A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

PHASE3RECRUITING

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

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Study details:

The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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:
  • 1. Vulnerable populations according to article L.1121-6 of the French Public Health Code.
  • 2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
  • 3. Individuals not affiliated with the social security system.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-06-12

    Primary completion: 2024-11-03

    Study completion finish: 2025-08-05

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT05764161

    Intervention or treatment

    DRUG: Ruxolitinib Cream

    DRUG: Vehicle Cream

    Conditions

    • Prurigo Nodularis

    Find a site

    Closest Location:

    Premier Specialists Pty Ltd

    Research sites nearby

    Select from list below to view details:

    • Premier Specialists Pty Ltd

      Kogarah, New South Wales, Australia

    • Liverpool Hospital

      Liverpool, New South Wales, Australia

    • Holdsworth House Medical Practice

      Sydney, New South Wales, Australia

    • Westmead Hospital

      Sydney, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Ruxolitinib 1.5% Cream
    • Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.
    DRUG: Ruxolitinib Cream
    • Ruxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period.
    PLACEBO_COMPARATOR: Vehicle Cream
    • Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.
    DRUG: Vehicle Cream
    • Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle-controlled period.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score ResponseDefined as achieving a ≥ 4-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline.Week 12

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    WI-NRS4 ResponseDefined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.Week 4
    Overall Treatment Success (TS)Defined as achieving both a WI-NRS4 response and an Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS).Week 12
    IGA-CPG-S-TSDefined as an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baselineWeek 12
    WI-NRS4 ResponseDefined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.Day 7
    Proportion of participants with WI-NRS4 at each postbaseline visit.Defined as percentage of participants that achieve a ≥ 4-point improvement in WI-NRS scoreUp to 52 weeks
    Change from baseline in WI-NRS scoreDefined as change in Intensity of itch. Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".Up to 52 weeks
    Time to ≥ 2-point improvement from baseline in WI-NRS scoreParticipants rate pruritus daily on Worst Itch \[pruritis\] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)Up to 52 weeks
    Time to ≥ 4-point improvement from baseline in WI-NRS scoreDefined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baselineUp to 52 weeks
    Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS scoreItch NRS is an 11-point scale (0 to 10) where 0 is "no itch" and 10 is the "worst itch imaginable".Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score
    Change from baseline in Skin Pain NRS scoreItch NRS is an 11-point scale (0 to 10) where 0 is "no itch" and 10 is the "worst itch imaginable".Up to 52 weeks
    IGA-TS response, defined as achieving IGA TS at each postbaseline visit.The IGA-CPG-s for chronic prurigo nodularis considers the number of nodules, also referred to as lesions, and uses them to determine an overall severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe).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.The IGA-CPG-A is an overall PN severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The IGA-CPG-A score is based on disease activity based on % of PN lesions with excoriations or crusts.Up to 56 weeks
    > 75% healed lesions from baseline in PAS at each postbaseline visit.PAS includes 5 items; descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions, and disease activity in terms of percentage of pruriginous lesions with excoriations/crusts on top.Up to 56 weeks
    Number of Treatment-emergent adverse events (TEAEs)TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.Up to 56 weeks
    Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 daysUp to 56 weeks
    Change from baseline in EQ-5D-5L score at each postbaseline visit.The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcomeUp to 56 weeks

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    References

    Clinical Trials Gov: A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

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