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

Pemphigus Vulgaris Clinical Trial

Official title:

A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03780166
• Other study ID #: INCB 50465-208
• Secondary ID: Parsaclisib
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2019
• Est. completion date: November 2020

Study information

• Verified date: September 2019
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pemphigus
• Pemphigus Vulgaris

Intervention

Drug:
• Parsaclisib
Parsaclisib administered orally once daily at the cohort-specified dose level.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment-emergent adverse events	Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.	Up to 20 weeks
Secondary	Cmax of Parsaclisib	Maximum observed concentration.	Up to 6 weeks
Secondary	tmax of Parsaclisib	Time to maximum concentration.	Up to 6 weeks
Secondary	Cmin of Parsaclisib	Minimum observed concentration over the dose interval.	Up to 6 weeks
Secondary	AUC0-t of Parsaclisib	Area under the concentration-time curve from time = 0 to the last measurable concentration at time = t.	Up to 6 weeks
Secondary	CL/F of Parsaclisib	Apparent oral dose clearance.	Up to 6 weeks