A Phase 2, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate Efficacy and Safety of LAD603 in Adult Subjects With Severe to Very Severe Alopecia Areata
Almirall, S.A.
Summary
The main aim of the study is to evaluate the effect of LAD603 in adult participants with severe to very severe alopecia areata (AA). The study will also evaluate the safety, pharmacokinetics (PK), immunogenicity and pharmacodynamic (PD) biomarkers of LAD603.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant is a male or female between 18 and 65 years old at the time of signing the informed consent. * Severe to very severe AA criteria: 1. Greater than or equal to (\>=) 50% hair loss of the scalp as measured by SALT without evidence of terminal hair regrowth within 6 months at both the Screening and Baseline (Day 1) visits. 2. Current episode of hair loss lasting at least 6 months and not exceeding 7 years. * Participants who are WOCBP or male must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD603 dur…
Interventions
- DrugLAD603
LAD603 administered subcutaneously.
- OtherPlacebo
LAD603 matching placebo administered subcutaneously.
Location
- Investigator Site 1Omaha, Nebraska