AS012 for Vitiligo

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
VitiligoAS012 - Drug
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if a new drug is effective and safe for people with a certain medical condition. The study will be done at multiple locations with people from different countries.

Eligible Conditions
  • Vitiligo

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Week 52

Week 24
Mean change from baseline in Vitiligo Area Scoring Index score
Mean change from baseline in Vitiligo Extent Score
Mean change in Vitiligo Impact Patient scale
Week 52
Mean change, from baseline, in Dermatology Life Quality Index
Physician's global assessment scores

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

5 Treatment Groups

AS012 dose regimen I
1 of 5
AS012 dose regimen II
1 of 5
AS012 dose regimen IV
1 of 5
AS012 dose regimen III
1 of 5
Placebo
1 of 5

Experimental Treatment

Non-Treatment Group

327 Total Participants · 5 Treatment Groups

Primary Treatment: AS012 · Has Placebo Group · Phase 2

AS012 dose regimen I
Drug
Experimental Group · 1 Intervention: AS012 · Intervention Types: Drug
AS012 dose regimen II
Drug
Experimental Group · 1 Intervention: AS012 · Intervention Types: Drug
AS012 dose regimen IV
Drug
Experimental Group · 1 Intervention: AS012 · Intervention Types: Drug
AS012 dose regimen III
Drug
Experimental Group · 1 Intervention: AS012 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 52

Who is running the clinical trial?

Sun Pharma Global FZELead Sponsor
33 Previous Clinical Trials
9,900 Total Patients Enrolled
Sun Pharmaceutical Industries LimitedLead Sponsor
59 Previous Clinical Trials
13,176 Total Patients Enrolled

Eligibility Criteria

Age 18 - 99 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You provide written informed consent.
You are male or female, or both, aged 18 years or older.

Who else is applying?

What state do they live in?
Tennessee100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Sun Pharma Site 14100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%