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

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

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.