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

Launched by INCYTE CORPORATION · Dec 17, 2018

Keywords

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Eligibility 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.