Clinical trial NCT06516965: A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prurigo Nodularis
Keywords: Prurigo nodularis
PN
INCB054707
chronic pruritus
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2024-07-24
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.


Eligibility criteria: Inclusion Criteria:

* Male and female participants 18 to 75 years of age.
* Clinical diagnosis of PN for at least 3 months prior to Screening visit.
* Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline.
* Total of ≥ 20 pruriginous lesions on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at Screening and Day 1/Baseline.
* Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
* Diagnosis of PN secondary to medications.
* Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit.
* Women who are pregnant (or are considering pregnancy) or breastfeeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
* Evidence of infection with TB, HBV, HCV or HIV.
* History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease.
* Laboratory values outside of the protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria apply.

Primary outcomes:
measure: Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Proportion of participants achieving Itch NRS4 at Week 24
timeFrame: Week 24
measure: Proportion of participants achieving IGA-CPG-S-TS at Week 24
timeFrame: Week 24
measure: Proportion of participants achieving Itch NRS4 at Week 4
timeFrame: Week 4
measure: Time to Itch NRS4
timeFrame: Up to 52 Weeks
measure: Change from baseline in Itch NRS score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percent change from baseline in NRS score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants achieving Itch NRS4 at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants achieving IGA-CPG-S-TS at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants achieving Investigator's Global Assessment - Chronic Prurigo Activity (IGA-CPG-A) at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants achieving ≥ 75% healed lesions in Prurigo Activity Score (PAS) at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
timeFrame: Up to 52 weeks
measure: Percent change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
timeFrame: Up to 52 weeks
measure: Proportion of participants with at least a 4-point decrease in DLQI score from baseline at each postbaseline visit for participants with DLQI score ≥ 4 at baseline
timeFrame: Up to 52 weeks
measure: Change from baseline in Skin Pain NRS score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percent change from baseline in Skin Pain NRS score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score at each postbasline visit
timeFrame: Up to 52 weeks
measure: Percent change from baseline in the HADS score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Change from baseline in EQ-5D-5L score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percent change from baseline in EQ-5D-5L score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percent change in FACIT-F score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants with at least a ≥ 4-point increase in FACIT-F score at each postbaseline visit for participants with FACIT-F score ≤ 48 at baseline
timeFrame: Up to 52 weeks
measure: Number of Participants with Treatment Emergent Adverse Events (TEAE)
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists Phoenix
state: Arizona
city: Scottsdale
country: United States
facility: Investigate Md
state: Arizona
city: Fayetteville
country: United States
facility: Premier Dermatology Clinical Trials Institute At Northwest Arkansas
state: Arkansas
city: Fountain Valley
country: United States
facility: First Oc Dermatology Research Inc
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute Clinical Research Specialists Inc
state: California
city: Aventura
country: United States
facility: Center For Clinical and Cosmetic Research
state: Florida
city: Boca Raton
country: United States
facility: Clearlyderm Dermatology
state: Florida
city: Coral Gables
country: United States
facility: Driven Research Llc
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Hollywood
country: United States
facility: Boynton Beach Facility
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research, Llc
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Miami
country: United States
facility: Ziaderm Research, Llc
state: Florida
city: Tamarac
country: United States
facility: Dh Tamarac Research Center Etna Medical Center Emc
state: Florida
city: Tampa
country: United States
facility: Nodal Medical Center, Llc
state: Florida
city: Tampa
country: United States
facility: Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location
state: Florida
city: Chicago
country: United States
facility: Chicago Cosmetic Surgery and Dermatology
state: Illinois
city: Clarksville
country: United States
facility: Dermatology Specialists Research Indiana
state: Indiana
city: New Albany
country: United States
facility: Southern Indiana Clinical Trials
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Rockville
country: United States
facility: Dermatology Associates Pc
state: Maryland
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Ann Arbor
country: United States
facility: Fivenson Dermatology
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Waterford
country: United States
facility: Michigan Dermatology Institute
state: Michigan
city: Saint Joseph
country: United States
facility: Medisearch Clinical Trials
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Portsmouth
country: United States
facility: Allcutis Research, Llc
state: New Hampshire
city: Hackensack
country: United States
facility: Schweiger Dermatology
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Suny Downstate Medical Center
state: New York
city: New York
country: United States
facility: Equity Medical, Llc
state: New York
city: New York
country: United States
facility: OPTISKIN
state: New York
city: Athens
country: United States
facility: Oakview Dermatology
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Institute
state: Ohio
city: Dublin
country: United States
facility: Centricity Research Aventiv Research Dublin
state: Ohio
city: Oklahoma City
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Philadelphia
country: United States
facility: Paddington Testing Co Inc
state: Pennsylvania
city: Yardley
country: United States
facility: Yardley Dermatology Associates
state: Pennsylvania
city: Murfreesboro
country: United States
facility: International Clinical Research Tennessee Llc
state: Tennessee
city: Dallas
country: United States
facility: Modern Research Associates Pllc
state: Texas
city: Murray
country: United States
facility: University of Utah Midvalley Dermatology
state: Utah
city: Burien
country: United States
facility: Aesthetic General Dermatology of Seattle
state: Washington
city: Morgantown
country: United States
facility: West Virginia Research Institute
state: West Virginia
city: Kogarah
country: Australia
facility: Premier Specialists Pty Ltd
state: New South Wales
city: Newcastle
country: Australia
facility: Novatrials
state: New South Wales
city: Sydney
country: Australia
facility: Skin & Cancer Foundation Australia
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Wolloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
city: Brugge
country: Belgium
facility: Az Sint-Jan Brugge Av
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent (Uz Gent)
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire (Chu) de Liege - Domaine Universitaire Du Sart Tilman
city: Loverval
country: Belgium
facility: Grand Hopital de Charleroi ¿ Site Imtr
city: Woluwe-saint-lambert
country: Belgium
facility: Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
city: Edmonton
country: Canada
facility: Skin Physicians
state: Alberta
city: Edmonton
country: Canada
facility: Alpha Research-Lucere Dermatology and Laser Clinic
state: Alberta
city: Barrie
country: Canada
facility: Simcoderm Medical and Surgical Dermatology Centre
state: Ontario
city: London
country: Canada
facility: Dermeffects
state: Ontario
city: Toronto
country: Canada
facility: North York Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Quebec City
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
city: Saskatoon
country: Canada
facility: Skinsense Medical Research
state: Saskatchewan
city: LAS Condes Santiago
country: Chile
facility: Centro Medico Skinmed Limitada
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos
city: Valdivia
country: Chile
facility: Clinical Research Chile Spa.
city: Prague
country: Czechia
facility: Clintrial S.R.O.
city: Prague
country: Czechia
facility: Sanatorium Profesora Arenbergera
city: Praha 13-stodulky
country: Czechia
facility: Sanixtra Prague
city: Aachen
country: Germany
facility: University Hospital Rwth Aachen
city: Buxtehude
country: Germany
facility: Elbe Kliniken Buxtehude
city: Chemnitz
country: Germany
facility: Drk Krankenhaus Chemnitz-Rabenstein
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
city: Darmstadt
country: Germany
facility: Rosenpark Research Gmbh
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
city: Frankfurt Am Main
country: Germany
facility: Klinikum Der Johann Wolfgang Goethe-Universitaet
city: Gottingen
country: Germany
facility: Universitaetsmedizin Goettingen
city: Magdeburg
country: Germany
facility: Magdeburger Company For Medical Studies and Services Gmbh
city: Mainz
country: Germany
facility: Dermatologische Gemeinschaftspraxis Dres. Quist
city: Muenchen
country: Germany
facility: Technischen Universitaet Muenchen
city: Muenster
country: Germany
facility: University Hospital Muenster
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg Aor
city: Witten
country: Germany
facility: Hautarztpraxis Dr. Hoffmann
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Hospital, Faculty of Medicine
city: Inashiki-gun
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center - Kasumigaura Campus (Tokyo Medical University Kasum
city: Kamimashiki-gun
country: Japan
facility: Noguchi Dermatology Clinic
city: Kawasaki-shi
country: Japan
facility: Nippon Medical School Musashikosugi Hospital
city: Kitakyushu
country: Japan
facility: University of Occupational and Environmental Health, Japan
city: Kobe
country: Japan
facility: Shimizu Dermatology Clinic
city: Minamikoshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Osaka
country: Japan
facility: Medical Corporation Jun Dermatology Clinic
city: Ota-ku
country: Japan
facility: Tanpopo Dermatology Clinic
city: Sakai
country: Japan
facility: Kume Derma Clinic
city: Sapporo
country: Japan
facility: Sapporo Skin Clinic
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
city: Tokorozawa-shi
country: Japan
facility: National Defence Medical College Hospital
city: Gdansk
country: Poland
facility: Akk Medical Sp. Z O.O. - Centrum Medyczne Tu Sie Leczy
city: Katowice
country: Poland
facility: Care Clinic Sp. Z O.O.
city: Lodz
country: Poland
facility: Santa Familia Ptg Lodz
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 Prof. Dr. Hab. N. Med. Dorota Krasowska
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Poznan
country: Poland
facility: Clinical Research Center Spolka Z Ograniczona Odpowiedzialnoscia Medic-R Spolka Komandytowa
city: Rzeszow
country: Poland
facility: Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
city: Torun
country: Poland
facility: Mics Centrum Medyczne Torun
city: Warszawa
country: Poland
facility: High-Med. Przychodnia Specjalistyczna
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Mswia
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Wroclaw
country: Poland
facility: Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska
city: Alicante
country: Spain
facility: Hospital General Universitario Dr Balmis
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol (Hugtp)
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Granada
country: Spain
facility: Hospital Clinico Universitario San Cecilio
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
city: Manises
country: Spain
facility: Hospital de Manises
city: Santiago de Compostela
country: Spain
facility: Area Sanitaria de Santiago de Compostela Y Barbanza - Complejo Hospitalario Universitario de Santiag
city: Seville
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari I Politecnic La Fe de Valencia - Instituto de Investigacion Sanitaria La Fe (I
city: Dudley
country: United Kingdom
facility: The Dudley Group Nhs Foundation Trust
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust
city: Liverpool
country: United Kingdom
facility: Broadgreen Hospital - Liverpool University Hospitals Nhs Foundation Trust
city: London
country: United Kingdom
facility: The Royal London Hospital - Barts Health Nhs Trust
city: London
country: United Kingdom
facility: Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
city: Poole
country: United Kingdom
facility: Poole Hospital - University Hospitals Dorset Nhs Foundation Trust
city: Redhill
country: United Kingdom
facility: Surrey and Sussex Healthcare Nhs Trust - East Surrey Hospital
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: