A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo

NonSegmental Vitiligo Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04818346
• Other study ID #: INCB 54707-205
• Status: Completed
• Phase: Phase 2
• Start date: May 6, 2021
• Est. completion date: May 24, 2023

Study information

• Verified date: March 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• NonSegmental Vitiligo
• Vitiligo

Intervention

Drug:
• INCB054707
INCB054707 will be administered once daily
• Placebo
Placebo or INCB054707 will be administered once daily

Locations

Country	Name	City	State
Canada	Investigative Site 014	Etobicoke	Ontario
Canada	Investigative Site 034	London	Ontario
Canada	Investigative Site 025	Mississauga	Ontario
Canada	Investigative Site 026	North York	Ontario
Canada	Investigative Site 031	Oakville	Ontario
Canada	Investigative Site 008	Peterborough	Ontario
Canada	Investigative Site 029	Quebec
Canada	Investigative Site 020	Winnipeg	Manitoba
United States	Investigative Site 002	Brighton	Massachusetts
United States	Investigative Site 003	Columbus	Ohio
United States	Investigative Site 024	Covington	Louisiana
United States	Investigative Site 033	Dallas	Texas
United States	Investigative Site 015	Gilbert	Arizona
United States	Investigative Site 010	Hoover	Alabama
United States	Investigative Site 006	Irvine	California
United States	Investigative Site 009	Los Angeles	California
United States	Investigative Site 018	Los Angeles	California
United States	Investigative Site 004	Murfreesboro	Tennessee
United States	Investigative Site 007	Norman	Oklahoma
United States	Investigative Site 032	Orange Park	Florida
United States	Investigative Site 021	Plymouth Meeting	Pennsylvania
United States	Investigative Site 001	Portland	Oregon
United States	Investigative Site 017	Sacramento	California
United States	Investigative Site 023	Saint Paul	Minnesota
United States	Investigative Site 012	San Antonio	Texas
United States	Investigative Site 028	Scottsdale	Arizona
United States	Investigative Site 030	Spokane	Washington
United States	Investigative Site 005	Tampa	Florida
United States	Investigative Site 022	Tampa	Florida
United States	Investigative Site 027	Verona	New Jersey
United States	Investigative Site 011	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24	The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. Percent change was calculated as ([post-Baseline value minus the Baseline value] / Baseline value) x 100.	Baseline; Week 24
Secondary	Percentage of Participants Achieving T-VASI50 at Week 24	T-VASI50 was defined as a 50% or greater reduction from Baseline in T-VASI. The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive body regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites.	Baseline; Week 24
Secondary	Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period.	up to Week 24
Secondary	Extension Period: Number of Participants With Any TEAE	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period.	from Week 25 up to Week 76