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

NCT04487860 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AS012-20-01
• Study Type: interventional
• Target: 327
• Locations: 2 countries
• Sites: 31

Brief Summary

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

Conditions

Non-segmental Vitiligo

Outcome Measures

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

  Week 24

Secondary Outcomes (4)

• Mean Change From Baseline in Vitiligo Extent Score (VES) on Clinical Pictures

  Week 24

• Mean Change in Vitiligo Impact Patient Scale

  Week 24

• Physician's Global Assessment Scores

  Week 52

• Mean Change From Baseline in Dermatology Life Quality Index

  Week 52

Study Arms (5)

AS012 dose regimen I

EXPERIMENTAL

Oral

Drug: AS012

AS012 dose regimen II

EXPERIMENTAL

Oral

Drug: AS012

AS012 dose regimen III

EXPERIMENTAL

Oral

Drug: AS012

AS012 dose regimen IV

EXPERIMENTAL

Oral

Drug: AS012

Placebo

PLACEBO COMPARATOR

Oral

Drug: Placebo

Interventions

AS012 DRUG

oral administration

AS012 dose regimen I; AS012 dose regimen II; AS012 dose regimen III; AS012 dose regimen IV

Placebo DRUG

oral administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (31)

Sun Pharma Site 15

Phoenix, Arizona, 85018, United States

Location

Sun Pharma Site 02

Bryant, Arkansas, 72022, United States

Location

Sun Pharma Site 09

Fremont, California, 94538, United States

Location

Sun pharma site 30

Los Angeles, California, 90036, United States

Location

Sun Pharma Site 01

Brandon, Florida, 33511., United States

Location

Sun Pharma Site 06

Fort Lauderdale, Florida, 33308, United States

Location

Sun Pharma Site 04

Miami, Florida, 33175, United States

Location

Sun Pharma Site 05

Miramar, Florida, 33027, United States

Location

Sun Pharma Site 10

Ormond Beach, Florida, 32174, United States

Location

Sun Pharma Site 14

West Lafayette, Indiana, 47906, United States

Location

Sun Pharma Site 12

Baton Rouge, Louisiana, 70809, United States

Location

Sun Pharma Site 13

New Orleans, Louisiana, 70115, United States

Location

Sun pharma site 31

Boston, Massachusetts, 02111, United States

Location

Sun Pharma Site 07

Troy, Michigan, 48084, United States

Location

Sun Pharma Site 29

East Greenwich, Rhode Island, 02818, United States

Location

Sun Pharma Site 08

Warwick, Rhode Island, 02886, United States

Location

Sun Pharma Site 03

Dallas, Texas, 75234, United States

Location

Sun Pharma Site 16

Pflugerville, Texas, 78660, United States

Location

Sun Pharma Site 11

Mill Creek, Washington, 98012, United States

Location

Sun Pharma Site 19

Ahmedabad, Gujarat, 380016, India

Location

Sun Pharma Site 20

Gandhinagar, Gujarat, 382428, India

Location

Sun Pharma Site 28

Rajkot, Gujarat, 360005, India

Location

Sun Pharma Site 23

Bangalore, Karnataka, 560074, India

Location

Sun PharmaSite 24

Mysuru, Karnataka, 570001, India

Location

Sun Pharma Site 21

Aurangabad, Maharashtra, 431001, India

Location

Sun Pharma Site 25

Nashik, Maharashtra, 422101, India

Location

Sun Pharma Site 26

Pune, Maharashtra, 411005, India

Location

Sun Pharma Site 17

Rājsamand, Rajasthan, 313202, India

Location

Sun Pharma Site 27

Lucknow, Uttar Pradesh, 226003, India

Location

Sun Pharma Site 18

Lucknow, Uttar Pradesh, 226005, India

Location

Sun Pharma Site 22

Chandigarh, 160012, India

Location

Results Point of Contact

• Title: Dr. Fabio Ikedo
• Organization: Aché Laboratórios Farmacêuticos S.A

fabio.ikedo@ache.com.br

55 11 26086933

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: January 13, 2021
• Primary Completion: May 20, 2022
• Study Completion: February 27, 2023
• Last Updated: March 10, 2025
• Results First Posted: March 10, 2025

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (12); US (19)