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

a study on Alopecia Areata

Summary

for people ages 18-70 (full criteria)
at Irvine, California and other locations
study started
estimated completion

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.

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 AreataAlopeciaBaricitinib

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.
  • 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 (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. Note: participants who have severe or very 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.
  • 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, Irvineaccepting new patients
    IrvineCalifornia92697United States
  • Alliance Research Centersaccepting new patients
    Laguna HillsCalifornia92653United States

Details

Status
accepting new patients
Start Date
Completion Date
(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
Study Type
Interventional
Last Updated