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

Last updated: April 10, 2025
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

2/3

Condition

Alopecia

Hair Loss

Treatment

Placebo

Baricitinib

Clinical Study ID

NCT03570749
16582
I4V-MC-JAHO
  • Ages 18-70
  • All Genders

Study 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

Inclusion Criteria:

  • Are at least 18 years and ≤60 years for males (≤70 years of age for females) at thetime of informed consent.

  • Must self-identify as either Black or African American in race in the open labeladdenda.

  • 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 GlobalAssessment (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

Exclusion Criteria:

  • Primarily "diffuse" type of AA.

  • Are currently experiencing other forms of alopecia or any other concomitantconditions that would interfere with evaluations of the effect of study medicationon AA.

  • Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequateresponse (for example, absence of significant terminal hair growth after at least 12weeks of treatment).

Study Design

Total Participants: 784
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
September 24, 2018
Estimated Completion Date:
January 29, 2025

Connect with a study center

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Calgary, T3A 2N1
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Markham, L3P1X2
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Mississauga, L5H 1G9
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Peterborough, K9J 5K2
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Québec, G1V 4X7
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Toronto, M4W 2N2
    Canada

    Site Not Available

  • Kurume University Hospital

    Kurume, Fukuoka 830 0011
    Japan

    Site Not Available

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka 431-3192
    Japan

    Site Not Available

  • Hamamatsu University School of Medicine University Hospital

    Hamamatsu, Shizuoka 431-3192
    Japan

    Site Not Available

  • Hamamatsu University School of Medicine, University Hospital

    Hamamatsu, Shizuoka 431-3192
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku-Ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Tokyo Medical Univ. Hospital

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Osaka City University Hospital

    Osaka, 545-8586
    Japan

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Geonggi-do 13620
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Jung-gu, Incheon 22332
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Junggu, Incheon 22332
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Incheon, Incheon-gwangyeoksi [Incheon] 22332
    Korea, Republic of

    Site Not Available

  • Chonbuk National University Hospital

    Jeon Ju-City, Jeon Ra Buk-Do, Korea 54907
    Korea, Republic of

    Site Not Available

  • Chonbuk National University Hospital

    Jeonju, Jeon Ra Buk-Do, Korea 54907
    Korea, Republic of

    Site Not Available

  • Jeonbuk National University Hospital

    Jeonju-si, Jeonrabugdo 54907
    Korea, Republic of

    Site Not Available

  • Kyung Pook National University Hospital

    Daegu, Korea 41944
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do 13620
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Busan, Pusan-Kwangyǒkshi 49241
    Korea, Republic of

    Site Not Available

  • Kyung-Hee University Hospital at Gangdong

    Seoul, Seoul-teukbyeolsi 134-090
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Dongjak-gu, Seoul-teukbyeolsi [Seoul] 06973
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 03312
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Jung-gu, Taegu-Kwangyǒkshi 41944
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon, Taejǒn-Kwangyǒkshi 35015
    Korea, Republic of

    Site Not Available

  • Chungang University Hospital

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • Eunpyeong St. Mary's Hospital

    Seoul, 03312
    Korea, Republic of

    Site Not Available

  • Konkuk University Medical Center

    Seoul, 05030
    Korea, Republic of

    Site Not Available

  • Kyunghee University Hospital at Gangdong

    Seoul, 05278
    Korea, Republic of

    Site Not Available

  • RM Pharma Specialists

    Mexico City, Distrito Federal 3100
    Mexico

    Site Not Available

  • Centro de Atención en Enfermedades Inflamatorias CATEI

    Guadalajara, Jalisco 44638
    Mexico

    Site Not Available

  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    Guadalajara, Jalisco 44650
    Mexico

    Site Not Available

  • Consultorio Privado de la Dra. Villanueva

    Guadalajara, Jalisco 44657
    Mexico

    Site Not Available

  • Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio

    Zapopan, Jalisco 45190
    Mexico

    Site Not Available

  • CRI Centro Regiomontano de Investigacion S.C.

    Monterrey, Nuevo Leon 64060
    Mexico

    Site Not Available

  • Centro Regiomontano de Investigacion

    Monterrey, Nuevo Leon 64060
    Mexico

    Site Not Available

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León 66460
    Mexico

    Site Not Available

  • B&B Investigaciones Medicas, SC

    Mazatlan, Sinaloa 82140
    Mexico

    Site Not Available

  • Derma Norte del Bajío

    Aguascalientes, 20130
    Mexico

    Site Not Available

  • Derma Norte del Bajío, S.C.

    Aguascalientes,
    Mexico

    Site Not Available

  • RM Pharma Specialists

    Distrito Federal, 3100
    Mexico

    Site Not Available

  • RM Pharma Specialists S.A. de C.V.

    Distrito Federal, 3100
    Mexico

    Site Not Available

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C

    Durango, 34000
    Mexico

    Site Not Available

  • Ponce Medical School Foundation Inc.

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • Ponce School of Medicine CAIMED Center

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • GCM Medical Group, PSC- Hato Rey

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • GCM Medical Group, PSC- Hato Rey Site

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Coastal Clinical Research, Inc

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Johnson Dermatology

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • California Dermatology & Clinical Research Institute

    Encinitas, California 92024
    United States

    Site Not Available

  • Alliance Research Centers

    Irvine, California 92612
    United States

    Site Not Available

  • Tilda Research

    Irvine, California 92612
    United States

    Site Not Available

  • University of CA, Irvine

    Irvine, California 92617
    United States

    Site Not Available

  • University of California, Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • Alliance Research Centers

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Stanford Health Care

    Redwood City, California 94063
    United States

    Site Not Available

  • Stanford Medicine Outpatient Center

    Redwood City, California 94063
    United States

    Site Not Available

  • Stanford University School of Medicine

    Redwood City, California 94063
    United States

    Active - Recruiting

  • University of California Davis Health

    Sacramento, California 95816
    United States

    Site Not Available

  • University of California Davis-Dermatology

    Sacramento, California 95816
    United States

    Site Not Available

  • University Clinical Trials

    San Diego, California 92123
    United States

    Site Not Available

  • University Clinical Trials, Inc.

    San Diego, California 92123
    United States

    Site Not Available

  • Mosaic Dermatology

    Santa Monica, California 90403
    United States

    Site Not Available

  • Church Street research Unit

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Howard University Hospital

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • Solutions Through Advanced Research

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33125
    United States

    Active - Recruiting

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Park Avenue Dermatology

    Orange Park, Florida 32073
    United States

    Site Not Available

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Site Not Available

  • Skin Care Physicians of Georgia

    Macon, Georgia 31217
    United States

    Site Not Available

  • Medaphase Inc

    Newnan, Georgia 30263
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • DS Research

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Forefront Research

    Louisville, Kentucky 40241
    United States

    Active - Recruiting

  • Callender Center For Clinical Research

    Glenn Dale, Maryland 20769
    United States

    Site Not Available

  • Callender Center for Clinical Research, LLC / Research

    Glenn Dale, Maryland 20769
    United States

    Active - Recruiting

  • ActivMed Practices and Research

    Beverly, Massachusetts 01915
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Clarkston Skin Research

    Clarkston, Michigan 48346
    United States

    Site Not Available

  • M Health Fairview University of Minnesota Medical Center - East Bank

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of Minnesota Medical School

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • ActivMed Practices & Research, Inc.

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • ActivMed Practices and Research

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467-2490
    United States

    Site Not Available

  • Marmur Medical

    New York, New York 10128
    United States

    Site Not Available

  • University of Rochester School of Medicine

    Rochester, New York 14642
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43230
    United States

    Site Not Available

  • OH State Univ College of Med

    Gahanna, Ohio 43230
    United States

    Active - Recruiting

  • Ohio State University

    Gahanna, Ohio 43230
    United States

    Site Not Available

  • NW Dermatology & Research Center, LLC

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Northwest Dermatology Institute

    Portland, Oregon 97210
    United States

    Site Not Available

  • OHSU Center for Health and Healing

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97201
    United States

    Site Not Available

  • Dermatology and Skin Surgery Center

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • The Pennsylvania Centre for Dermatology, LLC

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • Penn State Univ. Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Penn Medicine: University of Pennsylvania Health System

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • UPMC Clinical Trials

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania 19462
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Bellaire Dermatology

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Bellaire Dermatology Associates

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Modern Research Associates

    Dallas, Texas 75231
    United States

    Site Not Available

  • Center for Clinical Studies

    Houston, Texas 77004
    United States

    Site Not Available

  • Austin Institute for Clinical Research

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Center for Clinical Studies, LTD.LLP

    Webster, Texas 77598
    United States

    Site Not Available

  • University of Utah

    Murray, Utah 84107
    United States

    Site Not Available

  • University of Utah MidValley Dematology

    Murray, Utah 84107
    United States

    Site Not Available

  • Dermatology Associates

    Seattle, Washington 98101
    United States

    Site Not Available

  • Dermatology Associates of Seattle

    Seattle, Washington 98101
    United States

    Site Not Available

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