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

  • STATUS
    Recruiting
  • End date
    Dec 23, 2022
  • participants needed
    160
  • sponsor
    Incyte Corporation
Updated on 22 September 2021

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.

Details
Condition NonSegmental Vitiligo
Treatment Placebo, INCB054707
Clinical Study IdentifierNCT04818346
SponsorIncyte Corporation
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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