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

Study Overview
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Brief Summary
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This is a randomized, double blind, placebo-controlled, phase II study. The study will be performed as a multicenter, multinational study.

Official Title
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A Phase II, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo

Conditions
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Non-segmental Vitiligo

Intervention / Treatment
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* Drug: AS012
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent. Male or female ≥ 18 years of age at time of screening Stable (without new patches ≥ 1 year) or unstable (with new patches for the last 1 year) vitiligo VASI of ≥ 4 at screening and baseline Exclusion Criteria: Segmental vitiligo, focal, or mixed Vitiligo Subjects who have high risk of suicidality at the Screening assessment based on Investigator's judgment History of alcohol or drug abuse in the previous 2 years Subjects who were submitted to melanocyte transfer -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AS012 dose regimen I<br>Oral | Drug: AS012<br>* oral administration<br>|
| Experimental: AS012 dose regimen II<br>Oral | Drug: AS012<br>* oral administration<br>|
| Experimental: AS012 dose regimen III<br>Oral | Drug: AS012<br>* oral administration<br>|
| Experimental: AS012 dose regimen IV<br>Oral | Drug: AS012<br>* oral administration<br>|
| Placebo Comparator: Placebo<br>Oral | Drug: Placebo<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Vitiligo Extent Score | Natural distribution of vitiligo on body reﬂecting 6 different degrees of involvement (1 percent, 5 percent, 10 percent, 25 percent, 50 percent, 75 percent). | 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. Summary scores range from 0 to 100 | Week 24 | 
| Physician's global assessment scores | Score 0=no involvement or Score 1=limited extent with at least 2-point reduction from baseline | Week 52 | 
| 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. | Week 52 |