This study is in progress, not accepting new patients

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

Eligibility: for people ages 18-70 (full criteria)
Location: at UC Davis UC Irvine
Dates: study started September 2018
completion around January 2025

Description

Summary

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

Keywords

Alopecia Areata, Alopecia, Baricitinib

Eligibility

You can join if…

Open to people ages 18-70

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.

You CAN'T join if...

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).

Locations

University of California, Irvine
Irvine California 92697 United States
University of California Davis Health
Sacramento California 95816 United States
Mosaic Dermatology
Santa Monica California 90403 United States
Tilda Research
Irvine California 92612 United States
Dermatology Research Associates
Los Angeles California 90045 United States
University Clinical Trials
San Diego California 92123 United States
California Dermatology & Clinical Research Institute
Encinitas California 92024 United States
Stanford Medicine Outpatient Center
Redwood City California 94063 United States

Details

Status: in progress, not accepting new patients
Start Date: September 2018
Completion Date: January 2025 (estimated)
Sponsor: Eli Lilly and Company
Links: A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (Hair Loss)
ID: NCT03570749
Phase: Phase 2/3 Alopecia Research Study
Study Type: Interventional
Participants: Expecting 824 study participants
Last Updated: January 23, 2025