NCT07311564 A Study of LAD603 in Adults With Alopecia Areata
| NCT ID | NCT07311564 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Almirall, S.A. |
| Condition | Alopecia Areata |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2027-06-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 136 participants in total. It began in 2025-12-17 with a primary completion date of 2027-06-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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: 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.
Contact & Investigator
Davide Carluccio
✉ gco@almirall.comStudy Director
STUDY DIRECTOR
Almirall, S.A.
Frequently Asked Questions
Who can join the NCT07311564 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Alopecia Areata. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07311564 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07311564 currently recruiting?
Yes, NCT07311564 is actively recruiting participants. Contact the research team at gco@almirall.com for enrollment information.
Where is the NCT07311564 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT07311564 clinical trial?
NCT07311564 is sponsored by Almirall, S.A.. The principal investigator is Study Director at Almirall, S.A.. The trial plans to enroll 136 participants.