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A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
TREATMENT
Phase
PHASE3
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
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/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Ruxolitinib 1.5% Cream
| DRUG: Ruxolitinib Cream
|
PLACEBO_COMPARATOR: Vehicle Cream
| DRUG: Vehicle Cream
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response | Defined as achieving a ≥ 4-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline. | Week 12 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
WI-NRS4 Response | Defined 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-TS | Defined as an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline | Week 12 |
WI-NRS4 Response | Defined 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 score | Up to 52 weeks |
Change from baseline in WI-NRS score | 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". | Up to 52 weeks |
Time to ≥ 2-point improvement from baseline in WI-NRS score | Participants 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 score | Defined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baseline | Up to 52 weeks |
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". | Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score |
Change from baseline 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". | 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 days | Up 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 outcome | Up to 56 weeks |
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