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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
136
Investigator Site 1
Omaha, Nebraska, United States
RECRUITINGPercent 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).
Time frame: Baseline, Week 28
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.
Time frame: At Week 28
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).
Time frame: 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).
Time frame: At Week 28
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