A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
- Conditions
- Areata AlopeciaSkin DiseasesHypotrichosisAlopeciaHair DiseasesPathological Conditions, Anatomical
- Interventions
- Drug: Placebo
- Registration Number
- NCT05723198
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 595
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo Baricitinib Low Dose Baricitinib Participants will receive baricitinib low dose orally. Baricitinib High Dose Baricitinib Participants will receive baricitinib high dose orally.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20 Week 36
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving At Least 100% Improvement from Baseline (SALT100) Week 36 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 Mean Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety Score Baseline, Week 36 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.
Mean Change from Baseline in PROMIS Depression Score Baseline, Week 36 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.
Mean Change from Baseline in PROMIS Peer Relationship Score Baseline, Week 36 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).
Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI) Baseline, Week 36 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.
Percentage of Participants Achieving At Least 50% Improvement from Baseline (SALT50) Week 36 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 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 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 PK: Area Under the Concentration Curve (AUC) Baseline through Week 36 Percent Change from Baseline in SALT Score Baseline, Week 36 Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90) Week 36 Percentage of Participants Achieving an Absolute SALT ≤10 Week 36 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 Mean Change from Baseline in SALT Score Baseline, Week 36 Percentage of Participants Achieving At Least 75% Improvement from Baseline (SALT75) Week 36 Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS) Week 36 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.
Pharmacokinetics (PK): Maximum Concentration (Cmax) Baseline through Week 36 Change of Immunoglobulin G (IgG) Titers Pre-Vaccination to 4 Weeks and 12 Weeks Post-Vaccination
Trial Locations
- Locations (150)
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
🇫🇷Nantes, France
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Niedersachsen, Germany
Universitätsklinik und Poliklinik für Dermatologie und Venerologie
🇩🇪Halle, Germany
CareClinic
🇵🇱Katowice, Poland
Centrum Medyczne Angelius Provita
🇵🇱Katowice, Poland
Gabinet Dermatologiczny
🇵🇱Kielce, Poland
DERMEDIC Jacek Zdybski
🇵🇱Swietokrzyski, Poland
Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
🇵🇱Szczecin, Poland
Provita Poliklinika Sp. z o.o.
🇵🇱Warszawa, Poland
Royalderm Agnieszka Nawrocka
🇵🇱Warszawa, Poland
Centrum Medyczne Evimed
🇵🇱Warszawa, Poland
Centralny Szpital Kliniczny MSWiA
🇵🇱Warszawa, Poland
Klinika Ambroziak Sp. Z.O.O.
🇵🇱Warszawa, Poland
CityClinic Przychodnia Lekarsko-Psychologiczna
🇵🇱Wroclaw, Poland
Parc de Salut Mar - Hospital del Mar
🇪🇸Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitario Basurto
🇪🇸Bilbao (Bizkaia), Spain
Total Skin and Beauty Dermatology Center, PC
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Investigate MD
🇺🇸Scottsdale, Arizona, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
D&H Doral Research Center LLC
🇺🇸Doral, Florida, United States
University of Minnesota Medical School
🇺🇸Minneapolis, Minnesota, United States
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
Pecsi Tudomanyegyetem
🇭🇺Pecs, Hungary
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
Univerisity of Szeged
🇭🇺Szeged, Hungary
Southern California Dermatology, Inc.
🇺🇸Santa Ana, California, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Dermatology Physicians of Connecticut
🇺🇸Fairfield, Connecticut, United States
Florida Academic Centers Research and Education, LLC
🇺🇸Coral Gables, Florida, United States
The South Bend Clinic Center for Research
🇺🇸South Bend, Indiana, United States
Psoriahue Medicina Interdisciplinaria
🇦🇷Buenos Aires, Argentina
Skin and Cancer Foundation Australia - Darlinghurst Clinic
🇦🇺Darlinghurst, New South Wales, Australia
Skin Care Research, Inc
🇺🇸Hollywood, Florida, United States
Pediatric Skin Research, LLC
🇺🇸Coral Gables, Florida, United States
Solutions Through Advanced Research, Inc.
🇺🇸Jacksonville, Florida, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Michigan Center for Research Company
🇺🇸Clarkston, Michigan, United States
Jeonbuk National University Hospital
🇰🇷Jeonju-si, Korea, Republic of
Grupo Clínico CATEI SC
🇲🇽Guadalajara, Jalisco, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
🇲🇽Monterrey, NL, Mexico
Skin Care Physicians of Georgia
🇺🇸Macon, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Northshore University Healthsystem
🇺🇸Skokie, Illinois, United States
DermAssociates PC.
🇺🇸Rockville, Maryland, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Advanced Skin Research Center
🇺🇸Omaha, Nebraska, United States
Dermatology Specialists of Charlotte
🇺🇸Charlotte, North Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Cincinnati Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
OnSite Clinical Solutions
🇺🇸Charlotte, North Carolina, United States
Bexley Dermatology Research
🇺🇸Bexley, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
Northwest Dermatology Institute
🇺🇸Portland, Oregon, United States
The Pennsylvania Centre for Dermatology, LLC
🇺🇸Exton, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
International Clinical Research - Tennessee (IC Research)
🇺🇸Murfreesboro, Tennessee, United States
Dermatology Treatment and Research Center
🇺🇸Dallas, Texas, United States
Pediatric Dermatology of North Texas
🇺🇸Grapevine, Texas, United States
Austin Institute for Clinical Research, Inc.
🇺🇸Pflugerville, Texas, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Complete Dermatology
🇺🇸Sugar Land, Texas, United States
University of Utah MidValley Dematology
🇺🇸Murray, Utah, United States
Virginia Clinical Research
🇺🇸Norfolk, Virginia, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Caba, Buenos Aires, Argentina
Buenos Aires Skin
🇦🇷Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Hospital Universitario Austral
🇦🇷Pilar, Buenos Aires, Argentina
Instituto de Neumonología Y Dermatología
🇦🇷Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Fundación Respirar
🇦🇷Buenos Aires, Buenos Air, Argentina
Hospital del Niño Jesus
🇦🇷San Miguel de Tucuman, Provincia De Tucuman, Argentina
Centro Medico Privado de Reumatologia
🇦🇷SAN M. DE Tucuman, Tucumán, Argentina
Royal North Shore Hospital
🇦🇺Saint Leonards, New South Wales, Australia
Veracity Clinical Research Pty Ltd
🇦🇺Wooloongabba, Queensland, Australia
Sinclair Dermatology
🇦🇺Melbourne, Victoria, Australia
Institute for Skin, Health, and Immunity
🇦🇺Mitcham, Victoria, Australia
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
🇫🇷Nice, France
Hôpital Clocheville Chru-Tours Département Dermatologie
🇫🇷Tours Cedex, France
Clinexpert Kft.
🇭🇺Budapest, Hungary
Dermatology Research Institute
🇨🇦Calgary, Alberta, Canada
Wiseman Dermatology Research Inc.
🇨🇦Winnipeg, Manitoba, Canada
Skin Health
🇨🇦Cobourg, Ontario, Canada
Dr. Chih-ho Hong Medical Inc.
🇨🇦Surrey, British Columbia, Canada
Lynderm Research Inc.
🇨🇦Markham, Ontario, Canada
Research Toronto
🇨🇦Toronto, Ontario, Canada
CHRU de Brest - Hôpital Morvan
🇫🇷Brest CEDEX 2, France
AP-HM CHU Timone - Pharmacie Secteur Essais Cliniques
🇫🇷Marseille, France
Klinikum Rechts der Isar der TU München
🇩🇪München, Bayern, Germany
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
🇩🇪Berlin, Germany
University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology
🇩🇪Muenster, Germany
Somogy Megyei Kaposi Mor Oktato Korhaz
🇭🇺Kaposvar, Somogy, Hungary
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Kath. Kinderkrankenhaus Wilhelmstift
🇩🇪Hamburg, Germany
Ajou University Hospital
🇰🇷Suwon-City, Gyeonggido, 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
Centre de Sante Sabouraud
🇫🇷Paris, France
Universitätsklinikum Carl Gustav Carus
🇩🇪Dresden, Sachsen, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Schleswig-Holstein, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
🇩🇪Frankfurt am Main, Germany
Dermatologische Gemeinschaftspraxis Dres. Quist
🇩🇪Mainz, Germany
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
🇭🇺Debrecen, Hungary
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Rifu Dermatology Allergy Clinic
🇯🇵Miyagi-gun, Miyagi, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
Dankook University Hospital
🇰🇷Cheonan-si, Chungcheongnam-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Geonggi-do, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Pusan-Kwangyǒkshi, Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Kyorin University Hospital
🇯🇵Mitaka, Tokyo, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Yamaguchi University Hospital
🇯🇵Ube, Yamaguchi, Japan
Osaka City University Hospital
🇯🇵Osaka, Japan
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Chung-Ang University College of Medicine - Chung-Ang University Hospital (CAUH)
🇰🇷Seoul, Korea, Republic of
Eukarya PharmaSite
🇲🇽Monterrey, Nuevo León, Mexico
Hospital Angeles Chihuahua Unidad de Investigacion Clinica
🇲🇽Chihuahua, Mexico
Innovacion y Desarrollo de Estrategias en Salud SA de CV
🇲🇽Mexico City, Mexico
Mexico Centre for Clinical Research
🇲🇽Mexico City, Mexico
Specjalistyczny Gabinet Dermatologiczny s.c.
🇵🇱Krakow, Malopolskie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
Kyungpook National University Hospital
🇰🇷Jung-gu, Taegu-Kwangyǒkshi, Korea, Republic of
Chungnam national university hospital
🇰🇷Daejeon, Korea, Republic of
Arké SMO S.A de C.V
🇲🇽Veracruz, Mexico
High-Med Przychodnia Specjalistyczna
🇵🇱Warsaw, Masovian, Poland
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
🇵🇱Lodz, Lodzkie, Poland
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
🇵🇱Bialystok, Poland
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
🇵🇱Rzeszow, Podkarpackie, Poland
Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz
🇵🇱Bydgoszcz, Poland
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Universitario Infanta Leonor-INTERNAL MED
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias
🇪🇸Madrid, Spain
Clinica Pedro Jaen
🇪🇸Madrid, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Taipei Medical University Shuang Ho Hospital
🇨🇳New Taipei City, New Taipei, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung City, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan