Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAIR | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Incyte Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received two placebo tablets matched to baricitinib, administered orally once daily (QD) to maintain the blind. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 | 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. | Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in SALT Score at Week 36 | 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. 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. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (< 4 years versus ≥4 years), treatment group, and baseline value in the model. |
Not provided
Inclusion Criteria:
Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.
Have severe or very severe AA, as determined by all of the following:
Male or nonpregnant, nonbreastfeeding female participants.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | 35205 | United States | ||
| Investigate MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40214720 | Derived | King B, Mostaghimi A, Shimomura Y, Piraccini BM, Blume-Peytavi U, Sontag A, Dutronc Y, Denning K, Kolodsick J, Lu X, Srivastava A, Sinclair R. Safety of Baricitinib in Adults with Severe Alopecia Areata from Two Phase III Trials Over a Median of 2.3 Years and Up to 4 Years of Treatment. Am J Clin Dermatol. 2025 Jul;26(4):611-622. doi: 10.1007/s40257-025-00932-0. Epub 2025 Apr 11. | |
| 38904749 |
| Label | URL |
|---|---|
| A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata | View source |
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received two placebo tablets matched to baricitinib, administered orally once daily (QD) to maintain the blind in Period 1. |
| FG001 | 2 mg Baricitinib | Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind in Period 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Week 0 to Week 52) |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2020 | Jul 21, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
|
| Placebo | Drug | Administered orally |
|
| Baseline, Week 36 |
| Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) | 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. SALT50 indicates at least a 50 % improvement from baseline in the SALT score. | Week 12 |
| Percentage of Participants With Patient-Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥2-point Improvement From Baseline Among Participants With a Score of ≥3 at Baseline | PRO is an assessment of the particpant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair). | Week 36 |
| Time for Participants to Achieve SALT ≤ 20 at 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. Kaplan-Meier method was used for analysis. Time for participants to achieve salt ≤ 20 at week 36 were reported in this outcome measure. | Week 36 |
| Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥2 at Baseline) | ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB. | Week 36 |
| Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥2 at Baseline) | ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL. | Week 36 |
| Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥2 at Baseline) | PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs. | Week 36 |
| Percentage of Participants Achieving PRO Measure for EL 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure EL ≥2 at Baseline) | PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair. | Week 36 |
| Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score | Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors. | Baseline, Week 36 |
| Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36 | Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors. | Baseline, Week 36 |
| Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36 | Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors. | Baseline, Week 36 |
| Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36 | The HADS is a 14-item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (for example, 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression. LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. ≥4 years), treatment group and baseline score as fixed factors. | Baseline, Week 36 |
| Mean Change From Baseline in HADS Depression Score at Week 36 | The HADS is a 14-item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (for example, 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression. LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. ≥4 years), treatment group and baseline score as fixed factors. | Baseline,Week 36 |
| Scottsdale |
| Arizona |
| 85255 |
| United States |
| Center For Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| Quest Dermatology Research | Northridge | California | 91324 | United States |
| Kaiser Permanente Hospital | San Francisco | California | 94118 | United States |
| New England Research Associates | Bridgeport | Connecticut | 06606 | United States |
| Florida Academic Centers Research and Education, LLC | Coral Gables | Florida | 33134 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613-1244 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| The South Bend Clinic Center for Research | South Bend | Indiana | 46617 | United States |
| Qualmedica Research, LLC | Owensboro | Kentucky | 42303 | United States |
| Dermatology and Skin Cancer Specialists | Rockville | Maryland | 20850 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| Associated Skin Care Specialists | New Brighton | Minnesota | 55112 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Joseph J. Schwartz, M.D. | Troy | New York | 12180 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27516 | United States |
| Dermatology Specialists of Charlotte | Charlotte | North Carolina | 28211 | United States |
| M3-Emerging Medical Research | Raleigh | North Carolina | 27612 | United States |
| Bexley Dermatology Research | Bexley | Ohio | 43209 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Dermatologists of Southwest Ohio | Mason | Ohio | 45040 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| Northwest Dermatology Institute | Portland | Oregon | 97210 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Velocity Clinical Research, Providence | East Greenwich | Rhode Island | 02818 | United States |
| Suzanne Bruce and Associates, PA | Houston | Texas | 77056 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| Stat Research | CABA | Buenos Aires | C1023AAB | Argentina |
| Instituto de Neumonología y Dermatología | Capital Federal | Buenos Aires | 1425 | Argentina |
| Centro de Investigaciones Metabólicas (CINME) | Ciudad Autónoma de Buenos Aires | Buenos Aires | 1027 | Argentina |
| Buenos Aires Skin | Buenos Aires | Buenos Aires F.D. | 1055 | Argentina |
| Fundacion Respirar | Buenos Aires | Ciudad Autonoma Buenos Aires | C1426ABO | Argentina |
| Centro de Investigaciones Médicas Tucuman | SAN M. de Tucuman | Tucumán Province | T4000AXL | Argentina |
| Parra Dermatología | Mendoza | 5500 | Argentina |
| Woden Dermatology | Phillip | Australian Capital Territory | 2606 | Australia |
| Skin & Cancer Foundation Australia | Westmead | New South Wales | 2045 | Australia |
| Veracity Clinical Research Pty Ltd | Woolloongabba | Queensland | 4102 | Australia |
| Clinical Trials SA Pty Ltd | Campbelltown | South Australia | 5073 | Australia |
| Skin Health Institute Inc. | Carlton | Victoria | 3053 | Australia |
| Sinclair Dermatology | Melbourne | Victoria | 3002 | Australia |
| Fremantle Dermatology | Fremantle | Western Australia | 6160 | Australia |
| IDERJ - Instituto de Dermatologia e Estética do Brasil | Rio de Janeiro | Rio de Janeiro | 22470-220 | Brazil |
| Irmandade da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| Centro de Pesquisa Sao Lucas | Campinas | São Paulo | 13034-685 | Brazil |
| Hospital de Clínicas Da Universidade Estadual de Campinas | Campinas | São Paulo | 13083-888 | Brazil |
| Faculdade de Medicina do ABC | Santo André | São Paulo | 09060-870 | Brazil |
| IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | 22241-180 | Brazil |
| IPITEC | São Paulo | 01223-001 | Brazil |
| Servidor Público Estadual - IAMSPE - centro de estudos urológicos | São Paulo | 04039-901 | Brazil |
| Beijing Chao-Yang Hospital, Capital Medical University | Beijing | Beijing Municipality | 100020 | China |
| Beijing Friendship Hospital Affiliate of Capital University | Beijing | Beijing Municipality | 100050 | China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| Guangdong Province Dermatology Hospital | Guangzhou | Guangdong | 510018 | China |
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212000 | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710004 | China |
| HuaShan Hospital Affiliated To Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | 200071 | China |
| First Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi | 30001 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 310014 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310052 | China |
| Rabin Medical Center | Petah Tikva | Central District | 4941492 | Israel |
| Sheba Medical Center | Ramat Gan | Central District | 5262100 | Israel |
| Hadassah Medical Center | Jerusalem | Jerusalem | 9112001 | Israel |
| Emek Medical Center | Afula | Northern District | 1834111 | Israel |
| Rambam Medical Center | Haifa | Northern District | 3109601 | Israel |
| Soroka Medical Center | Beersheba | Southern District | 8410101 | Israel |
| Sourasky Medical Center | Tel Aviv | Tell Abīb | 6423906 | Israel |
| Yokohama Rosai Hospital | Yokohama | Kanagawa | 222-0036 | Japan |
| Hamamatsu University Hospital | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Juntendo Tokyo Koto Geriatric Medical Center | Koto-ku | Tokyo | 136-0075 | Japan |
| Kyorin University Hospital | Mitaka | Tokyo | 181-8611 | Japan |
| Tokyo Medical Univ. Hospital | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Yamaguchi University Hospital | Ube | Yamaguchi | 755-8505 | Japan |
| Osaka City University Hospital | Osaka | 545-8586 | Japan |
| Clinical Research Puerto Rico | San Juan | 00909 | Puerto Rico |
| Dankook University Hospital | Cheonan | Chungcheongnam-do | 31116 | South Korea |
| Soonchunhyang University Bucheon Hospital | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Boramae Medical Center | Dongjak-gu | Seoul-teukbyeolsi [Seoul] | 07061 | South Korea |
| Kyunghee University Hospital at Gangdong | Seoul | Seoul-teukbyeolsi [Seoul] | 134-090 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Chung Shan Medical University Hospital | Taichung | Taichung | 402 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Chang Gung Medical Foundation-Linkou Branch | Taoyuan | 333 | Taiwan |
| Derived |
| Craiglow B, Lee YW, Vano-Galvan S, Egeberg A, Dutronc Y, Durand F, Pierce E, Yu G, Chen YF, Mostaghimi A. Improvement in Measures of Quality of Life and Symptoms of Anxiety and Depression in Patients with Severe Alopecia Areata Achieving Sustained Scalp Hair Regrowth with Baricitinib. Dermatol Ther (Heidelb). 2024 Jul;14(7):1959-1968. doi: 10.1007/s13555-024-01208-x. Epub 2024 Jun 21. |
| 37991697 | Derived | Senna MM, Kwon O, Piraccini BM, Sinclair R, Ball S, Ding Y, Chen YF, Dutronc Y, King B. Clinical Benefits of Baricitinib Therapy According to Scalp Hair Regrowth in Patients with Severe Alopecia Areata. Dermatol Ther (Heidelb). 2023 Dec;13(12):3209-3220. doi: 10.1007/s13555-023-01063-2. Epub 2023 Nov 22. |
| 37556146 | Derived | Ko JM, Mayo TT, Bergfeld WF, Dutronc Y, Yu G, Ball SG, Somani N, Craiglow BG. Clinical Outcomes for Uptitration of Baricitinib Therapy in Patients With Severe Alopecia Areata: A Pooled Analysis of the BRAVE-AA1 and BRAVE-AA2 Trials. JAMA Dermatol. 2023 Sep 1;159(9):970-976. doi: 10.1001/jamadermatol.2023.2581. |
| 37381691 | Derived | Piraccini BM, Ohyama M, Craiglow B, Bewley A, Ding Y, Chen YF, Dutronc Y, Pierce E, Durand F, Mostaghimi A. Scalp hair regrowth is associated with improvements in health-related quality of life and psychological symptoms in patients with severe alopecia areata: results from two randomized controlled trials. J Dermatolog Treat. 2023 Dec;34(1):2227299. doi: 10.1080/09546634.2023.2227299. |
| 36855020 | Derived | Kwon O, Senna MM, Sinclair R, Ito T, Dutronc Y, Lin CY, Yu G, Chiasserini C, McCollam J, Wu WS, King B. Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata over 52 Weeks of Continuous Therapy in Two Phase III Trials (BRAVE-AA1 and BRAVE-AA2). Am J Clin Dermatol. 2023 May;24(3):443-451. doi: 10.1007/s40257-023-00764-w. Epub 2023 Mar 1. |
| 36763878 | Derived | King B, Mostaghimi A, Shimomura Y, Zlotogorski A, Choi GS, Blume-Peytavi U, Passeron T, Holzwarth K, Dutronc Y, McCollam J, Yang FE, Stanley S, Wu WS, Sinclair R. Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials. Br J Dermatol. 2023 Feb 10;188(2):218-227. doi: 10.1093/bjd/ljac059. |
| 35334197 | Derived | King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, Hordinsky M, Dutronc Y, Wu WS, McCollam J, Chiasserini C, Yu G, Stanley S, Holzwarth K, DeLozier AM, Sinclair R; BRAVE-AA Investigators. Two Phase 3 Trials of Baricitinib for Alopecia Areata. N Engl J Med. 2022 May 5;386(18):1687-1699. doi: 10.1056/NEJMoa2110343. Epub 2022 Mar 26. |
| FG002 | 4 mg Baricitinib | Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind in Period 1. |
| FG003 | Placebo/ Placebo | Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2. |
| FG004 | Placebo/ 2-mg Baricitinib | Participants who received two placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2. |
| FG005 | Placebo/ 4-mg Baricitinib | Participants who received two placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2. |
| FG006 | 2-mg Baricitinib/ 2-mg Baricitinib | Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2. |
| FG007 | 2-mg Baricitinib/ 4-mg Baricitinib | Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2. |
| FG008 | 4-mg Baricitinib/ Placebo | Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2. |
| FG009 | 4-mg Baricitinib/ 2-mg Baricitinib | Participants who received 4 mg Baricitinib at Period 1 switched to receive 2 mg Baricitinib administered orally QD in Period 2. |
| FG010 | 4-mg Baricitinib/ 4-mg Baricitinib | Participants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2. |
| Safety Population | All randomized participants who received at least one dose of study drug and did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. |
|
| Extended Safety Population | Extended safety population: Participants who were continuously treated from baseline with baricitinib 2 mg (n=173), 4 mg (n=258), or placebo (n=147) and were censored at the time of any dose change or after the permanent study drug discontinuation, whichever occurred earlier (N=578, [173+258+147]). |
|
| COMPLETED | Participants who completed Week 52 |
|
| NOT COMPLETED |
|
|
| Period 2 (Week 52 to Week 248) |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo |
|
| BG001 | 2 mg Baricitinib |
|
| BG002 | 4 mg Baricitinib |
|
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One participant was randomized inadvertently but not dosed and age was not obtained. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| ||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| ||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| ||||||||||
| Baseline Disease Severity of Alopecia Tool (SALT) Score | SALT uses a visual aid showing the division of the scalp hair into 4 areas - top of the head constituting 40% of total surface, the posterior/back of head 24%, right 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. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account for scoring. The score will range from 0% to 100%, with lower score indicating better health outcomes. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 | 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. | All randomized participants who had evaluable data for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 36 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in SALT Score at Week 36 | 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. 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. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (< 4 years versus ≥4 years), treatment group, and baseline value in the model. | All randomized participants with nonmissing baseline and at least one postbaseline measure who had evaluable data for this outcome measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment. | Posted | Least Squares Mean | Standard Error | percentage of change | Baseline, Week 36 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) | 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. SALT50 indicates at least a 50 % improvement from baseline in the SALT score. | All randomized participants who had evaluable data for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Patient-Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥2-point Improvement From Baseline Among Participants With a Score of ≥3 at Baseline | PRO is an assessment of the particpant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair). | All randomized participants with a baseline PRO scalp hair assessment score of ≥ 3 and who had evaluable data for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 36 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time for Participants to Achieve SALT ≤ 20 at 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. Kaplan-Meier method was used for analysis. Time for participants to achieve salt ≤ 20 at week 36 were reported in this outcome measure. | All randomized participants who had evaluable data for this outcome measure. | Posted | Median | 95% Confidence Interval | Days | Week 36 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥2 at Baseline) | ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB. | All randomized participants with baseline ClinRO measure for EB hair loss ≥ 2 and who had evaluable data for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 36 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥2 at Baseline) | ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL. | All randomized participants with baseline ClinRO measure for EL hair loss ≥ 2 and who had evaluable data for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 36 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥2 at Baseline) | PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs. | All randomized participants with baseline PRO measures for EB hair loss ≥2 and who had evaluable data for this outcome measure. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 36 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving PRO Measure for EL 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure EL ≥2 at Baseline) | PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair. | All randomized participants with baseline PRO Measure EL hair loss ≥2 and who had evaluable data for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 36 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score | Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors. | All randomized participants with baseline and at least one postbaseline Skindex-16 AA Symptoms Domain Score who had evaluable data for this outcome measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 36 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36 | Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors. | All randomized participants with baseline and at least one postbaseline Skindex-16 AA emotions domain score who had evaluable data for this outcome measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 36 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36 | Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors. | All randomized participants with baseline and at least one postbaseline Skindex-16 AA functioning domain score who had evaluable data for this outcome measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 36 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36 | The HADS is a 14-item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (for example, 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression. LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. ≥4 years), treatment group and baseline score as fixed factors. | All randomized participants with baseline and at least one postbaseline HADS anxiety score who had evaluable data for this outcome measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 36 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in HADS Depression Score at Week 36 | The HADS is a 14-item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (for example, 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression. LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. ≥4 years), treatment group and baseline score as fixed factors. | All randomized participants with baseline and at least one postbaseline HADS depression score who had evaluable data for this outcome measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline,Week 36 |
|
Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately).
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo |
| 0 | 171 | 3 | 171 | 44 | 171 |
| EG001 | 2 mg Baricitinib |
| 0 | 173 | 5 | 173 | 85 | 173 |
| EG002 | 4 mg Baricitinib |
| 0 | 258 | 16 | 258 | 133 | 258 |
| EG003 | All Baricitinib- Extended |
| 0 | 578 | 34 | 578 | 321 | 578 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Strangulated umbilical hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Endometrial cancer stage i | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 27.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 27.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Varicocele | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-595-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2025 | Nov 18, 2025 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000596027 | baricitinib |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Study Terminated by Sponsor |
|
| Physician Decision |
|
| Pregnancy |
|
| Protocol Defined Discontinuation Criteria Met at Week 76 |
|
| Lack of Adherence |
|
|
|
|
|
| Australia |
|
|
| Brazil |
|
|
| China |
|
|
| Israel |
|
|
| Japan |
|
|
| South Korea |
|
|
| Taiwan |
|
|
| United States |
|
|
|
| Odds Ratio (OR) |
| 19.72 |
| 2-Sided |
| 95 |
| 7.30 |
| 53.30 |
| Superiority |
Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind.
| OG002 | 4 mg Baricitinib | Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind. |
|
|
|
| 4 mg Baricitinib |
Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind. |
|
|
|
Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.
|
|
|
| 4 mg Baricitinib |
Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind. |
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind.
| OG002 | 4 mg Baricitinib | Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind. |
|
|
|
| OG002 | 4 mg Baricitinib | Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind. |
|
|
|
Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind.
| OG002 | 4 mg Baricitinib | Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind. |
|
|
|
| OG002 |
| 4 mg Baricitinib |
Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind. |
|
|
|
| OG002 |
| 4 mg Baricitinib |
Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind. |
|
|
|