Alopecia Areata
Conditions
Keywords
Hair Loss, Hypotrichosis, Alopecia
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.
Interventions
DRUGLAD603
LAD603 administered subcutaneously.
OTHERPlacebo
LAD603 matching placebo administered subcutaneously.
Sponsors
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change from Baseline in the Severity of Alopecia Tool (SALT) Score | Baseline, Week 28 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving an Absolute SALT Score Less than or Equal to (<=) 10/20 | At Week 28 | 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. |
| Percentage of Participants Achieving a Clinician-Reported Outcome (ClinRO) for Eyelash Hair Loss of 0/1 | At Week 28 | 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). |
| Percentage of Participants Achieving a ClinRO for Eyebrow Hair Loss of 0/1 | At Week 28 | 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). |
Countries
United States
Contacts
CONTACTDavide Carluccio
CONTACTEstrella García
STUDY_DIRECTORStudy Director
Almirall, S.A.
Outcome results
None listed