Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo

Mean Change From Baseline in Vitiligo Extent Score (VES) on Clinical Pictures

The Vitiligo Extent Score (VES) measures the overall vitiligo involvement in the body based on clinical pictures reflecting the natural distribution of the disease across 19 body areas (e.g., face, trunk, arms, legs, hands, axillae, back, gluteal). For each area, one representative image is selected, assigning one of six degrees of involvement (1%, 5%, 10%, 25%, 50%, 75%). The total and final score is the sum of the measurements from all areas, calculated using a conversion table available in the online calculator (www.vitiligo-calculator.com), and expressed as the extension of body surface area affected (0-100). Higher scores indicate worse clinical involvement. The VES change from baseline to Week 24 was assessed for the ITT population.

Time frame: Week 24

Mean Change in Vitiligo Impact Patient Scale

Subjects will be asked to complete a questionnaire to assess the burden experienced by individuals affected. For each of the statements in the Vitiligo Impact Patient Scale, 7 responses are suggested: always, very often, often, sometimes, rarely, never and not applicable. The individual answered as spontaneously as possible while thinking about their situation over the last 7 days. Summary scores range from 0 to 100. Higher values indicate a worse clinical condition.

Time frame: Week 24

Physician's Global Assessment Scores

Description: The investigator will perform an average assessment of all vitiligo lesions. The following scale will be used for the PGA: Score 0= No involvement, Score 1= Limited, Score 2= moderate, Score 3= Extensive or Score 4= Very extensive. Higher values indicate a worse clinical condition. The static Physician's Global Assessment determines vitiligo extend at a single point in time, without taking the baseline disease condition into consideration, in other words, represents the Proportion of subjects achieving a PGA score of "no involvement" (score 0) or "limited extent" (score 1) with at least 2-point reduction from Baseline Week 52.