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

Eli Lilly and Company254 sites in 3 countries595 target enrollmentFebruary 27, 2023

ConditionsAreata Alopecia Alopecia Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical

InterventionsPlacebo Baricitinib

DrugsBaricitinib Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Areata Alopecia
Sponsor: Eli Lilly and Company
Enrollment: 595
Locations: 254
Primary Endpoint: Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20
Status: Recruiting
Last Updated: 15 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 27, 2023

End Date

February 1, 2030

Last Updated

15 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

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.

Arms & Interventions

Placebo

Participants will receive placebo

Intervention: Placebo

Baricitinib Low Dose

Participants will receive baricitinib low dose orally.

Intervention: Baricitinib

Baricitinib High Dose

Participants will receive baricitinib high dose orally.

Intervention: Baricitinib

Outcomes

Primary Outcomes

Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20

Time Frame: Week 36

Secondary Outcomes

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)
Mean Change from Baseline in PROMIS Depression Score(Baseline, Week 36)
Mean Change from Baseline in PROMIS Peer Relationship Score(Baseline, Week 36)
Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI)(Baseline, Week 36)
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)
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)