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

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

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

Study Overview

• Status: Completed
• Conditions: Non-segmental Vitiligo
• Intervention / Treatment: Drug: Placebo; Drug: AS012

• Study Type: Interventional
• Enrollment (Actual): 327
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Sun Pharma Site 22
  • Gujrat
    • Ahmedabad, Gujrat, India, 380016
      • Sun Pharma Site 19
    • Gandhinagar, Gujrat, India, 382428
      • Sun Pharma Site 20
    • Rajkot, Gujrat, India, 360005
      • Sun Pharma Site 28
  • Karnataka
    • Bangalore, Karnataka, India, 560074
      • Sun Pharma Site 23
    • Mysuru, Karnataka, India, 570001
      • Sun PharmaSite 24
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431001
      • Sun Pharma Site 21
    • Nashik, Maharashtra, India, 422101
      • Sun Pharma Site 25
    • Pune, Maharashtra, India, 411005
      • Sun Pharma Site 26
  • Rajasthan,
    • Rajsamand, Rajasthan,, India, 313202
      • Sun Pharma Site 17
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226003
      • Sun Pharma Site 27
    • Lucknow, Uttar Pradesh, India, 226005
      • Sun Pharma Site 18
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Sun Pharma Site 15
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Sun Pharma Site 02
  • California
    • Fremont, California, United States, 94538
      • Sun Pharma Site 09
    • Los Angeles, California, United States, 90036
      • Sun pharma site 30
  • Florida
    • Brandon, Florida, United States, 33511.
      • Sun Pharma Site 01
    • Fort Lauderdale, Florida, United States, 33308
      • Sun Pharma Site 06
    • Miami, Florida, United States, 33175
      • Sun Pharma Site 04
    • Miramar, Florida, United States, 33027
      • Sun Pharma Site 05
    • Ormond Beach, Florida, United States, 32174
      • Sun Pharma Site 10
  • Indiana
    • West Lafayette, Indiana, United States, 47906
      • Sun Pharma Site 14
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Sun Pharma Site 12
    • New Orleans, Louisiana, United States, 70115
      • Sun Pharma Site 13
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Sun pharma site 31
  • Michigan
    • Troy, Michigan, United States, 48084
      • Sun Pharma Site 07
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Sun Pharma Site 29
    • Warwick, Rhode Island, United States, 02886
      • Sun Pharma Site 08
  • Texas
    • Dallas, Texas, United States, 75234
      • Sun Pharma Site 03
    • Pflugerville, Texas, United States, 78660
      • Sun Pharma Site 16
  • Washington
    • Mill Creek, Washington, United States, 98012
      • Sun Pharma Site 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provide written informed consent.
2. Male or female ≥ 18 years of age at time of screening
3. Stable (without new patches ≥ 1 year) or unstable (with new patches for the last 1 year) vitiligo
4. VASI of ≥ 4 at screening and baseline

Exclusion Criteria:

1. Segmental vitiligo, focal, or mixed Vitiligo
2. Subjects who have high risk of suicidality at the Screening assessment based on Investigator's judgment
3. History of alcohol or drug abuse in the previous 2 years

4. Subjects who were submitted to melanocyte transfer

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Oral	Drug: Placebo; oral administration
Experimental: AS012 dose regimen I; Oral	Drug: AS012; oral administration
Experimental: AS012 dose regimen II; Oral	Drug: AS012; oral administration
Experimental: AS012 dose regimen III; Oral	Drug: AS012; oral administration
Experimental: AS012 dose regimen IV; Oral	Drug: AS012; oral administration

What is the study measuring?

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 (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.	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.	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.	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

Collaborators and Investigators

• Sponsor: Ache Laboratorios Farmaceuticos S.A.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): February 27, 2023

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Vitiligo
• Other Study ID Numbers: AS012-20-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No