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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Prurigo Nodularis (TRuE-PN2 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
Willingness to avoid pregnancy or fathering children
Clinical diagnosis of PN ≥ 3 months before screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 56 weeks
Awards & highlights

TRuE-PN2 Trial Summary

This trial will test a new cream to see if it's safe and effective for Prurigo Nodularis, a skin condition.

Who is the study for?
This trial is for individuals with Prurigo Nodularis who've had it for at least 3 months, have a significant itch score (≥7), and more than six itchy lesions across two body areas. Participants must not be pregnant or planning to become so and should not have used certain medications recently.Check my eligibility
What is being tested?
The study tests Ruxolitinib cream's effectiveness in reducing itching and improving skin condition compared to a placebo cream (Vehicle Cream). It aims to determine how safe and tolerable the medication is for people with Prurigo Nodularis.See study design
What are the potential side effects?
While specific side effects are not listed, Ruxolitinib may commonly cause application site reactions, headaches, dizziness, or increased risk of infections. The trial will monitor participants closely for any adverse effects.

TRuE-PN2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with peripheral neuropathy for at least 3 months.
Select...
I have more than 6 itchy spots on at least 2 different parts of my body, covering less than 20% of my skin.
Select...
You have a score of 2 or higher on the IGA-CPG-S test during screening and at the start of the study.

TRuE-PN2 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response
Secondary outcome measures
> 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
9%
Upper respiratory tract infection
6%
Nasopharyngitis
4%
Headache
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib 0.75% Cream BID
Vehicle Cream BID
Ruxolitinib 1.5% Cream BID

TRuE-PN2 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 enter the open label extension (OLE) period for up to 40 weeks.
Group II: Vehicle CreamPlacebo 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 enter 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
~640

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
365 Previous Clinical Trials
55,115 Total Patients Enrolled
2 Trials studying Prurigo Nodularis
170 Patients Enrolled for Prurigo Nodularis

Media Library

Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05764161 — Phase 3
Prurigo Nodularis Research Study Groups: Ruxolitinib 1.5% Cream, Vehicle Cream
Prurigo Nodularis Clinical Trial 2023: Ruxolitinib Cream Highlights & Side Effects. Trial Name: NCT05764161 — Phase 3
Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05764161 — Phase 3

Frequently Asked Questions

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

Are researchers currently seeking participants for this research endeavor?

"According to the clinical trial registry, this study is currently recruiting participants. This trial was first posted on June 12th 2023 and was subsequently edited two weeks later."

Answered by AI

Is Ruxolitinib 1.5% Cream a risk-free treatment option?

"Due to the Phase 3 trial status of Ruxolitinib 1.5% Cream, there is evidence that this medication has proven efficacy and reliable safety features; thus our team at Power have awarded it a score of 3 on their scale."

Answered by AI

What is the enrollment number for this clinical research endeavor?

"This investigation requires 180 volunteers who meet its qualifications to get involved. Those interested can reach out to Dermatology Research Associates in Los Angeles, California or Clinical Science Institute Clinical Research Specialists Inc in Santa Monica, Florida."

Answered by AI

What is the geographic scope of this trial's administration?

"At present, 78 different sites have opened up recruitment for this medical trial. These include locations in Los Angeles, Santa Monica and Sherman Oaks as well as many other areas. To reduce the strain of travelling to a distant site, it is advisable to enrol at the closest facility possible."

Answered by AI

Does this investigation permit those younger than 65 to participate?

"According to the study's prerequisites for inclusion, participants must be of legal age (18) or above and no more than 99 years old."

Answered by AI

Am I a viable candidate to take part in this research?

"This medical trial seeks 180 individuals aged 18-99 suffering from prurigo nodularis. To qualify, patients must have a clinical diagnosis of PN for at least 3 months prior to the screening process; they must present with 6 or more itchy lesions on two different body parts and an IGA-CPG-S score of 2 or higher. Additionally, baseline PN related WI NRS scores should be 7 or greater and participants must agree to abstain from fathering children during the study period."

Answered by AI

Who else is applying?

What site did they apply to?
Aventiv Research Inc-Dublin
Marietta Dermatology the Skin Cancer Center Marietta
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I’ve tried everything else.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
2023. "A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05764161.
All > Prurigo Nodularis
~67 spots leftby Nov 2024
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