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

Phase 2

Completed

• Conditions: Non-segmental Vitiligo
• Interventions: Drug: AS012; Drug: Placebo

• Registration Number: NCT04487860
• Lead Sponsor: Sun Pharmaceutical Industries Limited

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

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-27
• Study Start: 2021-01-06
• Primary Completion: 2022-05-20
• Status Verified: 2022-06
• Study Completion: 2023-02-22
• Disposition First Submitted: 2023-03-09
• Last Update Submitted: 2023-03-23
• Disposition First Posted: 2023-03-27
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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

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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 & 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	Week 24	Natural distribution of vitiligo on body reflecting 6 different degrees of involvement (1 percent, 5 percent, 10 percent, 25 percent, 50 percent, 75 percent).
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. Summary scores range from 0 to 100
Physician's global assessment scores	Week 52	Score 0=no involvement or Score 1=limited extent with at least 2-point reduction from baseline
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 (28)

Sun Pharma Site 04; 🇺🇸 Miami, Florida, United States

Sun Pharma Site 15; 🇺🇸 Phoenix, Arizona, United States

Sun Pharma Site 11; 🇺🇸 Mill Creek, Washington, United States

Sun Pharma Site 06; 🇺🇸 Fort Lauderdale, Florida, United States

Sun Pharma Site 08; 🇺🇸 Warwick, Rhode Island, United States

Sun Pharma Site 09; 🇺🇸 Fremont, California, United States

Sun Pharma Site 16; 🇺🇸 Pflugerville, Texas, United States

Sun Pharma Site 01; 🇺🇸 Brandon, Florida, United States

Sun Pharma Site 14; 🇺🇸 West Lafayette, Indiana, United States

Sun Pharma Site 10; 🇺🇸 Ormond Beach, Florida, United States

Sun Pharma Site 13; 🇺🇸 New Orleans, Louisiana, United States

Sun Pharma Site 17; 🇮🇳 Rajsamand, Rajasthan,, India

Sun Pharma Site 02; 🇺🇸 Bryant, Arkansas, United States

Sun Pharma Site 05; 🇺🇸 Miramar, Florida, United States

Sun Pharma Site 07; 🇺🇸 Troy, Michigan, United States

Sun Pharma Site 03; 🇺🇸 Dallas, Texas, United States

Sun Pharma Site 20; 🇮🇳 Gandhinagar, Gujrat, India

Sun Pharma Site 28; 🇮🇳 Rajkot, Gujrat, India

Sun Pharma Site 19; 🇮🇳 Ahmedabad, Gujrat, India

Sun PharmaSite 24; 🇮🇳 Mysuru, Karnataka, India

Sun Pharma Site 21; 🇮🇳 Aurangabad, Maharashtra, India

Sun Pharma Site 26; 🇮🇳 Pune, Maharashtra, India

Sun Pharma Site 18; 🇮🇳 Lucknow, Uttar Pradesh, India

Sun Pharma Site 27; 🇮🇳 Lucknow, Uttar Pradesh, India

Sun Pharma Site 22; 🇮🇳 Chandigarh, India

Sun Pharma Site 12; 🇺🇸 Baton Rouge, Louisiana, United States

Sun Pharma Site 23; 🇮🇳 Bangalore, Karnataka, India

Sun Pharma Site 25; 🇮🇳 Nashik, Maharashtra, India