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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04487860
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

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

Condition or disease Intervention/treatment Phase
Non-segmental Vitiligo Drug: AS012 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo
Actual Study Start Date : January 6, 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: AS012 dose regimen I
Oral
Drug: AS012
oral administration

Experimental: AS012 dose regimen II
Oral
Drug: AS012
oral administration

Experimental: AS012 dose regimen III
Oral
Drug: AS012
oral administration

Experimental: AS012 dose regimen IV
Oral
Drug: AS012
oral administration

Placebo Comparator: Placebo
Oral
Drug: Placebo
oral administration




Primary Outcome Measures :
  1. Mean change from baseline in Vitiligo Area Scoring Index score [ Time Frame: Week 24 ]
    Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state


Secondary Outcome Measures :
  1. Mean change from baseline in Vitiligo Extent Score [ Time Frame: Week 24 ]
    Natural distribution of vitiligo on body reflecting 6 different degrees of involvement (1 percent, 5 percent, 10 percent, 25 percent, 50 percent, 75 percent).

  2. Mean change in Vitiligo Impact Patient scale [ Time Frame: Week 24 ]
    subjects will be asked to complete a questionnaire to assess the burden experienced by individuals affected. Summary scores range from 0 to 100

  3. Physician's global assessment scores [ Time Frame: Week 52 ]
    Score 0=no involvement or Score 1=limited extent with at least 2-point reduction from baseline

  4. Mean change, from baseline, in Dermatology Life Quality Index [ Time Frame: Week 52 ]

    The DLQI scores are based on the response from the patient. Each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0.

    The higher the score, the more quality of life is impaired OR lower scores indicate better quality of life.




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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487860


Contacts
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Contact: Head Clinical Development 912266455645 clinical.trials@sparcmail.com

Locations
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United States, Arkansas
SunFZE Site 02 Recruiting
Bryant, Arkansas, United States, 72022
United States, California
SunFZE Site 09 Recruiting
Fremont, California, United States, 94538
United States, Florida
SunFZE Site 01 Not yet recruiting
Brandon, Florida, United States, 33511.
SunFZE Site 06 Not yet recruiting
Fort Lauderdale, Florida, United States, 33308
SunFZE Site 04 Not yet recruiting
Miami, Florida, United States, 33175
SunFZE Site 05 Not yet recruiting
Miramar, Florida, United States, 33027
SunFZE Site 10 Not yet recruiting
Ormond Beach, Florida, United States, 32174
United States, Louisiana
SunFZE Site 12 Recruiting
Baton Rouge, Louisiana, United States, 70809
SunFZE Site 13 Recruiting
New Orleans, Louisiana, United States, 70115
United States, Michigan
SunFZE Site 07 Not yet recruiting
Troy, Michigan, United States, 48084
United States, Rhode Island
SunFZE Site 08 Not yet recruiting
Warwick, Rhode Island, United States, 02886
United States, Texas
SunFZE Site 03 Not yet recruiting
Dallas, Texas, United States, 75234
United States, Washington
SunFZE Site 11 Not yet recruiting
Mill Creek, Washington, United States, 98012
Sponsors and Collaborators
Sun Pharma Global FZE
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Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT04487860    
Other Study ID Numbers: AS012-20-01
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases