Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
136 participants
INTERVENTIONAL
2025-12-17
2027-09-06
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LAD603 Dose A
Participants will receive LAD603 Dose A , Subcutaneous (SC) injection from Day 1 up to 28 weeks.
LAD603
LAD603 administered subcutaneously.
LAD603 Dose B
Participants will receive LAD603 Dose B, SC injection from Day 1 up to 28 weeks.
LAD603
LAD603 administered subcutaneously.
LAD603 Dose C
Participants will receive LAD603 Dose C, SC injection from Day 1 up to 28 weeks.
LAD603
LAD603 administered subcutaneously.
Placebo for LAD603
Participants will receive Placebo for LAD603 SC injection from Day 1 up to 28 weeks.
Placebo
LAD603 matching placebo administered subcutaneously.
Interventions
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LAD603
LAD603 administered subcutaneously.
Placebo
LAD603 matching placebo administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Almirall, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Almirall, S.A.
Locations
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Investigator Site 1
Omaha, Nebraska, United States
Countries
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Central Contacts
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Other Identifiers
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2025-523342-27-00
Identifier Type: CTIS
Identifier Source: secondary_id
M-00223-20
Identifier Type: -
Identifier Source: org_study_id