Clinical trial NCT03570749: A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 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: PHASE2
PHASE3
Conditions: Alopecia Areata
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Incyte Corporation
First posted: 2018-06-27
Enrollment: 784
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: This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.


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.
* Must self-identify as either Black or African American in race in the open label addenda.
* 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 Alopecia Areata Investigator Global Assessment (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.
* 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: Percentage of Participants Achieving 50% Improvement of SALT (SALT50)
timeFrame: Week 12
measure: Percent Change from Baseline in SALT Score
timeFrame: Baseline, Week 36
measure: Time for Participants to Achieve SALT ≤ 20
timeFrame: Baseline through Week 36
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 Eye Lash (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 PRO Measure for EB 0 or 1 with ≥2-point improvement from Baseline (Among Participants with Patient Reported Outcome (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: Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score
timeFrame: Week 36
measure: Mean Change From Baseline in HADS Depression Score
timeFrame: Week 36
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc
state: Alabama
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Irvine
country: United States
facility: Tilda Research
state: California
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Redwood City
country: United States
facility: Stanford Medicine Outpatient Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Health
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: Santa Monica
country: United States
facility: Mosaic Dermatology
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Newnan
country: United States
facility: Medaphase Inc
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Glenn Dale
country: United States
facility: Callender Center For Clinical Research
state: Maryland
city: Beverly
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Clarkston
country: United States
facility: Clarkston Skin Research
state: Michigan
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center - East Bank
state: Minnesota
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, Inc.
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester School of Medicine
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Portland
country: United States
facility: Northwest Dermatology Institute
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Exton
country: United States
facility: The Pennsylvania Centre for Dermatology, LLC
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Univ. Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Medicine: University of Pennsylvania Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Clinical Trials
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies, LTD.LLP
state: Texas
city: Murray
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: Dermatology Associates of Seattle
state: Washington
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine, University Hospital
state: Shizuoka
city: Shinjuku-Ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon-gwangyeoksi [Incheon]
city: Jeonju-si
country: Korea, Republic of
facility: Jeonbuk National University Hospital
state: Jeonrabugdo
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan-Kwangyǒkshi
city: Dongjak-gu
country: Korea, Republic of
facility: Chung-Ang University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kyung-Hee University Hospital at Gangdong
state: Seoul-teukbyeolsi
city: Jung-gu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Taegu-Kwangyǒkshi
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Taejǒn-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Guadalajara
country: Mexico
facility: Centro de Atención en Enfermedades Inflamatorias CATEI
state: Jalisco
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.
state: Jalisco
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Investigacion
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo León
city: Mazatlan
country: Mexico
facility: B&B Investigaciones Medicas, SC
state: Sinaloa
city: Aguascalientes
country: Mexico
facility: Derma Norte del Bajío
city: Distrito Federal
country: Mexico
facility: RM Pharma Specialists
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC- Hato Rey Site
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.