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Phase 2
Age: 18Years - 65Years
All Genders
ID07311564

Phase 2 Study to Test Safety and Effectiveness of LAD603 Injections in Adults Aged 18 to 65 With Severe Alopecia Areata

Led by Almirall, S.A. · Updated on 2026-05-20

136

Participants Needed

1

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of LAD603 in adults aged 18 to 65 with severe to very severe alopecia areata AA, a condition causing significant scalp hair loss. This Phase 2, randomized, placebo-controlled, and double-blind study aims to assess the efficacy of LAD603 on hair loss severity, as well as its safety, how the body processes the drug pharmacokinetics, immune response to the drug immunogenicity, and related biomarkers. Participants will be randomly assigned to receive one of three different doses of LAD603 or a placebo. Each treatment involves subcutaneous injections administered from Day 1 through Week 28. The study includes four groups LAD603 Dose A, Dose B, Dose C, and a placebo group. Treatments are given regularly during this 28-week period to monitor effects and safety. During the study, participants will have their hair loss severity measured using the Severity of Alopecia Tool SALT score at baseline and Week 28. Additional assessments include clinician-reported outcomes for eyelash and eyebrow hair loss at Week 28. Researchers will monitor safety, side effects, and immune responses throughout the 28 weeks. Participation involves regular visits for injections, assessments, and laboratory tests to collect relevant data on LAD603s impact and safety.

CONDITIONS

Brief Title

A Study of LAD603 in Adults With Alopecia Areata

Research Team

D

Davide Carluccio

E

Estrella García

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