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

NCT04818346 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: INCB 54707-205
• Study Type: interventional
• Target: 171
• Locations: 2 countries
• Sites: 31

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.

Conditions

NonSegmental Vitiligo

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Participants Achieving T-VASI50 at Week 24

  Baseline; Week 24

• Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

  up to Week 24

• Extension Period: Number of Participants With Any TEAE

  from Week 25 up to Week 76

Study Arms (4)

INCB054707 Dose A followed by Dose C

EXPERIMENTAL

Participants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).

Drug: INCB054707

INCB054707 Dose B

EXPERIMENTAL

Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2).

Drug: INCB054707

INCB054707 Dose C

EXPERIMENTAL

Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2).

Drug: INCB054707

Placebo followed by INCB054707 Dose C

PLACEBO COMPARATOR

Participants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).

Drug: Placebo

Interventions

INCB054707 DRUG

INCB054707 will be administered once daily

Also known as: Povorcitinib

INCB054707 Dose A followed by Dose C; INCB054707 Dose B; INCB054707 Dose C

Placebo DRUG

Placebo or INCB054707 will be administered once daily

Placebo followed by INCB054707 Dose C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (31)

Investigative Site 010

Hoover, Alabama, 35244, United States

Location

Investigative Site 015

Gilbert, Arizona, 85295, United States

Location

Investigative Site 028

Scottsdale, Arizona, 85260, United States

Location

Investigative Site 006

Irvine, California, 92697, United States

Location

Investigative Site 009

Los Angeles, California, 90036, United States

Location

Investigative Site 018

Los Angeles, California, 90045, United States

Location

Investigative Site 017

Sacramento, California, 95815, United States

Location

Investigative Site 032

Orange Park, Florida, 32073, United States

Location

Investigative Site 005

Tampa, Florida, 33613, United States

Location

Investigative Site 022

Tampa, Florida, 33614, United States

Location

Investigative Site 011

West Palm Beach, Florida, 33401, United States

Location

Investigative Site 024

Covington, Louisiana, 70433, United States

Location

Investigative Site 002

Brighton, Massachusetts, 02135, United States

Location

Investigative Site 023

Saint Paul, Minnesota, 55112, United States

Location

Investigative Site 027

Verona, New Jersey, 07044, United States

Location

Investigative Site 003

Columbus, Ohio, 43215, United States

Location

Investigative Site 007

Norman, Oklahoma, 73071, United States

Location

Investigative Site 001

Portland, Oregon, 97223, United States

Location

Investigative Site 021

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Investigative Site 004

Murfreesboro, Tennessee, 37130, United States

Location

Investigative Site 033

Dallas, Texas, 75230, United States

Location

Investigative Site 012

San Antonio, Texas, 78213, United States

Location

Investigative Site 030

Spokane, Washington, 99202, United States

Location

Investigative Site 020

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Investigative Site 014

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Investigative Site 034

London, Ontario, N6H 5LR, Canada

Location

Investigative Site 025

Mississauga, Ontario, L5H 1G9, Canada

Location

Investigative Site 026

North YORK, Ontario, M2M4J5, Canada

Location

Investigative Site 031

Oakville, Ontario, L6J 7W5, Canada

Location

Investigative Site 008

Peterborough, Ontario, K9J 5K2, Canada

Location

Investigative Site 029

Québec, Quebec, Q1V 4X7, Canada

Location

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 26, 2021
• Study Start: May 6, 2021
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2023
• Last Updated: April 11, 2024
• Results First Posted: July 5, 2023

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

CA (8); US (23)