From Time Zero to Infinity [AUC (0-∞)] of Baricitinib
Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib
Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid
Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose

The Cmax of simvastatin \[a cytochrome P450 (CYP) 3A substrate\] and its active acid metabolite (simvastatin acid) is reported.

PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid
Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose

The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.

PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib
Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose
PK: Area Under the Concentration Curve From Time 0 to Infinity [AUC (0-∞)] of Baricitinib
Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole
Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose
PK: AUC(0-∞) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole
Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose
PK: Maximum Concentration (Cmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole
Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose
PK: Cmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole
Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole
Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose
PK: Tmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole
Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose
PK: Area Under the Concentration Versus Time Curve From 0 to Infinity [AUC(0-∞)] of Baricitinib
Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol
Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose
PK: Cmax of Levonorgestrel
Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Ethinyl Estradiol
Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose
PK: AUC(0-∞) of Levonorgestrel
Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib (LY3009104)
Predose up to 48 hours (h) postdose
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Baricitinib
Predose up to 48 h postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin
Predose up to 24 hours post-dose on Days 7 and 16
PK: Maximum Concentration (Cmax) of Digoxin
Predose up to 24 hours post-dose on Days 7 and 16
PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
Predose up to 24 hours post-dose on Days 7 and 16
Secondary Endpoints
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 52
Change from Baseline in Number of Manual Insulin Boluses
Baseline, Week 52
Rate of Clinically Significant Hypoglycemic Events
Baseline through Week 52
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BaricitinibEXPERIMENTALParticipants will receive baricitinib orally
PlaceboPLACEBO_COMPARATORParticipants will receive placebo orally
Baricitinib High DoseEXPERIMENTALParticipants will receive baricitinib high dose orally.
Baricitinib Low DoseEXPERIMENTALParticipants will receive baricitinib low dose orally.
Baricitinib + Standard of Care (SOC)EXPERIMENTAL4 milligrams (mg) of baricitinib (given as two 2 mg tablets) administered orally every day (QD) with standard of care.
Placebo + SOCPLACEBO_COMPARATORPlacebo (given as two placebo tablets) administered orally QD with standard of care.
Cohort 1 BaricitinibEXPERIMENTALBaricitinib given orally.
Cohort 1 TocilizumabACTIVE_COMPARATORTocilizumab given Subcutaneously (SC).
Cohort 2 BaricitinibEXPERIMENTALBaricitinib given orally.
AdalimumabACTIVE_COMPARATORParticipants received adalimumab administered subcutaneously (SC) once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing \<30 kilograms (kg), or 40 mg every 2 weeks for participants weighing ≥30 kg.
2 mg BaricitinibEXPERIMENTALParticipants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
4 mg BaricitinibEXPERIMENTALParticipants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.
Placebo/ PlaceboPLACEBO_COMPARATORParticipants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
Placebo/ 2-mg BaricitinibEXPERIMENTALParticipants who received two placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
Placebo/ 4-mg BaricitinibEXPERIMENTALParticipants who received two placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
2-mg Baricitinib/ 2-mg BaricitinibEXPERIMENTALParticipants who received 2 mg Baricitinib at Period 1 continued to receive same 2 mg Baricitinib dose administered orally QD in Period 2.
2-mg Baricitinib/ 4-mg BaricitinibEXPERIMENTALParticipants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
4-mg Baricitinib/ PlaceboEXPERIMENTALParticipants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
4-mg Baricitinib/ 2-mg BaricitinibEXPERIMENTALParticipants who received 4 mg Baricitinib at Period 1 switched to receive 2 mg Baricitinib administered orally QD in Period 2.
4-mg Baricitinib/ 4-mg BaricitinibEXPERIMENTALParticipants who received 4 mg Baricitinib at Period 1 continued to receive same 4 mg Baricitinib administered orally QD in Period 2.
Baricitinib Open Label High Dose (PK Lead-in)EXPERIMENTALParticipants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension (1 mL) QD.
Baricitinib Medium DoseEXPERIMENTALParticipants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.
4 Milligram (mg) BaricitinibEXPERIMENTAL4 mg Baricitinib administered orally once daily in combination with topical corticosteroids (TCS). Placebo administered orally once daily to match 2 mg Baricitinib.
2 milligram (mg) BaricitinibEXPERIMENTALParticipants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered orally once daily (QD) for 52 weeks.
1 mg BaricitinibEXPERIMENTAL1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Long Term Extension(LTE) Substudy 4mg Baricitinib to 4mg Baricitinib (Responders/Partial Responders)EXPERIMENTAL4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE Substudy 4 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders)EXPERIMENTAL4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE Substudy 2 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders)EXPERIMENTAL2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE Substudy 2 mg Baricitinib to 1 mg Baricitinib (Responders/Partial Responders)EXPERIMENTAL2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter SubstudyEXPERIMENTAL4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter SubstudyEXPERIMENTAL2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter SubstudyEXPERIMENTAL1 mg administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE Placebo (Responders/Partial Responders) - Did Not Enter SubstudyPLACEBO_COMPARATORPlacebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
LTE 4 mg Baricitinib (Non-responders) - Did Not Enter SubstudyEXPERIMENTAL4 mg administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE 2 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter SubstudyEXPERIMENTAL2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE 2 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter SubstudyEXPERIMENTAL2 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE 1 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter SubstudyEXPERIMENTAL1 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE 1 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter SubstudyEXPERIMENTAL1 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE Placebo to 2 mg Baricitinib (Non-responders) - Did Not Enter SubstudyEXPERIMENTALPlacebo rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
LTE Placebo to 4 mg Baricitinib (Non-responders) - Did Not Enter SubstudyEXPERIMENTALPlacebo rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Responders and Partial Responders (RPR)-PlaceboPLACEBO_COMPARATORResponders or partial responders (RPR) \[Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study\] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.
RPR-Bari 1-milligram (mg)EXPERIMENTALRPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.
RPR-Bari 2-mgEXPERIMENTALRPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.
RPR-Bari 4-mgEXPERIMENTALRPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.
Non-responders (NR): Bari 1 mg to 2 mgEXPERIMENTALNon-responder (NR) \[those not meeting definition of RPR\] participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
NR: Bari 1 mg to 4 mgEXPERIMENTALNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
NR: Bari 2 mg to 2 mgEXPERIMENTALNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
NR: Bari 2 mg to 4 mgEXPERIMENTALNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
NR: Bari 4 mg to 4 mgEXPERIMENTALNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
NR: Placebo to Bari 2 mgEXPERIMENTALNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
NR: Placebo to Bari 4 mgEXPERIMENTALNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Bari 1 mgEXPERIMENTALParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.
Bari 2 mgEXPERIMENTALParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.
Bari 4 mgEXPERIMENTALParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.
Bari 2-mg Open-Label AddendumEXPERIMENTALParticipants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.
2mg BaricitinibEXPERIMENTAL2mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
1mg BaricitinibEXPERIMENTAL1mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
4 mg Baricitinib Maximum Extended Enrollment CohortEXPERIMENTAL4 mg Baricitinib administered orally once daily. Placebo 1 mg, and 2 mg administered orally every day to match.
2 mg Baricitinib Maximum Extended Enrollment CohortEXPERIMENTAL2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
1 mg Baricitinib Maximum Extended Enrollment CohortEXPERIMENTAL1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
Placebo Maximum Extended Enrollment CohortPLACEBO_COMPARATORPlacebo administered orally once daily.
2 mg Baricitinib Step-downEXPERIMENTAL2 mg Baricitinib administered orally once daily in the 96-week Step-down period. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
4 mg Baricitinib Step-downEXPERIMENTAL4 mg Baricitinib administered orally once daily in the 96-week Step-down period. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Baricitinib 2 mgEXPERIMENTALBaricitinib 2 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Baricitinib 4 mgEXPERIMENTALBaricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Baricitinib + MTXEXPERIMENTALBaricitinib 4 milligram (mg) administered orally once daily through Week 52. Participants received methotrexate (MTX) orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
MTXACTIVE_COMPARATORMTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
baricitinib + steroid-sparing drug +/- glucocorticoid taperEXPERIMENTAL* Participants will be treated with baricitinib 4 mg daily for up to 16 weeks in combination with a background steroid sparing medication * Participants who are on steroids at the time of enrollment will continue the steroid at a dose of prednisone (or equivalent) ≤ 20mg PO daily at Baseline and complete an 8 week taper of their steroid medication per a standardized protocol
Immediate-start armEXPERIMENTALParticipants will receive 4mg baracitinib daily for 24 weeks from the baseline visit in week 0. After treatment participants will be followed up for 12 weeks.
Delayed-start armEXPERIMENTALAfter the baseline visit in week 0, participants will wait for a 12 week treatment delay and will then receive 4mg baracitinib daily from week 12-week 36 (i.e. for 24 weeks). After treatment participants will be followed up for 4 weeks for safety.
Aicardi Goutières Syndrome patients receiving BaricitinibEXPERIMENTALBaricitinib will be taken by mouth or via gastrostomy feeding tube or nasogastric tube as directed by the study doctor. Baricitinib will be dosed by patient age, weight range and estimated glomerular filtration rate (eGFR). Dosing formulations in use in this study will include 1 mg and 2 mg tablets and will be used without splitting. Dispersion will be permitted to aid in swallowing.
Placebo Phase 2PLACEBO_COMPARATORParticipants received three placebo tablets administered orally once daily (QD). Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve Severity of Alopecia Tool (SALT) ≤20 (less than or equal to 20) during the study period.
1 Milligram (mg) / 4 mg Baricitinib Phase 2EXPERIMENTALParticipants received one 1 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind through Week 12. Following the decision point at Week 12, participants were transitioned to receive one 4 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind, and continued treatment through Week 200.
2 mg Baricitinib Phase 2EXPERIMENTALParticipants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
4 mg Baricitinib Phase 2EXPERIMENTALParticipants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
Placebo Phase 3PLACEBO_COMPARATORParticipants received two placebo tablets administered orally QD. Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve SALT≤20 during this treatment period.
2 mg Baricitinib Phase 3EXPERIMENTALParticipants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
4 mg Baricitinib Phase 3EXPERIMENTALParticipants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Placebo/ Placebo Phase 3PLACEBO_COMPARATORParticipants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
Placebo/ 2 mg Baricitinib Phase 3EXPERIMENTALParticipants who received Placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
Placebo/ 4 mg Baricitinib Phase 3EXPERIMENTALParticipants who received Placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
2 mg Baricitinib /2 mg Baricitinib Phase 3EXPERIMENTALParticipants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.
2 mg Baricitinib /4 mg Baricitinib Phase 3EXPERIMENTALParticipants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
2 mg Baricitinib / Placebo Phase 3EXPERIMENTALParticipants who received 2 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
4 mg Baricitinib / Placebo Phase 3EXPERIMENTALParticipants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
4 mg Baricitinib /4 mg Baricitinib Phase 3EXPERIMENTALParticipants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.
4 mg Baricitinib Phase 3 Open-Label AddendumEXPERIMENTALParticipants who received one 4 mg Baricitinib tablet administered orally QD.
Baricitinib 0.75 mg/0.5 mg QDEXPERIMENTALAdministered orally, 0.75 mg given as one 0.75 mg tablets and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
Baricitinib 0.75 mg/0.5 mg BIDEXPERIMENTALAdministered orally, 0.75 mg given as one 0.75 tablet and 2 placebo in the morning and one 0.75 mg tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one 0.5 mg tablet in the evening. Placebo tablets given to maintain blind.
Baricitinib 1.5 mg/1 mgEXPERIMENTALAdministered orally, 1.5 mg given as two 0.75 mg tablets and 1 placebo tablet in the morning and one placebo tablet in the evening for 24 weeks or 1 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
Baricitinib 4 mg/2.75 mgEXPERIMENTALAdministered orally, 4 mg given as one tablet and 2 placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 2.75 mg given as two 1 mg tablets and one 0.75 mg tablet in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
Baricitinib 8 mgEXPERIMENTALPart A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.
Baricitinib 10 mgEXPERIMENTALPart A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or discontinued from the study for 12 weeks. Part C: Participants re-randomized to 4mg dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.
1-mg Baricitinib (LY3009104)EXPERIMENTAL1 x 1-mg baricitinib capsule + 1 identical placebo capsule, both administered orally once daily for 12 weeks. Participants who complete this treatment arm will be randomized in a 1:1 ratio to either the 4-mg baricitinib or 8-mg baricitinib arms. Participants rerandomized to 8-mg baricitinib arm at Week 12 will switch to 4-mg baricitinib once a day after the approval of protocol amendment (d) and will receive that switched dose until Week 64. The dosage form changed from capsule in treatment period (up to Week 12) to tablet in extension period (Week 13 to 64) per protocol amendment (b).
2-mg Baricitinib (LY3009104)EXPERIMENTAL2 x 1-mg baricitinib capsules administered orally once daily for 12 weeks. Participants who complete this treatment arm will be randomized in a 1:1 ratio to either the 4-mg baricitinib or 8-mg baricitinib arms. Participants rerandomized to 8-mg baricitinib arm at Week 12 will switch to 4-mg baricitinib once a day after the approval of protocol amendment (d) and will receive that switched dose until Week 64. The dosage form changed from capsule in treatment period (up to Week 12) to tablet in extension period (Week 13 to 64) per protocol amendment (b).
4-mg Baricitinib (LY3009104)EXPERIMENTAL1 x 4-mg baricitinib capsule + 1 identical placebo capsule, both administered orally once daily for 12 weeks. Participants who complete this 12-week period will remain on this treatment regimen in tablet form.
8-mg Baricitinib (LY3009104)EXPERIMENTAL2 x 4-mg baricitinib capsules administered orally once daily for 12 weeks. Participants who complete this 12-week period will remain on this treatment regimen in tablet form. Participants taking 8-mg baricitinib tablet form will switch to 4-mg baricitinib once a day after the approval of protocol amendment (d) and will receive that switched dose until Week 64.
Baricitinib T1 (Part A)EXPERIMENTAL4 mg (milligram) baricitinib suspension test formulation (TF) administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
Baricitinib T2 (Part A)EXPERIMENTAL4 mg baricitinib suspension formulation (TF) administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
Baricitinib R (Part A)EXPERIMENTAL4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
Baricitinib TF Fasted (Part B)EXPERIMENTAL4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast. (TF fasting)
Baricitinib TF Fed (Part B)EXPERIMENTAL4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
4mg BaricitinibEXPERIMENTAL4mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
10mg BaricitinibEXPERIMENTAL10mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
Baricitinib Test Treatment 1 (T1)EXPERIMENTALSingle oral dose of 2 × 4 milligram (mg) baricitinib commercial formulation tablet fasted on Day 1 in one of five periods.
Baricitinib Reference Treatment 1 (R1)EXPERIMENTALSingle oral dose of 1 × 8 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods.
Baricitinib Test Treatment 2 (T2)EXPERIMENTALSingle oral dose of 1 × 4 mg baricitinib commercial formulation tablet fasted on Day 1 in one of five periods.
Baricitinib Reference Treatment 2 (R2)EXPERIMENTALSingle oral dose of 1 × 4 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods.
Baricitinib Test Treatment 2 with Meal (T2F)EXPERIMENTALSingle oral dose of 1 × 4 mg baricitinib commercial formulation tablet after food intake on Day 1 in one of five periods.
Baricitinib + CiclosporinEXPERIMENTALSingle oral dose of 4 mg baricitinib co-administered with a single oral dose of 600 mg ciclosporin on Day 4
SimvastatinEXPERIMENTALSingle oral dose of 40 milligrams (mg) simvastatin on Day 1.
Baricitinib + SimvastatinEXPERIMENTALOral doses of 10 mg baricitinib once daily (QD) on Days 3 to 7, with a single oral dose of 40 mg simvastatin coadministered on Day 6.
Baricitinib + OmeprazoleEXPERIMENTALBaricitinib - 10 mg tablet administered orally, once, on Day 10. Omeprazole - 40 mg capsule administered orally once daily (QD) for 8 days (Days 3 through 10).
Baricitinib + ProbenecidEXPERIMENTALOral doses of 1000 mg probenecid once daily on Days 3 through 7, with a single oral dose of 4 mg baricitinib co-administered on Day 5
Baricitinib + KetoconazoleEXPERIMENTALBaricitinib - 10 milligrams (mg) administered orally once on Day 1 of Period 1 and on Day 6 of Period 2. Ketoconazole - 400 mg administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2.
Baricitinib + FluconazoleEXPERIMENTALBaricitinib - 10 mg administered orally once on Day 1 of Period 1 and on Day 7 of Period 2. Fluconazole - 400 mg administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
Baricitinib + RifampicinEXPERIMENTALOral doses of 600 mg rifampicin once daily on Days 3 to 11, with a single oral dose of 10 mg baricitinib co-administered on Day 10.
Baricitinib + MicrogynonEXPERIMENTALMicrogynon \[30 micrograms (µg) ethinyl estradiol and 150 µg levonorgestrel\] administered orally, once daily (QD), on Days 1 and 29. Baricitinib, 10 milligrams (mg), administered orally QD on Days 23 through 30.
Baricitinib (Healthy)EXPERIMENTALGroup 1: 4 milligrams (mg) baricitinib administered once, orally, to participants with normal hepatic function.
Baricitinib (Moderate)EXPERIMENTALGroup 2: 4 mg baricitinib administered once, orally, to participants with moderate hepatic impairment.
Baricitinib (Mild)EXPERIMENTALGroup 3: 4 mg baricitinib administered once, orally, to participants with mild hepatic impairment. Enrollment is contingent on data from Groups 1 and 2.
Baricitinib + DigoxinEXPERIMENTALDigoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16. Baricitinib - 10 mg administered orally, QD, on Days 8 through 16.
Interventions
NameTypeDescription
BaricitinibDRUGAdministered orally
PlaceboDRUGAdministered orally
TocilizumabDRUGAdministered SC
AdalimumabDRUGAdministered SC
Topical corticosteroidDRUGAdministered as standard-of-care
cDMARDDRUGParticipants will continue to take background cDMARD therapy throughout study.
MethotrexateDRUGAdministered orally
Baricitinib PlaceboDRUGBaricitinib placebo administered orally once daily.
MTX PlaceboDRUGMTX placebo administered orally once weekly.
Folic AcidDRUGAdministered orally every day
Adalimumab PlaceboDRUGAdalimumab placebo administered SC.
Baricitinib (LY3009104) 4 mgDRUGbaricitinib 4 mg tablet taken orally once daily
Triamcinolone (Optional)DRUGAdministered topically
Baricitinib suspensionDRUGAdministered orally
Baricitinib tabletDRUGAdministered orally
[^13C4D3^15N]-baricitinibDRUG4 micrograms (μg) administered intravenously (IV)
CiclosporinDRUGAdministered orally
SimvastatinDRUGAdministered orally
OmeprazoleDRUGAdministered orally
ProbenecidDRUGAdministered orally
KetoconazoleDRUGAdministered orally
FluconazoleDRUGAdministered orally
RifampicinDRUGAdministered orally
MicrogynonDRUGAdministered orally
DigoxinDRUGAdministered orally
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Eligibility Criteria
Age Range1 Year to 35 Years
SexALL
Healthy VolunteersNo
Study Sites136

Inclusion Criteria: * Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention * Have at least one diabetes-related autoantibody found at screening * Show signs of remaining beta-cell function * stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at ...

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MEDIUMJul 17, 2026NCT04088396Status: RECRUITING → ACTIVE_NOT_RECRUITING
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MEDIUMJul 17, 2026NCT04088396Status: RECRUITING → ACTIVE_NOT_RECRUITING
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LOWJul 7, 2026NCT07222332lastUpdatePostDate: changed
LOWJul 7, 2026NCT07222137lastUpdatePostDate: changed
LOWJul 6, 2026NCT04088396lastUpdatePostDate: changed
LOWJul 6, 2026NCT04088396lastUpdatePostDate: changed
LOWJun 23, 2026NCT03773965lastUpdatePostDate: changed
LOWJun 23, 2026NCT07222332lastUpdatePostDate: changed
LOWJun 23, 2026NCT07222137lastUpdatePostDate: changed