Prurigo nodularis

A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis

Incyte Study ID:
INCB 54707-206
CT.gov ID:
NCT05061693
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Results Available

Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
Available Languages: English
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Clinical Study Purpose

The purpose of this study is to evaluate the efficacy and safety of INCB054707 in participants with prurigo nodularis over a 16-week double-blind placebo-controlled treatment period, followed by a 24 -week single blind extension period.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Prurigo nodularis
    • PRODUCT
  • Drug: INCB054707
  • Drug: Placebo
    • COLLABORATORS
    N/A
    DATE
    Nov 2021 - Aug 2023
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18 - N/A
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    Investigative Site US001
    Fountain Valley, CA, US, 92708
    Name
    Investigative Site US002
    Dublin, OH, US, 43016
    Name
    Investigative Site US006
    Saint Joseph, MO, US, 64506
    Name
    Investigative Site US005
    AUSTIN, TX, US, 78745
    Name
    Investigative Site US004
    PORTSMOUTH, NH, US, 03801
    Name
    Investigative Site US007
    HOUSTON, TX, US, 77004

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Clinical diagnosis of PN for at least 3 months before screening.
    • Inadequate response or intolerant to ongoing or prior PN therapy.

    Exclusion Criteria

    • Have chronic pruritus due to a condition other than PN; have neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.
    • Current use of a medication known to cause pruritus.

    Protocol Summary

    Incyte Study ID:
    INCB 54707-206
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    146
    Primary Outcome
    Open

    Proportion of participants achieving ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score

    Timeframe: Week 16

    Secondary Outcome
    Open

    Proportion of participants achieving Investigator's Global Assessment Treatment Success (IGA-TS)

    Timeframe: Week 16

    Time to ≥ 4-point improvement from baseline in Itch NRS score

    Timeframe: Up to Week 48

    Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: Up to Week 48