Efficacy and Safety of LAD603 in Adults with Severe to Very Severe Alopecia Areata: A Phase 2, Randomized, Placebo-Controlled Study

Trial ID: 2025-523342-27-00
Protocol: M-00223-20
Sponsor: Almirall S.A.

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Diseases & Conditions

Alopecia areata

Objectives

The primary objective of this study is to evaluate the clinical efficacy of LAD603 compared to placebo in adult patients presenting with severe to very severe alopecia areata. This investigation aims to determine the therapeutic potential of the intervention in managing this specific autoimmune condition.

Participants

The study involves 22 participants diagnosed with alopecia areata. The population consists of adult males and females between the ages of 18 and 65 years. Eligible subjects must present with severe to very severe hair loss, characterized by at least 50% scalp hair loss as measured by the SALT score. The clinical presentation includes patchy scalp hair loss, alopecia totalis, or alopecia universalis. Inclusion requires a current episode of hair loss that has persisted for a minimum of 6 months and does not exceed 7 years. Participants must also adhere to specific pregnancy avoidance requirements.

Plans and Procedures

This Phase 2, randomized, placebo-controlled, double-blind clinical study is designed to evaluate the efficacy and safety of LAD603 in adult subjects with severe to very severe alopecia areata. The study utilizes a subcutaneous injection of either the test product or a placebo. The primary endpoint is the percent change from baseline in the SALT score at Week 28. The research methodology involves a screening visit to assess eligibility based on specific hair loss criteria, followed by a baseline visit on Day 1. Participants will undergo subsequent follow-up visits to monitor clinical response and safety throughout the trial duration. Early termination may occur based on investigator discretion or protocol non-compliance.

Treatment

LAD603 is administered as a solution for injection via subcutaneous injection. This investigational product is evaluated for the treatment of adult subjects with severe to very severe alopecia areata.

The placebo used in this study is a placebo for LAD603, which serves as the comparator treatment in this randomized, double-blind, placebo-controlled clinical trial.

Efficacy

The primary efficacy endpoint is the percent change from baseline in the SALT score at Week 28. This assessment is utilized to evaluate the clinical efficacy of LAD603 in adult subjects diagnosed with alopecia areata.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Subject is a male or female between 18 and 65 years old at the time of signing the informed consent.
Subject is able to understand and willing to comply with study requirements as per Investigator’s opinion.
Subject provides written informed consent in accordance with institutional and regulatory guidelines, prior to any study-related procedures being performed.
AA criteria: a)Patchy scalp hair loss (including ophiasis or sisaipho variants), alopecia totalis (AT), or alopecia universalis (AU): AT is defined as complete (100%) scalp hair loss. AU is defined as complete (100%) scalp, facial, and body hair loss. b)≥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. c) 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 during the study

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Exclusion Criteria

Subjects have other types of alopecia (including but not limited to traction, scarring alopecia).
Subjects with "diffuse" type AA
History of male or female-pattern hair loss (>Hamilton stage III or >Ludwig stage II).
Subjects with history or presence of hair transplants.
Use of adhesive wigs, other than banded perimeter wigs, during the study.
Currently has an active form of other inflammatory skin disease(s) or evidence of skin condition (eg, psoriasis, seborrheic dermatitis, lupus) at the time of the Screening or Baseline (Day 1) visits that is expected to interfere with the assessment of alopecia areata severity. (For the avoidance of doubt, when no interference is expected, subjects could participate if they are otherwise eligible, including adhering to the allowed/permitted medication requirements.)