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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 56 weeks
Awards & highlights
TRuE-PN1 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.Check my eligibility
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.See study design
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.
TRuE-PN1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My nerve pain score is 7 or higher.
Select...
I have more than 6 itchy spots on at least 2 different parts of my body.
TRuE-PN1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 56 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 56 weeks
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 moreSide effects data
From 2020 Phase 3 trial • 631 Patients • NCT037456389%
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-PN1 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
~640
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
365 Previous Clinical Trials
55,009 Total Patients Enrolled
3 Trials studying Prurigo
350 Patients Enrolled for Prurigo
Haq Nawaz, mdStudy DirectorIncyte Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Over 20% of my body, excluding my head, needs treatment.My thyroid function is not under control.I haven't had UV therapy or significant sun exposure in the last 4 weeks.You have had active eczema rashes in the past 3 months.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.I do not have any serious health issues that could affect the study's evaluation.You have struggled with alcohol or drug addiction in the past year.I experience itching due to nerve issues or psychological reasons.I have long-term itching not caused by nerve damage.My nerve pain score is 7 or higher.I have more than 6 itchy spots on at least 2 different parts of my body.I am able to give my consent and am not under legal protection.You have been ordered to stay in a mental health facility by a court or government authority.
Research Study Groups:
This trial has the following groups:- Group 1: Vehicle Cream BID
- Group 2: Ruxolitinib 1.5% Cream
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor include participants who are under the age of 45?
"Eligible participants for this trial must be aged 18 or above and below 99."
Answered by AI
Are there any eligibility requirements for me to participate in this research?
"To be accepted to this clinical trial, patients must present with prurigo and their age should lie between 18 and 99. In total, 200 participants are needed for the study."
Answered by AI
How many medical facilities are presently conducting this clinical trial?
"Potential participants have the opportunity to join this research out of 81 locations, including Phoenix, Fort Smith and Fountain Valley. To reduce transportation costs for those involved, it is recommended that they select the closest trial centre available."
Answered by AI
Are there any remaining vacancies available for applicants to partake in this experiment?
"Yes, the details posted on clinicaltrials.gov demonstrate that this study is currently taking part in patient recruitment. The trial began seeking volunteers on March 10th 2023 and was last updated May 12th 2023. Approximately 200 participants are needed from 81 different sites across the country."
Answered by AI
Is Ruxolitinib 1.5% Cream a safe and viable therapeutic option?
"Our assessment at Power score the safety of Ruxolitinib 1.5% Cream 3 out of a possible 3, due to existing evidence from Phase 3 trials verifying its efficacy and multiple rounds confirming it is safe."
Answered by AI
How many participants are involved in the research project?
"Affirmative. According to the information published on clinicaltrials.gov, this experiment is still seeking volunteers and has been since March 10th 2023 - with its last update occurring May 12th of the same year. 200 participants are sought out from 81 separate locations for the study."
Answered by AI
Who else is applying?
What site did they apply to?
Johnson Dermatology
What portion of applicants met pre-screening criteria?
Did not meet criteria
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