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

Sponsor
Incyte Corporation (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03780166
Collaborator
(none)
0
Enrollment
1
Arm
20.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris
Anticipated Study Start Date :
Mar 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2020
Anticipated Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Parsaclisib

Drug: Parsaclisib
Parsaclisib administered orally once daily at the cohort-specified dose level.
Other Names:
  • INCB050465

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Cmax of Parsaclisib [Up to 6 weeks]

      Maximum observed concentration.

    2. tmax of Parsaclisib [Up to 6 weeks]

      Time to maximum concentration.

    3. Cmin of Parsaclisib [Up to 6 weeks]

      Minimum observed concentration over the dose interval.

    4. 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.

    5. CL/F of Parsaclisib [Up to 6 weeks]

      Apparent oral dose clearance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Kathleen Butler, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT03780166
    Other Study ID Numbers:
    • INCB 50465-208
    • Parsaclisib
    First Posted:
    Dec 19, 2018
    Last Update Posted:
    Sep 13, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Incyte Corporation
    Pemphigus vulgaris
    phosphatidylinositol 3-kinase delta
    immunoglobulin G autoantibodies
    Additional relevant MeSH terms:
    Pemphigus

    Study Results

    No Results Posted as of Sep 13, 2019