A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo (NCT04818346) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo
United States171 participantsStarted 2021-05-06
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24