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Topical Therapy

Maximal Use Ruxolitinib 1.5% for Prurigo Nodularis

Phase 1
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Total estimated treatment BSA ≥ 25% (excluding the scalp) at screening and baseline
Baseline PN-related WI-NRS score ≥ 7. Baseline WI-NRS score is defined as the 7-day average of WI-NRS scores before Day 1 (data from a minimum of 4 out of 7 days prior to Day 1 is needed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks, including 30 days of safety follow-up
Awards & highlights

Study Summary

This trial is being done to see if it is safe and well-tolerated to use a cream called ruxolitinib 1.5% on people with a skin condition called Prur

Who is the study for?
This trial is for individuals with skin conditions like Prurigo, Prurigo Nodularis, or Atopic Dermatitis. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors such as other medical conditions or treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing Ruxolitinib Cream at a concentration of 1.5% to see how safe and tolerable it is when used to its maximum recommended amount by people with Prurigo Nodularis (PN).See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects of topical medications like ruxolitinib cream can include skin irritation, redness, itching or burning sensation at the application site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Over 25% of my body, excluding my head, is affected and needs treatment.
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My average pain score is 7 or higher over the past week.
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I have itchy skin lesions in at least two different areas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks, including 30 days of safety follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks, including 30 days of safety follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with TEAEs leading to dose interruption or discontinuation
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Ruxolitinib pharmacokinetic (PK) parameters in plasma

Trial Design

1Treatment groups
Experimental Treatment
Group I: Maximal Use Ruxolitinib 1.5%Experimental Treatment1 Intervention
Participants will apply ruxolitinib 1.5% cream BID through Week 4 to all pruriginous lesions. At Week 4, participants who have completed 4 weeks of treatment with no safety concerns may enter the optional 4-week treatment extension period, during which all participants will apply ruxolitinib 1.5% cream BID to existing pruriginous lesions.

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
365 Previous Clinical Trials
55,271 Total Patients Enrolled
2 Trials studying Prurigo Nodularis
326 Patients Enrolled for Prurigo Nodularis
Incyte Medical MonitorStudy DirectorIncyte Corporation
23 Previous Clinical Trials
5,048 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities for individuals to enroll as participants in this ongoing medical research study?

"Indeed, as indicated on clinicaltrials.gov, this trial is actively seeking eligible participants. The initial posting of the trial occurred on January 31st, 2024 and the most recent update was made on January 10th, 2024."

Answered by AI

Which specific individuals are considered the ideal candidates for inclusion in this clinical trial?

"In order to be eligible for this clinical study, potential participants must have a diagnosis of prurigo nodularis and fall within the age range of 18 to 65. The trial has capacity for a total of 30 individuals."

Answered by AI

What is the total number of participants being recruited for this clinical investigation?

"To successfully carry out this research, a total of 30 eligible participants who meet the trial's inclusion criteria are required. The sponsor, Incyte Corporation, will oversee the study from various locations including Oakland Hills Dermatology Pc in Auburn Hills, Michigan and North Texas Center For Clinical Research Ntccr in Frisco, Pennsylvania."

Answered by AI

Are there a significant number of medical facilities in the United States conducting this clinical trial?

"To minimize travel requirements, it is beneficial to choose a clinical trial site closest to your location. Currently, this study is being conducted at 13 different sites across various locations such as Auburn Hills, Frisco, Philadelphia, and several others."

Answered by AI

Is the age criterion for participation in this medical study limited to individuals below 75 years old?

"This investigation is open to individuals aged 18 years and above, but below the age of 65."

Answered by AI

What is the safety profile of Ruxolitinib 1.5% when used at its maximum recommended dosage?

"Due to the nature of this Phase 1 trial, which has limited data supporting safety and efficacy, our team at Power considers the safety rating for Maximal Use Ruxolitinib 1.5% to be a score of 1 on a scale from 1 to 3."

Answered by AI

Who else is applying?

What site did they apply to?
Advanced Pharma Cr, Llc
Central Sooner Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream
2024. "A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06213831.
All > Prurigo Nodularis > Fort Worth
~16 spots leftby Dec 2024
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