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

NCT03780166 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: INCB 50465-208Parsaclisib
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pemphigus Vulgaris

Keywords

Pemphigus vulgaris; phosphatidylinositol 3-kinase delta; immunoglobulin G autoantibodies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cmax of Parsaclisib

  Up to 6 weeks

• tmax of Parsaclisib

  Up to 6 weeks

• Cmin of Parsaclisib

  Up to 6 weeks

• AUC0-t of Parsaclisib

  Up to 6 weeks

• CL/F of Parsaclisib

  Up to 6 weeks

Study Arms (1)

Parsaclisib

EXPERIMENTAL

Drug: Parsaclisib

Interventions

Parsaclisib DRUG

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

Also known as: INCB050465

Parsaclisib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

MeSH Terms

Conditions

Pemphigus

Interventions

parsaclisib

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kathleen Butler, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: March 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: September 13, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share