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

Ache Laboratorios Farmaceuticos

Status and phase: Completed; Phase 2

Conditions: Non-segmental Vitiligo

Treatments: Drug: AS012; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04487860

AS012-20-01

Details and patient eligibility

About

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

Enrollment: 327 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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327 participants in 5 patient groups, including a placebo group

AS012 dose regimen I

Experimental group

Description:

Oral

Treatment:

Drug: AS012

AS012 dose regimen II

Experimental group

Description:

Oral

Treatment:

Drug: AS012

AS012 dose regimen III

Experimental group

Description:

Oral

Treatment:

Drug: AS012

AS012 dose regimen IV

Experimental group

Description:

Oral

Treatment:

Drug: AS012

Placebo

Placebo Comparator group

Description:

Oral

Treatment:

Drug: Placebo