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A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
Sponsor: Eli Lilly and Company
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.
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
784
Start Date
2018-09-24
Completion Date
2025-01-29
Last Updated
2026-04-16
Healthy Volunteers
No
Conditions
Interventions
Baricitinib
Administered orally.
Placebo
Administered orally.
Locations (75)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Coastal Clinical Research, Inc
Mobile, Alabama, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Alliance Research Centers
Irvine, California, United States
University of CA, Irvine
Irvine, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Stanford Health Care
Redwood City, California, United States
University of California Davis-Dermatology
Sacramento, California, United States
University Clinical Trials, Inc.
San Diego, California, United States
Mosaic Dermatology
Santa Monica, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
Medaphase Inc
Newnan, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Forefront Research
Louisville, Kentucky, United States
Callender Center for Clinical Research, LLC / Research
Glenn Dale, Maryland, United States
ActivMed Practices and Research
Beverly, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Clarkston Skin Research
Clarkston, Michigan, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
ActivMed Practices and Research
Portsmouth, New Hampshire, United States
University of Rochester School of Medicine
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
OH State Univ College of Med
Gahanna, Ohio, United States
NW Dermatology & Research Center, LLC
Portland, Oregon, United States
Oregon Medical Research Center
Portland, Oregon, United States
OHSU Center for Health and Healing
Portland, Oregon, United States
Dermatology and Skin Surgery Center
Exton, Pennsylvania, United States
Penn State Univ. Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Bellaire Dermatology
Bellaire, Texas, United States
Modern Research Associates
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
University of Utah MidValley Dematology
Murray, Utah, United States
Dermatology Associates
Seattle, Washington, United States
Kurume University Hospital
Kurume, Fukuoka, Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, Japan
Tokyo Medical Univ. Hospital
Shinjuku-ku, Tokyo, Japan
Osaka City University Hospital
Osaka, Japan
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, Mexico
Consultorio Privado de la Dra. Villanueva
Guadalajara, Jalisco, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, N.L., Mexico
CRI Centro Regiomontano de Investigacion S.C.
Monterrey, Nuevo León, Mexico
B&B Investigaciones Medicas, SC
Mazatlán, Sinaloa, Mexico
Derma Norte del Bajío, S.C.
Aguascalientes, Mexico
RM Pharma Specialists S.A. de C.V.
Distrito Federal, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, Mexico
Ponce School of Medicine CAIMED Center
Ponce, PR, Puerto Rico
GCM Medical Group, PSC- Hato Rey
San Juan, PR, Puerto Rico
Seoul National University Bundang Hospital
Seongnam, Geonggi-do, South Korea
Inha University Hospital
Jung-gu, Incheon, South Korea
Chonbuk National University Hospital
Jeonju, Jeon Ra Buk-Do, Korea, South Korea
Pusan National University Hospital
Busan, Korea, South Korea
Kyung Pook National University Hospital
Daegu, Korea, South Korea
Chungnam National University Hospital
Daejeon, Korea, South Korea
Seoul National University Hospital
Seoul, South Korea
Eunpyeong St. Mary's Hospital
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Kyunghee University Hospital at Gangdong
Seoul, South Korea
Chungang University Hospital
Seoul, South Korea