Recruiting
Phase 2

LAD603

Sponsor:

Almirall, S.A.

Code:

NCT07311564

Conditions

Alopecia Areata

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

LAD603

Placebo

Study Details

Brief 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.

Conditions

Alopecia Areata

Study ID

NCT07311564

Start date

Dec 17, 2025

Status verified date

Jan, 2026

Completion date

Nov 21, 2027

Anticipated

Primary completion date

Jun 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LAD603 Dose A

Participants will receive LAD603 Dose A , Subcutaneous (SC) injection from Day 1 up to 28 weeks.

experimental: LAD603 Dose B

Participants will receive LAD603 Dose B, SC injection from Day 1 up to 28 weeks.

experimental: LAD603 Dose C

Participants will receive LAD603 Dose C, SC injection from Day 1 up to 28 weeks.

placebo comparator: Placebo for LAD603

Participants will receive Placebo for LAD603 SC injection from Day 1 up to 28 weeks.

Interventions

LAD603

LAD603 administered subcutaneously.

Placebo

LAD603 matching placebo administered subcutaneously.

Primary outcome measure

  • Percent Change from Baseline in the Severity of Alopecia Tool (SALT) Score [ Time Frame: Baseline, Week 28 ]

Central Contacts and Locations

Central contacts

Davide Carluccio

gco@almirall.com

Estrella García

gco@almirall.com

Locations

Investigator Site 1

Recruiting

Omaha, Nebraska, United States, 68144

More Information

Sponsor

Almirall, S.A.

Last update posted

May 20, 2026

Last verified

Jan, 2026

Keywords

  • Hair Loss
  • Hypotrichosis
  • Alopecia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Almirall, S.A. on 2026-05-20.