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

Browse trials for

• Vitiligo 343

Vitiligo

343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.

This study's enrollment of 327 is above the median of 36 across 265 interventional studies indexed under Vitiligo.

Lead sponsor

Ache Laboratorios Farmaceuticos S.A. is the lead sponsor of 36 studies on the registry; 5 are open to participants now.

Study arms

• Experimental
  AS012 dose regimen I

  Oral

  Drug: AS012

• Experimental
  AS012 dose regimen II

  Oral

  Drug: AS012

• Experimental
  AS012 dose regimen III

  Oral

  Drug: AS012

• Experimental
  AS012 dose regimen IV

  Oral

  Drug: AS012

• Placebo comparator
  Placebo

  Oral

  Drug: Placebo

Interventions

• DrugAS012

  oral administration

• DrugPlacebo

  oral administration

Primary outcomes

1. Mean Change From Baseline in Vitiligo Area Scoring Index Score

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

   Time frame: Week 24

Secondary outcomes

1. 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

2. 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

3. 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.

   Time frame: Week 52

4. Mean Change From Baseline in Dermatology Life Quality Index

   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.

   Time frame: Week 52

Baseline characteristics

Study documents

• Study protocol ↗ · May 20, 2022
• Statistical analysis plan ↗ · Jul 27, 2022

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No