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NCT Number: NCT07311564

A Study of LAD603 in Adults With 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigator Site 1

Omaha, Nebraska, 68144, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LAD603

Drug

LAD603 administered subcutaneously.

Placebo

Other

LAD603 matching placebo administered subcutaneously.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Davide Carluccio

CONTACT

[email protected]

Estrella García

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 31, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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