A Study of LAD603 in Adults With Alopecia Areata

May 19, 2026 updated by: Almirall, S.A.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Investigator Site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LAD603 Dose A
Participants will receive LAD603 Dose A , Subcutaneous (SC) injection from Day 1 up to 28 weeks.
Drug: LAD603
LAD603 administered subcutaneously.
Experimental: LAD603 Dose B
Participants will receive LAD603 Dose B, SC injection from Day 1 up to 28 weeks.
Drug: LAD603
LAD603 administered subcutaneously.
Experimental: LAD603 Dose C
Participants will receive LAD603 Dose C, SC injection from Day 1 up to 28 weeks.
Drug: LAD603
LAD603 administered subcutaneously.
Placebo Comparator: Placebo for LAD603
Participants will receive Placebo for LAD603 SC injection from Day 1 up to 28 weeks.
Other: Placebo
LAD603 matching placebo administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change from Baseline in the Severity of Alopecia Tool (SALT) Score
Time Frame: Baseline, Week 28
The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).
Baseline, Week 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving an Absolute SALT Score Less than or Equal to (<=) 10/20
Time Frame: At Week 28
Percentage of participants achieving an absolute SALT score of <= 10/20. The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss). Total percentage of patients with absolute SALT score of <= 10/20 will be calculated.
At Week 28
Percentage of Participants Achieving a Clinician-Reported Outcome (ClinRO) for Eyelash Hair Loss of 0/1
Time Frame: At Week 28
The ClinROs for Eyelash Hair Loss is a clinician reported assessment which measures the severity and impact of hair loss in these specific areas. It comprises a 4-point category response options (0 to 3) rating the extent of eyebrow hair loss. This scale ranges from no hair loss (0) to complete hair loss (3).
At Week 28
Percentage of Participants Achieving a ClinRO for Eyebrow Hair Loss of 0/1
Time Frame: At Week 28
The ClinROs for Eyebrow Hair is a clinician reported assessment which measures the severity and impact of hair loss in these specific areas. It comprises a 4-point category response options (0 to 3) rating the extent of eyebrow hair loss. This scale ranges from no hair loss (0) to complete hair loss (3).
At Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Almirall, S.A.

Investigators

  • Study Director: Study Director, Almirall, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2025

Primary Completion (Estimated)

June 23, 2027

Study Completion (Estimated)

November 21, 2027

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-00223-20
  • 2025-523342-27-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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