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

Non-segmental Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04487860
• Other study ID #: AS012-20-01
• Status: Completed
• Phase: Phase 2
• Start date: January 6, 2021
• Est. completion date: February 22, 2023

Study information

• Verified date: June 2022
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: February 22, 2023
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Non-segmental Vitiligo
• Vitiligo

Intervention

Drug:
• AS012
oral administration
• Placebo
oral administration

Locations

Country	Name	City	State
India	Sun Pharma Site 19	Ahmedabad	Gujrat
India	Sun Pharma Site 21	Aurangabad	Maharashtra
India	Sun Pharma Site 23	Bangalore	Karnataka
India	Sun Pharma Site 22	Chandigarh
India	Sun Pharma Site 20	Gandhinagar	Gujrat
India	Sun Pharma Site 18	Lucknow	Uttar Pradesh
India	Sun Pharma Site 27	Lucknow	Uttar Pradesh
India	Sun PharmaSite 24	Mysuru	Karnataka
India	Sun Pharma Site 25	Nashik	Maharashtra
India	Sun Pharma Site 26	Pune	Maharashtra
India	Sun Pharma Site 28	Rajkot	Gujrat
India	Sun Pharma Site 17	Rajsamand	Rajasthan,
United States	Sun Pharma Site 12	Baton Rouge	Louisiana
United States	Sun Pharma Site 01	Brandon	Florida
United States	Sun Pharma Site 02	Bryant	Arkansas
United States	Sun Pharma Site 03	Dallas	Texas
United States	Sun Pharma Site 06	Fort Lauderdale	Florida
United States	Sun Pharma Site 09	Fremont	California
United States	Sun Pharma Site 04	Miami	Florida
United States	Sun Pharma Site 11	Mill Creek	Washington
United States	Sun Pharma Site 05	Miramar	Florida
United States	Sun Pharma Site 13	New Orleans	Louisiana
United States	Sun Pharma Site 10	Ormond Beach	Florida
United States	Sun Pharma Site 16	Pflugerville	Texas
United States	Sun Pharma Site 15	Phoenix	Arizona
United States	Sun Pharma Site 07	Troy	Michigan
United States	Sun Pharma Site 08	Warwick	Rhode Island
United States	Sun Pharma Site 14	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean change from baseline in Vitiligo Extent Score	Natural distribution of vitiligo on body re?ecting 6 different degrees of involvement (1 percent, 5 percent, 10 percent, 25 percent, 50 percent, 75 percent).	Week 24
Secondary	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
Secondary	Physician's global assessment scores	Score 0=no involvement or Score 1=limited extent with at least 2-point reduction from baseline	Week 52
Secondary	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