Prurigo nodularis

A Study to evaluate the efficacy and safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

Incyte Study ID:
INCB18424-320
CT.gov ID:
NCT05764161
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

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Prurigo nodularis
    • PRODUCT
  • Drug: Ruxolitinib Cream
  • Drug: Vehicle Cream
    • COLLABORATORS
    N/A
    DATE
    Jun 2023 - Dec 2024
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18 - 99 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Clinical diagnosis of PN ≥ 3 months before screening.
    • ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area <20% BSA.

    Exclusion Criteria

    • Chronic pruritus due to a condition other than PN
    • Total estimated BSA treatment area (excluding the scalp) > 20%.

    Clinical Study Locations

    Location
    Status
    Location
    LANDESKRANKENHAUS UNIVERSITATSKLINIKUM GRAZ
    GRAZ, Austria, 08036
    Status
    Recruiting
    Location
    ORDENSKLINIKUM LINZ GMBH ELISABETHINEN
    LINZ, Austria, 04020
    Status
    Recruiting
    Location
    SOZIALMEDIZINISCHES ZENTRUM OST-DONAUSPITAL
    VIENNA, Austria, 01220
    Status
    Recruiting
    Location
    VERACITY CLINICAL RESEARCH
    WOOLLOONGABBA, QLD, Australia, 04102
    Status
    Recruiting
    Location
    HOLDSWORTH HOUSE MEDICAL PRACTICE
    SYDNEY, NSW, Australia, 02010
    Status
    Recruiting
    Location
    PARATUS CLINICAL RESEARCH, WODEN
    PHILLIP, Australia, 02606
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB18424-320
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    190
    Primary Outcome
    Open

    Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response

    Timeframe: Week 12

    Secondary Outcome
    Open

    WI-NRS4 Response

    Timeframe: Week 4

    Overall Treatment Success (TS)

    Timeframe: Week 12

    IGA-CPG-S-TS

    Timeframe: Week 12

    WI-NRS4 Response

    Timeframe: Day 7

    Proportion of participants with WI-NRS4 at each postbaseline visit.

    Timeframe: Up to 52 weeks

    Change from baseline in WI-NRS score

    Timeframe: Up to 52 weeks

    Time to ≥ 2-point improvement from baseline in WI-NRS score

    Timeframe: Up to 52 weeks

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

    Timeframe: Up to 52 weeks

    Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score

    Timeframe: Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score

    Change from baseline in Skin Pain NRS score

    Timeframe: Up to 52 weeks

    IGA-TS response, defined as achieving IGA TS at each postbaseline visit.

    Timeframe: Up to 56 weeks

    IGA-CPG-A 0 or 1 response, defined as achieving an IGA score of 0 or 1 at each postbaseline visit.

    Timeframe: Up to 56 weeks

    > 75% healed lesions from baseline in PAS at each postbaseline visit.

    Timeframe: Up to 56 weeks

    Number of Treatment-emergent adverse events (TEAEs)

    Timeframe: Up to 56 weeks

    Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.

    Timeframe: Up to 56 weeks

    Change from baseline in EQ-5D-5L score at each postbaseline visit.

    Timeframe: Up to 56 weeks