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NCT05723198PHASE3Recruiting

A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata

Eli Lilly and Company

Start Date

2/27/2023

Completion Date

9/1/2033

Summary

The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age. The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension (LTE) Period, and a 4-week Post-treatment Follow-up period. Some individuals may be eligible to receive treatment after completing the LTE, for a maximum of 180 weeks.

Eligibility Criteria

Age Range: 6 years to 17 years

Inclusion Criteria: * Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old). * Have severe areata alopecia (AA) for at least 1 year * Diagnosis for at least 1 year * Current AA episode of at least 6 months' duration * SALT score ≥50% at screening and baseline * History of trial and failure with at least 1 available treatment (topical or other) for AA * History of psychological counseling related to AA * Current episode of severe AA of less than 8 years. * Note: Participants who have 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. Exclusion Criteria: * Primarily "diffuse" type of AA (characterized by diffuse hair shedding). * Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA. * Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden * Have uncontrolled arterial hypertension * Have had major surgery within 8 weeks prior to screening or will require major surgery during the study * Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking IP or interfere with the interpretation of data. * Have a positive test for hepatitis B virus (HBV) infection * Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid \[RNA\]). * Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.

Interventions

DRUG

Baricitinib

DRUG

Placebo

Interested in This Trial?

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Conditions

Areata AlopeciaAlopeciaHypotrichosisHair DiseasesSkin DiseasesPathological Conditions, Anatomical

Locations

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama 35205

United States

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Investigate MD

Scottsdale, Arizona 85255

United States

California Dermatology & Clinical Research Institute

Encinitas, California 92024

United States

Dermatology Research Associates

Los Angeles, California 90045

United States

University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology

San Diego, California 92123

United States

The Permanente Medical Group, Inc.

San Francisco, California 94118

United States

Southern California Dermatology, Inc.

Santa Ana, California 92701

United States

Dermatology Physicians of Connecticut

Fairfield, Connecticut 06824

United States

Skin Care Research, Inc

Boca Raton, Florida 33486

United States

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida 33134

United States

D&H Doral Research Center LLC

Doral, Florida 33122

United States

Skin Care Research, Inc

Hollywood, Florida 33021

United States

Solutions Through Advanced Research, Inc.

Jacksonville, Florida 32256

United States

University of Miami Miller School of Medicine

Miami, Florida 33125

United States

Pediatric Skin Research, LLC

Miami, Florida 33156

United States

Skin Care Physicians of Georgia

Macon, Georgia 31217

United States

Northwestern University

Chicago, Illinois 60611

United States

Northshore University Healthsystem

Skokie, Illinois 60077

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana 46250

United States

The South Bend Clinic Center for Research

South Bend, Indiana 46617

United States

DermAssociates PC.

Rockville, Maryland 20850

United States

Michigan Center for Research Company

Clarkston, Michigan 48346

United States

University of Minnesota Medical School

Minneapolis, Minnesota 55455

United States

MediSearch Clinical Trials

Saint Joseph, Missouri 64506

United States

Advanced Skin Research Center

Omaha, Nebraska 68144

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Dermatology Specialists of Charlotte

Charlotte, North Carolina 28277

United States

OnSite Clinical Solutions

Charlotte, North Carolina 28277

United States

Bexley Dermatology Research

Bexley, Ohio 43209

United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio 45229

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma 74136

United States

Northwest Dermatology Institute

Portland, Oregon 97210

United States

The Pennsylvania Centre for Dermatology, LLC

Exton, Pennsylvania 19341

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

International Clinical Research - Tennessee (IC Research)

Murfreesboro, Tennessee 37130

United States

Dermatology Treatment and Research Center

Dallas, Texas 75230

United States

Pediatric Dermatology of North Texas

Grapevine, Texas 76051

United States

Texas Dermatology and Laser Specialists

San Antonio, Texas 78218

United States

Complete Dermatology

Sugar Land, Texas 77479

United States

University of Utah MidValley Dematology

Murray, Utah 84107

United States

Virginia Clinical Research

Norfolk, Virginia 23502

United States

University of Wisconsin-Madison

Madison, Wisconsin 53715

United States

Psoriahue Medicina Interdisciplinaria

Buenos Aires, C1425DKG

Argentina

Fundación Respirar

Buenos Aires, C1426ABP

Argentina

Derma Internacional SA

Buenos Aires,

Argentina

Buenos Aires Skin

Ciudad Autonoma Buenos Aires, C1055AA0

Argentina

Instituto de Neumonología Y Dermatología

Ciudad Autonoma Buenos Aires, C1425BEA

Argentina

Hospital Universitario Austral

Pilar, 1629

Argentina

Centro Medico Privado de Reumatologia

SAN M. de Tucuman, T4000AXL

Argentina

Hospital del Niño Jesus

San Miguel de Tucumán, 4000

Argentina

Skin and Cancer Foundation Australia - Darlinghurst Clinic

Darlinghurst, 2010

Australia

Sinclair Dermatology

Melbourne, 3002

Australia

Institute for Skin, Health, and Immunity

Mitcham, 3132

Australia

Veracity Clinical Research Pty Ltd

Wooloongabba, 4102

Australia

Dermatology Research Institute

Calgary, T2J 7E1

Canada

Skin Health

Cobourg, K9A 0Z4

Canada

Lynderm Research Inc.

Markham, L3P 1X2

Canada

Dr. Chih-ho Hong Medical Inc.

Surrey, V3R 6A7

Canada

Research Toronto

Toronto, M4W 2N2

Canada

Wiseman Dermatology Research Inc.

Winnipeg, R3M 3Z4

Canada

CHRU de Brest - Hôpital Morvan

Brest, 29609

France

AP-HM CHU Timone - Pharmacie Secteur Essais Cliniques

Marseille, 13005

France

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, 44093

France

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, 06202

France

Centre de Sante Sabouraud

Paris, 75010

France

Hôpital Clocheville Chru-Tours Département Dermatologie

Tours, 37044

France

Fachklinik Bad Bentheim

Bad Bentheim, 48455

Germany

Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

Berlin, 10117

Germany

Universitätsklinikum Carl Gustav Carus

Dresden, 01307

Germany

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, 60590

Germany

Kath. Kinderkrankenhaus Wilhelmstift

Hamburg, 22149

Germany

Dermatologische Gemeinschaftspraxis Dres. Quist

Mainz, 55128

Germany

Klinikum Rechts der Isar der TU München

München, 80802

Germany

University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology

Münster, 48149

Germany

Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

Debrecen, 4032

Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, 7400

Hungary

Pecsi Tudomanyegyetem

Pécs, 7632

Hungary

Hamamatsu University Hospital

Hamamatsu, 431-3192

Japan

Kurume University Hospital

Kurume, 830-0011

Japan

Kyorin University Hospital

Mitaka, 181-8611

Japan

Rifu Dermatology Allergy Clinic

Miyagi-gun, 981 0112

Japan

Niigata University Medical & Dental Hospital

Niigata, 951-8520

Japan

Osaka City University Hospital

Osaka, 545-8586

Japan

Tokyo Medical University Hospital

Shinjuku-ku, 160-0023

Japan

Yamaguchi University Hospital

Ube, 755-8505

Japan

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, 80-546

Poland

CareClinic

Katowice, 40 568

Poland

Centrum Medyczne Angelius Provita

Katowice, 40-611

Poland

Gabinet Dermatologiczny

Kielce, 25-155

Poland

Specjalistyczny Gabinet Dermatologiczny s.c.

Krakow, 30 002

Poland

Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak

Lodz, 90-436

Poland

Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie

Rzeszów, 35 055

Poland

DERMEDIC Jacek Zdybski

Swietokrzyski, 27 400

Poland

Provita Poliklinika Sp. z o.o.

Warsaw, 02 647

Poland

Royalderm Agnieszka Nawrocka

Warsaw, 02 962

Poland

Centralny Szpital Kliniczny MSWiA

Warsaw, 02-507

Poland

Centrum Medyczne Evimed

Warsaw, 02-625

Poland

Klinika Ambroziak Sp. Z.O.O.

Warsaw, 02-953

Poland

CityClinic Przychodnia Lekarsko-Psychologiczna

Wroclaw, 50-566

Poland

Pusan National University Hospital

Busan, 49241

South Korea

Dankook University Hospital

Cheonan-si, 31116

South Korea

Chungnam national university hospital

Daejeon, 35015

South Korea

Inha University Hospital

Incheon, 22332

South Korea

Jeonbuk National University Hospital

Jeonju, 54907

South Korea

Kyungpook National University Hospital

Junggu, 41944

South Korea

Seoul National University Bundang Hospital

Seongnam-si, 13620

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

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

Seoul, 03312

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Konkuk University Medical Center

Seoul, 05030

South Korea

Kyunghee University Hospital at Gangdong

Seoul, 05278

South Korea

Chung-Ang University College of Medicine - Chung-Ang University Hospital (CAUH)

Seoul, 06973

South Korea

Ajou University Hospital

Suwon, 16499

South Korea

Hospital Universitario Germans Trias i Pujol

Badalona, 08916

Spain

Parc de Salut Mar - Hospital del Mar

Barcelona, 08003

Spain

Hospital Universitario Basurto

Bilbao (Bizkaia), 48013

Spain

Clinica Pedro Jaen

Madrid, 28006

Spain

Hospital Universitario Infanta Leonor-INTERNAL MED

Madrid, 28031

Spain

Hospital General Universitario de Valencia

Valencia, 46014

Spain

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235

Taiwan

Chung Shan Medical University Hospital

Taichung, 40201

Taiwan

National Cheng Kung University Hospital

Tainan, 70403

Taiwan

National Taiwan University Hospital

Taipei, 100

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan