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

Who is this study for? Adult patients with Alopecia Areata
What treatments are being studied? Baricitinib
Status: Completed
Location: See all (75) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Coastal Clinical Research, Inc
Mobile
Arkansas
Johnson Dermatology
Fort Smith
California
California Dermatology & Clinical Research Institute
Encinitas
Tilda Research
Irvine
University of California, Irvine
Irvine
Dermatology Research Associates
Los Angeles
Stanford Medicine Outpatient Center
Redwood City
University of California Davis Health
Sacramento
University Clinical Trials
San Diego
Mosaic Dermatology
Santa Monica
Connecticut
Yale University School of Medicine
New Haven
Florida
Solutions Through Advanced Research
Jacksonville
University of Miami Miller School of Medicine
Miami
Park Avenue Dermatology
Orange Park
ForCare Clinical Research
Tampa
Georgia
Skin Care Physicians of Georgia
Macon
Medaphase Inc
Newnan
Illinois
Northwestern University
Chicago
Kentucky
DS Research
Louisville
Massachusetts
ActivMed Practices and Research
Beverly
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Maryland
Callender Center For Clinical Research
Glenn Dale
Michigan
Clarkston Skin Research
Clarkston
Minnesota
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis
New Hampshire
ActivMed Practices & Research, Inc.
Portsmouth
New York
Montefiore Medical Center
Bronx
University of Rochester School of Medicine
Rochester
Ohio
Cleveland Clinic
Cleveland
University Hospitals Cleveland Medical Center
Cleveland
Ohio State University
Columbus
Oregon
Northwest Dermatology Institute
Portland
Oregon Health and Science University
Portland
Oregon Medical Research Center
Portland
Pennsylvania
The Pennsylvania Centre for Dermatology, LLC
Exton
Penn State Univ. Milton S. Hershey Medical Center
Hershey
Penn Medicine: University of Pennsylvania Health System
Philadelphia
UPMC Clinical Trials
Pittsburgh
Dermatology Associates of Plymouth Meeting
Plymouth Meeting
South Carolina
Medical University of South Carolina
Charleston
Texas
Bellaire Dermatology Associates
Bellaire
Modern Research Associates
Dallas
Center for Clinical Studies
Houston
Austin Institute for Clinical Research
Pflugerville
Dermatology Clinical Research Center of San Antonio
San Antonio
Texas Dermatology and Laser Specialists
San Antonio
Center for Clinical Studies, LTD.LLP
Webster
Utah
University of Utah
Murray
Washington
Dermatology Associates of Seattle
Seattle
Other Locations
Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu
Kurume University Hospital
Kurume
Osaka City University Hospital
Osaka
Tokyo Medical University Hospital
Shinjuku-ku
Mexico
Derma Norte del Bajío
Aguascalientes
RM Pharma Specialists
Distrito Federal
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango
Centro de Atención en Enfermedades Inflamatorias CATEI
Guadalajara
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara
B&B Investigaciones Medicas, SC
Mazatlan
Centro Regiomontano de Investigacion
Monterrey
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey
Puerto Rico
Ponce Medical School Foundation Inc.
Ponce
GCM Medical Group, PSC- Hato Rey Site
San Juan
Republic of Korea
Pusan National University Hospital
Busan
Chungnam National University Hospital
Daejeon
Chung-Ang University Hospital
Dongjak-gu
Inha University Hospital
Incheon
Jeonbuk National University Hospital
Jeonju-si
Kyungpook National University Hospital
Jung-gu
Seoul National University Bundang Hospital
Seongnam
Konkuk University Medical Center
Seoul
Kyung-Hee University Hospital at Gangdong
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul
Time Frame
Start Date: 2018-09-24
Completion Date: 2025-01-29
Participants
Target number of participants: 784
Treatments
Experimental: Baricitinib High Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Experimental: Baricitinib Low Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Placebo_comparator: Placebo
Placebo administered orally.
Experimental: Open-Label Addenda Baricitinib High Dose
Baricitinib will be administered orally during the open-label addenda.
Sponsors
Leads: Eli Lilly and Company
Collaborators: Incyte Corporation

This content was sourced from clinicaltrials.gov