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

Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state

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.

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.

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.

The DLQI scores are based on the response from the patient. Each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired OR lower scores indicate better quality of life.