A Study of LAD603 in Adults With Alopecia Areata
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LAD603, Placebo.
- Who it may be relevant to
- Registry conditions: Alopecia Areata. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug LAD603
LAD603 administered subcutaneously. - Other Placebo
LAD603 matching placebo administered subcutaneously.
Primary outcome measures
- Percent Change from Baseline in the Severity of Alopecia Tool (SALT) Score [Time frame: Baseline, Week 28]
Secondary outcome measures (3)
- Percentage of Participants Achieving an Absolute SALT Score Less than or Equal to (<=) 10/20 [Time frame: At Week 28]
- Percentage of Participants Achieving a Clinician-Reported Outcome (ClinRO) for Eyelash Hair Loss of 0/1 [Time frame: At Week 28]
- Percentage of Participants Achieving a ClinRO for Eyebrow Hair Loss of 0/1 [Time frame: At Week 28]
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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Investigator Site 1 — Omaha
Identifiers
NCT: NCT07311564 · M-00223-20 · 2025-523342-27-00