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

Primary Purpose

Pemphigus Vulgaris

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Parsaclisib
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pemphigus Vulgaris focused on measuring Pemphigus vulgaris, phosphatidylinositol 3-kinase delta, immunoglobulin G autoantibodies

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Parsaclisib

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Cmax of Parsaclisib
    Maximum observed concentration.
    tmax of Parsaclisib
    Time to maximum concentration.
    Cmin of Parsaclisib
    Minimum observed concentration over the dose interval.
    AUC0-t of Parsaclisib
    Area under the concentration-time curve from time = 0 to the last measurable concentration at time = t.
    CL/F of Parsaclisib
    Apparent oral dose clearance.

    Full Information

    First Posted
    December 17, 2018
    Last Updated
    September 11, 2019
    Sponsor
    Incyte Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03780166
    Brief Title
    A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris
    Official Title
    A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study was withdrawn due to insufficient interest in study participation due to recent approval in this rare condition.
    Study Start Date
    March 2019 (Anticipated)
    Primary Completion Date
    November 2020 (Anticipated)
    Study Completion Date
    November 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Incyte Corporation

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pemphigus Vulgaris
    Keywords
    Pemphigus vulgaris, phosphatidylinositol 3-kinase delta, immunoglobulin G autoantibodies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Parsaclisib
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Parsaclisib
    Other Intervention Name(s)
    INCB050465
    Intervention Description
    Parsaclisib administered orally once daily at the cohort-specified dose level.
    Primary Outcome Measure Information:
    Title
    Number of treatment-emergent adverse events
    Description
    Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
    Time Frame
    Up to 20 weeks
    Secondary Outcome Measure Information:
    Title
    Cmax of Parsaclisib
    Description
    Maximum observed concentration.
    Time Frame
    Up to 6 weeks
    Title
    tmax of Parsaclisib
    Description
    Time to maximum concentration.
    Time Frame
    Up to 6 weeks
    Title
    Cmin of Parsaclisib
    Description
    Minimum observed concentration over the dose interval.
    Time Frame
    Up to 6 weeks
    Title
    AUC0-t of Parsaclisib
    Description
    Area under the concentration-time curve from time = 0 to the last measurable concentration at time = t.
    Time Frame
    Up to 6 weeks
    Title
    CL/F of Parsaclisib
    Description
    Apparent oral dose clearance.
    Time Frame
    Up to 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kathleen Butler, MD
    Organizational Affiliation
    Incyte Corporation
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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