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

Primary Purpose

Non-segmental Vitiligo

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AS012
Placebo
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-segmental Vitiligo

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    -

Sites / Locations

  • Sun Pharma Site 15
  • Sun Pharma Site 02
  • Sun Pharma Site 09
  • Sun Pharma Site 01
  • Sun Pharma Site 06
  • Sun Pharma Site 04
  • Sun Pharma Site 05
  • Sun Pharma Site 10
  • Sun Pharma Site 14
  • Sun Pharma Site 12
  • Sun Pharma Site 13
  • Sun Pharma Site 07
  • Sun Pharma Site 08
  • Sun Pharma Site 03
  • Sun Pharma Site 16
  • Sun Pharma Site 11
  • Sun Pharma Site 19
  • Sun Pharma Site 20
  • Sun Pharma Site 28
  • Sun Pharma Site 23
  • Sun PharmaSite 24
  • Sun Pharma Site 21
  • Sun Pharma Site 25
  • Sun Pharma Site 26
  • Sun Pharma Site 17
  • Sun Pharma Site 27
  • Sun Pharma Site 18
  • Sun Pharma Site 22

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AS012 dose regimen I

AS012 dose regimen II

AS012 dose regimen III

AS012 dose regimen IV

Placebo

Arm Description

Oral

Oral

Oral

Oral

Oral

Outcomes

Primary Outcome Measures

Mean change from baseline in Vitiligo Area Scoring Index score
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

Mean change from baseline in Vitiligo Extent Score
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
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
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
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.

Full Information

First Posted
July 22, 2020
Last Updated
March 23, 2023
Sponsor
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04487860
Brief Title
Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
February 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-segmental Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AS012 dose regimen I
Arm Type
Experimental
Arm Description
Oral
Arm Title
AS012 dose regimen II
Arm Type
Experimental
Arm Description
Oral
Arm Title
AS012 dose regimen III
Arm Type
Experimental
Arm Description
Oral
Arm Title
AS012 dose regimen IV
Arm Type
Experimental
Arm Description
Oral
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral
Intervention Type
Drug
Intervention Name(s)
AS012
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Mean change from baseline in Vitiligo Area Scoring Index score
Description
Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Mean change from baseline in Vitiligo Extent Score
Description
Natural distribution of vitiligo on body reflecting 6 different degrees of involvement (1 percent, 5 percent, 10 percent, 25 percent, 50 percent, 75 percent).
Time Frame
Week 24
Title
Mean change in Vitiligo Impact Patient scale
Description
subjects will be asked to complete a questionnaire to assess the burden experienced by individuals affected. Summary scores range from 0 to 100
Time Frame
Week 24
Title
Physician's global assessment scores
Description
Score 0=no involvement or Score 1=limited extent with at least 2-point reduction from baseline
Time Frame
Week 52
Title
Mean change, from baseline, in Dermatology Life Quality Index
Description
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.
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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 -
Facility Information:
Facility Name
Sun Pharma Site 15
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Sun Pharma Site 02
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Facility Name
Sun Pharma Site 09
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Sun Pharma Site 01
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511.
Country
United States
Facility Name
Sun Pharma Site 06
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Sun Pharma Site 04
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Sun Pharma Site 05
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Sun Pharma Site 10
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Sun Pharma Site 14
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Facility Name
Sun Pharma Site 12
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Sun Pharma Site 13
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Sun Pharma Site 07
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Sun Pharma Site 08
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Sun Pharma Site 03
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Sun Pharma Site 16
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Sun Pharma Site 11
City
Mill Creek
State/Province
Washington
ZIP/Postal Code
98012
Country
United States
Facility Name
Sun Pharma Site 19
City
Ahmedabad
State/Province
Gujrat
ZIP/Postal Code
380016
Country
India
Facility Name
Sun Pharma Site 20
City
Gandhinagar
State/Province
Gujrat
ZIP/Postal Code
382428
Country
India
Facility Name
Sun Pharma Site 28
City
Rajkot
State/Province
Gujrat
ZIP/Postal Code
360005
Country
India
Facility Name
Sun Pharma Site 23
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560074
Country
India
Facility Name
Sun PharmaSite 24
City
Mysuru
State/Province
Karnataka
ZIP/Postal Code
570001
Country
India
Facility Name
Sun Pharma Site 21
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431001
Country
India
Facility Name
Sun Pharma Site 25
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422101
Country
India
Facility Name
Sun Pharma Site 26
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411005
Country
India
Facility Name
Sun Pharma Site 17
City
Rajsamand
State/Province
Rajasthan,
ZIP/Postal Code
313202
Country
India
Facility Name
Sun Pharma Site 27
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Sun Pharma Site 18
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226005
Country
India
Facility Name
Sun Pharma Site 22
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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