Phase 2
N=327
Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo
Non-segmental Vitiligo
Bottom Line
View on ClinicalTrials.gov: NCT04487860 ↗Enrolled (actual)
327
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Mean Change From Baseline in Vitiligo Area Scoring Index Score — -0.472; -0.271; -0.706; -1.145 score on a scale — p=0.7905
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AS012 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Vitiligo Area Scoring Index Score |
-0.472; -0.271; -0.706; -1.145; -0.110 | 0.7905 |
| SECONDARY Mean Change From Baseline in Vitiligo Extent Score (VES) on Clinical Pictures |
-0.507; -0.671; -0.284; -0.454; -1.218 | 0.8989 |
| SECONDARY Mean Change in Vitiligo Impact Patient Scale |
-2.72; -3.48; -4.24; -2.50; -2.06 | 0.8593 |
| SECONDARY Physician's Global Assessment Scores |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Mean Change From Baseline in Dermatology Life Quality Index |
0.2; 0.0; -0.8; -0.6; -2.0; -0.2 | — |
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 Criteria
- 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 Criteria
- 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
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Data sourced from ClinicalTrials.gov (NCT04487860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.