Status:
WITHDRAWN
A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris
Lead Sponsor:
Incyte Corporation
Conditions:
Pemphigus Vulgaris
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety and tolerability of parsaclisib in participants with mild to moderate pemphigus vulgaris.
Eligibility Criteria
Inclusion
- Clinically documented and confirmed diagnosis of pemphigus vulgaris: minimum of 6 months of pemphigus vulgaris diagnosis; positive for anti-desmoglein (DSG)1 or DSG3; Pemphigus Disease Area Index score of 8 to 45 points; active skin, scalp, or mucosal lesions.
- Disease progression after treatment with standard therapies that are known to confer clinical benefit, or intolerant to treatment; there is no limit to the number of prior treatment regimens.
- Willingness to avoid pregnancy or fathering children.
- If required, willing to receive Pneumocystis jirovecii pneumonia prophylaxis during the study period.
Exclusion
- Pregnant or breast-feeding female.
- Participants with pemphigus vulgaris who are treatment-naive.
- Use of protocol-specified medications within defined periods before baseline.
- Evidence or history of clinically significant infection or protocol-defined medical conditions
- Laboratory values outside the protocol-defined range at screening.
- Known or suspected allergy to parsaclisib or any component of the study drug.
- Known history of clinically significant drug or alcohol abuse in the last year before baseline.
- Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03780166
Start Date
March 1 2019
End Date
November 1 2020
Last Update
September 13 2019
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