Not currently recruiting at UC Irvine

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

a study on Alopecia

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Irvine, California and other locations
Dates
study start
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. 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 CA, Irvine in progress, not accepting new patients
    Irvine California 92617 United States
  • Alliance Research Centers in progress, not accepting new patients
    Irvine California 92612 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
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 Alopecia Research Study
Study Type
Interventional
Participants
Expecting 824 study participants
Last Updated