A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata

Status: Recruiting
Location: See all (132) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 Period, and a 4-week Post-treatment Follow-up period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Total Skin and Beauty Dermatology Center, PC
RECRUITING
Birmingham
University of Alabama at Birmingham
NOT_YET_RECRUITING
Birmingham
Arizona
Investigate MD
RECRUITING
Scottsdale
California
California Dermatology & Clinical Research Institute
NOT_YET_RECRUITING
Encinitas
Dermatology Research Associates
RECRUITING
Los Angeles
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
RECRUITING
San Diego
The Permanente Medical Group, Inc.
RECRUITING
San Francisco
Southern California Dermatology, Inc.
RECRUITING
Santa Ana
Connecticut
Dermatology Physicians of Connecticut
NOT_YET_RECRUITING
Fairfield
Florida
Skin Care Research, Inc
NOT_YET_RECRUITING
Boca Raton
Florida Academic Centers Research and Education, LLC
COMPLETED
Coral Gables
D&H Doral Research Center LLC
NOT_YET_RECRUITING
Doral
Skin Care Research, Inc
NOT_YET_RECRUITING
Hollywood
Solutions Through Advanced Research, Inc.
RECRUITING
Jacksonville
Pediatric Skin Research, LLC
RECRUITING
Miami
University of Miami Miller School of Medicine
NOT_YET_RECRUITING
Miami
Georgia
Skin Care Physicians of Georgia
RECRUITING
Macon
Illinois
Northwestern University
NOT_YET_RECRUITING
Chicago
Northshore University Healthsystem
RECRUITING
Skokie
Indiana
Dawes Fretzin Clinical Research Group, LLC
RECRUITING
Indianapolis
The South Bend Clinic Center for Research
RECRUITING
South Bend
Maryland
DermAssociates PC.
RECRUITING
Rockville
Michigan
Michigan Center for Research Company
RECRUITING
Clarkston
Minnesota
University of Minnesota Medical School
RECRUITING
Minneapolis
Missouri
MediSearch Clinical Trials
RECRUITING
Saint Joseph
North Carolina
Dermatology Specialists of Charlotte
RECRUITING
Charlotte
OnSite Clinical Solutions
RECRUITING
Charlotte
Nebraska
Advanced Skin Research Center
RECRUITING
Omaha
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Bexley Dermatology Research
RECRUITING
Bexley
Cincinnati Childrens Hospital Medical Center
NOT_YET_RECRUITING
Cincinnati
University Hospitals Cleveland Medical Center
NOT_YET_RECRUITING
Cleveland
Oklahoma
Vital Prospects Clinical Research Institute, P.C.
RECRUITING
Tulsa
Oregon
Northwest Dermatology Institute
RECRUITING
Portland
Pennsylvania
The Pennsylvania Centre for Dermatology, LLC
COMPLETED
Exton
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
International Clinical Research - Tennessee (IC Research)
RECRUITING
Murfreesboro
Texas
Dermatology Treatment and Research Center
NOT_YET_RECRUITING
Dallas
Pediatric Dermatology of North Texas
RECRUITING
Grapevine
Texas Dermatology and Laser Specialists
RECRUITING
San Antonio
Complete Dermatology
RECRUITING
Sugar Land
Utah
University of Utah MidValley Dematology
NOT_YET_RECRUITING
Murray
Virginia
Virginia Clinical Research
RECRUITING
Norfolk
Wisconsin
University of Wisconsin-Madison
RECRUITING
Madison
Other Locations
Argentina
Derma Internacional SA
RECRUITING
Buenos Aires
Fundación Respirar
RECRUITING
Buenos Aires
Psoriahue Medicina Interdisciplinaria
RECRUITING
Buenos Aires
Buenos Aires Skin
RECRUITING
Ciudad Autonoma Buenos Aires
Instituto de Neumonología Y Dermatología
RECRUITING
Ciudad Autonoma Buenos Aires
Hospital Universitario Austral
NOT_YET_RECRUITING
Pilar
Centro Medico Privado de Reumatologia
COMPLETED
San M. De Tucuman
Hospital del Niño Jesus
RECRUITING
San Miguel De Tucumán
Australia
Skin and Cancer Foundation Australia - Darlinghurst Clinic
COMPLETED
Darlinghurst
Sinclair Dermatology
RECRUITING
Melbourne
Institute for Skin, Health, and Immunity
RECRUITING
Mitcham
Royal North Shore Hospital
NOT_YET_RECRUITING
Saint Leonards
Veracity Clinical Research Pty Ltd
RECRUITING
Wooloongabba
Canada
Dermatology Research Institute
RECRUITING
Calgary
Skin Health
RECRUITING
Cobourg
Lynderm Research Inc.
RECRUITING
Markham
Dr. Chih-ho Hong Medical Inc.
RECRUITING
Surrey
Research Toronto
RECRUITING
Toronto
Wiseman Dermatology Research Inc.
RECRUITING
Winnipeg
France
CHRU de Brest - Hôpital Morvan
NOT_YET_RECRUITING
Brest
AP-HM CHU Timone - Pharmacie Secteur Essais Cliniques
RECRUITING
Marseille
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
RECRUITING
Nantes
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
RECRUITING
Nice
Centre de Sante Sabouraud
RECRUITING
Paris
Hôpital Clocheville Chru-Tours Département Dermatologie
RECRUITING
Tours
Germany
Fachklinik Bad Bentheim
RECRUITING
Bad Bentheim
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
RECRUITING
Berlin
Universitätsklinikum Carl Gustav Carus
RECRUITING
Dresden
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
RECRUITING
Frankfurt Am Main
Universitätsklinik und Poliklinik für Dermatologie und Venerologie
NOT_YET_RECRUITING
Halle
Kath. Kinderkrankenhaus Wilhelmstift
RECRUITING
Hamburg
Universitaetsklinikum Hamburg-Eppendorf
NOT_YET_RECRUITING
Hamburg
Universitätsklinikum Schleswig-Holstein
NOT_YET_RECRUITING
Lübeck
Dermatologische Gemeinschaftspraxis Dres. Quist
RECRUITING
Mainz
Klinikum Rechts der Isar der TU München
NOT_YET_RECRUITING
München
University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology
RECRUITING
Münster
Hungary
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
COMPLETED
Debrecen
Somogy Megyei Kaposi Mor Oktato Korhaz
NOT_YET_RECRUITING
Kaposvár
Pecsi Tudomanyegyetem
RECRUITING
Pécs
Japan
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Kurume University Hospital
RECRUITING
Kurume
Kyorin University Hospital
RECRUITING
Mitaka
Rifu Dermatology Allergy Clinic
RECRUITING
Miyagi-gun
Niigata University Medical & Dental Hospital
RECRUITING
Niigata
Osaka City University Hospital
RECRUITING
Osaka
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Yamaguchi University Hospital
RECRUITING
Ube
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
RECRUITING
Gdansk
CareClinic
RECRUITING
Katowice
Centrum Medyczne Angelius Provita
RECRUITING
Katowice
Gabinet Dermatologiczny
RECRUITING
Kielce
Specjalistyczny Gabinet Dermatologiczny s.c.
RECRUITING
Krakow
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
RECRUITING
Lodz
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
RECRUITING
Rzeszów
DERMEDIC Jacek Zdybski
RECRUITING
Swietokrzyski
Centralny Szpital Kliniczny MSWiA
RECRUITING
Warsaw
Centrum Medyczne Evimed
RECRUITING
Warsaw
Klinika Ambroziak Sp. Z.O.O.
RECRUITING
Warsaw
Provita Poliklinika Sp. z o.o.
RECRUITING
Warsaw
Royalderm Agnieszka Nawrocka
RECRUITING
Warsaw
CityClinic Przychodnia Lekarsko-Psychologiczna
RECRUITING
Wroclaw
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Dankook University Hospital
RECRUITING
Cheonan-si
Chungnam national university hospital
RECRUITING
Daejeon
Inha University Hospital
RECRUITING
Incheon
Jeonbuk National University Hospital
RECRUITING
Jeonju
Kyungpook National University Hospital
RECRUITING
Junggu
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Chung-Ang University College of Medicine - Chung-Ang University Hospital (CAUH)
RECRUITING
Seoul
Konkuk University Medical Center
RECRUITING
Seoul
Kyunghee University Hospital at Gangdong
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Spain
Hospital General Universitario de Alicante
NOT_YET_RECRUITING
Alicante
Hospital Universitario Germans Trias i Pujol
RECRUITING
Badalona
Parc de Salut Mar - Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario Basurto
COMPLETED
Bilbao (bizkaia)
Clinica Pedro Jaen
RECRUITING
Madrid
Hospital Universitario Infanta Leonor-INTERNAL MED
RECRUITING
Madrid
Hospital General Universitario de Valencia
RECRUITING
Valencia
Taiwan
Taipei Medical University Shuang Ho Hospital
NOT_YET_RECRUITING
New Taipei City
Chung Shan Medical University Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
NOT_YET_RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
NOT_YET_RECRUITING
Taoyuan District
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2023-02-27
Estimated Completion Date: 2029-08
Participants
Target number of participants: 595
Treatments
Experimental: Baricitinib High Dose
Participants will receive baricitinib high dose orally.
Experimental: Baricitinib Low Dose
Participants will receive baricitinib low dose orally.
Placebo_comparator: Placebo
Participants will receive placebo
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov