J5D-MC-FPAC
Research type
Research Study
Full title
A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants with Severe Alopecia Areata.
IRAS ID
1013615
Contact name
Maryna Kvochka
Contact email
Sponsor organisation
Eli Lilly and Company
Clinicaltrials.gov Identifier
Research summary
Study J5D-MC-FPAC (FPAC) will evaluate the effectiveness and safety of a new drug called LY4005130 in adults with severe alopecia areata (AA). AA is a condition that causes sudden, patchy hair loss. It affects people of all ages and backgrounds and can vary in severity from small round patches to complete hair loss across the scalp and body. AA is an autoimmune condition, where immune cells mistakenly attack hair follicles, stopping them from producing new hair. The exact cause of this is not fully understood.
LY4005130 is a monoclonal antibody, which is a lab-made protein designed to target specific proteins to treat various diseases.
Despite recent therapeutic advances, current treatments for AA remain insufficient to meet the needs of patients. Current treatments for AA are associated with potential severe side effects, and they may not continue to be effective after they are stopped (hair regrowth is not retained).
This study aims to evaluate the efficacy and safety of LY4005130 given every 4 weeks by injection into a vein compared with placebo in adult participants with severe AA.
The FPAC study will enrol participants from 18 to -50 years of age with severe AA that meet specific criteria. Approximately 60 participants who meet the entry criteria will be randomly assigned in a 1:1 ratio to receive either LY4005130 or placebo. This means that there is a 50% chance of participants in this study receiving the investigational medicine or the placebo.
The study duration will be approximately 48 weeks, with the following study periods:
• Screening period: up to 5 weeks (35 days)
• Treatment period: 24 weeks, and
• Post-treatment safety follow-up period: 19 weeks after the last treatment visit
Approximately 60 participants worldwide, and 7 patients in the UK will take part in study, which will run for about 11 months.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
26/SC/0078
Date of REC Opinion
29 Apr 2026
REC opinion
Further Information Favourable Opinion