Asthma

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma

Incyte Study ID:
INCB54707-208
CT.gov ID:
NCT05851443
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

The study is being conducted to evaluate the effect of 3 dosing regimens of

povorcitinib on pulmonary function

Clinical Study Summary

MEDICAL CONDITION(S)
  • Asthma
    • PRODUCT
  • Drug: povorcitinib
  • Drug: ICS-LABA
    • COLLABORATORS
    N/A
    DATE
    Jul 2023 - Oct 2025
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18 - 65 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Location
    Status
    Location
    KERN ALLERGY MEDICAL CLINIC, INC
    BAKERSFIELD, CA, US, 93301
    Status
    Recruiting
    Location
    OTTAWA ALLERGY RESEARCH CORPORATION
    OTTAWA, ON, Canada, K1H 1E4
    Status
    Recruiting
    Location
    CARE RESEARCH CENTER, INC
    MIAMI, FL, US, 33175
    Status
    Completed
    Location
    QUALITY ASSURANCE RESEARCH CENTER
    SAN ANTONIO, TX, US, 78207
    Status
    Recruiting
    Location
    CENTRE FOR LUNG HEALTH
    VANCOUVER, BC, Canada, V5Z 1M9
    Status
    Recruiting
    Location
    DR. SYED ANEES MEDICINE PROFESSIONAL CORPORATION
    WINDSOR, ON, Canada, N8X 1T3
    Status
    Recruiting

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening.
    • Pre-BD FEV1 < 80% predicted according to central over read value at Visit 2.

    Exclusion Criteria

    • Maintenance use of asthma controllers other than ICS-LABA.
    • Have undergone bronchial thermoplasty.

    Protocol Summary

    Incyte Study ID:
    INCB54707-208
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Double (Participant, Investigator)
    Interventions:
    Drug
    Enrollment:
    240
    Primary Outcome
    Open

    Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)

    Timeframe: Baseline ; Week 24

    Secondary Outcome
    Open

    Number of asthma exacerbations during the Placebo Controlled (PC) period

    Timeframe: Up to 28 weeks

    Absolute change from baseline in pre-BD FEV1 at each visit

    Timeframe: Up to 14 months

    Percent change from baseline in pre-BD FEV1 at each visit

    Timeframe: Up to 14 months

    Absolute change from baseline in post-BD FEV1 at week 24

    Timeframe: Baseline; Week 24

    Percent change from baseline in post-BD FEV1 at week 24

    Timeframe: Baseline; Week 24

    Absolute change from baseline in pre-BD FVC at each visit

    Timeframe: Up to 14 months

    Percent change from baseline in pre-BD FVC at each visit

    Timeframe: Up to 14 months