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

Completed · Phase 2 · Has a placebo group

Conditions studied: NonSegmental Vitiligo

In brief

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.

Key facts

Study ID

NCT04818346

Run by

Incyte Corporation

People needed

171

Starts

2021-05-06

Expected to finish

2023-05-24

Last updated by the study team

2024-04-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• Further inclusion criteria apply.

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.
• Further exclusion criteria apply.

Where it is running

• Investigative Site 010 — Hoover, Alabama, United States
• Investigative Site 015 — Gilbert, Arizona, United States
• Investigative Site 028 — Scottsdale, Arizona, 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 017 — Sacramento, California, United States
• Investigative Site 032 — Orange Park, Florida, United States
• Investigative Site 005 — Tampa, Florida, United States
• Investigative Site 022 — Tampa, Florida, United States
• Investigative Site 011 — West Palm Beach, Florida, United States
• Investigative Site 024 — Covington, Louisiana, United States
• Investigative Site 002 — Brighton, Massachusetts, United States
• Investigative Site 023 — Saint Paul, Minnesota, United States
• Investigative Site 027 — Verona, New Jersey, United States
• Investigative Site 003 — Columbus, Ohio, United States
• Investigative Site 007 — Norman, Oklahoma, United States
• Investigative Site 001 — Portland, Oregon, United States
• Investigative Site 021 — Plymouth Meeting, Pennsylvania, United States
• Investigative Site 004 — Murfreesboro, Tennessee, United States
• Investigative Site 033 — Dallas, Texas, United States
• Investigative Site 012 — San Antonio, Texas, United States
• Investigative Site 030 — Spokane, Washington, United States
• Investigative Site 020 — Winnipeg, Manitoba, Canada
• Investigative Site 014 — Etobicoke, Ontario, Canada

Full record on ClinicalTrials.gov

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