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AS012 for Vitiligo

Phase 2
Waitlist Available
Research Sponsored by Sun Pharma Global FZE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline in Vitiligo Area Scoring Index score
Secondary outcome measures
Mean change from baseline in Vitiligo Extent Score
Mean change in Vitiligo Impact Patient scale
Mean change, from baseline, in Dermatology Life Quality Index
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: AS012 dose regimen IVExperimental Treatment1 Intervention
Oral
Group II: AS012 dose regimen IIIExperimental Treatment1 Intervention
Oral
Group III: AS012 dose regimen IIExperimental Treatment1 Intervention
Oral
Group IV: AS012 dose regimen IExperimental Treatment1 Intervention
Oral
Group V: PlaceboPlacebo Group1 Intervention
Oral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AS012
2021
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

Sun Pharma Global FZELead Sponsor
33 Previous Clinical Trials
9,824 Total Patients Enrolled
Sun Pharmaceutical Industries LimitedLead Sponsor
64 Previous Clinical Trials
13,184 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are senior citizens ineligible for this research project?

"This study is only for people aged 18 to 99. On the clinicaltrials.gov website, there are 10 trials listed for people under 18 and 36 trials for those over 65."

Answered by AI

Which type of person do you think would be most helped by this clinical trial?

"327 patients that fit the age range of 18 to 99 and have been diagnosed with vitiligo are being recruited for this study. The most pertinent screening criteria are as follows: The patient must be able to provide written informed consent, they must be male or female, they must have had stable or unstable vitiligo for at least a year, and their VASI score must be ≥ 4."

Answered by AI

What is the latest status of AS012's journey through the FDA?

"While there is some data backing AS012's safety, it lacks evidence of efficacy and thus received a score of 2."

Answered by AI

Does this clinical trial have a large geographical spread?

"Currently, the study is being conducted at 32 different sites. However, these locations are subject to change. If you enroll in the study, it would be beneficial for you to choose a site that is close to your location to minimize travel time and other related difficulties."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
Sun Pharma Site 14
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo
2021. "Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04487860.
~77 spots leftby Apr 2025
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