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A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN) (TRuE-PN2)

Primary Purpose

Prurigo Nodularis

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 Nodularis focused on measuring PN, INCB18424-320, INCB18424, Prurigo, Prurigo Nodularis, Skin Diseases, Dermatitis, ruxolitinib

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

  • Northwest Arkansas Clinical Trials CenterRecruiting
  • Dermatology Research AssociatesRecruiting
  • Clinical Science Institute Clinical Research Specialists IncRecruiting
  • Cura Clinical ResearchRecruiting
  • Ars - Maitland Clinical Research UnitRecruiting
  • Marietta Dermatology the Skin Cancer Center Marietta
  • The South Bend Clinic Main CampusRecruiting
  • Activmed Practices Research, Llc BeverlyRecruiting
  • Beth Israel Deaconess Medical Center (Bidmc)
  • Oakview DermatologyRecruiting
  • Aventiv Research Inc-DublinRecruiting
  • Wright State Physicians, Inc.Recruiting
  • University of Pennsylvania-Perelman School of Medicine
  • University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building
  • Dermdox Center For DermatologyRecruiting
  • Dermresearch, Inc.Recruiting
  • Premier Specialists Pty Ltd
  • Novatrials
  • Liverpool Hospital
  • Holdsworth House Medical Practice
  • Westmead Hospital
  • Veracity Clinical Research
  • The Alfred Hospital
  • Paratus Clinical Research, Woden
  • Landeskrankenhaus Universitatsklinikum Graz
  • Ordensklinikum Linz Gmbh Elisabethinen
  • Sozialmedizinisches Zentrum Ost-Donauspital
  • Medical Center Medconsult Pleven Ood
  • Medical Center- Prolet Ltd
  • Medical Center Unimed Eood
  • Dcc 'Alexandrovska', Eood
  • Medical Center Hera Eood
  • Umhat 'Prof. Dr. St. Kirkovich', Ad
  • Kingsway Clinical ResearchRecruiting
  • Lynderm Research IncRecruiting
  • North York Research Inc.Recruiting
  • Skin Centre For DermatologyRecruiting
  • Diex Recherche Quebec Inc.Recruiting
  • Karma Clinical Trials Inc.
  • Herlev Og Gentofte Hospital
  • Sjaellands Universitetshospital
  • Bordeaux Chu Hopital Saint - Andre
  • Chu Dijon-Bourgogne
  • Hopital Edouard Herriot - Chu Lyon
  • Chu de Nice - Hospital L Archet
  • Hospital Saint Louis
  • Centre Hospitalier Universitaire de Poitiers
  • Chu de Rouen - Hospital Charles Nicolle
  • Chu Amiens - Hopital Sud
  • Klinikum Bielefeld Rosenhohe Dermatologie
  • Universitatsklinikum Frankfurt
  • Universitatsmedizin Goettingen
  • Gemeinschaftspraxis Dr. Scholz, Dr. Sebastian
  • Universitaetsklinikum Muenster
  • Company For Medical Study & Service Selters Gmbh
  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli
  • Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia
  • Azienda Ospedaliero Universitaria Pisana
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • The Catholic University of Korea Seoul St. Mary'S Hospital
  • Korea University Guro Hospital
  • Ajou University Hospital
  • Diamond Clinic Specjalistyczne Poradnie Lekarskie
  • Dermoklinika
  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
  • Solumed Centrum Medyczne
  • Dermaceum Centrum Badan Klinicznych
  • Dermmedica Sp. Z O.O.
  • Hospital Universitari Germans Trias I Pujol
  • Hospital Universitario de Gran Canaria Doctor Negrin
  • Hospital Universitario Ramon Y Cajal
  • Hospital Universitario 12 de Octubre
  • Clinica Gaias Santiago
  • Dermatology & Skin Care Clinic
  • Centre Hospitalier Universitaire Vaudois
  • Universitaetsspital Zuerich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ruxolitinib 1.5% Cream

Vehicle Cream

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 enter the open label extension (OLE) period for up to 40 weeks.

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.

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 to 10) 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 to 10) 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-CPG-s for chronic prurigo nodularis considers the number of nodules, also referred to as lesions, and uses them to determine an overall severity rating 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 IGA-CPG-A score is based on disease activity based on % of PN lesions with excoriations or crusts.
> 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
March 1, 2023
Last Updated
October 18, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05764161
Brief Title
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
Acronym
TRuE-PN2
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
June 12, 2023 (Actual)
Primary Completion Date
November 3, 2024 (Anticipated)
Study Completion Date
August 5, 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 Nodularis
Keywords
PN, INCB18424-320, INCB18424, Prurigo, Prurigo Nodularis, Skin Diseases, Dermatitis, ruxolitinib

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
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 enter the open label extension (OLE) period for up to 40 weeks.
Arm Title
Vehicle Cream
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 enter the open label extension (OLE) period for up to 40 weeks.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib Cream
Other Intervention Name(s)
Opzelura, INCB018424 phosphate cream
Intervention Description
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period.
Intervention Type
Drug
Intervention Name(s)
Vehicle Cream
Intervention Description
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle-controlled period.
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 to 10) where 0 is "no itch" and 10 is the "worst itch imaginable".
Time Frame
Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score
Title
Change from baseline in Skin Pain NRS score
Description
Itch NRS is an 11-point scale (0 to 10) 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-CPG-s for chronic prurigo nodularis considers the number of nodules, also referred to as lesions, and uses them to determine an overall severity rating 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 IGA-CPG-A score is based on disease activity based on % of PN lesions with excoriations or crusts.
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
Facility Information:
Facility Name
Northwest Arkansas Clinical Trials Center
City
Arkansas
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Science Institute Clinical Research Specialists Inc
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Cura Clinical Research
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Name
Ars - Maitland Clinical Research Unit
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Marietta Dermatology the Skin Cancer Center Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060-1047
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
The South Bend Clinic Main Campus
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Individual Site Status
Recruiting
Facility Name
Activmed Practices Research, Llc Beverly
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center (Bidmc)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Withdrawn
Facility Name
Oakview Dermatology
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Individual Site Status
Recruiting
Facility Name
Aventiv Research Inc-Dublin
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Individual Site Status
Recruiting
Facility Name
Wright State Physicians, Inc.
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania-Perelman School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Dermdox Center For Dermatology
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermresearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Name
Premier Specialists Pty Ltd
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
02217
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Novatrials
City
Kotara
State/Province
New South Wales
ZIP/Postal Code
02289
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
02170
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Holdsworth House Medical Practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
02010
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
02145
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Veracity Clinical Research
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
04102
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
03004
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Paratus Clinical Research, Woden
City
Phillip
ZIP/Postal Code
02606
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Landeskrankenhaus Universitatsklinikum Graz
City
Graz
ZIP/Postal Code
08036
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Ordensklinikum Linz Gmbh Elisabethinen
City
Linz
ZIP/Postal Code
04020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Sozialmedizinisches Zentrum Ost-Donauspital
City
Vienna
ZIP/Postal Code
01220
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Medical Center Medconsult Pleven Ood
City
Pleven
ZIP/Postal Code
05800
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Medical Center- Prolet Ltd
City
Ruse
ZIP/Postal Code
07000
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Medical Center Unimed Eood
City
Sevlievo
ZIP/Postal Code
05400
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Dcc 'Alexandrovska', Eood
City
Sofia
ZIP/Postal Code
01431
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Medical Center Hera Eood
City
Sofia
ZIP/Postal Code
01510
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Umhat 'Prof. Dr. St. Kirkovich', Ad
City
Stara Zagora
ZIP/Postal Code
06000
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Kingsway Clinical Research
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M8X 1Y9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Individual Site Status
Recruiting
Facility Name
North York Research Inc.
City
North York
State/Province
Ontario
ZIP/Postal Code
M2M 4J5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Skin Centre For Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Diex Recherche Quebec Inc.
City
Quebec
ZIP/Postal Code
G1V 4T3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Karma Clinical Trials Inc.
City
St. John's
ZIP/Postal Code
A1A 4Y3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Herlev Og Gentofte Hospital
City
Hellerup
ZIP/Postal Code
02900
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Sjaellands Universitetshospital
City
Roskilde
ZIP/Postal Code
04000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Bordeaux Chu Hopital Saint - Andre
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Chu Dijon-Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital Edouard Herriot - Chu Lyon
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Chu de Nice - Hospital L Archet
City
Nice Cedex 3
ZIP/Postal Code
06200
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hospital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Chu de Rouen - Hospital Charles Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Chu Amiens - Hopital Sud
City
Salouel
ZIP/Postal Code
80480
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Klinikum Bielefeld Rosenhohe Dermatologie
City
Bielefeld
ZIP/Postal Code
33647
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsmedizin Goettingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Gemeinschaftspraxis Dr. Scholz, Dr. Sebastian
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Company For Medical Study & Service Selters Gmbh
City
Selters
ZIP/Postal Code
56242
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia
City
Perugia
ZIP/Postal Code
06129
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
City
Rome
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
The Catholic University of Korea Seoul St. Mary'S Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Diamond Clinic Specjalistyczne Poradnie Lekarskie
City
Krakow
ZIP/Postal Code
31-559
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Dermoklinika
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
City
Malbork
ZIP/Postal Code
82-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Solumed Centrum Medyczne
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Dermaceum Centrum Badan Klinicznych
City
Wroclaw
ZIP/Postal Code
50-414
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Dermmedica Sp. Z O.O.
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitari Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario de Gran Canaria Doctor Negrin
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Clinica Gaias Santiago
City
Santiago de Compostela
ZIP/Postal Code
15002
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Dermatology & Skin Care Clinic
City
Buochs
ZIP/Postal Code
06374
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsspital Zuerich
City
Zürich-flughafen
ZIP/Postal Code
08058
Country
Switzerland
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 Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

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