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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05764161




Registration number
NCT05764161
Ethics application status
Date submitted
1/03/2023
Date registered
10/03/2023

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
Scientific title
A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis
Secondary ID [1] 0 0
INCB18424-320
Universal Trial Number (UTN)
Trial acronym
TRuE-PN2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prurigo Nodularis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Ruxolitinib Cream
Treatment: Drugs - Vehicle Cream

Experimental: Ruxolitinib 1.5% Cream - 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.

Placebo comparator: Vehicle Cream - 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: Drugs: Ruxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period.

Treatment: Drugs: Vehicle Cream
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle-controlled period.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Worst-Itch Numeric Rating Scale (WI-NRS) = 4-point improvement in WI-NRS score Response
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
WI-NRS4 Response
Timepoint [1] 0 0
Week 4
Secondary outcome [2] 0 0
Overall Treatment Success (TS)
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
IGA-CPG-S-TS
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
WI-NRS4 Response
Timepoint [4] 0 0
Day 7
Secondary outcome [5] 0 0
Proportion of participants with WI-NRS4 at each postbaseline visit.
Timepoint [5] 0 0
Up to 52 weeks
Secondary outcome [6] 0 0
Change from baseline in WI-NRS score
Timepoint [6] 0 0
Up to 52 weeks
Secondary outcome [7] 0 0
Time to = 2-point improvement from baseline in WI-NRS score
Timepoint [7] 0 0
Up to 52 weeks
Secondary outcome [8] 0 0
Time to = 4-point improvement from baseline in WI-NRS score
Timepoint [8] 0 0
Up to 52 weeks
Secondary outcome [9] 0 0
Skin pain response, defined as a = 2-point improvement in Skin Pain NRS score
Timepoint [9] 0 0
Skin pain response, defined as a = 2-point improvement in Skin Pain NRS score
Secondary outcome [10] 0 0
Change from baseline in Skin Pain NRS score
Timepoint [10] 0 0
Up to 52 weeks
Secondary outcome [11] 0 0
IGA-TS response, defined as achieving IGA TS at each postbaseline visit.
Timepoint [11] 0 0
Up to 56 weeks
Secondary outcome [12] 0 0
IGA-CPG-A 0 or 1 response, defined as achieving an IGA score of 0 or 1 at each postbaseline visit.
Timepoint [12] 0 0
Up to 56 weeks
Secondary outcome [13] 0 0
> 75% healed lesions from baseline in PAS at each postbaseline visit.
Timepoint [13] 0 0
Up to 56 weeks
Secondary outcome [14] 0 0
Number of Treatment-emergent adverse events (TEAEs)
Timepoint [14] 0 0
Up to 56 weeks
Secondary outcome [15] 0 0
Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
Timepoint [15] 0 0
Up to 56 weeks
Secondary outcome [16] 0 0
Change from baseline in EQ-5D-5L score at each postbaseline visit.
Timepoint [16] 0 0
Up to 56 weeks

Eligibility
Key inclusion criteria
* Clinical diagnosis of PN = 3 months before screening.
* = 6 pruriginous lesions on = 2 different body areas (such as right and left leg) at screening and baseline having a treatment area <20% BSA.
* IGA-CPG-S score of = 2 at screening and baseline.
* Baseline PN-related WI-NRS score = 7.
* Willingness to avoid pregnancy or fathering children.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Chronic pruritus due to a condition other than PN
* Total estimated BSA treatment area (excluding the scalp) > 20%.
* Neuropathic and psychogenic pruritus
* Active atopic dermatitis lesions within 3 months of screening and baseline.
* Uncontrolled thyroid function
* Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results.
* Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.
* Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline
* Pregnant or lactating, or considering pregnancy.
* History of alcoholism or drug addiction within 1 year
* Known allergy or reaction to any of the components of the study drug.
* Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
* Employees of the sponsor or investigator or otherwise dependents of them.
* The following participants are excluded in France:

1. Vulnerable populations according to article L.1121-6 of the French Public Health Code.
2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
3. Individuals not affiliated with the social security system.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/08/2025
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Premier Specialists Pty Ltd - Kogarah
Recruitment hospital [2] 0 0
Novatrials - Kotara
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [5] 0 0
Westmead Hospital - Sydney
Recruitment hospital [6] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Paratus Clinical Research, Woden - Phillip
Recruitment postcode(s) [1] 0 0
02217 - Kogarah
Recruitment postcode(s) [2] 0 0
02289 - Kotara
Recruitment postcode(s) [3] 0 0
02170 - Liverpool
Recruitment postcode(s) [4] 0 0
02010 - Sydney
Recruitment postcode(s) [5] 0 0
02145 - Sydney
Recruitment postcode(s) [6] 0 0
04102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
03004 - Melbourne
Recruitment postcode(s) [8] 0 0
02606 - Phillip
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Austria
State/province [12] 0 0
Graz
Country [13] 0 0
Austria
State/province [13] 0 0
Linz
Country [14] 0 0
Austria
State/province [14] 0 0
Vienna
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Pleven
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Ruse
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Sevlievo
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Stara Zagora
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Denmark
State/province [22] 0 0
Hellerup
Country [23] 0 0
Denmark
State/province [23] 0 0
Roskilde
Country [24] 0 0
France
State/province [24] 0 0
Bordeaux
Country [25] 0 0
France
State/province [25] 0 0
Dijon
Country [26] 0 0
France
State/province [26] 0 0
Lyon
Country [27] 0 0
France
State/province [27] 0 0
Nice Cedex 3
Country [28] 0 0
France
State/province [28] 0 0
Poitiers Cedex
Country [29] 0 0
France
State/province [29] 0 0
Salouel
Country [30] 0 0
Germany
State/province [30] 0 0
Bielefeld
Country [31] 0 0
Germany
State/province [31] 0 0
Frankfurt Am Main
Country [32] 0 0
Germany
State/province [32] 0 0
Göttingen
Country [33] 0 0
Germany
State/province [33] 0 0
Mahlow
Country [34] 0 0
Germany
State/province [34] 0 0
Muenster
Country [35] 0 0
Italy
State/province [35] 0 0
Milano
Country [36] 0 0
Italy
State/province [36] 0 0
Napoli
Country [37] 0 0
Italy
State/province [37] 0 0
Perugia
Country [38] 0 0
Italy
State/province [38] 0 0
Pisa
Country [39] 0 0
Italy
State/province [39] 0 0
Rome
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seoul
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Suwon
Country [42] 0 0
Poland
State/province [42] 0 0
Krakow
Country [43] 0 0
Poland
State/province [43] 0 0
Lodz
Country [44] 0 0
Poland
State/province [44] 0 0
Lublin
Country [45] 0 0
Poland
State/province [45] 0 0
Malbork
Country [46] 0 0
Poland
State/province [46] 0 0
Poznan
Country [47] 0 0
Poland
State/province [47] 0 0
Wroclaw
Country [48] 0 0
Spain
State/province [48] 0 0
Badalona
Country [49] 0 0
Spain
State/province [49] 0 0
Las Palmas de Gran Canaria
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
Santiago de Compostela
Country [52] 0 0
Switzerland
State/province [52] 0 0
Buochs
Country [53] 0 0
Switzerland
State/province [53] 0 0
Lausanne
Country [54] 0 0
Switzerland
State/province [54] 0 0
Zurich-flughafen

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Incyte Corporation Call Center (US)
Address 0 0
Country 0 0
Phone 0 0
1.855.463.3463
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Available to whom?
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05764161