CompletedPhase 2

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

United States327 participantsStarted 2021-01-13

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Mean Change From Baseline in Vitiligo Area Scoring Index Score

Timeframe: Week 24

NCT IDNCT04487860

SponsorAche Laboratorios Farmaceuticos S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-20

Results submitted2024-08-29