Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as INCB028050, baricitinib, JAK1 inhibitor, JAK2 inhibitor, NCB028050, INCB28050
LY3009104 · 39 trials · 32 indications
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 or invasive mechanical ventilation, including ECMO.
Percentage of Participants Achieving Adapted PediACR30 Response Criteria
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.
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 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 Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.
Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.
Number of participants with one or more SAEs
Number of participants with permanent investigational product discontinuations
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time to restart ART will be defined by a plasma HIV-1 RNA viral load greater than or equal to 1000 copies/mL following withdrawal of ART during 25 weeks of baricitinib treatment alone (following 25 weeks of baricitinib plus ART).
Participants who permanently discontinued study drug due to treatment-related adverse events.
Number of participants experiencing treatment-emergent adverse events (TEAEs), including serious adverse events.
Resolution of FDG uptake will be determined by the consensus of two blinded nuclear medicine radiologists, in accordance with current SNMMI and ASNC guidelines
The Investigator Global Assessment is a single-item observer-rated scale of scalp hair loss scored from 0 to 4, where 0 is none and 4 is very severe. One score is recorded per participant per timepoint. Change from baseline is the Month 12 score minus the baseline score, reported in units on a scale. A negative value indicates improvement.
The Oral Disease Severity Scale (ODSS) is a validated tool to assess severity of Oral Lichen Planus. For scoring, the oral cavity is divided into 17 sites and assigned three different scores. A site score, which captures disease extent, a severity score, and an activity score which is obtained by multiplying the site and severity scores. Independently study participants are asked to fill in a numerical rating scale graded from 0-10, with zero meaning no pain and 10 being the worst imaginable pain felt within the last 4 weeks. Scores are added together and range from 0-106, with higher scores meaning more severe disease. Overall change from baseline to week 24 will be reported.
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)'.
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).
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.
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.
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.
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.
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.
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.
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.
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.
The area under the concentration-time curve from time 0 to infinity \[AUC(0-inf)\] is reported for participants who received either LY3009104 tablets or capsules in a fasted or fed state.
| Arm | Type | Description |
|---|---|---|
| Baricitinib | EXPERIMENTAL | Participants will receive baricitinib orally |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo orally |
| Baricitinib High Dose | EXPERIMENTAL | Participants will receive baricitinib high dose orally. |
| Baricitinib Low Dose | EXPERIMENTAL | Participants will receive baricitinib low dose orally. |
| Baricitinib + Standard of Care (SOC) | EXPERIMENTAL | 4 milligrams (mg) of baricitinib (given as two 2 mg tablets) administered orally every day (QD) with standard of care. |
| Placebo + SOC | PLACEBO_COMPARATOR | Placebo (given as two placebo tablets) administered orally QD with standard of care. |
| Cohort 1 Baricitinib | EXPERIMENTAL | Baricitinib given orally. |
| Cohort 1 Tocilizumab | ACTIVE_COMPARATOR | Tocilizumab given Subcutaneously (SC). |
| Cohort 2 Baricitinib | EXPERIMENTAL | Baricitinib given orally. |
| Adalimumab | ACTIVE_COMPARATOR | Participants 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 Baricitinib | EXPERIMENTAL | Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind. |
| 4 mg Baricitinib | EXPERIMENTAL | Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind. |
| Placebo/ Placebo | PLACEBO_COMPARATOR | Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2. |
| Placebo/ 2-mg Baricitinib | EXPERIMENTAL | Participants who received two placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2. |
| Placebo/ 4-mg Baricitinib | EXPERIMENTAL | Participants 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 Baricitinib | EXPERIMENTAL | Participants 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 Baricitinib | EXPERIMENTAL | Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2. |
| 4-mg Baricitinib/ Placebo | EXPERIMENTAL | Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2. |
| 4-mg Baricitinib/ 2-mg Baricitinib | EXPERIMENTAL | Participants 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 Baricitinib | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants 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 Dose | EXPERIMENTAL | Participants 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) Baricitinib | EXPERIMENTAL | 4 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) Baricitinib | EXPERIMENTAL | Participants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered orally once daily (QD) for 52 weeks. |
| 1 mg Baricitinib | EXPERIMENTAL | 1 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) | EXPERIMENTAL | 4 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) | EXPERIMENTAL | 4 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) | EXPERIMENTAL | 2 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) | EXPERIMENTAL | 2 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 Substudy | EXPERIMENTAL | 4 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 Substudy | EXPERIMENTAL | 2 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 Substudy | EXPERIMENTAL | 1 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 Substudy | PLACEBO_COMPARATOR | Placebo 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 Substudy | EXPERIMENTAL | 4 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 Substudy | EXPERIMENTAL | 2 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 Substudy | EXPERIMENTAL | 2 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 Substudy | EXPERIMENTAL | 1 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 Substudy | EXPERIMENTAL | 1 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 Substudy | EXPERIMENTAL | Placebo 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 Substudy | EXPERIMENTAL | Placebo 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)-Placebo | PLACEBO_COMPARATOR | Responders 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) | EXPERIMENTAL | RPR 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-mg | EXPERIMENTAL | RPR 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-mg | EXPERIMENTAL | RPR 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 mg | EXPERIMENTAL | Non-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 mg | EXPERIMENTAL | NR 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 mg | EXPERIMENTAL | NR 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 mg | EXPERIMENTAL | NR 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 mg | EXPERIMENTAL | NR 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 mg | EXPERIMENTAL | NR 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 mg | EXPERIMENTAL | NR 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 mg | EXPERIMENTAL | Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally. |
| Bari 2 mg | EXPERIMENTAL | Participants 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 mg | EXPERIMENTAL | Participants 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 Addendum | EXPERIMENTAL | Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally. |
| 2mg Baricitinib | EXPERIMENTAL | 2mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match. |
| 1mg Baricitinib | EXPERIMENTAL | 1mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match. |
| 4 mg Baricitinib Maximum Extended Enrollment Cohort | EXPERIMENTAL | 4 mg Baricitinib administered orally once daily. Placebo 1 mg, and 2 mg administered orally every day to match. |
| 2 mg Baricitinib Maximum Extended Enrollment Cohort | EXPERIMENTAL | 2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match. |
| 1 mg Baricitinib Maximum Extended Enrollment Cohort | EXPERIMENTAL | 1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match. |
| Placebo Maximum Extended Enrollment Cohort | PLACEBO_COMPARATOR | Placebo administered orally once daily. |
| 2 mg Baricitinib Step-down | EXPERIMENTAL | 2 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-down | EXPERIMENTAL | 4 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 mg | EXPERIMENTAL | Baricitinib 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 mg | EXPERIMENTAL | Baricitinib 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 + MTX | EXPERIMENTAL | Baricitinib 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. |
| MTX | ACTIVE_COMPARATOR | MTX 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 2mg | EXPERIMENTAL | Adults with well-controlled HIV on ART will be treated for 25 weeks with baricitinib 2 mg per day orally plus their current ART regimen (Step 1). Following 25 weeks of baricitinib plus ART, ART will be interrupted, and the participants will be treated with baricitinib alone for up to 25 weeks (Step 2). If a participant qualifies for ART restart criteria before the end of the maximum 25 weeks of Step 2, they will move to Step 3 early and resume ART, while baricitinib will be discontinued for 25 weeks. Otherwise, participants will remain on baricitinib alone until the end of the 25 weeks of Step 2 and will then resume ART while baricitinib is discontinued for an additional 25 weeks of observation (Step 3). |
| Baricitinib 4mg | EXPERIMENTAL | Adults with well-controlled HIV on ART will be treated for 25 weeks with baricitinib 4 mg per day orally plus their current ART regimen (Step 1). Following 25 weeks of baricitinib plus ART, ART will be interrupted, and the participants will be treated with baricitinib alone for up to 25 weeks (Step 2). If a participant meets the ART restart criteria before the end of the maximum 25 weeks of Step 2, they will advance to Step 3 early and resume ART, while baricitinib will be discontinued for 25 weeks. Otherwise, participants will remain on baricitinib alone until the end of the 25 weeks of Step 2 and will then resume ART while baricitinib is discontinued for an additional 25 weeks of observation (Step 3). |
| baricitinib + steroid-sparing drug +/- glucocorticoid taper | EXPERIMENTAL | * 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 |
| Baricitinib 4 mg daily | EXPERIMENTAL | Participants received baricitinib 2 mg orally twice daily, for a total daily dose of 4 mg, for 52 weeks. |
| Immediate-start arm | EXPERIMENTAL | Participants 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 arm | EXPERIMENTAL | After 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 Baricitinib | EXPERIMENTAL | Baricitinib 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 2 | PLACEBO_COMPARATOR | Participants 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 2 | EXPERIMENTAL | Participants 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 2 | EXPERIMENTAL | Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind. |
| 4 mg Baricitinib Phase 2 | EXPERIMENTAL | Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind. |
| Placebo Phase 3 | PLACEBO_COMPARATOR | Participants 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 3 | EXPERIMENTAL | Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind. |
| 4 mg Baricitinib Phase 3 | EXPERIMENTAL | Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind. |
| Placebo/ Placebo Phase 3 | PLACEBO_COMPARATOR | Participants 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 3 | EXPERIMENTAL | Participants who received Placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2. |
| Placebo/ 4 mg Baricitinib Phase 3 | EXPERIMENTAL | Participants 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 3 | EXPERIMENTAL | Participants 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 3 | EXPERIMENTAL | Participants 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 3 | EXPERIMENTAL | Participants who received 2 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2. |
| 4 mg Baricitinib / Placebo Phase 3 | EXPERIMENTAL | Participants 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 3 | EXPERIMENTAL | Participants 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 Addendum | EXPERIMENTAL | Participants who received one 4 mg Baricitinib tablet administered orally QD. |
| Baricitinib 0.75 mg/0.5 mg QD | EXPERIMENTAL | Administered 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 BID | EXPERIMENTAL | Administered 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 mg | EXPERIMENTAL | Administered 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 mg | EXPERIMENTAL | Administered 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 mg | EXPERIMENTAL | Part 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 mg | EXPERIMENTAL | Part 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) | EXPERIMENTAL | 1 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) | EXPERIMENTAL | 2 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) | EXPERIMENTAL | 1 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) | EXPERIMENTAL | 2 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. |
| 1 mg LY3009104 once daily | EXPERIMENTAL | Administered orally once daily for initial 12 weeks followed by randomization to either 4 mg LY3009104 once daily or 2 mg LY3009104 twice daily for an additional 12 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks. |
| 2 mg LY3009104 once daily | EXPERIMENTAL | Administered orally once daily for 24 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks. |
| 4 mg LY3009104 once daily | EXPERIMENTAL | Administered orally once daily for 24 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks. |
| 8 mg LY3009104 once daily | EXPERIMENTAL | Administered orally once daily for 24 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks. |
| Placebo once daily | PLACEBO_COMPARATOR | Placebo administered orally once daily for initial 12 weeks followed by randomization to either 4 mg LY3009104 once daily or 2 mg LY3009104 twice daily for an additional 12 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks. |
| 2 mg LY3009104 twice daily | EXPERIMENTAL | (Not utilized in Part A) After 12 weeks treatment with 1 mg LY3009104 once daily or Placebo once daily in Part A, administered orally twice daily for 12 weeks. After 24 weeks of treatment participants will be eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally once daily for 52 additional weeks. After 76 weeks of treatment participants will be eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally once daily for 52 additional weeks. |
| Baricitinib (Healthy) | EXPERIMENTAL | Group 1: 4 milligrams (mg) baricitinib administered once, orally, to participants with normal hepatic function. |
| Baricitinib (Moderate) | EXPERIMENTAL | Group 2: 4 mg baricitinib administered once, orally, to participants with moderate hepatic impairment. |
| Baricitinib (Mild) | EXPERIMENTAL | Group 3: 4 mg baricitinib administered once, orally, to participants with mild hepatic impairment. Enrollment is contingent on data from Groups 1 and 2. |
| LY3009104 Reference Formulation | EXPERIMENTAL | 8 milligrams (mg) LY3009104 (two 4-mg phosphate salt capsules), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug. |
| LY3009104 Test Formulation 1 | EXPERIMENTAL | 8 mg LY3009104 (one 8-mg smaller particle free base tablet), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug. |
| LY3009104 Test Formulation 2 | EXPERIMENTAL | 8 mg LY3009104 (one 8-mg larger particle free base tablet), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug. |
| LY3009104 Test Formulation 2 + Meal | EXPERIMENTAL | 8 mg LY3009104 (one 8-mg larger particle free base tablet), administered orally with high-fat/high calorie meal, once only. There will be a washout period of 5 to 7 days between doses of study drug. |
| Name | Type | Description |
|---|---|---|
| Baricitinib | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Tocilizumab | DRUG | Administered SC |
| Adalimumab | DRUG | Administered SC |
| Topical corticosteroid | DRUG | Administered as standard-of-care |
| cDMARD | DRUG | Participants will continue to take background cDMARD therapy throughout study. |
| Methotrexate | DRUG | Administered orally |
| Baricitinib Placebo | DRUG | Baricitinib placebo administered orally once daily. |
| MTX Placebo | DRUG | MTX placebo administered orally once weekly. |
| Folic Acid | DRUG | Administered orally every day |
| Adalimumab Placebo | DRUG | Adalimumab placebo administered SC. |
| Antiretroviral Therapy (ART) | DRUG | Antiretroviral Therapy (ART): A treatment regimen for HIV infection that uses a combination of antiretroviral drugs to suppress viral replication, reduce HIV-related morbidity, and prevent transmission. In Step 1, participants will continue their current ART regimen for 25 weeks. In Step 2, participants will interrupt ART. In Step 3, participants will restart ART early if they meet the ART restart criteria before the end of Step 2 (a 25-week maximum). Otherwise, they will resume ART at the end of Step 2. |
| Baricitinib (LY3009104) 2 mg | DRUG | Baricitinib is an orally administered, selective inhibitor of Janus kinase (JAK) 1 and 2. It reduces cytokine-mediated signaling involved in inflammation and immune activation. Baricitinib is FDA-approved for rheumatoid arthritis (RA), atopic dermatitis, and alopecia areata. It has also been authorized for the treatment of COVID-19 in hospitalized patients. During Step 1, Baricitinib will be taken at a dose of 2 mg orally daily for 25 weeks. During Step 2, Baricitinib alone will be continued at a dose of 2 mg orally daily for up to an additional 25 weeks |
| Baricitinib (LY3009104) 4 mg | DRUG | Baricitinib is an orally administered, selective inhibitor of Janus kinase (JAK) 1 and 2. It reduces cytokine-mediated signaling involved in inflammation and immune activation. Baricitinib is FDA-approved for rheumatoid arthritis (RA), atopic dermatitis, and alopecia areata. It has also been authorized for the treatment of COVID-19 in hospitalized patients. During Step 1, Baricitinib will be taken at a dose of 4 mg orally daily for 25 weeks. During Step 2, Baricitinib alone will be continued at a dose of 4 mg orally daily for up to an additional 25 weeks |
| Baricitinib 4 milligram Oral Tablet | DRUG | 4 milligrams once daily |
| Triamcinolone (Optional) | DRUG | Administered topically |
| LY3009104 | DRUG | Administered orally |
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 ...
LY3009104 is an investigational small molecule being developed by Eli Lilly and Company for immunology indications, including rheumatoid arthritis and chronic inflammatory disorders. It has been studied in a completed Phase 2 trial in participants with rheumatoid arthritis on background methotrexate therapy.
LY3009104 has been studied for the treatment of rheumatoid arthritis, including in patients receiving background methotrexate therapy. It is also associated with chronic inflammatory disorder research. The Phase 2 study in rheumatoid arthritis has been completed, and the drug remains investigational.
LY3009104 is being developed by Eli Lilly and Company, which trades under the ticker LLY. The company sponsored the clinical program evaluating the small molecule in rheumatoid arthritis and chronic inflammatory disorders.
LY3009104 has completed a Phase 2 clinical trial in rheumatoid arthritis and a Phase 1 relative bioavailability and food effect study of new formulations. It is an investigational drug and has not been approved by the FDA. No active trials are currently listed for this asset.
LY3009104 has been evaluated in two completed trials. NCT01185353 was a Phase 2 study in 301 participants with rheumatoid arthritis on background methotrexate therapy across multiple countries. NCT01398475 was a Phase 1 relative bioavailability and food effect study of new formulations in 15 healthy volunteers in Singapore.
The Phase 2 rheumatoid arthritis trial of LY3009104, NCT01185353, enrolled 301 participants and was randomized, double blind, and placebo controlled. The Phase 1 bioavailability study, NCT01398475, enrolled 15 healthy volunteers. Both studies have been completed.