A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata

Alopecia Areata Clinical Trial

— BRAVE-AA2  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03899259
• Other study ID #: 16978
• Secondary ID: I4V-MC-JAIR
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 8, 2019
• Est. completion date: July 29, 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Baricitinib
Administered orally
• Placebo
Administered orally

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Incyte Corporation

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  China,  Israel,  Japan,  Korea, Republic of,  Puerto Rico,  Taiwan, 

Outcome

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

External Links

•   A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata