A Study of LAD603 in Adults With Alopecia Areata
Almirall, S.A. · NCT07311564
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–65 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 136
- US sites recruiting
- 1
- Study start
- December 17, 2025
- Record last updated
- May 20, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: LAD603; Placebo
Conditions: Alopecia Areata
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Investigator Site 1
Omaha, NE 68144
Study contacts (from the official record)
- Davide Carluccio · gco@almirall.com
- Estrella García · gco@almirall.com
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