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

Prurigo Nodularis Clinical Trial

— TRuE-PN2  

Official title:

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764161
• Other study ID #: INCB18424-320
• Status: Recruiting
• Phase: Phase 3
• Start date: June 12, 2023
• Est. completion date: August 5, 2025

Study information

• Verified date: June 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 5, 2025
• Est. primary completion date: November 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Neurodermatitis
• Prurigo
• Prurigo Nodularis

Intervention

Drug:
• Ruxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period.
• Vehicle Cream
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle-controlled period.

Locations

Country	Name	City	State
Australia	Premier Specialists Pty Ltd	Kogarah	New South Wales
Australia	Novatrials	Kotara	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Paratus Clinical Research, Woden	Phillip
Australia	Holdsworth House Medical Practice	Sydney	New South Wales
Australia	Westmead Hospital	Sydney	New South Wales
Australia	Veracity Clinical Research	Woolloongabba	Queensland
Austria	Landeskrankenhaus Universitatsklinikum Graz	Graz
Austria	Ordensklinikum Linz Gmbh Elisabethinen	Linz
Austria	Sozialmedizinisches Zentrum Ost-Donauspital	Vienna
Bulgaria	Medical Center Medconsult Pleven Ood	Pleven
Bulgaria	Medical Center- Prolet Ltd	Ruse
Bulgaria	Medical Center Unimed Eood	Sevlievo
Bulgaria	Dcc 'Alexandrovska', Eood	Sofia
Bulgaria	Medical Center Hera Eood	Sofia
Bulgaria	Umhat Prof. Dr. Stoyan Kirkovich Ad	Stara Zagora
Canada	Kingsway Clinical Research	Etobicoke	Ontario
Canada	Lynderm Research Inc	Markham	Ontario
Canada	North York Research Inc.	North York	Ontario
Canada	Skin Centre For Dermatology	Peterborough	Ontario
Canada	Diex Recherche Quebec Inc.	Quebec
Denmark	Herlev Og Gentofte Hospital	Hellerup
Denmark	Sjaellands Universitetshospital	Roskilde
France	Bordeaux Chu Hopital Saint - Andre	Bordeaux
France	Chu Dijon-Bourgogne	Dijon
France	Hopital Edouard Herrio	Lyon
France	Chu de Nice - Hospital L Archet	Nice Cedex 3
France	Hospital Saint Louis	Paris
France	Centre Hospitalier Universitaire de Poitiers	Poitiers Cedex
France	Chu de Rouen - Hospital Charles Nicolle	Rouen
France	Chu Amiens - Hopital Sud	Salouel
Germany	Klinikum Bielefeld Rosenhohe Dermatologie	Bielefeld
Germany	Universitatsklinikum Frankfurt	Frankfurt Am Main
Germany	Universitatsmedizin Goettingen	Göttingen
Germany	Dermatologische Gemeinschaftspraxis Mahlow	Mahlow
Germany	Universitatsklinikum Munster	Muenster
Italy	Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli	Napoli
Italy	Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia	Perugia
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Rome
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary'S Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Poland	Diamond Clinic Specjalistyczne Poradnie Lekarskie	Krakow
Poland	Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak	Lodz
Poland	Luxderm Specjalistyczny Gabinet Dermatologiczny	Lublin
Poland	Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.	Malbork
Poland	Solumed Centrum Medyczne	Poznan
Poland	Dermaceum Centrum Badan Klinicznych	Wroclaw
Poland	Dermmedica Sp. Z O.O.	Wroclaw
Spain	Ceim Hospital Universitari Germans Trias I Pujol	Badalona
Spain	Hospital Universitario de Gran Canaria Doctor Negrin	Las Palmas de Gran Canaria
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Clinica Gaias Santiago	Santiago de Compostela
Switzerland	Dermatology & Skin Care Clinic	Buochs
Switzerland	Centre Hospitalier Universitaire Vaudois (Chuv)	Lausanne
Switzerland	Universitatsspital Zurich	Zuerich
United States	Northwest Arkansas Clinical Trials Center	Arkansas	Arkansas
United States	Oakview Dermatology	Athens	Ohio
United States	Dermresearch, Inc.	Austin	Texas
United States	Axon Clinical Research	Baltimore	Maryland
United States	Activmed Practices Research, Llc Beverly	Beverly	Massachusetts
United States	University of Alabama At Birmingham	Birmingham	Alabama
United States	Aventiv Research Inc-Dublin	Dublin	Ohio
United States	Wright State Physicians, Inc.	Fairborn	Ohio
United States	Dermatology Research Associates	Los Angeles	California
United States	Marietta Dermatology the Skin Cancer Center Marietta	Marietta	Georgia
United States	Ars - Maitland Clinical Research Unit	Orlando	Florida
United States	University of Pennsylvania-Perelman School of Medicine	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building	Pittsburgh	Pennsylvania
United States	Clinical Science Institute Clinical Research Specialists Inc	Santa Monica	California
United States	Cura Clinical Research	Sherman Oaks	California
United States	The South Bend Clinic Main Campus	South Bend	Indiana
United States	Dermdox Center For Dermatology	Sugarloaf	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Bulgaria,  Canada,  Denmark,  France,  Germany,  Italy,  Korea, Republic of,  Poland,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 12
Secondary	WI-NRS4 Response	Defined as achieving a = 4-point improvement (reduction) in WI-NRS score from baseline.	Week 4
Secondary	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).	Week 12
Secondary	IGA-CPG-S-TS	Defined as an IGA-CPG-S score of 0 or 1 with a = 2 grade improvement from baseline	Week 12
Secondary	WI-NRS4 Response	Defined as achieving a = 4-point improvement (reduction) in WI-NRS score from baseline.	Day 7
Secondary	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	Up to 52 weeks
Secondary	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".	Up to 52 weeks
Secondary	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)	Up to 52 weeks
Secondary	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	Up to 52 weeks
Secondary	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".	Skin pain response, defined as a = 2-point improvement in Skin Pain NRS score
Secondary	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".	Up to 52 weeks
Secondary	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).	Up to 56 weeks
Secondary	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.	Up to 56 weeks
Secondary	> 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.	Up to 56 weeks
Secondary	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.	Up to 56 weeks
Secondary	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	Up to 56 weeks
Secondary	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	Up to 56 weeks