Alopecia Areata Clinical Trial
— BRAVE-AA2Official title:
A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
Verified date | April 2024 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).
Status | Active, not recruiting |
Enrollment | 546 |
Est. completion date | July 29, 2024 |
Est. primary completion date | January 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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: - Current AA episode of more than 6 months' duration and hair loss encompassing =50% of the scalp, as measured by SALT (AA-IGA of 3 or 4) at screening and baseline. - No spontaneous improvement over the past 6 months. - Current episode of severe or very severe AA of less than 8 years. Note: participants who have severe or very severe AA for =8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years. - Male or nonpregnant, nonbreastfeeding female participants. Exclusion Criteria: - Primarily "diffuse" type of AA. - Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA. - Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment). |
Country | Name | City | State |
---|---|---|---|
Argentina | Buenos Aires Skin | Buenos Aires | Ciudad Autónoma De Buenos Aires |
Argentina | Fundacion Respirar | Buenos Aires | |
Argentina | Stat Research | Caba | Buenos Aires |
Argentina | Instituto de Neumonología y Dermatología | Ciudad Autonoma Buenos Aires | |
Argentina | Centro de Investigaciones Metabólicas (CINME) | Ciudad Autónoma de Buenos Aires | Buenos Aires |
Argentina | Parra Dermatología | Mendoza | |
Argentina | Centro Medico Privado de Reumatologia | SAN M. DE Tucuman | Tucuman |
Australia | Clinical Trials SA Pty Ltd | Adelaide | South Australia |
Australia | Skin Health Institute Inc. | Carlton | Victoria |
Australia | Fremantle Dermatology | Perth | Western Australia |
Australia | Woden Dermatology | Phillip | Australian Capital Territory |
Australia | Sinclair Dermatology | Victoria | |
Australia | Skin & Cancer Foundation Australia | Westmead | New South Wales |
Australia | Veracity Clinical Research Pty Ltd | Woolloongabba | Queensland |
Brazil | Centro de Pesquisa Sao Lucas | Campinas | São Paulo |
Brazil | Faculdade de Ciências Médicas - UNICAMP | Campinas | Sao Paulo |
Brazil | Irmandade da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Brazil | IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | |
Brazil | IDERJ - Instituto de Dermatologia e Estética do Brasil | Rio de Janeiro | RJ |
Brazil | Fundação Faculdade de Medicina do ABC | Santo André | Sao Paulo |
Brazil | Hospital Central - Santa Casa de São Paulo | São Paulo | |
Brazil | Hospital de Servidor Publico Estadual | São Paulo | |
China | Beijing Chao-Yang Hospital, Capital Medical University | Beijing | Beijing |
China | Beijing Friendship Hospital Affiliate of Capital University | Beijing | Beijing |
China | Chinese PLA General Hospital | Beijing | |
China | Peking University Third Hospital | Beijing | Beijing |
China | Xiangya Hospital Central South University | Changsha | Hunan |
China | Guangdong Province Dermatology Hospital | Guangzhou | Guangdong |
China | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang |
China | Jiangsu Province Hospital | Nanjing | Jiangsu |
China | HuaShan Hospital Affiliated To Fudan University | Shanghai | Shanghai |
China | Shanghai Dermatology Hospital | Shanghai | |
China | 1st affiliated Hospital of Shanxi Medical University | Tai Yuan | Shan XI |
China | Tianjin Medical University General Hospital | Tianjin | |
China | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'An | Shaanxi |
China | Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu |
Israel | Emek Medical Center | Afula | |
Israel | Soroka Medical Center | Beer Sheva | |
Israel | Rambam Medical Center | Haifa | |
Israel | Hadassah Medical Center | Jerusalem | |
Israel | Rabin Medical Center | Petach Tikva | |
Israel | Sheba Medical Center | Ramat Gan | |
Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
Japan | Juntendo University Hospital | Bunkyo-ku | Tokyo |
Japan | Hamamatsu University School of Medicine, University Hospital | Hamamatsu | Shizuoka |
Japan | Kyorin University Hospital | Mitaka | Tokyo |
Japan | Osaka City University Hospital | Osaka | |
Japan | Tokyo Medical Univ. Hospital | Shinjuku-ku | Tokyo |
Japan | Juntendo Tokyo Koto Geriatric Medical Center | Tokyo | |
Japan | Yamaguchi University Hospital | Ube | Yamaguchi |
Japan | Yokohama Rosai Hospital | Yokohama | Kanagawa |
Korea, Republic of | Soonchunhyang University Bucheon Hospital | Bucheon | Gyeonggi-do |
Korea, Republic of | Dankook University Hospital | Cheonan | Chungcheongnam-do |
Korea, Republic of | Boramae Medical Center | Dongjak-gu | Seoul-teukbyeolsi [Seoul] |
Korea, Republic of | Kyunghee University Hospital at Gangdong | Seoul | Seoul-teukbyeolsi [Seoul] |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
Korea, Republic of | Ajou University Hospital | Suwon | Gyeonggi-do |
Puerto Rico | Clinical Research Puerto Rico | San Juan | |
Taiwan | Chung Shan Medical University Hospital | Taichung City (r.o.c) | |
Taiwan | National Cheng Kung University Hospital | Tainan | |
Taiwan | National Taiwan University Hospital | Taipei City | |
Taiwan | Chang Gung Medical Foundation-Linkou Branch | Taoyuan | |
United States | Great Lakes Research Group, Inc. | Bay City | Michigan |
United States | Bexley Dermatology Research | Bexley | Ohio |
United States | Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | New England Research Associates | Bridgeport | Connecticut |
United States | University of North Carolina Dermatology and Skin Cancer Cen | Chapel Hill | North Carolina |
United States | Dermatology Specialists of Charlotte | Charlotte | North Carolina |
United States | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan |
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
United States | Florida Academic Centers Research and Education, LLC | Coral Gables | Florida |
United States | Velocity Clinical Research, Providence | East Greenwich | Rhode Island |
United States | Hamzavi Dermatology | Fort Gratiot | Michigan |
United States | First OC Dermatology | Fountain Valley | California |
United States | Center For Dermatology Clinical Research, Inc. | Fremont | California |
United States | Suzanne Bruce and Associates, PA | Houston | Texas |
United States | Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana |
United States | Dermatologists of Southwest Ohio | Mason | Ohio |
United States | New Horizon Research Center | Miami | Florida |
United States | Associated Skin Care Specialists | New Brighton | Minnesota |
United States | Virginia Clinical Research, Inc. | Norfolk | Virginia |
United States | Quest Dermatology Research | Northridge | California |
United States | Qualmedica Research, LLC | Owensboro | Kentucky |
United States | Northwest Dermatology Institute | Portland | Oregon |
United States | Oregon Dermatology and Research Center | Portland | Oregon |
United States | Center for Medical Research, LLC | Providence | Rhode Island |
United States | M3-Emerging Medical Research | Raleigh | North Carolina |
United States | Dermatology and Skin Cancer Specialists | Rockville | Maryland |
United States | MediSearch Clinical Trials | Saint Joseph | Missouri |
United States | Progressive Clinical Research | San Antonio | Texas |
United States | Kaiser Permanente Hospital | San Francisco | California |
United States | Investigate MD | Scottsdale | Arizona |
United States | The South Bend Clinic Center for Research | South Bend | Indiana |
United States | ForCare Clinical Research | Tampa | Florida |
United States | Joseph J. Schwartz, M.D. | Troy | New York |
United States | Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | Incyte Corporation |
United States, Argentina, Australia, Brazil, China, Israel, Japan, Korea, Republic of, Puerto Rico, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 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 into4 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. | 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. | 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). | Week 36 | |
Secondary | Time for Participants to Achieve SALT = 20 | Time for participants to achieve SALT = 20 | Week 52 | |
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. | 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. | 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. | 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. | 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. |
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. |
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. |
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. |
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. |
Baseline,Week 36 |
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