A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata

Trial ID or NCT#

NCT03570749

Status

recruiting iconRECRUITING

Purpose

This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata

Eligibility Criteria

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent. - Must self-identify as either Black or African American in race in the open label addenda. - Have severe or very severe AA, as determined by all of the following: - Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by SALT Alopecia Areata Investigator Global Assessment (AA-IGA) of 3 or 4) at screening and baseline. - No spontaneous improvement over the past 6 months. - Current episode of severe or very severe AA of less than 8 years. - Male or nonpregnant, nonbreastfeeding female participants.
Exclusion Criteria:
  1. - Primarily "diffuse" type of AA. - Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA. - Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).
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Investigator(s)

Justin M Ko, MD, MBA
Justin M Ko, MD, MBA
Dermatologist, Melanoma specialist, Cutaneous oncology specialist, Hair loss specialist, Psoriasis specialist
Clinical Professor, Dermatology

View on ClinicalTrials.gov