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

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

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.

Study Overview

• Status: Completed
• Conditions: NonSegmental Vitiligo
• Intervention / Treatment: Drug: INCB054707; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, Q1V 4X7
    • Investigative Site 029
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Investigative Site 020
  • Ontario
    • Etobicoke, Ontario, Canada, M8X 1Y9
      • Investigative Site 014
    • London, Ontario, Canada, N6H 5LR
      • Investigative Site 034
    • Mississauga, Ontario, Canada, L5H 1G9
      • Investigative Site 025
    • North York, Ontario, Canada, M2M4J5
      • Investigative Site 026
    • Oakville, Ontario, Canada, L6J 7W5
      • Investigative Site 031
    • Peterborough, Ontario, Canada, K9J 5K2
      • Investigative Site 008
• United States
  • Alabama
    • Hoover, Alabama, United States, 35244
      • Investigative Site 010
  • Arizona
    • Gilbert, Arizona, United States, 85295
      • Investigative Site 015
    • Scottsdale, Arizona, United States, 85260
      • Investigative Site 028
  • California
    • Irvine, California, United States, 92697
      • Investigative Site 006
    • Los Angeles, California, United States, 90036
      • Investigative Site 009
    • Los Angeles, California, United States, 90045
      • Investigative Site 018
    • Sacramento, California, United States, 95815
      • Investigative Site 017
  • Florida
    • Orange Park, Florida, United States, 32073
      • Investigative Site 032
    • Tampa, Florida, United States, 33613
      • Investigative Site 005
    • Tampa, Florida, United States, 33614
      • Investigative Site 022
    • West Palm Beach, Florida, United States, 33401
      • Investigative Site 011
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Investigative Site 024
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Investigative Site 002
  • Minnesota
    • Saint Paul, Minnesota, United States, 55112
      • Investigative Site 023
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • Investigative Site 027
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Investigative Site 003
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Investigative Site 007
  • Oregon
    • Portland, Oregon, United States, 97223
      • Investigative Site 001
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Investigative Site 021
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • Investigative Site 004
  • Texas
    • Dallas, Texas, United States, 75230
      • Investigative Site 033
    • San Antonio, Texas, United States, 78213
      • Investigative Site 012
  • Washington
    • Spokane, Washington, United States, 99202
      • Investigative Site 030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INCB054707 Dose A followed by Dose C; Participants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).	Drug: INCB054707; INCB054707 will be administered once daily; Other Names: Povorcitinib
Experimental: INCB054707 Dose B; Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2).	Drug: INCB054707; INCB054707 will be administered once daily; Other Names: Povorcitinib
Experimental: INCB054707 Dose C; Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2).	Drug: INCB054707; INCB054707 will be administered once daily; Other Names: Povorcitinib
Placebo Comparator: Placebo followed by INCB054707 Dose C; Participants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).	Drug: Placebo; Placebo or INCB054707 will be administered once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Actual): May 24, 2022
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: INCB 54707-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No