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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04487860
Recruitment Status : Active, not recruiting
First Posted : July 27, 2020
Last Update Posted : August 29, 2022
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited

Tracking Information
First Submitted Date  ICMJE July 22, 2020
First Posted Date  ICMJE July 27, 2020
Last Update Posted Date August 29, 2022
Actual Study Start Date  ICMJE January 6, 2021
Actual Primary Completion Date May 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
Mean change from baseline in Vitiligo Area Scoring Index score [ Time Frame: Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2020)
  • 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).
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
  • Mean change from baseline in Vitiligo Extent Score [ Time Frame: Week 24 ]
    The VES is assessed by the Physician on a set of pictures to assess the extent of depigmentation for 19 separate areas of the body reflecting 6 different degrees of involvement (1%, 5%, 10%, 25%, 50%, 75%).
  • Mean change in self-assessment Vitiligo Extent Score [ Time Frame: Week 24 ]
    assessed by the patient on a set of pictures to assess the extent of depigmentation for 12 separate areas of the body reflecting 6 degrees of involvement (1%, 5%, 10%, 25%, 50%, and 75%).
  • Mean change in Vitiligo Impact Patient scale [ Time Frame: Week 24 ]
  • Mean change, from baseline, in Vitiligo Area Scoring Index score [ Time Frame: Week 52 ]
  • 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
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo
Official Title  ICMJE 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
Brief Summary This is a randomized, double blind, placebo-controlled, phase II study. The study will be performed as a multicenter, multinational study. I
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-segmental Vitiligo
Intervention  ICMJE
  • Drug: AS012
    oral administration
  • Drug: Placebo
    oral administration
Study Arms  ICMJE
  • Experimental: AS012 dose regimen I
    Oral
    Intervention: Drug: AS012
  • Experimental: AS012 dose regimen II
    Oral
    Intervention: Drug: AS012
  • Experimental: AS012 dose regimen III
    Oral
    Intervention: Drug: AS012
  • Experimental: AS012 dose regimen IV
    Oral
    Intervention: Drug: AS012
  • Placebo Comparator: Placebo
    Oral
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 6, 2022)
327
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2020)
300
Estimated Study Completion Date  ICMJE January 2023
Actual Primary Completion Date May 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04487860
Other Study ID Numbers  ICMJE AS012-20-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Sun Pharmaceutical Industries Limited
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sun Pharmaceutical Industries Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Pharmaceutical Industries Limited
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP