Clinical trial NCT04818346: A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 Followed by an Extension Period in Participants With Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NonSegmental Vitiligo
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of INCB054707 over a 24-week placebo-controlled double-blind treatment period, followed by a 28-week double-blind extension period in participants with nonsegmental vitiligo.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of nonsegmental vitiligo.
* History of prior vitiligo treatment with a total duration of at least 3 months.
* Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
* Willingness to avoid pregnancy or fathering children
* Further inclusion criteria apply.

Exclusion Criteria:

* Other forms of vitiligo (eg, segmental) or other skin depigmentation disorders.
* Uncontrolled thyroid function at screening as determined by the investigator.
* Women who are pregnant (or who are considering pregnancy) or lactating.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
* Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
* Laboratory values outside of the protocol-defined ranges.
* Further exclusion criteria apply.

Primary outcomes:
measure: Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
timeFrame: Baseline; Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving T-VASI50 at Week 24
timeFrame: Baseline; Week 24
measure: Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to Week 24
measure: Extension Period: Number of Participants With Any TEAE
timeFrame: from Week 25 up to Week 76
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Investigative Site 010
state: Alabama
city: Gilbert
country: United States
facility: Investigative Site 015
state: Arizona
city: Scottsdale
country: United States
facility: Investigative Site 028
state: Arizona
city: Irvine
country: United States
facility: Investigative Site 006
state: California
city: Los Angeles
country: United States
facility: Investigative Site 009
state: California
city: Los Angeles
country: United States
facility: Investigative Site 018
state: California
city: Sacramento
country: United States
facility: Investigative Site 017
state: California
city: Orange Park
country: United States
facility: Investigative Site 032
state: Florida
city: Tampa
country: United States
facility: Investigative Site 005
state: Florida
city: Tampa
country: United States
facility: Investigative Site 022
state: Florida
city: West Palm Beach
country: United States
facility: Investigative Site 011
state: Florida
city: Covington
country: United States
facility: Investigative Site 024
state: Louisiana
city: Brighton
country: United States
facility: Investigative Site 002
state: Massachusetts
city: Saint Paul
country: United States
facility: Investigative Site 023
state: Minnesota
city: Verona
country: United States
facility: Investigative Site 027
state: New Jersey
city: Columbus
country: United States
facility: Investigative Site 003
state: Ohio
city: Norman
country: United States
facility: Investigative Site 007
state: Oklahoma
city: Portland
country: United States
facility: Investigative Site 001
state: Oregon
city: Plymouth Meeting
country: United States
facility: Investigative Site 021
state: Pennsylvania
city: Murfreesboro
country: United States
facility: Investigative Site 004
state: Tennessee
city: Dallas
country: United States
facility: Investigative Site 033
state: Texas
city: San Antonio
country: United States
facility: Investigative Site 012
state: Texas
city: Spokane
country: United States
facility: Investigative Site 030
state: Washington
city: Winnipeg
country: Canada
facility: Investigative Site 020
state: Manitoba
city: Etobicoke
country: Canada
facility: Investigative Site 014
state: Ontario
city: London
country: Canada
facility: Investigative Site 034
state: Ontario
city: Mississauga
country: Canada
facility: Investigative Site 025
state: Ontario
city: North York
country: Canada
facility: Investigative Site 026
state: Ontario
city: Oakville
country: Canada
facility: Investigative Site 031
state: Ontario
city: Peterborough
country: Canada
facility: Investigative Site 008
state: Ontario
city: Quebec
country: Canada
facility: Investigative Site 029
Study officials:
References: