Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo
Lead Sponsor:
Incyte Corporation
Conditions:
NonSegmental Vitiligo
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2023
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT04818346
Start Date
May 6 2021
End Date
May 24 2023
Last Update
April 11 2024
Active Locations (31)
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1
Investigative Site 010
Hoover, Alabama, United States, 35244
2
Investigative Site 015
Gilbert, Arizona, United States, 85295
3
Investigative Site 028
Scottsdale, Arizona, United States, 85260
4
Investigative Site 006
Irvine, California, United States, 92697