Actively Recruiting
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of LAD603 in Adults With Severe to Very Severe Alopecia Areata
Led by Almirall, S.A. · Updated on 2026-05-20
136
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
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 LAD603's impact and safety.
CONDITIONS
Brief Title
A Study of LAD603 in Adults With Alopecia Areata
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is a male or female between 18 and 65 years old at the time of signing the informed consent.
- Severe to very severe alopecia areata with at least 50% scalp hair loss as measured by SALT, with no terminal hair regrowth within 6 months at Screening and Baseline.
- Current episode of hair loss lasting at least 6 months but not more than 7 years.
- Participants who are women of childbearing potential or male must agree to pregnancy avoidance requirements during the study.
You will not qualify if you...
- Participants have other types of alopecia, including traction or scarring alopecia.
- Participants with diffuse type alopecia areata.
- Active inflammatory skin diseases (such as psoriasis, seborrheic dermatitis, lupus) that could interfere with alopecia areata assessment at Screening or Baseline.
- Previous severe adverse reaction to subcutaneous medication.
- Liver safety lab results at Screening showing ALT or AST ≥2.5 times upper limit of normal, total bilirubin ≥1.5 times upper limit (or ≥3 times in Gilbert's syndrome), or alkaline phosphatase ≥1.5 times upper limit.
- Intention to use prohibited medications or failure to complete required washout periods for such medications.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 28 weeks
Participants receive subcutaneous injections of LAD603 or placebo from Day 1 up to 28 weeks.
Trial Site Locations
Total: 1 location
1
Investigator Site 1
Omaha, Nebraska, United States, 68144
Actively Recruiting
Research Team
D
Davide Carluccio
E
Estrella García
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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