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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Prurigo (TRuE-PN1 Trial)

Phase 3

Recruiting

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Baseline PN-related WI-NRS score ≥ 7

≥ 6 pruriginous lesions on ≥ 2 different body areas at screening and baseline having a treatment area <20% BSA

Must not have

Total estimated BSA treatment area (excluding the scalp) > 20%

Uncontrolled thyroid function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 56 weeks

Awards & highlights

Pivotal Trial

Summary

This trial looks at how safe and well-tolerated a cream (Ruxolitinib) is in people with a skin condition (Prurigo Nodularis).

Who is the study for?

This trial is for individuals with Prurigo Nodularis (PN) who've had it for at least 3 months, have a moderate to severe itchiness score, and multiple itchy lesions in different body areas. Participants must not be pregnant or planning pregnancy and should avoid excessive UV exposure. Those with other skin conditions, uncontrolled thyroid issues, recent drug addiction history, or taking certain medications are excluded.

What is being tested?

The study is testing Ruxolitinib cream's safety and effectiveness against a placebo (Vehicle Cream) in treating PN. Participants will apply the creams to see if there's an improvement in their condition compared to those using the non-active cream.

What are the potential side effects?

Possible side effects of Ruxolitinib cream may include application site reactions like redness or irritation, headaches, dizziness, changes in blood counts leading to increased infection risk or bleeding problems. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My nerve pain score is 7 or higher.

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I have more than 6 itchy spots on at least 2 different parts of my body.

Exclusion Criteria

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

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Over 20% of my body, excluding my head, needs treatment.

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My thyroid function is not under control.

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I experience itching due to nerve issues or psychological reasons.

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I have long-term itching not caused by nerve damage.

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I am able to give my consent and am not under legal protection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 56 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 56 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response

Secondary study objectives

> 75% healed lesions from baseline in PAS at each postbaseline visit.

Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.

Change from baseline in EQ-5D-5L score at each postbaseline visit.

+12 more

Side effects data

From 2020 Phase 3 trial • 631 Patients • NCT03745638

Upper respiratory tract infection

Nasopharyngitis

Headache

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Ruxolitinib 0.75% Cream BID

Vehicle Cream BID

Ruxolitinib 1.5% Cream BID

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ruxolitinib 1.5% CreamExperimental Treatment1 Intervention

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 apply ruxolitinib 1.5% cream the open label extension (OLE) period for up to 40 weeks.

Group II: Vehicle Cream BIDPlacebo Group1 Intervention

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 apply ruxolitinib 1.5% cream topically during the open label extension (OLE) period for up to 40 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib Cream

2018

Completed Phase 3

~740

0 / 7Eligibility criteria met