Clinical Trial Details for

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

NCT ID: NCT05764161

Last Updated: February 09, 2024

Official Title

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

Purpose

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

The Study at a Glance

Status: RECRUITING

Phase: Phase 3

Gender: ALL

Age: 18 Years - 99 Years

Condition: Prurigo Nodularis

Study Type: Interventional

Lead Sponsor: Incyte Corporation

Eligibility

Ages Eligible for Study: 18 Years to 99 Years

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

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.

Additional Information, Locations & Contacts

Collaborators: Not provided

Investigators: Not provided

Please refer to this study by its clinicaltrials.gov identifier: NCT05764161
Location

University of Alabama At Birmingham

Birmingham, Alabama, United States

Northwest Arkansas Clinical Trials Center

Arkansas, Arkansas, United States

Dermatology Research Associates

Los Angeles, California, United States

Clinical Science Institute Clinical Research Specialists Inc

Santa Monica, California, United States

Cura Clinical Research

Sherman Oaks, California, United States

Ars - Maitland Clinical Research Unit

Orlando, Florida, United States

Marietta Dermatology the Skin Cancer Center Marietta

Marietta, Georgia, United States

The South Bend Clinic Main Campus

South Bend, Indiana, United States

Axon Clinical Research

Baltimore, Maryland, United States

Activmed Practices Research, Llc Beverly

Beverly, Massachusetts, United States

Montefiore Medical Center (Mmc)

Bronx, New York, United States

Oakview Dermatology

Athens, Ohio, United States

Aventiv Research Inc-Dublin

Dublin, Ohio, United States

Wright State Physicians, Inc.

Fairborn, Ohio, 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

Dermdox Center For Dermatology

Sugarloaf, Pennsylvania, United States

Dermresearch, Inc.

Austin, Texas, United States

Premier Specialists Pty Ltd

Kogarah, New South Wales, Australia

Novatrials

Kotara, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Holdsworth House Medical Practice

Sydney, New South Wales, Australia

Westmead Hospital

Sydney, New South Wales, Australia

Veracity Clinical Research

Woolloongabba, Queensland, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Paratus Clinical Research, Woden

Phillip, Australia

Landeskrankenhaus Universitatsklinikum Graz

Graz, Austria

Ordensklinikum Linz Gmbh Elisabethinen

Linz, Austria

Sozialmedizinisches Zentrum Ost-Donauspital

Vienna, Austria

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, Bulgaria

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, Canada

Karma Clinical Trials Inc.

St. John's, Canada

Herlev Og Gentofte Hospital

Hellerup, Denmark

Sjaellands Universitetshospital

Roskilde, Denmark

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, France

Klinikum Bielefeld Rosenhohe Dermatologie

Bielefeld, Germany

Universitatsklinikum Frankfurt

Frankfurt Am Main, Germany

Universitatsmedizin Goettingen

Göttingen, Germany

Dermatologische Gemeinschaftspraxis Mahlow

Mahlow, Germany

Universitatsklinikum Munster

Muenster, Germany

Company For Medical Study & Service Selters Gmbh

Selters, Germany

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 S. Maria Della Misericordia

Perugia, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, Italy

Korea University Anam Hospital

Seoul, Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of

Asan Medical Center

Seoul, Korea, Republic of

The Catholic University of Korea Seoul St. Mary'S Hospital

Seoul, Korea, Republic of

Korea University Guro Hospital

Seoul, Korea, Republic of

Ajou University Hospital

Suwon, Korea, Republic of

Diamond Clinic Specjalistyczne Poradnie Lekarskie

Krakow, Poland

Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak

Lodz, 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, Poland

Ceim Hospital Universitari Germans Trias I Pujol

Badalona, Spain

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Clinica Gaias Santiago

Santiago de Compostela, Spain

Dermatology & Skin Care Clinic

Buochs, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Universitatsspital Zurich

Zurich-flughafen, Switzerland

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