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A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN) (TRuE-PN1)

Primary Purpose

Prurigo

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib Cream
Vehicle Cream
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prurigo focused on measuring Prurigo, Prurigo Nodularis, PN, Skin Diseases, Dermatitis, Eczematous, ruxolitinib, INCB 18424

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama At Birmingham
  • Medical Dermatology Specialists PhoenixRecruiting
  • Johnson DermatologyRecruiting
  • First Oc DermatologyRecruiting
  • University of Miami
  • Dermatology Associates PcRecruiting
  • Clarkston Medical GroupRecruiting
  • Revival Research Institute, Llc TroyRecruiting
  • Medisearch Clinical TrialsRecruiting
  • Wake Forest University
  • UC Health, Llc
  • University Hospitals Cleveland Medical CenterRecruiting
  • Central Sooner ResearchRecruiting
  • Dermatology Associates of Plymouth MeetingRecruiting
  • Medical University of South Carolina
  • International Clinical Research Tennessee LlcRecruiting
  • North Texas Center For Clinical Research Ntccr
  • Austin Institute For Clinical Research Aicr PflugervilleRecruiting
  • Center For Clinical StudiesRecruiting
  • Premier Clinical ResearchRecruiting
  • Conexa Investigacion Clinica S.A.
  • Cedic Centro de Investigaciones ClinicasRecruiting
  • Buenos Aires Skin
  • Psoriahue-Medicina InterdisciplinarRecruiting
  • Cinme - Centro de Investigaciones Metabolicas
  • Centro de Investigaciones Medicas Mar Del PlataRecruiting
  • Fundacion ScherbovskyRecruiting
  • Hospital Universitario Austral
  • Instituto de Especialidades de La Salud Rosario
  • Centro de Investigaciones Medicas TucumanRecruiting
  • Cliniques Universitaires Ucl Saint-Luc
  • Ulb Hospital Erasme
  • Az Sint-LucasRecruiting
  • Universitair Ziekenhuis Gent
  • Universitair Ziekenhuis (Uz) Leuven
  • Centre Hospitalier Universitaire de Liege - Sart Tilman
  • Chu Ucl Namur de Saint Elisabeth
  • Beacon DermatologyRecruiting
  • Simcomed Health LtdRecruiting
  • DermeffectsRecruiting
  • Toronto Research CentreRecruiting
  • Centre de Recherche Saint-LouisRecruiting
  • Centro Medico Skinmed
  • Ciec - Centro Internacional de Estudios Cli-Nicos
  • Clinical Research Chile Spa.
  • Hospital Prive D'Antony
  • Hospital Morvan
  • Chru de Lille Hopital Claude Huriez
  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
  • University Hospital of Saint Etienne
  • University Medical Center Rwth Aachen
  • Fachklinik Bad Bentheim DermatologieRecruiting
  • Universitaetsklinikum Carl Gustav Carus Tu DresdenRecruiting
  • Universitatsklinikum Schleswig Holstein
  • Universitaetsmedizin Der Johannes-Gutenberg-Universitaet Mainz
  • Universitats-Hautklink Tubingen
  • Hautarztpraxis Dr. Med. Matthias Hoffmann
  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
  • Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
  • Asl 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore
  • Polyclinic Federico Ii
  • Fondazione Policlinico Universitario Agostino Gemelli Irccs
  • Istituto Clinico Humanitas
  • Ospedali Riuniti Di Ancona
  • Amsterdam University Medical Centre
  • Bravis Ziekenhuis
  • Pratia McM Krakow
  • ETG LODZ
  • Luxderm Specjalistyczny Gabinet Dermatologiczny
  • Kliniczny Szpital Wojewodzki Nr 1 Im.F.Chopina
  • Clinical Research Group Sp. Z.O.ORecruiting
  • Dorota Bystrzanowska 'High-Med'. Przychodnia Specjalistyczna
  • Centralny Szpital Kliniczny Mswia
  • Hospital General Unviersitario de Alicante
  • Hospital Universitario Reina Sofia
  • Hospital de Manises
  • Hospital Universitario Quironsalud Madrid
  • Complejo Hospitalario Universitario de Santiago

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Vehicle Cream BID

Ruxolitinib 1.5% Cream

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response
Defined as achieving a ≥ 4-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline.

Secondary Outcome Measures

WI-NRS4 Response
Defined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.
Overall Treatment Success (TS)
Defined as achieving both a WI-NRS4 response and an Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS).
IGA-CPG-S-TS
Defined as an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline
WI-NRS4 Response
Defined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.
Proportion of participants with WI-NRS4 at each postbaseline visit.
Defined as percentage of participants that achieve a ≥ 4-point improvement in WI-NRS score
Change from baseline in WI-NRS score
Defined as change in Intensity of itch. Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".
Time to ≥ 2-point improvement from baseline in WI-NRS score
Participants rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time to ≥ 4-point improvement from baseline in WI-NRS score
Defined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baseline
Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score
Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
Change from baseline in Skin Pain NRS score
Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
IGA-TS response, defined as achieving IGA TS at each postbaseline visit.
The IGA for chronic prurigo nodularis considers the number of nodules, also referred to as lesions, and uses them to determine an overall severity rating on on a 5-point scale ranging from 0 (clear skin) to 4 (severe).
IGA-CPG-A 0 or 1 response, defined as achieving an IGA score of 0 or 1 at each postbaseline visit.
The IGA-CPG-A is an overall PN severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting.
> 75% healed lesions from baseline in PAS at each postbaseline visit.
PAS includes 5 items; descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions, and disease activity in terms of percentage of pruriginous lesions with excoriations/crusts on top.
Number of Treatment-emergent adverse events (TEAEs)
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days
Change from baseline in EQ-5D-5L score at each postbaseline visit.
The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome

Full Information

First Posted
January 25, 2023
Last Updated
October 18, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05755438
Brief Title
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
Acronym
TRuE-PN1
Official Title
A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
August 7, 2024 (Anticipated)
Study Completion Date
December 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
Detailed Description
The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prurigo
Keywords
Prurigo, Prurigo Nodularis, PN, Skin Diseases, Dermatitis, Eczematous, ruxolitinib, INCB 18424

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vehicle Cream BID
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Ruxolitinib 1.5% Cream
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib Cream
Other Intervention Name(s)
INCB018424 phosphate cream
Intervention Description
Ruxolitinib cream 1.5% twice daily (BID) during the vehicle controlled (DBVC)and open label treatment period (OLE).
Intervention Type
Drug
Intervention Name(s)
Vehicle Cream
Intervention Description
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle controlled period (DBVC).
Primary Outcome Measure Information:
Title
Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response
Description
Defined as achieving a ≥ 4-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
WI-NRS4 Response
Description
Defined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.
Time Frame
Week 4
Title
Overall Treatment Success (TS)
Description
Defined as achieving both a WI-NRS4 response and an Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS).
Time Frame
Week 12
Title
IGA-CPG-S-TS
Description
Defined as an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline
Time Frame
Week 12
Title
WI-NRS4 Response
Description
Defined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.
Time Frame
Day 7
Title
Proportion of participants with WI-NRS4 at each postbaseline visit.
Description
Defined as percentage of participants that achieve a ≥ 4-point improvement in WI-NRS score
Time Frame
Up to 52 weeks
Title
Change from baseline in WI-NRS score
Description
Defined as change in Intensity of itch. Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".
Time Frame
Up to 52 weeks
Title
Time to ≥ 2-point improvement from baseline in WI-NRS score
Description
Participants rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time Frame
Up to 52 weeks
Title
Time to ≥ 4-point improvement from baseline in WI-NRS score
Description
Defined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baseline
Time Frame
Up to 52 weeks
Title
Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score
Description
Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
Time Frame
Up to 52 weeks
Title
Change from baseline in Skin Pain NRS score
Description
Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
Time Frame
Up to 52 weeks
Title
IGA-TS response, defined as achieving IGA TS at each postbaseline visit.
Description
The IGA for chronic prurigo nodularis considers the number of nodules, also referred to as lesions, and uses them to determine an overall severity rating on on a 5-point scale ranging from 0 (clear skin) to 4 (severe).
Time Frame
Up to 56 weeks
Title
IGA-CPG-A 0 or 1 response, defined as achieving an IGA score of 0 or 1 at each postbaseline visit.
Description
The IGA-CPG-A is an overall PN severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting.
Time Frame
Up to 56 weeks
Title
> 75% healed lesions from baseline in PAS at each postbaseline visit.
Description
PAS includes 5 items; descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions, and disease activity in terms of percentage of pruriginous lesions with excoriations/crusts on top.
Time Frame
Up to 56 weeks
Title
Number of Treatment-emergent adverse events (TEAEs)
Description
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time Frame
Up to 56 weeks
Title
Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
Description
The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days
Time Frame
Up to 56 weeks
Title
Change from baseline in EQ-5D-5L score at each postbaseline visit.
Description
The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome
Time Frame
Up to 56 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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: Vulnerable populations according to article L.1121-6 of the French Public Health Code. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code. Individuals not affiliated with the social security system.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haq Nawaz, md
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Medical Dermatology Specialists Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Name
Johnson Dermatology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Individual Site Status
Recruiting
Facility Name
First Oc Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Dermatology Associates Pc
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Name
Clarkston Medical Group
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Individual Site Status
Recruiting
Facility Name
Revival Research Institute, Llc Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Name
Medisearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UC Health, Llc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Associates of Plymouth Meeting
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
International Clinical Research Tennessee Llc
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Center For Clinical Research Ntccr
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Austin Institute For Clinical Research Aicr Pflugerville
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Individual Site Status
Recruiting
Facility Name
Center For Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Name
Conexa Investigacion Clinica S.A.
City
Buenos Aires
ZIP/Postal Code
01012
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Cedic Centro de Investigaciones Clinicas
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
01125
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Buenos Aires Skin
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1055AAO
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Psoriahue-Medicina Interdisciplinar
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1425DKG
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cinme - Centro de Investigaciones Metabolicas
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1056ABJ
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Centro de Investigaciones Medicas Mar Del Plata
City
Mar Del Plata
ZIP/Postal Code
B7600FYK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion Scherbovsky
City
Mendoza
ZIP/Postal Code
05500
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Austral
City
Pilar
ZIP/Postal Code
B1629ODT
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Instituto de Especialidades de La Salud Rosario
City
Rosario
ZIP/Postal Code
02000
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Centro de Investigaciones Medicas Tucuman
City
San Miguel de Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Ucl Saint-Luc
City
Brussels
ZIP/Postal Code
01200
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Ulb Hospital Erasme
City
Bruxelles
ZIP/Postal Code
01070
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Az Sint-Lucas
City
Gent
ZIP/Postal Code
09000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
09000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Universitair Ziekenhuis (Uz) Leuven
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Liege - Sart Tilman
City
Liege
ZIP/Postal Code
04000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Chu Ucl Namur de Saint Elisabeth
City
Namur
ZIP/Postal Code
05000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Beacon Dermatology
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Simcomed Health Ltd
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 1G7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Dermeffects
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Research Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre de Recherche Saint-Louis
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centro Medico Skinmed
City
Las Condes
ZIP/Postal Code
7580206
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Ciec - Centro Internacional de Estudios Cli-Nicos
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Clinical Research Chile Spa.
City
Valdivia
ZIP/Postal Code
5090000
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Hospital Prive D'Antony
City
Antony
ZIP/Postal Code
92160
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hospital Morvan
City
Brest Cedex 2
ZIP/Postal Code
29609
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Chru de Lille Hopital Claude Huriez
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Not yet recruiting
Facility Name
University Hospital of Saint Etienne
City
Saint-etienne Cedex 2
ZIP/Postal Code
42270
Country
France
Individual Site Status
Not yet recruiting
Facility Name
University Medical Center Rwth Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Fachklinik Bad Bentheim Dermatologie
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Carl Gustav Carus Tu Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Schleswig Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsmedizin Der Johannes-Gutenberg-Universitaet Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitats-Hautklink Tubingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Hautarztpraxis Dr. Med. Matthias Hoffmann
City
Witten
ZIP/Postal Code
58453
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Asl 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore
City
Coppito
ZIP/Postal Code
67100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Polyclinic Federico Ii
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli Irccs
City
Roma
ZIP/Postal Code
00137
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Ospedali Riuniti Di Ancona
City
Torrette
ZIP/Postal Code
60123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Amsterdam University Medical Centre
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Bravis Ziekenhuis
City
Bergen Op Zoom
ZIP/Postal Code
4624 VT
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Pratia McM Krakow
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
ETG LODZ
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Luxderm Specjalistyczny Gabinet Dermatologiczny
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Kliniczny Szpital Wojewodzki Nr 1 Im.F.Chopina
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Clinical Research Group Sp. Z.O.O
City
Warszawa
ZIP/Postal Code
01-142
Country
Poland
Individual Site Status
Recruiting
Facility Name
Dorota Bystrzanowska 'High-Med'. Przychodnia Specjalistyczna
City
Warszawa
ZIP/Postal Code
01-817
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centralny Szpital Kliniczny Mswia
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Hospital General Unviersitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Manises
City
Manises
ZIP/Postal Code
46940
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Quironsalud Madrid
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

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