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Topical Therapy

Ruxolitinib Cream for Prurigo

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)

Must not have

Chronic or acute pruritus due to a condition other than PN

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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).

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have long-lasting or sudden itchiness not caused by nerve damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 16 weeks, including 30 days of safety follow-up

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with TEAEs leading to dose interruption or discontinuation

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

Secondary study objectives

Ruxolitinib pharmacokinetic (PK) parameters in plasma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met