drugset
drugset / Trial / NCT04487860

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

NCT04487860 ↗

Phase 2 Completed 327 enrolled Ache Laboratorios Farmaceuticos S.A.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2021-01-13
Primary completion
2022-05-20
Completion
2023-02-27

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs AS012 Dose Regimen I; p = 0.7905; ANCOVA NCT04487860 ↗

registry analysis (superiority test); Placebo vs AS012 Dose Regimen II; p = 0.7372; ANCOVA NCT04487860 ↗

registry analysis (superiority test); Placebo vs AS012 Dose Regimen III; p = 0.2989; ANCOVA NCT04487860 ↗

registry analysis (superiority test); Placebo vs AS012 Dose Regimen IV; p = 0.3328; ANCOVA NCT04487860 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject AS012 Unknown — Oral

Indications

vitiligo