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Clinical Trials in the USA / NCT07311564
Recruiting Phase 2

A Study of LAD603 in Adults With Alopecia Areata

NCT07311564 · tracked via the Priya Life Science USA tracker
Sponsor
Almirall, S.A.
Phase
Phase 2
Started
2025-12-17
Last updated
2026-05-20

Condition(s) studied

Alopecia Areata

Investigational drug(s) / intervention(s)

LAD603Placebo

LAD603: LAD603 administered subcutaneously.

Placebo: LAD603 matching placebo administered subcutaneously.

Study 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.

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)

Trial sites (1)

FacilityCityRegionStatus
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.

View NCT07311564 on ClinicalTrials.gov ↗ ← All trials in the USA