Clinical trial NCT05764161: A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prurigo Nodularis
Keywords: PN
INCB18424-320
INCB18424
Prurigo
Prurigo Nodularis
Skin Diseases
Dermatitis
ruxolitinib
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response
timeFrame: Week 12
Secondary outcomes:
measure: WI-NRS4 Response
timeFrame: Week 4
measure: Overall Treatment Success (TS)
timeFrame: Week 12
measure: IGA-CPG-S-TS
timeFrame: Week 12
measure: WI-NRS4 Response
timeFrame: Day 7
measure: Proportion of participants with WI-NRS4 at each postbaseline visit.
timeFrame: Up to 52 weeks
measure: Change from baseline in WI-NRS score
timeFrame: Up to 52 weeks
measure: Time to ≥ 2-point improvement from baseline in WI-NRS score
timeFrame: Up to 52 weeks
measure: Time to ≥ 4-point improvement from baseline in WI-NRS score
timeFrame: Up to 52 weeks
measure: Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score
timeFrame: Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score
measure: Change from baseline in Skin Pain NRS score
timeFrame: Up to 52 weeks
measure: IGA-TS response, defined as achieving IGA TS at each postbaseline visit.
timeFrame: Up to 56 weeks
measure: IGA-CPG-A 0 or 1 response, defined as achieving an IGA score of 0 or 1 at each postbaseline visit.
timeFrame: Up to 56 weeks
measure: > 75% healed lesions from baseline in PAS at each postbaseline visit.
timeFrame: Up to 56 weeks
measure: Number of Treatment-emergent adverse events (TEAEs)
timeFrame: Up to 56 weeks
measure: Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
timeFrame: Up to 56 weeks
measure: Change from baseline in EQ-5D-5L score at each postbaseline visit.
timeFrame: Up to 56 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham
state: Alabama
city: Arkansas
country: United States
facility: Northwest Arkansas Clinical Trials Center
state: Arkansas
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute Clinical Research Specialists Inc
state: California
city: Sherman Oaks
country: United States
facility: Cura Clinical Research
state: California
city: Orlando
country: United States
facility: Ars - Maitland Clinical Research Unit
state: Florida
city: Marietta
country: United States
facility: Marietta Dermatology the Skin Cancer Center Marietta
state: Georgia
city: South Bend
country: United States
facility: The South Bend Clinic Main Campus
state: Indiana
city: Baltimore
country: United States
facility: Axon Clinical Research
state: Maryland
city: Beverly
country: United States
facility: Activmed Practices Research, Llc Beverly
state: Massachusetts
city: Athens
country: United States
facility: Oakview Dermatology
state: Ohio
city: Dublin
country: United States
facility: Aventiv Research Inc-Dublin
state: Ohio
city: Fairborn
country: United States
facility: Wright State Physicians, Inc.
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building
state: Pennsylvania
city: Sugarloaf
country: United States
facility: Dermdox Center For Dermatology
state: Pennsylvania
city: Austin
country: United States
facility: Dermresearch, Inc.
state: Texas
city: Kogarah
country: Australia
facility: Premier Specialists Pty Ltd
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Phillip
country: Australia
facility: Paratus Clinical Research, Woden
city: Graz
country: Austria
facility: Landeskrankenhaus Universitatsklinikum Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz Gmbh Elisabethinen
city: Vienna
country: Austria
facility: Sozialmedizinisches Zentrum Ost-Donauspital
city: Pleven
country: Bulgaria
facility: Medical Center Medconsult Pleven Ood
city: Ruse
country: Bulgaria
facility: Medical Center- Prolet Ltd
city: Sevlievo
country: Bulgaria
facility: Medical Center Unimed Eood
city: Sofia
country: Bulgaria
facility: Dcc 'Alexandrovska', Eood
city: Sofia
country: Bulgaria
facility: Medical Center Hera Eood
city: Stara Zagora
country: Bulgaria
facility: Umhat Prof. Dr. Stoyan Kirkovich Ad
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: North York
country: Canada
facility: North York Research Inc.
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre For Dermatology
state: Ontario
city: Quebec
country: Canada
facility: Diex Recherche Quebec Inc.
city: Hellerup
country: Denmark
facility: Herlev Og Gentofte Hospital
city: Roskilde
country: Denmark
facility: Sjaellands Universitetshospital
city: Bordeaux
country: France
facility: Bordeaux Chu Hopital Saint - Andre
city: Dijon
country: France
facility: Chu Dijon-Bourgogne
city: Lyon
country: France
facility: Hopital Edouard Herrio
city: Nice Cedex 3
country: France
facility: Chu de Nice - Hospital L Archet
city: Poitiers Cedex
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Salouel
country: France
facility: Chu Amiens - Hopital Sud
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld Rosenhohe Dermatologie
city: Frankfurt Am Main
country: Germany
facility: Universitatsklinikum Frankfurt
city: Göttingen
country: Germany
facility: Universitatsmedizin Goettingen
city: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Mahlow
city: Muenster
country: Germany
facility: Universitatsklinikum Munster
city: Milano
country: Italy
facility: Fondazione Irccs Ca Granda Ospedale Maggiore
city: Napoli
country: Italy
facility: Universita Degli Studi Della Campania Luigi Vanvitelli
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary'S Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Krakow
country: Poland
facility: Diamond Clinic Specjalistyczne Poradnie Lekarskie
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
city: Lublin
country: Poland
facility: Luxderm Specjalistyczny Gabinet Dermatologiczny
city: Malbork
country: Poland
facility: Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne
city: Wroclaw
country: Poland
facility: Dermaceum Centrum Badan Klinicznych
city: Wroclaw
country: Poland
facility: Dermmedica Sp. Z O.O.
city: Badalona
country: Spain
facility: Ceim Hospital Universitari Germans Trias I Pujol
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrin
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Santiago de Compostela
country: Spain
facility: Clinica Gaias Santiago
city: Buochs
country: Switzerland
facility: Dermatology & Skin Care Clinic
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (Chuv)
city: Zurich-flughafen
country: Switzerland
facility: Universitatsspital Zurich
Study officials:
References: