A Study of LAD603 in Adults With Alopecia Areata

Last updated: January 9, 2026
Sponsor: Almirall, S.A.
Overall Status: Active - Recruiting

Phase

2

Condition

Alopecia

Hair Loss

Treatment

LAD603

Placebo

Clinical Study ID

NCT07311564
M-00223-20
2025-523342-27-00
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Participant is a male or female between 18 and 65 years old at the time of signingthe informed consent.

  • Severe to very severe AA criteria:

  1. Greater than or equal to (>=) 50% hair loss of the scalp as measured by SALTwithout evidence of terminal hair regrowth within 6 months at both theScreening and Baseline (Day 1) visits.

  2. Current episode of hair loss lasting at least 6 months and not exceeding 7years.

  • Participants who are WOCBP or male must agree to the requirements for the avoidanceof pregnancy and exposure of the participant's partner to LAD603 during the study,

Exclusion

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 ofskin condition (e.g., psoriasis, seborrheic dermatitis, lupus) at the time of theScreening or Baseline (Day 1) visits that is expected to interfere with theassessment of alopecia areata severity.

Other Medical Conditions

  • Participant has previous severe adverse reaction to subcutaneously administeredmedication.

  • Participant has any of the following liver safety laboratory results at Screening

  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater thanor equal to (>=) 2.5 × upper limit of normal (ULN)

  2. Total bilirubin (TBL) >=1.5 × ULN (TBL >=3 × ULN in participants with Gilbert'ssyndrome)

  3. Alkaline phosphatase (ALP) >=1.5 × ULNPrior/Concomitant Therapy

  • Intention to use any concomitant medication that is not permitted by this protocolor failure to undergo the required washout period for a particular prohibitedmedication.

Study Design

Total Participants: 136
Treatment Group(s): 2
Primary Treatment: LAD603
Phase: 2
Study Start date:
December 17, 2025
Estimated Completion Date:
November 21, 2027

Connect with a study center

  • Investigator Site 1

    Omaha 5074472, Nebraska 5073708 68144
    United States

    Active - Recruiting

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