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
EU CT Number:
2022-502461-23-00
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 - Oct 2025
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18 - 99 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    LANDESKRANKENHAUS UNIVERSITATSKLINIKUM GRAZ
    GRAZ, Austria, 08036
    Name
    ORDENSKLINIKUM LINZ GMBH ELISABETHINEN
    LINZ, Austria, 04020
    Name
    SOZIALMEDIZINISCHES ZENTRUM OST-DONAUSPITAL
    VIENNA, Austria, 01220
    Name
    VERACITY CLINICAL RESEARCH
    WOOLLOONGABBA, QLD, Australia, 04102
    Name
    HOLDSWORTH HOUSE MEDICAL PRACTICE
    SYDNEY, NSW, Australia, 02010
    Name
    PARATUS CLINICAL RESEARCH, WODEN
    PHILLIP, Australia, 02606
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    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%.
    Requirements information
    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.
    • IGA-CPG-S score of ≥ 2 at screening and baseline.
    • Baseline PN-related WI-NRS score ≥ 7.
    • Willingness to avoid pregnancy or fathering children.
    Exclusion Criteria
    • Chronic pruritus due to a condition other than PN
    • Total estimated BSA treatment area (excluding the scalp) > 20%.
    • Neuropathic and psychogenic pruritus
    • Active atopic dermatitis lesions within 3 months of screening and baseline.
    • Uncontrolled thyroid function
    • Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc
    • Protocol defined abnormal laboratory results.
    • Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.
    • Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline
    • or
    • Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline
    • Pregnant or lactating, or considering pregnancy.
    • History of alcoholism or drug addiction within 1 year
    • Known allergy or reaction to any of the components of the study drug.
    • Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
    • Employees of the sponsor or investigator or otherwise dependents of them.
    • The following participants are excluded in France:
    • a.Vulnerable populations according to article L.1121-6 of the French Public Health Code.
    • b.Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
    • c.Individuals not affiliated with the social security system.

    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: Ruxolitinib Cream
  • Drug: Vehicle Cream
    • 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