Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03952559 | A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis | PHASE3 | ACTIVE NOT_RECRUITING | 516 | — | — | May 24, 2019 | May 1, 2026 | Apr 24, 2026 | 78 | Argentina, Australia +15 |
| NCT03733301 | A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis | PHASE3 | COMPLETED | 329 | — | — | Nov 16, 2018 | Aug 22, 2019 | Aug 11, 2020 | 68 | Argentina, Australia +8 |
| NCT03428100 | A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable | PHASE3 | COMPLETED | 463 | — | — | May 15, 2018 | Apr 20, 2023 | May 14, 2024 | 103 | Austria, Belgium +12 |
| NCT03334435 | A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis | PHASE3 | COMPLETED | 1,645 | — | — | Mar 28, 2018 | Jul 12, 2023 | Sep 3, 2024 | 185 | Argentina, Australia +17 |
| NCT03435081 | A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis | PHASE3 | COMPLETED | 440 | — | — | Feb 20, 2018 | Aug 16, 2021 | Sep 9, 2022 | 81 | United States, Canada +1 |
| NCT03334422 | Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis | PHASE3 | COMPLETED | 615 | — | — | Nov 27, 2017 | Dec 12, 2018 | Jan 22, 2020 | 80 | Argentina, Australia +8 |
| NCT03334396 | A Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis | PHASE3 | COMPLETED | 660 | — | — | Nov 23, 2017 | Aug 16, 2019 | Aug 18, 2020 | 93 | Czechia, Denmark +8 |
| NCT02576938 | A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis | PHASE2 | COMPLETED | 124 | — | — | Feb 1, 2016 | Mar 1, 2017 | Jun 17, 2020 | 13 | United States, Japan |
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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 High Dose | EXPERIMENTAL | Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind. |
| 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. |
| Baricitinib Low 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. |
| Placebo | PLACEBO_COMPARATOR | Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension. |
| 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 mg Baricitinib | EXPERIMENTAL | 2 mg Baricitinib administered orally once daily in combination with TCS. Placebo administered orally once daily to match 4 mg Baricitinib. |
| 4 mg Baricitinib | EXPERIMENTAL | 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind. |
| 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. |
| 2 milligram (mg) Baricitinib | EXPERIMENTAL | 2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
| 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. |
| Baricitinib | EXPERIMENTAL | Administered once daily in multiple oral dose cohorts for 16 weeks (Triamcinolone 0.1% topical also permitted) |
| Name | Type | Description |
|---|---|---|
| Baricitinib | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Topical corticosteroid | DRUG | Administered as standard-of-care |
| Triamcinolone (Optional) | DRUG | Administered topically |
Inclusion Criteria: * At or above the 5th percentile of weight for age. * Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old). * Have had inadequate response or intolerance to existing topical (...