Ulcerative Colitis

A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis

Incyte Study ID:
INCB 39110-210
CT.gov ID:
NCT03627052
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
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Clinical Study Purpose

The purpose of this study is to evaluate the efficacy and safety of itacitinib in participants with moderate to severe ulcerative colitis (UC).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Ulcerative Colitis
    • PRODUCT
  • Drug: Itacitinib
  • Drug: Placebo
    • COLLABORATORS
    N/A
    DATE
    Sep 2018 - Nov 2019
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18 - 74 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Confirmed diagnosis of UC at least 12 weeks before screening based on clinical, endoscopic, and histopathological evidence.
    • Have a 3-component Mayo score of 4 to 9, which includes a modified Mayo Endoscopy Score (mMES) of ≥ 2 as determined by a central reader, a rectal bleeding score of ≥ 1, and a stool frequency score of ≥ 1.

    Exclusion Criteria

    • Clinical signs of fulminant colitis or toxic megacolon.
    • Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical or radiographic findings suggestive of Crohn's disease.

    Clinical Study Locations

    Location
    Status
    Location
    Yuma Gastro, LLC
    Yuma, Arizona, US, 85364
    Status
    Withdrawn
    Location
    eStudySite - Chula Vista
    Chula Vista, California, US, 91911
    Status
    Withdrawn
    Location
    Advanced Pharma CR, LLC
    Miami, Florida, US, 33147
    Status
    Withdrawn
    Location
    Advanced Research Institute, Inc.
    New Port Richey, Florida, US, 34653
    Status
    Withdrawn
    Location
    LENUS Research
    Sweetwater, Florida, US, 33172
    Status
    Withdrawn
    Location
    Remington-Davis, Inc. Clinical Research
    Columbus, Ohio, US, 43215
    Status
    Withdrawn

    Protocol Summary

    Incyte Study ID:
    INCB 39110-210
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Double (Participant, Investigator)
    Interventions:
    Drug
    Enrollment:
    0
    Primary Outcome
    Open

    Proportion of participants with a Clinical Response

    Timeframe: Week 8

    Secondary Outcome
    Open

    Proportion of participants with Endoscopic Response

    Timeframe: Week 8

    Proportion of participants with Mucosal Healing

    Timeframe: Week 8

    Proportion of participants in Endoscopic Remission

    Timeframe: Week 8

    Proportion of participants in Clinical Remission

    Timeframe: Week 8

    Change from baseline in 3-component Mayo score

    Timeframe: Week 8

    Change from baseline in Physician's Global Assessment score

    Timeframe: Week 8

    Change in Quality of Life score as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)

    Timeframe: Week 8

    Cmax of itacitinib

    Timeframe: Week 4

    Ctau of itacitinib

    Timeframe: Weeks 2 and 4

    Stool concentration of itacitinib -~30-hr collection

    Timeframe: Week 4

    Number of treatment-emergent adverse events

    Timeframe: Up to approximately 60 weeks