Status:
COMPLETED
Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo
Lead Sponsor:
Ache Laboratorios Farmaceuticos S.A.
Conditions:
Non-segmental Vitiligo
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, double blind, placebo-controlled, phase II study. The study will be performed as a multicenter, multinational study.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- \-
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2023
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT04487860
Start Date
January 13 2021
End Date
February 27 2023
Last Update
March 10 2025
Active Locations (31)
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1
Sun Pharma Site 15
Phoenix, Arizona, United States, 85018
2
Sun Pharma Site 02
Bryant, Arkansas, United States, 72022
3
Sun Pharma Site 09
Fremont, California, United States, 94538
4
Sun pharma site 30
Los Angeles, California, United States, 90036