Prurigo nodularis

A study to evaluate the safety and tolerability of maximal use Ruxolitinib Cream

Incyte Study ID:
INCB18424-110
CT.gov ID:
NCT06213831
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 determine the safety and tolerability of ruxolitinib 1.5% cream under maximal use conditions in participants with Prurigo Nodularis (PN).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Prurigo nodularis
    • PRODUCT
  • Drug: Ruxolitinib Cream 1.5%
    • COLLABORATORS
    N/A
    DATE
    Feb 2024 - Aug 2025
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18 - 65 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    FIRST OC DERMATOLOGY
    FOUNTAIN VALLEY, CA, US, 92708
    Name
    ADVANCED PHARMA CR, LLC
    MIAMI, FL, US, 33147
    Name
    DERMRESEARCH, INC.
    AUSTIN, TX, US, 78759
    Name
    NORTH TEXAS CENTER FOR CLINICAL RESEARCH NTCCR
    FRISCO, TX, US, 75034
    Name
    CENTRAL SOONER RESEARCH
    OKLAHOMA CITY, OK, US, 73170
    Name
    REVIVAL RESEARCH INSTITUTE, LLC TROY
    TROY, MI, US, 48084

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Clinical diagnosis of PN ≥ 3 months before screening.
    • Pruriginous lesions (defined as papules, nodules, plaques, umbilicated lesions, and linear lesions) on ≥ 2 different body areas (such as right and left leg) at screening and baseline.

    Exclusion Criteria

    • Chronic or acute pruritus due to a condition other than PN.
    • Active AD lesions (signs and symptoms other than dry skin) within 6 months of screening and baseline.

    Protocol Summary

    Incyte Study ID:
    INCB18424-110
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    23
    Primary Outcome
    Open

    Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Up to 16 weeks, including 30 days of safety follow-up

    Number of participants with TEAEs leading to dose interruption or discontinuation

    Timeframe: Up to 16 weeks, including 30 days of safety follow-up

    Secondary Outcome
    Open

    Ruxolitinib pharmacokinetic (PK) parameters in plasma

    Timeframe: Up to 16 weeks, including 30 days of safety follow-up