Clinical trial NCT06807424: A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced Participants With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Arthritis, Psoriatic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2025-02-04
Enrollment: 750
Sex: ALL
Minimum age (years): 18
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 efficacy of icotrokinra compared to placebo in biologic-experienced participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.


Eligibility criteria: Inclusion Criteria:

* Participants must have been previously treated with 1 biologic agent for psoriatic arthritis (PsA) or psoriasis and the reason for discontinuation must be documented
* Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening
* Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (\>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory.
* Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
* Have active plaque psoriasis with at least one psoriatic plaque of \>= 2 cm diameter or nail changes consistent with psoriasis
* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

Exclusion Criteria:

* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
* Currently has a malignancy or has a history of malignancy within 5 years prior to screening
* Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
* Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or Lyme disease
* Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments

Primary outcomes:
measure: Proportion of Participants who Achieved an American College of Rheumatology (ACR) ACR 20 Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Proportion of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to (>=) 3 Percent (%) and With Baseline IGA Score of >=2
timeFrame: Week 16
measure: Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
timeFrame: Week 16
measure: Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
timeFrame: Week 16
measure: Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And >=2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
timeFrame: Week 16
measure: Proportion of Participants who Achieved an ACR 50 Response at Week 16
timeFrame: Week 16
measure: Proportion of Participants who Achieved an ACR 70 Response at Week 16
timeFrame: Week 16
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16
timeFrame: From baseline up to Week 16
measure: Changes From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
timeFrame: From baseline up to Week 16
measure: Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline
timeFrame: Week 16
measure: Change From Baseline in Enthesitis Score at Week 16 in Participants With Enthesitis at Baseline
timeFrame: Baseline and Week 16
measure: Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline
timeFrame: Week 16
measure: Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline
timeFrame: From baseline up to Week 16
measure: Proportion of Participants who Achieved Minimal Disease Activity (MDA) at Week 16
timeFrame: Week 16
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16
timeFrame: From baseline up to Week 16
Other outcomes:
Locations:
city: Glendale
country: United States
facility: AARA Clinical Research
state: Arizona
city: Mesa
country: United States
facility: AARA Clinical Research
state: Arizona
city: Jonesboro
country: United States
facility: Arthritis and Rheumatism Associates ARA Jonesboro
state: Arkansas
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology And Immunology Specialists
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Skokie
country: United States
facility: Clinic of Robert Hozman
state: Illinois
city: Hagerstown
country: United States
facility: Klein And Associates M D P A
state: Maryland
city: Brookline
country: United States
facility: DM Clinical Research
state: Massachusetts
city: Eagan
country: United States
facility: St Paul Rheumatology PA
state: Minnesota
city: Albuquerque
country: United States
facility: Albuquerque Rehabilitation and Rheumatology
state: New Mexico
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Oklahoma City
country: United States
facility: Rheumatology Associates of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Irving
country: United States
facility: AARA Clinical Research Lone Star Arthritis and Rheumatology
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Buenos Aires
country: Argentina
facility: Instituto Medico De Alta Complejidad (IMAC)
city: Buenos aires
country: Argentina
facility: ARCIS Salud SRL Aprillus asistencia e investigacion
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Militar Central Cir. My. Dr. Cosme Argerich
city: Ciudad de Buenos Aires
country: Argentina
facility: Arsema
city: Ciudad De San Miguel De Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia Tucuman
city: Ipswich
country: Australia
facility: Ipswich Hospital
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit
city: South Woodville
country: Australia
facility: Queen Elizabeth Hospital
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
city: Sliven
country: Bulgaria
facility: Diagnostic Consulting Center I Sliven
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD
city: Sofia
country: Bulgaria
facility: UMHAT St. Ivan Rilski
city: Sofia
country: Bulgaria
facility: ASIMP Rheumatology Centre St Irina EOOD
city: Waterloo
country: Canada
facility: Alliance Clinical Trials
state: Ontario
city: Trois Rivieres
country: Canada
facility: Centre de Recherche Musculo Squelettique
state: Quebec
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Tong Ren Hospital Capital Medical University
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
city: ChangSha
country: China
facility: Xiangya Hospital Central South University
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chengdu
country: China
facility: Sichuan Provincial Peoples Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical Hospital
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
city: Jinhua
country: China
facility: Jinhua municipal central hospital
city: Linyi City
country: China
facility: Linyi City People Hospital
city: Nanchang
country: China
facility: The Second Affiliatde Hospital To Nanchang University
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai skin disease hospital
city: Shenzhen
country: China
facility: Shenzhen People s Hospital
city: Suzhou
country: China
facility: Second Affiliated Hospital of Soochow University
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Xian City
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Breclav
country: Czechia
facility: RHEUMA s r o
city: Brno
country: Czechia
facility: Revmacentrum MUDr Mostera s r o
city: Brno
country: Czechia
facility: Revmatologie s r o
city: Hlucin
country: Czechia
facility: L K N Arthrocentrum
city: Ostrava
country: Czechia
facility: CCR Ostrava S R O
city: Ostrava
country: Czechia
facility: MUDr Rosypalova s r o
city: Praha
country: Czechia
facility: FN Motol
city: Uherske Hradiste
country: Czechia
facility: Medical Plus S R O
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital
city: Herning
country: Denmark
facility: Regionshospitalet Godstrup
city: Svendborg
country: Denmark
facility: Svendborg Hospital Odense University Hospital
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Hamburg
country: Germany
facility: Hamburger Rheuma Forschungszentrum II
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
city: Langenau
country: Germany
facility: Praxis Dr. med. Beate Schwarz - Germany
city: Ratingen
country: Germany
facility: Rheumaforschung - Studienambulanz Dr. Wassenberg
city: Tubingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
city: Budapest
country: Hungary
facility: Revita Kft
city: Budapest
country: Hungary
facility: Qualiclinic Kft
city: Budapest
country: Hungary
facility: Uno Medical Trials Ltd.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Reumatologiai Klinika
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Kecskemet
country: Hungary
facility: Bacs Kiskun Varmegyei Oktatokorhaz
city: Szolnok
country: Hungary
facility: MAV Korhaz es Rendelointezet
city: Veszprem
country: Hungary
facility: Vital Medical Center Orvosi es Fogaszati Kozpont
city: Chuo ku
country: Japan
facility: St. Luke's International Hospital
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Hyogo
country: Japan
facility: Kita-harima Medical Center
city: Oita
country: Japan
facility: Maeshima Rheumatology Clinic
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Sanuki
country: Japan
facility: Sanuki Municipal Hospital
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
city: Shimotsuga Gun
country: Japan
facility: Dokkyo Medical University Hospital
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
city: Bialystok
country: Poland
facility: NZOZ Osteo Medic S C Artur Racewicz i Jerzy Supronik
city: Bialystok
country: Poland
facility: Specderm Poznanska sp j
city: Bialystok
country: Poland
facility: ClinicMed Daniluk Nowak Spolka Komandytowa
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy
city: Elblag
country: Poland
facility: Ambulatorium sp. z o.o.
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
city: Krakow
country: Poland
facility: Malopolskie Badania Kliniczne Sp z o o
city: Krakow
country: Poland
facility: Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
city: Krakow
country: Poland
facility: Centrum Medyczne All Med
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Lublin
country: Poland
facility: Zespol Poradni Specjalistycznych Reumed Filia nr 1
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK MED S C
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park
city: Wroclaw
country: Poland
facility: DermMedica Sp z o o
city: Bucharest
country: Romania
facility: S C Delta Health Care S R L
city: Craiova
country: Romania
facility: Ecomed Research SRL
city: Iasi
country: Romania
facility: Centrul Medical Unirea
city: Ramnicu Valcea
country: Romania
facility: Medaudio Optica S R L
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Cordoba
country: Spain
facility: Hosp Reina Sofia
city: Madrid
country: Spain
facility: Hosp. Univ. Infanta Leonor
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Sevilla
country: Spain
facility: Hosp. Infanta Luisa
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Hsin Chu
country: Taiwan
facility: National Taiwan University Hospital Hsin Chu Branch
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Saraburi
country: Thailand
facility: Saraburi Hospital
city: Songkhla
country: Thailand
facility: Songklanagarind hospital
city: Barnet
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: Basingstoke
country: United Kingdom
facility: Basingstoke And North Hampshire Hospital
city: Christchurch
country: United Kingdom
facility: University Hospitals Dorset NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Larbert
country: United Kingdom
facility: Forth Valley Royal Hospital
city: Staffordshire
country: United Kingdom
facility: Haywood Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: