Clinical trial NCT04487860: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-segmental Vitiligo
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2020-07-27
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

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Primary outcomes:
measure: Mean Change From Baseline in Vitiligo Area Scoring Index Score
timeFrame: Week 24
Secondary outcomes:
measure: Mean Change From Baseline in Vitiligo Extent Score (VES) on Clinical Pictures
timeFrame: Week 24
measure: Mean Change in Vitiligo Impact Patient Scale
timeFrame: Week 24
measure: Physician's Global Assessment Scores
timeFrame: Week 52
measure: Mean Change From Baseline in Dermatology Life Quality Index
timeFrame: Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Sun Pharma Site 15
state: Arizona
city: Bryant
country: United States
facility: Sun Pharma Site 02
state: Arkansas
city: Fremont
country: United States
facility: Sun Pharma Site 09
state: California
city: Los Angeles
country: United States
facility: Sun pharma site 30
state: California
city: Brandon
country: United States
facility: Sun Pharma Site 01
state: Florida
city: Fort Lauderdale
country: United States
facility: Sun Pharma Site 06
state: Florida
city: Miami
country: United States
facility: Sun Pharma Site 04
state: Florida
city: Miramar
country: United States
facility: Sun Pharma Site 05
state: Florida
city: Ormond Beach
country: United States
facility: Sun Pharma Site 10
state: Florida
city: West Lafayette
country: United States
facility: Sun Pharma Site 14
state: Indiana
city: Baton Rouge
country: United States
facility: Sun Pharma Site 12
state: Louisiana
city: New Orleans
country: United States
facility: Sun Pharma Site 13
state: Louisiana
city: Boston
country: United States
facility: Sun pharma site 31
state: Massachusetts
city: Troy
country: United States
facility: Sun Pharma Site 07
state: Michigan
city: East Greenwich
country: United States
facility: Sun Pharma Site 29
state: Rhode Island
city: Warwick
country: United States
facility: Sun Pharma Site 08
state: Rhode Island
city: Dallas
country: United States
facility: Sun Pharma Site 03
state: Texas
city: Pflugerville
country: United States
facility: Sun Pharma Site 16
state: Texas
city: Mill Creek
country: United States
facility: Sun Pharma Site 11
state: Washington
city: Ahmedabad
country: India
facility: Sun Pharma Site 19
state: Gujrat
city: Gandhinagar
country: India
facility: Sun Pharma Site 20
state: Gujrat
city: Rajkot
country: India
facility: Sun Pharma Site 28
state: Gujrat
city: Bangalore
country: India
facility: Sun Pharma Site 23
state: Karnataka
city: Mysuru
country: India
facility: Sun PharmaSite 24
state: Karnataka
city: Aurangabad
country: India
facility: Sun Pharma Site 21
state: Maharashtra
city: Nashik
country: India
facility: Sun Pharma Site 25
state: Maharashtra
city: Pune
country: India
facility: Sun Pharma Site 26
state: Maharashtra
city: Rajsamand
country: India
facility: Sun Pharma Site 17
state: Rajasthan,
city: Lucknow
country: India
facility: Sun Pharma Site 27
state: Uttar Pradesh
city: Lucknow
country: India
facility: Sun Pharma Site 18
state: Uttar Pradesh
city: Chandigarh
country: India
facility: Sun Pharma Site 22
Study officials:
References: