A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris
- Registration Number
- NCT03780166
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of this study is to assess the safety and tolerability of parsaclisib in participants with mild to moderate pemphigus vulgaris.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Parsaclisib Parsaclisib -
- Primary Outcome Measures
Name Time Method Number of treatment-emergent adverse events Up to 20 weeks Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
- Secondary Outcome Measures
Name Time Method CL/F of Parsaclisib Up to 6 weeks Apparent oral dose clearance.
Cmax of Parsaclisib Up to 6 weeks Maximum observed concentration.
tmax of Parsaclisib Up to 6 weeks Time to maximum concentration.
AUC0-t of Parsaclisib Up to 6 weeks Area under the concentration-time curve from time = 0 to the last measurable concentration at time = t.
Cmin of Parsaclisib Up to 6 weeks Minimum observed concentration over the dose interval.