A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis
- Registration Number
- NCT06807424
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 750
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group III: Placebo Placebo Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra Dose 1 or Dose 2 at Week 16. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 1 or Dose 2. Group I: Icotrokinra Dose 1 Icotrokinra Participants will receive icotrokinra Dose 1. Participants who have not discontinued will be eligible to enter a long term extension (LTE) and will continue to receive icotrokinra Dose 1. Group II: Icotrokinra Dose 2 Icotrokinra Participants will receive icotrokinra Dose 2. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 2. Group III: Placebo Icotrokinra Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra Dose 1 or Dose 2 at Week 16. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 1 or Dose 2.
- Primary Outcome Measures
Name Time Method Proportion of Participants who Achieved an American College of Rheumatology (ACR) ACR 20 Response at Week 16 Week 16 The ACR 20 responders are participants with an improvement of greater than or equal to (\>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity \[arthritis, VAS\] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).
- Secondary Outcome Measures
Name Time Method 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 Week 16 The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2 Week 16 The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2 Week 16 The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants who achieved at least a 100 percent improvement from baseline in the PASI score.
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 Week 16 Proportion of participants with an IGA psoriasis score of 0 or 1 And \>=2 grade improvement from baseline at Week 16 among participants with \>=3% BSA and an IGA Score of \>=2 at Baseline will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling, each using a 5-point scale: using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe) scale. The IGA score of psoriasis is based upon the average of induration, erythema, and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Proportion of Participants who Achieved an ACR 50 Response at Week 16 Week 16 The ACR 50 responders are participants with an improvement of \>= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity (arthritis, VAS) scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).
Proportion of Participants who Achieved an ACR 70 Response at Week 16 Week 16 The ACR 70 responders are participants with an improvement of \>= 70% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity (arthritis, VAS) scale, Physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16 From baseline up to Week 16 The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Changes From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16 From baseline up to Week 16 SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0 to 100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline Week 16 Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Change From Baseline in Enthesitis Score at Week 16 in Participants With Enthesitis at Baseline Baseline and Week 16 Enthesitis will be assessed using the LEI. The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline Week 16 Dactylitis is characterized by swelling of the entire finger or toe. Presence and severity of dactylitis will be assessed in both hand and feet using a scoring system from 0 to 3 (0: no dactylitis, 1: mild dactylitis, 2: moderate dactylitis, 3: severe dactylitis). The result for each digit are summed to produce a final dactylitis score with a range from 0 to 60. Higher score indicates greater severity.
Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline From baseline up to Week 16 Dactylitis is characterized by swelling of the entire finger or toe. Presence and severity of dactylitis will be assessed in both hand and feet using a scoring system from 0 to 3 (0: no dactylitis, 1: mild dactylitis, 2: moderate dactylitis, 3: severe dactylitis). The result for each digit are summed to produce a final dactylitis score with a range from 0 to 60. Change from baseline in dactylitis score measure the change in dactylitis, where a negative change indicates an improvement and a positive change indicates a worsening.
Proportion of Participants who Achieved Minimal Disease Activity (MDA) at Week 16 Week 16 MDA criteria are a composite of 7 outcome measures used in PsA. Participants are classified as achieving MDA if they fulfill at least 5 out of the 7 outcome measures: tender joint count less than or equal to (\<=) 1; swollen joint count \<= 1; psoriasis activity and severity index \<= 1 or body surface area \<= 3 percent (%); patient pain VAS score of \<= 15; patient global disease activity VAS (arthritis and psoriasis) score of \<= 20; health assessment questionnaire (HAQ) score \<= 0.5; and tender entheseal points \<= 1.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16 From baseline up to Week 16 The FACIT-fatigue is a self-administered, 13 item questionnaire measuring items on tiredness, weakness, and difficulty conducting usual activities due to fatigue. Responses to all items are rated on a 5-point Likert response scale ranging from 0 "not at all" to 4 "very much." The total score ranges from 0 to 52, with higher values indicating less fatigue.
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Trial Locations
- Locations (138)
Hosp. Virgen Del Rocio
🇪🇸Sevilla, Spain
National Taiwan University Hospital Hsin Chu Branch
🇨🇳Hsin Chu, Taiwan
Regionshospitalet Godstrup
🇩🇰Herning, Denmark
AARA Clinical Research
🇺🇸Mesa, Arizona, United States
Arthritis and Rheumatism Associates ARA Jonesboro
🇺🇸Jonesboro, Arkansas, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
Omega Research Consultants
🇺🇸DeBary, Florida, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Integral Rheumatology And Immunology Specialists
🇺🇸Plantation, Florida, United States
Clinic of Robert Hozman
🇺🇸Skokie, Illinois, United States
Klein And Associates M D P A
🇺🇸Hagerstown, Maryland, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
St Paul Rheumatology PA
🇺🇸Eagan, Minnesota, United States
Albuquerque Rehabilitation and Rheumatology
🇺🇸Albuquerque, New Mexico, United States
Joint and Muscle Research Institute
🇺🇸Charlotte, North Carolina, United States
Rheumatology Associates of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
AARA Clinical Research Lone Star Arthritis and Rheumatology
🇺🇸Irving, Texas, United States
Instituto Medico De Alta Complejidad (IMAC)
🇦🇷Buenos Aires, Argentina
ARCIS Salud SRL Aprillus asistencia e investigacion
🇦🇷Buenos aires, Argentina
Hospital Militar Central Cir. My. Dr. Cosme Argerich
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Arsema
🇦🇷Ciudad de Buenos Aires, Argentina
Centro Medico Privado de Reumatologia Tucuman
🇦🇷Ciudad De San Miguel De Tucuman, Argentina
Ipswich Hospital
🇦🇺Ipswich, Australia
Rheumatology Research Unit
🇦🇺Maroochydore, Australia
Queen Elizabeth Hospital
🇦🇺South Woodville, Australia
Royal North Shore Hospital
🇦🇺St Leonards, Australia
Diagnostic Consulting Center I Sliven
🇧🇬Sliven, Bulgaria
Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD
🇧🇬Sofia, Bulgaria
UMHAT St. Ivan Rilski
🇧🇬Sofia, Bulgaria
ASIMP Rheumatology Centre St Irina EOOD
🇧🇬Sofia, Bulgaria
Alliance Clinical Trials
🇨🇦Waterloo, Ontario, Canada
Centre de Recherche Musculo Squelettique
🇨🇦Trois Rivieres, Quebec, Canada
Peking University Third Hospital
🇨🇳Beijing, China
Beijing Tong Ren Hospital Capital Medical University
🇨🇳Beijing, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, China
Xiangya Hospital Central South University
🇨🇳ChangSha, China
West China Hospital Sichuan University
🇨🇳Chengdu, China
Sichuan Provincial Peoples Hospital
🇨🇳Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Nanfang Hospital of Southern Medical Hospital
🇨🇳Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, China
The First Hospital of Jiaxing
🇨🇳Jiaxing, China
Jinhua municipal central hospital
🇨🇳Jinhua, China
Linyi City People Hospital
🇨🇳Linyi City, China
The Second Affiliatde Hospital To Nanchang University
🇨🇳Nanchang, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, China
Pingxiang People's Hospital
🇨🇳Pingxiang, China
Huashan Hospital Fudan University
🇨🇳Shanghai, China
Shanghai skin disease hospital
🇨🇳Shanghai, China
Shenzhen People s Hospital
🇨🇳Shenzhen, China
Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xian City, China
RHEUMA s r o
🇨🇿Breclav, Czechia
Revmacentrum MUDr Mostera s r o
🇨🇿Brno, Czechia
Revmatologie s r o
🇨🇿Brno, Czechia
L K N Arthrocentrum
🇨🇿Hlucin, Czechia
CCR Ostrava S R O
🇨🇿Ostrava, Czechia
MUDr Rosypalova s r o
🇨🇿Ostrava, Czechia
FN Motol
🇨🇿Praha, Czechia
Medical Plus S R O
🇨🇿Uherske Hradiste, Czechia
Aarhus University Hospital
🇩🇰Aarhus N, Denmark
Sydvestjysk Sygehus
🇩🇰Esbjerg, Denmark
Frederiksberg Hospital
🇩🇰Frederiksberg, Denmark
Svendborg Hospital Odense University Hospital
🇩🇰Svendborg, Denmark
Vejle Sygehus
🇩🇰Vejle, Denmark
ISA - Interdisciplinary Study Association GmbH
🇩🇪Berlin, Germany
Hamburger Rheuma Forschungszentrum II
🇩🇪Hamburg, Germany
Rheumazentrum Ruhrgebiet
🇩🇪Herne, Germany
Praxis Dr. med. Beate Schwarz - Germany
🇩🇪Langenau, Germany
Rheumaforschung - Studienambulanz Dr. Wassenberg
🇩🇪Ratingen, Germany
Universitatsklinikum Tubingen
🇩🇪Tubingen, Germany
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
🇭🇺Budapest, Hungary
Revita Kft
🇭🇺Budapest, Hungary
Qualiclinic Kft
🇭🇺Budapest, Hungary
Uno Medical Trials Ltd.
🇭🇺Budapest, Hungary
Debreceni Egyetem Reumatologiai Klinika
🇭🇺Debrecen, Hungary
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
🇭🇺Gyula, Hungary
Bacs Kiskun Varmegyei Oktatokorhaz
🇭🇺Kecskemet, Hungary
MAV Korhaz es Rendelointezet
🇭🇺Szolnok, Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont
🇭🇺Veszprem, Hungary
St. Luke's International Hospital
🇯🇵Chuo ku, Japan
Kansai Medical University Hospital
🇯🇵Hirakata, Japan
Kita-harima Medical Center
🇯🇵Hyogo, Japan
Maeshima Rheumatology Clinic
🇯🇵Oita, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka, Japan
Sanuki Municipal Hospital
🇯🇵Sanuki, Japan
Sasebo Chuo Hospital
🇯🇵Sasebo, Japan
Dokkyo Medical University Hospital
🇯🇵Shimotsuga Gun, Japan
Kyorin University Hospital
🇯🇵Tokyo, Japan
Mie University Hospital
🇯🇵Tsu, Japan
NZOZ Osteo Medic S C Artur Racewicz i Jerzy Supronik
🇵🇱Bialystok, Poland
Specderm Poznanska sp j
🇵🇱Bialystok, Poland
ClinicMed Daniluk Nowak Spolka Komandytowa
🇵🇱Bialystok, Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Ambulatorium sp. z o.o.
🇵🇱Elblag, Poland
Centrum Kliniczno Badawcze
🇵🇱Elblag, Poland
Centrum Medyczne Pratia Gdynia
🇵🇱Gdynia, Poland
Malopolskie Badania Kliniczne Sp z o o
🇵🇱Krakow, Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
🇵🇱Krakow, Poland
Centrum Medyczne All Med
🇵🇱Krakow, Poland
Pratia MCM Krakow
🇵🇱Krakow, Poland
Zespol Poradni Specjalistycznych Reumed Filia nr 1
🇵🇱Lublin, Poland
NZOZ Lecznica MAK MED S C
🇵🇱Nadarzyn, Poland
MICS Centrum Medyczne Torun
🇵🇱Torun, Poland
MICS Centrum Medyczne Warszawa
🇵🇱Warszawa, Poland
Centrum Medyczne Reuma Park
🇵🇱Warszawa, Poland
DermMedica Sp z o o
🇵🇱Wroclaw, Poland
S C Delta Health Care S R L
🇷🇴Bucharest, Romania
Ecomed Research SRL
🇷🇴Craiova, Romania
Centrul Medical Unirea
🇷🇴Iasi, Romania
Medaudio Optica S R L
🇷🇴Ramnicu Valcea, Romania
Hosp Univ A Coruna
🇪🇸A Coruna, Spain
Hosp Reina Sofia
🇪🇸Cordoba, Spain
Hosp. Univ. Infanta Leonor
🇪🇸Madrid, Spain
Hosp. Univ. Marques de Valdecilla
🇪🇸Santander, Spain
Hosp. Clinico Univ. de Santiago
🇪🇸Santiago de Compostela, Spain
Hosp. Virgen Macarena
🇪🇸Sevilla, Spain
Hosp. Infanta Luisa
🇪🇸Sevilla, Spain
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Chi Mei Medical Center
🇨🇳Tainan, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Phramongkutklao Hospital
🇹🇭Bangkok, Thailand
Rajavithi Hospital
🇹🇭Bangkok, Thailand
Siriraj Hospital
🇹🇭Bangkok, Thailand
Saraburi Hospital
🇹🇭Saraburi, Thailand
Songklanagarind hospital
🇹🇭Songkhla, Thailand
Royal Free London NHS Foundation Trust
🇬🇧Barnet, United Kingdom
Basingstoke And North Hampshire Hospital
🇬🇧Basingstoke, United Kingdom
University Hospitals Dorset NHS Foundation Trust
🇬🇧Christchurch, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Forth Valley Royal Hospital
🇬🇧Larbert, United Kingdom
Haywood Hospital
🇬🇧Staffordshire, United Kingdom