Clinical trial NCT03899259: A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alopecia Areata
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Incyte Corporation
First posted: 2019-04-02
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20
timeFrame: Week 36
Secondary outcomes:
measure: Percent Change From Baseline in SALT Score at Week 36
timeFrame: Baseline, Week 36
measure: Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)
timeFrame: Week 12
measure: 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
timeFrame: Week 36
measure: Time for Participants to Achieve SALT ≤ 20
timeFrame: Week 52
measure: 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)
timeFrame: Week 36
measure: 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)
timeFrame: Week 36
measure: 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)
timeFrame: Week 36
measure: 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)
timeFrame: Week 36
measure: Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score
timeFrame: Baseline, Week 36
measure: Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36
timeFrame: Baseline, Week 36
measure: Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36
timeFrame: Baseline, Week 36
measure: Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36
timeFrame: Baseline, Week 36
measure: Mean Change From Baseline in HADS Depression Score at Week 36
timeFrame: Baseline,Week 36
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Scottsdale
country: United States
facility: Investigate MD
state: Arizona
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Hospital
state: California
city: Bridgeport
country: United States
facility: New England Research Associates
state: Connecticut
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education, LLC
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic Center for Research
state: Indiana
city: Owensboro
country: United States
facility: Qualmedica Research, LLC
state: Kentucky
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: New Brighton
country: United States
facility: Associated Skin Care Specialists
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Troy
country: United States
facility: Joseph J. Schwartz, M.D.
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Dermatology Specialists of Charlotte
state: North Carolina
city: Raleigh
country: United States
facility: M3-Emerging Medical Research
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Portland
country: United States
facility: Northwest Dermatology Institute
state: Oregon
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Caba
country: Argentina
facility: Stat Research
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Instituto de Neumonología y Dermatología
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundacion Respirar
state: Ciudad Autonoma Buenos Aires
city: Buenos Aires
country: Argentina
facility: Buenos Aires Skin
state: Ciudad Autónoma De Buenos Aires
city: SAN M. DE Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
state: Tucuman
city: Mendoza
country: Argentina
facility: Parra Dermatología
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Westmead
country: Australia
facility: Skin & Cancer Foundation Australia
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
city: Campbelltown
country: Australia
facility: Clinical Trials SA Pty Ltd
state: South Australia
city: Carlton
country: Australia
facility: Skin Health Institute Inc.
state: Victoria
city: Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: IDERJ - Instituto de Dermatologia e Estética do Brasil
state: RJ
city: Campinas
country: Brazil
facility: Hospital de Clínicas Da Universidade Estadual de Campinas
state: Sao Paulo
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: Sao Paulo
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: IBPClin - Instituto Brasil de Pesquisa Clínica
city: São Paulo
country: Brazil
facility: IPITEC
city: São Paulo
country: Brazil
facility: Servidor Público Estadual - IAMSPE - centro de estudos urológicos
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Affiliate of Capital University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Province Dermatology Hospital
state: Guangdong
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Xi'An
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: HuaShan Hospital Affiliated To Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
city: Taiyuan
country: China
facility: First Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
state: HaDarom
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Afula
country: Israel
facility: Emek Medical Center
state: HaTsafon
city: Haifa
country: Israel
facility: Rambam Medical Center
state: HaTsafon
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
state: Tell Abīb
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
city: Yokohama
country: Japan
facility: Yokohama Rosai Hospital
state: Kanagawa
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Juntendo Tokyo Koto Geriatric Medical Center
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical Univ. Hospital
state: Tokyo
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
state: Chungcheongnam-do
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Dongjak-gu
country: Korea, Republic of
facility: Boramae Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Hospital at Gangdong
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
city: Taichung city
country: Taiwan
facility: Chung Shan Medical University Hospital
state: Taichung
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.