A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris

• Status: Withdrawn
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and tolerability of parsaclisib in participants with mild to moderate pemphigus vulgaris.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

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.