A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
- Conditions
- Prurigo Nodularis
- Interventions
- Drug: Vehicle Cream
- Registration Number
- NCT05764161
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 190
- 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.
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Chronic pruritus due to a condition other than PN
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Total estimated BSA treatment area (excluding the scalp) > 20%.
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Neuropathic and psychogenic pruritus
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Active atopic dermatitis lesions within 3 months of screening and baseline.
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Uncontrolled thyroid function
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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.
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Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.
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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
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Pregnant or lactating, or considering pregnancy.
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History of alcoholism or drug addiction within 1 year
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Known allergy or reaction to any of the components of the study drug.
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Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
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Employees of the sponsor or investigator or otherwise dependents of them.
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The following participants are excluded in France:
- Vulnerable populations according to article L.1121-6 of the French Public Health Code.
- Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
- Individuals not affiliated with the social security system.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Cream 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. Ruxolitinib 1.5% Cream Ruxolitinib 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.
- Primary Outcome Measures
Name Time Method Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response Week 12 Defined as achieving a ≥ 4-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline.
- Secondary Outcome Measures
Name Time Method Overall Treatment Success (TS) Week 12 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).
WI-NRS4 Response Day 7 Defined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.
Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score Itch NRS is an 11-point scale (0 to 10) where 0 is "no itch" and 10 is the "worst itch imaginable".
> 75% healed lesions from baseline in PAS at each postbaseline visit. Up to 56 weeks 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.
Time to ≥ 2-point improvement from baseline in WI-NRS score Up to 52 weeks Participants rate pruritus daily on Worst Itch \[pruritis\] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Number of Treatment-emergent adverse events (TEAEs) Up to 56 weeks 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.
Proportion of participants with WI-NRS4 at each postbaseline visit. Up to 52 weeks Defined as percentage of participants that achieve a ≥ 4-point improvement in WI-NRS score
IGA-CPG-A 0 or 1 response, defined as achieving an IGA score of 0 or 1 at each postbaseline visit. Up to 56 weeks 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.
Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit. Up to 56 weeks The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days
IGA-CPG-S-TS Week 12 Defined as an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline
Time to ≥ 4-point improvement from baseline in WI-NRS score Up to 52 weeks Defined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baseline
IGA-TS response, defined as achieving IGA TS at each postbaseline visit. Up to 56 weeks 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).
Change from baseline in WI-NRS score Up to 52 weeks Defined 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".
Change from baseline in Skin Pain NRS score Up to 52 weeks Itch NRS is an 11-point scale (0 to 10) where 0 is "no itch" and 10 is the "worst itch imaginable".
Change from baseline in EQ-5D-5L score at each postbaseline visit. Up to 56 weeks The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome
Trial Locations
- Locations (76)
University of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Northwest Arkansas Clinical Trials Center
🇺🇸Arkansas, Arkansas, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Clinical Science Institute Clinical Research Specialists Inc
🇺🇸Santa Monica, California, United States
Cura Clinical Research
🇺🇸Sherman Oaks, California, United States
Ars - Maitland Clinical Research Unit
🇺🇸Orlando, Florida, United States
Marietta Dermatology the Skin Cancer Center Marietta
🇺🇸Marietta, Georgia, United States
The South Bend Clinic Main Campus
🇺🇸South Bend, Indiana, United States
Axon Clinical Research
🇺🇸Baltimore, Maryland, United States
Activmed Practices Research, Llc Beverly
🇺🇸Beverly, Massachusetts, United States
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