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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523342-27-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAD603 Dose A | Experimental | Participants will receive LAD603 Dose A , Subcutaneous (SC) injection from Day 1 up to 28 weeks. |
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| LAD603 Dose B | Experimental | Participants will receive LAD603 Dose B, SC injection from Day 1 up to 28 weeks. |
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| LAD603 Dose C | Experimental | Participants will receive LAD603 Dose C, SC injection from Day 1 up to 28 weeks. |
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| Placebo for LAD603 | Placebo Comparator | Participants will receive Placebo for LAD603 SC injection from Day 1 up to 28 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAD603 | Drug | LAD603 administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in the Severity of Alopecia Tool (SALT) Score | The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss). | Baseline, Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving an Absolute SALT Score Less than or Equal to (<=) 10/20 | Percentage of participants achieving an absolute SALT score of <= 10/20. The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss). Total percentage of patients with absolute SALT score of <= 10/20 will be calculated. | At Week 28 |
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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:
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
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Davide Carluccio | Contact | gco@almirall.com | ||
| Estrella GarcÃa | Contact | gco@almirall.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Almirall, S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 1 | Recruiting | Omaha | Nebraska | 68144 | United States |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| ID | Term |
|---|---|
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| Placebo | Other | LAD603 matching placebo administered subcutaneously. |
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| Percentage of Participants Achieving a Clinician-Reported Outcome (ClinRO) for Eyelash Hair Loss of 0/1 | The ClinROs for Eyelash Hair Loss is a clinician reported assessment which measures the severity and impact of hair loss in these specific areas. It comprises a 4-point category response options (0 to 3) rating the extent of eyebrow hair loss. This scale ranges from no hair loss (0) to complete hair loss (3). | At Week 28 |
| Percentage of Participants Achieving a ClinRO for Eyebrow Hair Loss of 0/1 | The ClinROs for Eyebrow Hair is a clinician reported assessment which measures the severity and impact of hair loss in these specific areas. It comprises a 4-point category response options (0 to 3) rating the extent of eyebrow hair loss. This scale ranges from no hair loss (0) to complete hair loss (3). | At Week 28 |
| D013568 | Pathological Conditions, Signs and Symptoms |