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

Skin Diseases Clinical Trial

— BRAVE-AA-PEDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723198
• Other study ID #: 16875
• Secondary ID: I4V-MC-JAIO2022-
• Status: Recruiting
• Phase: Phase 3
• Start date: February 27, 2023
• Est. completion date: August 10, 2029

Study information

• Verified date: February 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: -317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 595
• Est. completion date: August 10, 2029
• Est. primary completion date: April 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Hypotrichosis
• Pathological Conditions, Anatomical
• Skin Diseases

Intervention

Drug:
• Baricitinib
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Argentina	Fundación Respirar	Buenos Aires	Buenos Air
Argentina	Psoriahue Medicina Interdisciplinaria	Buenos Aires
Argentina	Centro de Investigaciones Metabólicas (CINME)	Caba	Buenos Aires
Argentina	Buenos Aires Skin	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	Instituto de Neumonología Y Dermatología	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	Hospital Universitario Austral	Pilar	Buenos Aires
Argentina	Hospital del Niño Jesus	San Miguel de Tucuman	Provincia De Tucuman
Argentina	Centro Medico Privado de Reumatologia	San Miguel De Tucumán	Tucumán
Australia	The Skin Hospital	Darlinghurst	New South Wales
Australia	Sinclair Dermatology	Melbourne	Victoria
Australia	Institute for Skin, Health, and Immunity	Mitcham	Victoria
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland
Canada	Dermatology Research Institute	Calgary	Alberta
Canada	Skin Health	Cobourg	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Dr. Chih-ho Hong Medical Inc.	Surrey	British Columbia
Canada	Research Toronto	Toronto	Ontario
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
France	CHRU de Brest - Hôpital Morvan	Brest CEDEX 2
France	AP-HM CHU Timone	Marseille
France	Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu	Nantes
France	CHU de Nice Hopital de L'Archet	Nice
France	Centre de Sante Sabouraud	Paris
France	Hôpital Clocheville Chru-Tours Département Dermatologie	Tours Cedex
Germany	Fachklinik Bad Bentheim	Bad Bentheim	Niedersachsen
Germany	Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)	Berlin
Germany	Universitätsklinikum Carl Gustav Carus	Dresden
Germany	Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt	Frankfurt am Main
Germany	Universitätsklinik und Poliklinik für Dermatologie und Venerologie	Halle
Germany	Kath. Kinderkrankenhaus Wilhelmstift	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitaetsklinikum Schleswig-Holstein	Luebeck	Schleswig-Holstein
Germany	Dermatologische Gemeinschaftspraxis Dres. Quist	Mainz
Germany	Klinikum Rechts der Isar der TU Muenchen	Muenchen	Bayern
Germany	University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology	Muenster
Hungary	Clinexpert Tatabánya Ltd.	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika	Debrecen	Hajdu-Bihar
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	University of Szeged	Szeged	Csongrad
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Kyorin University Hospital	Mitaka	Tokyo
Japan	Rifu Dermatology Allergy Clinic	Miyagi-gun	Miyagi
Japan	Niigata University Medical & Dental Hospital	Niigata
Japan	Osaka City University Hospital	Osaka
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Yamaguchi University Hospital	Ube	Yamaguchi
Korea, Republic of	Pusan National University Hospital	Busan	Pusan-Kwangyokshi
Korea, Republic of	Dankook University Hospital	Cheonan-si	Chungcheongnam-do [Chungnam]
Korea, Republic of	Chungnam University Hospital	Daejeon	Jung-gu
Korea, Republic of	Inha University Hospital	Incheon	Incheon-gwangyeoksi [Incheon]
Korea, Republic of	Jeonbuk National University Hospital	Jeonju-si
Korea, Republic of	Kyung Pook National University Hospital	Jung-gu	Taegu-Kwangyokshi
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Geonggi-do
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Kyunghee University Hospital at Gangdong	Seoul	Seoul, Korea
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do
Mexico	Hospital Angeles Chihuahua Unidad de Investigacion Clinica	Chihuahua
Mexico	Grupo Clínico CATEI SC	Guadalajara	Jalisco
Mexico	Innovacion y Desarrollo de Estrategias en Salud SA de CV	Mexico City
Mexico	Mexico Centre for Clinical Research	Mexico City
Mexico	Eukarya PharmaSite	Monterrey	Nuevo León
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey	Nuevo León
Mexico	Arké SMO S.A de C.V	Veracruz
Poland	NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL	Bialystok
Poland	Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz	Bydgoszcz
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie
Poland	CareClinic	Katowice
Poland	Centrum Medyczne Angelius Provita	Katowice	Slaskie
Poland	Gabinet Dermatlogiczny. Beata Krecisz	Kielce
Poland	Specjalistyczny Gabinet Dermatologiczny s.c.	Krakow	Malopolskie
Poland	Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Lodzkie
Poland	DERMEDIC Jacek Zdybski	Ostrowiec Swietokrzyski
Poland	Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie	Rzeszow	Podkarpackie
Poland	Laser Clinic Dermatologia Laserowa Medycyna Estetyczna	Szczecin
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warsaw	Malopolskie
Poland	High-Med Przychodnia Specjalistyczna	Warsaw	Masovian
Poland	Centrum Medyczne Evimed	Warszawa
Poland	Klinika Ambroziak Sp. Z.O.O.	Warszawa
Poland	Provita Poliklinika Sp. z o	Warszawa
Poland	Royalderm Agnieszka Nawrocka	Warszawa
Poland	CityClinic Przychodnia Lekarsko-Psychologiczna	Wroclaw
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitari Germans Trias i Pujol (HUGTP)	Badalona
Spain	Hospital del Mar	Barcelona	Catalunya [Cataluña]
Spain	Hospital Universitario Basurto	Bilbao
Spain	Clinica Pedro Jaen	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Hospital Universitario Quiron Salud Madrid	Pozuelo de Alarcon
Spain	Hospital General Universitario de Valencia	Valencia
Taiwan	Taipei Medical University Shuang Ho Hospital	New Taipei City	New Taipei
Taiwan	Chung Shan Medical University Hospital	Taichung City	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital - Taipei	Taoyuan
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Bexley Dermatology Research	Bexley	Ohio
United States	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Skin Care Research, Inc	Boca Raton	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Dermatology Specialists of Charlotte	Charlotte	North Carolina
United States	OnSite Clinical Solutions	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio
United States	Michigan Center for Research Company	Clarkston	Michigan
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Florida Academic Centers Research and Education, LLC	Coral Gables	Florida
United States	Pediatric Skin Research, LLC	Coral Gables	Florida
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	D&H Doral Research Center LLC	Doral	Florida
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	The Pennsylvania Centre for Dermatology, LLC	Exton	Pennsylvania
United States	Dermatology Physicians of Connecticut	Fairfield	Connecticut
United States	Pediatric Dermatology of North Texas	Grapevine	Texas
United States	Skin Care Research, Inc	Hollywood	Florida
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Solutions Through Advanced Research	Jacksonville	Florida
United States	Dermatology Research Associates	Los Angeles	California
United States	Skin Care Physicians of Georgia	Macon	Georgia
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	University of Minnesota Medical School	Minneapolis	Minnesota
United States	International Clinical Research	Murfreesboro	Tennessee
United States	University of Utah MidValley Dematology	Murray	Utah
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Advanced Skin Research Center	Omaha	Nebraska
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	Northwest Dermatology Institute	Portland	Oregon
United States	DermAssociates PC.	Rockville	Maryland
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology	San Diego	California
United States	The Permanente Medical Group, Inc.	San Francisco	California
United States	Southern California Dermatology, Inc.	Santa Ana	California
United States	Investigate MD	Scottsdale	Arizona
United States	NorthShore University HealthSystem	Skokie	Illinois
United States	The South Bend Clinic Center for Research	South Bend	Indiana
United States	Complete Dermatology	Sugar Land	Texas
United States	ForCare Clinical Research	Tampa	Florida
United States	Vital Prospects Clinical Research Institute, PC	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  France,  Germany,  Hungary,  Japan,  Korea, Republic of,  Mexico,  Poland,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) =20		Week 36
Secondary	Percent Change from Baseline in SALT Score		Baseline, Week 36
Secondary	Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90)		Week 36
Secondary	Percentage of Participants Achieving an Absolute SALT =10		Week 36
Secondary	Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 Among Participants 12 Years and Older with PRO for Scalp Hair Assessment Score =3 at Baseline		Week 36
Secondary	Mean Change from Baseline in SALT Score		Baseline, Week 36
Secondary	Percentage of Participants Achieving At Least 50% Improvement from Baseline (SALT50)		Week 36
Secondary	Percentage of Participants Achieving At Least 75% Improvement from Baseline (SALT75)		Week 36
Secondary	Percentage of Participants Achieving At Least 100% Improvement from Baseline (SALT100)		Week 36
Secondary	Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EB Hair Loss =2 at Baseline		Week 36
Secondary	Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EL Hair Loss =2 at Baseline		Week 36
Secondary	Percentage of Participants Achieving PRO Measure for EB 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EB =2 at Baseline)		Week 36
Secondary	Percentage of Participants Achieving PRO Measure for EL 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EL =2 at Baseline)		Week 36
Secondary	Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS)	The HADS is a participant-rated instrument used to assess both anxiety and depression and is available in a pediatric self-report for participants =12 years old. This instrument consists of 14 item questionnaires, each item is rated on a 4-point scale. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.	Week 36
Secondary	Mean Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety Score	The PROMIS Anxiety Short Form (8 questions, 8a v2.0) is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages =5 years). Both pediatric self-report and proxy-report versions assess anxiety "in the past seven days". Response options range from 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores are converted to T-Scores with higher scores representing greater anxiety.	Baseline, Week 36
Secondary	Mean Change from Baseline in PROMIS Depression Score	The PROMIS Depression Short Form (8a v2.0 and 6a v2.0) is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages =5 years). Both pediatric self-report and proxy-report versions assess depression "in the past seven days." Response options range from 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores are converted to T-Scores with higher scores representing greater depression.	Baseline, Week 36
Secondary	Mean Change from Baseline in PROMIS Peer Relationship Score	The PROMIS Peer Relationships Short Form planned to be used in the study measures 2 aspects of social functioning, friendship quality and peer acceptance, and is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages 5 to <8 years).	Baseline, Week 36
Secondary	Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI)	The FDLQI is a 10-item validated questionnaire designed for adult (>16 years old) family members of participants. The questionnaire is completed by family members of the AA participants (for example, parents/caregivers) and measures the secondary impact of the participant's skin disease on family QoL. Response categories include "not at all/not relevant," "only a little," "quite a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, with unanswered ("not relevant") responses scored as 0.	Baseline, Week 36
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax)		Baseline through Week 36
Secondary	PK: Area Under the Concentration Curve (AUC)		Baseline through Week 36
Secondary	Change of Immunoglobulin G (IgG) Titers		Pre-Vaccination to 4 Weeks and 12 Weeks Post-Vaccination

External Links

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