LAD603 treatment for adults with severe to very severe alopecia areata

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

This trial will test whether LAD603 can help adults with severe to very severe alopecia areata regrow scalp hair.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Almirall, S.A. (Industry-sponsored)
• Locations: 1 site (Omaha, Nebraska)
• Trial ID: NCT07311564 on ClinicalTrials.gov

What this trial studies

This phase 2 interventional study will administer LAD603 or placebo to adult participants and follow them for hair outcomes and safety. It enrolls adults 18 to 65 with severe to very severe AA (≥50% scalp hair loss by SALT) whose current episode has lasted between 6 months and 7 years. Investigators will monitor scalp hair using SALT, collect safety labs, and measure pharmacokinetics, immunogenicity, and pharmacodynamic biomarkers. The trial is sponsored by Almirall and conducted at an investigator site in Omaha, Nebraska.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–65 with severe to very severe alopecia areata (≥50% scalp hair loss by SALT) whose current hair-loss episode has lasted at least 6 months but no more than 7 years and who can follow pregnancy-avoidance requirements if applicable.

Not a fit: Patients with other types of hair loss (for example scarring or traction alopecia), diffuse AA, active inflammatory skin disease, those outside the 18–65 age range, or with episodes shorter than 6 months or longer than 7 years are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If effective, LAD603 could produce meaningful scalp-hair regrowth and reduce severe hair loss in adults with alopecia areata.

How similar studies have performed: Other systemic agents for severe AA, notably JAK inhibitors, have produced positive results, so the therapeutic approach has precedent, but LAD603 itself is a novel agent still being tested.

Eligibility criteria

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 during the study,

Exclusion Criteria:

AA, Skin Specific, and Other Inflammatory Diseases

* Participants have other types of alopecia (including but not limited to traction, scarring alopecia).
* Participants with "diffuse" type AA.
* Currently has an active form of other inflammatory skin disease(s) or evidence of skin condition (e.g., 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.

Other Medical Conditions

* Participant has previous severe adverse reaction to subcutaneously administered medication.
* Participant has any of the following liver safety laboratory results at Screening

  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to (\>=) 2.5 × upper limit of normal (ULN)
  2. Total bilirubin (TBL) \>=1.5 × ULN (TBL \>=3 × ULN in participants with Gilbert's syndrome)
  3. Alkaline phosphatase (ALP) \>=1.5 × ULN

     Prior/Concomitant Therapy
* Intention to use any concomitant medication that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication.

Where this trial is running

Omaha, Nebraska

• Investigator Site 1 — Omaha, Nebraska, United States (Recruiting)

Study contacts

• Study coordinator: Davide Carluccio

Conditions Alopecia Areata; Hair Loss; Hypotrichosis; Alopecia