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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Percent Change from Baseline in the Severity of Alopecia Tool (SALT) Score — 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).
Trial sites (1)
Facility
City
Region
Status
Investigator Site 1
Omaha
Nebraska
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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