Clinical trial NCT06878404: A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve 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-naïve 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: 2025-03-17
Enrollment: 540
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 participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.


Eligibility criteria: Inclusion Criteria:

* 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 previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis
* 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
* 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 Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Proportion of Participants Who Achieve 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 an IGA Score of >=2 at Baseline
timeFrame: Week 16
measure: Proportion of Participants Who Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
timeFrame: Week 16
measure: Proportion of Participants Who Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
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 an IGA Score of >=2 at Baseline
timeFrame: Week 16
measure: Proportion of Participants who Achieve an ACR 50 Response at Week 16
timeFrame: Week 16
measure: Proportion of Participants who Achieve 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 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 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 (LEI) at Week 16 in Participants With Enthesitis at Baseline
timeFrame: From Baseline to 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 to Week 16
measure: Proportion of Participants who Achieve 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 to Week 16
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Arthritis and Rheumatism Associates ARA Jonesboro
state: Arkansas
city: DeBary
country: United States
facility: Omega Research Consultants
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology And Immunology Specialists
state: Florida
city: Willowbrook
country: United States
facility: Willow Rheumatology and Wellness PLLC
state: Illinois
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Buenos Aires
country: Argentina
facility: Cosultorios Reumatologógicos Pampa
city: Buenos Aires
country: Argentina
facility: Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Mindout Research
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: Cordoba
country: Argentina
facility: Consultora Integral de Salud SRL
city: San Fernando
country: Argentina
facility: MR Medicina Reumatologica
city: Ipswich
country: Australia
facility: Ipswich Hospital
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit
city: Parramatta
country: Australia
facility: BJC Health
city: South Woodville
country: Australia
facility: Queen Elizabeth Hospital
city: Tiwi
country: Australia
facility: Royal Darwin Hospital
city: Haskovo
country: Bulgaria
facility: MC Medtech Services Ltd
city: Ruse
country: Bulgaria
facility: Medical Center Teodora
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: Linyi City
country: China
facility: Linyi City People Hospital
city: Nanchang
country: China
facility: Jiangxi Provincial Peoples 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: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
city: Suzhou
country: China
facility: Soochow University, The Second Affiliated Hospital of
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: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
city: Breclav
country: Czechia
facility: RHEUMA s r o
city: Brno Zidenice
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: MUDr Rosypalova s r o
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
city: Praha 4
country: Czechia
facility: Thomayerova nemocnice
city: Praha 5
country: Czechia
facility: FN Motol
city: Praha
country: Czechia
facility: Revmatologicky ustav
city: Uherske Hradiste
country: Czechia
facility: Medical Plus S R O
city: Zlin
country: Czechia
facility: PV Medical 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: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
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: Studienzentrum Dr Schwarz Germany
city: Tubingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Budapest
country: Hungary
facility: Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
city: Budapest
country: Hungary
facility: Revita Kft
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: Qualiclinic Kft
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft
city: Budapest
country: Hungary
facility: Uno Medical Trials Ltd.
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Szolnok
country: Hungary
facility: MAV Korhaz es Rendelointezet
city: Veszprem
country: Hungary
facility: Vital Medical Center Orvosi es Fogaszati Kozpont
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Itabashi Ku
country: Japan
facility: Teikyo University Hospital
city: Kita Gun
country: Japan
facility: Kagawa University Hospital
city: Oita
country: Japan
facility: Maeshima Rheumatology Clinic
city: Osaka
country: Japan
facility: Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
city: Sasebo
country: Japan
facility: Sasebo Chuo 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: Olsztyn
country: Poland
facility: Etyka Osrodek Badan Klinicznych
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: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp. Clinic de Barcelona
city: Cordoba
country: Spain
facility: Hosp Reina Sofia
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Malaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Sevilla
country: Spain
facility: Hosp. Infanta Luisa
city: Sevilla
country: Spain
facility: Hosp. Quiron Sagrado Corazon
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Hsin Chu
country: Taiwan
facility: National Taiwan University Hospital Hsin Chu Branch
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center Yong Kang
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Phra Nakhon Si Ayutthaya
country: Thailand
facility: Phra Nakhon Si Ayutthaya Hospital
city: Saraburi
country: Thailand
facility: Saraburi Hospital
city: Songkhla
country: Thailand
facility: Songklanagarind hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: