Ruxolitinib Cream for Prurigo
(TRuE-PN1 Trial)

Recruiting in Palo Alto (17 mi)

+98 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Incyte Corporation

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with peripheral neuropathy for at least 3 months.

You have a score of 2 or higher on the IGA-CPG-S test at the initial and follow-up screenings.

Willingness to avoid pregnancy or fathering children

+2 more

Exclusion Criteria

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

My thyroid function is not under control.

Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching

+13 more

Participant Groups

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.

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.

Ruxolitinib Cream is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Opzelura for: