Acne Inversa

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Incyte Study ID:
INCB054707-801
CT.gov ID:
NCT06855498
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
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Clinical Study Purpose

Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Acne Inversa
    • PRODUCT
  • Drug: povorcitinib
    • COLLABORATORS
    N/A
    DATE
    Feb 2025 - Feb 2028
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Status
    Contact Us
    Name
    Investigative Site CA001
    PETERBOROUGH, ON, Canada, K9J 5K2
    Status
    Not yet recruiting
    Name
    Investigative Site CA002
    LONDON, ON, Canada, N6H 5L5
    Status
    Not yet recruiting
    Name
    Investigative Site CA003
    WINNIPEG, MB, Canada, R3M 3Z4
    Status
    Not yet recruiting
    Name
    Investigative Site CA004
    BARRIE, ON, Canada, L4M 7G1
    Status
    Not yet recruiting
    Name
    Investigative Site CA005
    EDMONTON, AB, Canada, T6G 1C3
    Status
    Not yet recruiting
    Name
    Investigative Site CA007
    MONTREAL, QC, Canada, H2X 2V1
    Status
    Not yet recruiting

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Ability to comprehend and willingness to sign a written ICF for the study.
    • Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment.

    Exclusion Criteria

    • Had been permanently discontinued from study treatment during the parent study.
    • Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study.

    Protocol Summary

    Incyte Study ID:
    INCB054707-801
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    600
    Primary Outcome
    Open

    Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: Up to approximately 3 years

    Secondary Outcome
    Open

    Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit

    Timeframe: Up to approximately 3 years