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

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

Overview

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.

Interventions

• Drug Baricitinib
  Administered orally
• Drug Placebo
  Administered orally

Primary outcome measures

• Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20 [Time frame: Week 36]

Secondary outcome measures (12)

• Percent Change from Baseline in SALT Score [Time frame: Baseline, Week 36]
• Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90) [Time frame: Week 36]
• Percentage of Participants Achieving an Absolute SALT ≤10 [Time frame: 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 [Time frame: Week 36]
• Mean Change from Baseline in SALT Score [Time frame: Baseline, Week 36]
• Percentage of Participants Achieving At Least 50% Improvement from Baseline (SALT50) [Time frame: Week 36]
• Percentage of Participants Achieving At Least 75% Improvement from Baseline (SALT75) [Time frame: Week 36]
• Percentage of Participants Achieving At Least 100% Improvement from Baseline (SALT100) [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: Week 36]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 44 centers

• Total Skin and Beauty Dermatology Center, PC — Birmingham
• University of Alabama at Birmingham — Birmingham
• Investigate MD — Scottsdale
• California Dermatology & Clinical Research Institute — Encinitas
• Dermatology Research Associates — Los Angeles
• University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adol — San Diego
• The Permanente Medical Group, Inc. — San Francisco
• Southern California Dermatology, Inc. — Santa Ana
• … and 36 more centers

Poland · 14 centers

Center list to be confirmed — check the primary protocol.

South Korea · 14 centers

Center list to be confirmed — check the primary protocol.

Argentina · 8 centers

• Psoriahue Medicina Interdisciplinaria — Buenos Aires
• Fundación Respirar — Buenos Aires
• Derma Internacional SA — Buenos Aires
• Buenos Aires Skin — Ciudad Autonoma Buenos Aires
• Instituto de Neumonología Y Dermatología — Ciudad Autonoma Buenos Aires
• Hospital Universitario Austral — Pilar
• Centro Medico Privado de Reumatologia — SAN M. de Tucuman
• Hospital del Niño Jesus — San Miguel de Tucumán

Germany · 8 centers

• Fachklinik Bad Bentheim — Bad Bentheim
• Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) — Berlin
• Universitätsklinikum Carl Gustav Carus — Dresden
• Klinikum der Johann Wolfgang Goethe-Universität Frankfurt — Frankfurt am Main
• Kath. Kinderkrankenhaus Wilhelmstift — Hamburg
• Dermatologische Gemeinschaftspraxis Dres. Quist — Mainz
• Klinikum Rechts der Isar der TU München — München
• University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative De — Münster

Japan · 8 centers

• Hamamatsu University Hospital — Hamamatsu
• … and 7 more centers

Canada · 6 centers

• Dermatology Research Institute — Calgary
• Skin Health — Cobourg
• Lynderm Research Inc. — Markham
• Dr. Chih-ho Hong Medical Inc. — Surrey
• Research Toronto — Toronto
• Wiseman Dermatology Research Inc. — Winnipeg

France · 6 centers

• CHRU de Brest - Hôpital Morvan — Brest
• AP-HM CHU Timone - Pharmacie Secteur Essais Cliniques — Marseille
• Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu — Nantes
• Centre Hospitalier Universitaire de Nice - Hôpital l'Archet — Nice
• Centre de Sante Sabouraud — Paris
• Hôpital Clocheville Chru-Tours Département Dermatologie — Tours

Spain · 6 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 6 centers

Center list to be confirmed — check the primary protocol.

Australia · 4 centers

• Skin and Cancer Foundation Australia - Darlinghurst Clinic — Darlinghurst
• Sinclair Dermatology — Melbourne
• Institute for Skin, Health, and Immunity — Mitcham
• Veracity Clinical Research Pty Ltd — Wooloongabba

Hungary · 3 centers

• Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum — Debrecen
• Somogy Megyei Kaposi Mor Oktato Korhaz — Kaposvár
• Pecsi Tudomanyegyetem — Pécs

Identifiers

NCT: NCT05723198 · 16875 · I4V-MC-JAIO · 2022-502700-78-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗