NCT07311564 · Almirall, S.A.
A Study of LAD603 in Adults With Alopecia Areata
What this 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, how the drug moves through the body (PK), immunogenicity and how the drug affects the body (PD) biomarkers of LAD603.
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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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Omaha, Nebraska
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations