Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo
- Registration Number
- NCT04487860
- Lead Sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Brief Summary
This is a randomized, double blind, placebo-controlled, phase II study. The study will be performed as a multicenter, multinational study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 327
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AS012 dose regimen II AS012 Oral AS012 dose regimen I AS012 Oral AS012 dose regimen III AS012 Oral AS012 dose regimen IV AS012 Oral Placebo Placebo Oral
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Vitiligo Area Scoring Index Score Week 24 Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Vitiligo Extent Score (VES) on Clinical Pictures Week 24 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.
Mean Change in Vitiligo Impact Patient Scale Week 24 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.
Physician's Global Assessment Scores Week 52 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.
Mean Change From Baseline in Dermatology Life Quality Index 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.
Trial Locations
- Locations (31)
Sun Pharma Site 25
🇮🇳Nashik, Maharashtra, India
Sun pharma site 30
🇺🇸Los Angeles, California, United States
Sun pharma site 31
🇺🇸Boston, Massachusetts, United States
Sun Pharma Site 29
🇺🇸East Greenwich, Rhode Island, United States
Sun Pharma Site 15
🇺🇸Phoenix, Arizona, United States
Sun Pharma Site 02
🇺🇸Bryant, Arkansas, United States
Sun Pharma Site 09
🇺🇸Fremont, California, United States
Sun Pharma Site 01
🇺🇸Brandon, Florida, United States
Sun Pharma Site 06
🇺🇸Fort Lauderdale, Florida, United States
Sun Pharma Site 04
🇺🇸Miami, Florida, United States
Sun Pharma Site 05
🇺🇸Miramar, Florida, United States
Sun Pharma Site 10
🇺🇸Ormond Beach, Florida, United States
Sun Pharma Site 14
🇺🇸West Lafayette, Indiana, United States
Sun Pharma Site 12
🇺🇸Baton Rouge, Louisiana, United States
Sun Pharma Site 13
🇺🇸New Orleans, Louisiana, United States
Sun Pharma Site 07
🇺🇸Troy, Michigan, United States
Sun Pharma Site 08
🇺🇸Warwick, Rhode Island, United States
Sun Pharma Site 03
🇺🇸Dallas, Texas, United States
Sun Pharma Site 16
🇺🇸Pflugerville, Texas, United States
Sun Pharma Site 11
🇺🇸Mill Creek, Washington, United States
Sun Pharma Site 19
🇮🇳Ahmedabad, Gujrat, India
Sun Pharma Site 20
🇮🇳Gandhinagar, Gujrat, India
Sun Pharma Site 28
🇮🇳Rajkot, Gujrat, India
Sun Pharma Site 23
🇮🇳Bangalore, Karnataka, India
Sun PharmaSite 24
🇮🇳Mysuru, Karnataka, India
Sun Pharma Site 21
🇮🇳Aurangabad, Maharashtra, India
Sun Pharma Site 26
🇮🇳Pune, Maharashtra, India
Sun Pharma Site 17
🇮🇳Rajsamand, Rajasthan,, India
Sun Pharma Site 27
🇮🇳Lucknow, Uttar Pradesh, India
Sun Pharma Site 18
🇮🇳Lucknow, Uttar Pradesh, India
Sun Pharma Site 22
🇮🇳Chandigarh, India