Hives

Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria

Incyte Study ID:
INCB54707-207
CT.gov ID:
NCT05936567
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Clinical Study Purpose

This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Hives
    • PRODUCT
  • Drug: Povorcitinib
  • Drug: Placebo
    • COLLABORATORS
    N/A
    DATE
    Jul 2023 - Feb 2025
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18 - 65 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    CHARITE UNIVERSITAETSMEDIZIN BERLIN - CAMPUS BENJAMIN FRANKLIN
    BERLIN, Germany, 12200
    Name
    UNIVERSITATS-HAUTKLINK TUBINGEN
    TUEBINGEN, Germany, 72076
    Name
    UNIVERSITAETSKLINIKUM CARL GUSTAV CARUS TU DRESDEN
    DRESDEN, Germany, 01307
    Name
    UNIVERSITATSKLINIKUM FRANKFURT
    FRANKFURT, Germany, 60590
    Name
    KLIFOS - KLINISCHE FORSCHUNG OSNABRUCK
    OSNABRÜCK, Germany, 49074
    Name
    UNIVERSITAETSKLINIKUM SCHLESWIG-HOLSTEIN - CAMPUS KIEL
    KIEL, Germany, 24105

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Participants are eligible to be included in the study only if all of the following criteria apply:
    • CSU diagnosis for ≥ 3 months prior to screening.

    Exclusion Criteria

    • Treatment with an anti-IgE biologic (eg, omalizumab) within 8 weeks prior to screening.
    • Clearly defined underlying etiology for chronic urticarias other than CSU

    Protocol Summary

    Incyte Study ID:
    INCB54707-207
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    136
    Primary Outcome
    Open

    Change from baseline in the urticaria activity score (UAS7)

    Timeframe: 12 Weeks

    Secondary Outcome
    Open

    Proportion of participants who achieve UAS7 ≤ 6 (controlled disease) at Week 12

    Timeframe: 12 Weeks

    Time to first achievement of UAS7 ≤ 6 (controlled disease) during the PC period

    Timeframe: 12 Weeks

    Proportion of participants with UAS7 = 0 at Week 12.

    Timeframe: 12 Weeks