A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by Janssen Research & Development, LLC
Sponsor
Janssen Research & Development, LLC
Information Provided by (Responsible Party)
Janssen Research & Development, LLC
Clinicaltrials.gov Identifier
NCT06878404
Other Study ID Numbers:
77242113PSA3001
First Submitted
March 12, 2025
First Posted
March 16, 2025
Last Update Posted
April 12, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Arthritis, Psoriatic
Drug: IcotrokinraDrug: IcotrokinraDrug: IcotrokinraDrug: Icotrokinra

Study Design

Study TypeInterventional
Actual Enrollment552 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA 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 Start DateFebruary 20, 2025
Actual Primary Completion Date3w 1d from now
Actual Study Completion Date1yr 8mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Group I: Icotrokinra Dose 1
Participants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.
Drug: Icotrokinra
Icotrokinra will be administered.
Group II: Icotrokinra Dose 2
Participants will receive icotrokinra dose 2. Participants who continue into a LTE will continue to receive icotrokinra dose 2.
Drug: Icotrokinra
Icotrokinra will be administered.
Group III: Placebo
Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.
Drug: Icotrokinra
Icotrokinra will be administered.
Group IV: Active Reference Comparator
Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.
Drug: Icotrokinra
Icotrokinra will be administered.

Outcome Measures

Primary Outcome Measures
  1. Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at 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 VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
Secondary Outcome Measures
  1. 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
    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.
  2. 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
    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.
  3. 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
    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.
  4. 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
    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).
  5. Proportion of Participants who Achieve an ACR 50 Response at 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 VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
  6. Proportion of Participants who Achieve an ACR 70 Response at 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 VAS scale, Physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
  7. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At 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 is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0-3 where 0 = least difficulty and 3 = extreme difficulty.
  8. Changes From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at 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 is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains are averaged to calculate PCS. Total score range for PCS is 0-100 (100=highest level of physical functioning).
  9. Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline
    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). Resolution is defined as participants have enteritis (LEI score \>0) at baseline and no enthesis (LEO score =0) at the visit (week 16).
  10. Change From Baseline in Enthesitis Score (LEI) at Week 16 in Participants With Enthesitis at Baseline
    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 total scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
  11. Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline
    Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. Resolution is defined as participants have dactylitis (score \>0) at baseline and no dactylitis (score =0) at the visit (week 16).
  12. Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline
    Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.
  13. Proportion of Participants who Achieve Minimal Disease Activity (MDA) at Week 16
    MDA criteria are a composite of 7 outcome measures used in PsA. Participants are classified as achieving MDA if they fulfill 5 of 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; 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.
  14. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsJanssen Research & Development, LLC
Locations
Arthritis and Rheumatism Associates ARA Jonesboro | Jonesboro Arkansas, United States, 72401Omega Research Consultants | DeBary Florida, United States, 32713Integral Rheumatology And Immunology Specialists | Plantation Florida, United States, 33324Clinical Research of West Florida | Tampa Florida, United States, 33606Willow Rheumatology and Wellness PLLC | Willowbrook Illinois, United States, 60527Joint and Muscle Research Institute | Charlotte North Carolina, United States, 28204Altoona Center For Clinical Research | Duncansville Pennsylvania, United States, 16635Arthritis and Rheumatology Research Institute | Allen Texas, United States, 75013Naiara Alvarez MD Integrative Rheumatology of South TX | Harlingen Texas, United States, 78550Cosultorios Reumatologógicos Pampa | Buenos Aires , Argentina, 1428Mindout Research | Buenos Aires , Argentina, C1417EYGHospital Central Militar Cirujano Mayor Dr Cosme Argerich | Buenos Aires , Argentina, C1426BOSArsema | Ciudad de Buenos Aires , Argentina, C1431Centro Medico Privado de Reumatologia Tucuman | Ciudad de San Miguel de Tucuman , Argentina, T4000AXLConsultora Integral de Salud SRL | Córdoba , Argentina, CP5000MR Medicina Reumatologica | San Fernando , Argentina, B1646GHPInstituto Medico De Alta Complejidad (IMAC) | San Isidro , Argentina, B1642IPNIpswich Hospital | Ipswich , Australia, 4305Rheumatology Research Unit | Maroochydore , Australia, 4558BJC Health | Parramatta , Australia, 2150Queen Elizabeth Hospital | South Woodville , Australia, 5011Royal Darwin Hospital | Tiwi , Australia, 0810MC Medtech Services Ltd | Haskovo , Bulgaria, 6304Exacta Medica | Pleven , Bulgaria, 5803Medical Center Artmed | Plovdiv , Bulgaria, 4002Medical Center Teodora | Rousse , Bulgaria, 7012Peking University Third Hospital | Beijing , China, 100191Beijing Tong Ren Hospital Capital Medical University | Beijing , China, 100730The First Bethune Hospital of Jilin University | Changchun , China, 130021Xiangya Hospital Central South University | Changsha , China, 410008West China Hospital Sichuan University | Chengdu , China, 610041Sichuan Provincial Peoples Hospital | Chengdu , China, 610072The First Affiliated Hospital of Chongqing Medical University | Chongqing , China, 4000016Nanfang Hospital of Southern Medical Hospital | Guangzhou , China, 510515The Affiliated Hospital of Guizhou Medical University | Guiyang , China, 561113Linyi City People Hospital | Linyi , China, 276002Jiangxi Provincial Peoples Hospital | Nanchang , China, 330006The Second Affiliated Hospital of Nanchang University | Nanchang , China, 330008Affiliated Hospital of Nantong University | Nantong , China, 226001Pingxiang People's Hospital | Pingxiang , China, 337055Huashan Hospital Fudan University | Shanghai , China, 200040Shanghai skin disease hospital | Shanghai , China, 200443Shenzhen People s Hospital | Shenzhen , China, 518020The Third Hospital of Hebei Medical University | Shijiazhuang , China, 050051Second Affiliated Hospital of Soochow University | Suzhou , China, 215000Shanxi Bethune Hospital | Taiyuan , China, 030032The First Affiliated Hospital of Wenzhou Medical University | Wenzhou , China, 325000The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an , China, 710006Affiliated Hospital of Jiangsu University | Zhenjiang , China, 212001Revmatologie s r o | Brno , Czechia, 63800Revmacentrum MUDr Mostera s r o | Brno-Židenice , Czechia, 615 00RHEUMA s r o | Břeclav , Czechia, 690 02L K N Arthrocentrum | Hlučín , Czechia, 748 01Revimex Pro s r o | Karvina Frystat , Czechia, 73301CCR Ostrava S R O | Ostrava , Czechia, 70200MUDr Rosypalova s r o | Ostrava , Czechia, 70800Revmatologicky ustav | Prague , Czechia, 128 00Revmatologicka Ordinace | Prague , Czechia, 140 00Thomayerova nemocnice | Prague , Czechia, 140 59FN Motol | Prague , Czechia, 150 00Medical Plus S R O | Uherské Hradiště , Czechia, 68601PV Medical S R O | Zlín , Czechia, 76001Aarhus University Hospital | Aarhus N , Denmark, 8200Sydvestjysk Sygehus | Esbjerg , Denmark, 6700Frederiksberg Hospital | Frederiksberg , Denmark, 2000Regionshospitalet Godstrup | Herning , Denmark, 7400Svendborg Hospital Odense University Hospital | Svendborg , Denmark, 5700Vejle Sygehus | Vejle , Denmark, 7100Fachklinik Bad Bentheim | Bad Bentheim , Germany, 48455Charite Universitaetsmedizin Berlin | Berlin , Germany, 10117ISA - Interdisciplinary Study Association GmbH | Berlin , Germany, 10789Universitatsklinikum Carl Gustav Carus Dresden | Dresden , Germany, 01307Medizinische Fakultat der Albert Ludwigs Universitat Freiburg | Freiburg im Breisgau , Germany, 79104Hamburger Rheuma Forschungszentrum II | Hamburg , Germany, 20095Rheumazentrum Ruhrgebiet | Herne , Germany, 44649Studienzentrum Dr Schwarz Germany | Langenau , Germany, 89129Johannes Wesling Klinikum Minden | Minden , Germany, 32429Universitatsklinikum Tubingen | Tübingen , Germany, 72076Prince of Wales Hospital | Hong Kong , Hong Kong, 000000Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz | Budapest , Hungary, 1027Revita Kft | Budapest , Hungary, 1027Obudai Egeszsegugyi Centrum Kft | Budapest , Hungary, 1036Synexus Magyarorszag Kft | Budapest , Hungary, 1036Qualiclinic Kft | Budapest , Hungary, 1134Uno Medical Trials Ltd. | Budapest , Hungary, 1152University of Debrecen | Debrecen , Hungary, 4032Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Gyula , Hungary, 5700Obudai Egeszsegugyi Centrum Kft 1 | Kaposvár , Hungary, 7400University of Szeged | Szeged , Hungary, 6725MAV Korhaz es Rendelointezet | Szolnok , Hungary, 5000Vital Medical Center Orvosi es Fogaszati Kozpont | Veszprém , Hungary, 8200Marengo Cims Hospital | Ahmedabad , India, 380060Apollo Hospitals | Bhubaneswar , India, 751005Nizams Institute of Medical Sciences | Hyderabad , India, 500082Apollo Multispeciality Hospital Ltd | Kolkata , India, 700054Kokilaben Dhirubhai Ambani Hsp And Med Research Inst | Mumbai , India, 400053JSS Hospital | Mysuru , India, 570004All India Institute of Medical Sciences | New Delhi , India, 110029Indraprastha Apollo Hospital | New Delhi , India, 1100776Fortis Hospital | Noida , India, 201301SIDS Hospital & Research Centre | Surat , India, 395002Fukuoka University Hospital | Fukuoka , Japan, 814 0180Teikyo University Hospital | Itabashi Ku , Japan, 173 8606Kagawa University Hospital | Kita Gun , Japan, 761 0793Nagoya City University Hospital | Nagoya , Japan, 467 8602Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital | Osaka , Japan, 550 0006Maeshima Rheumatology Clinic | Ōita , Japan, 870 0823Sasebo Chuo Hospital | Sasebo , Japan, 857 1195Tohoku University Hospital | Sendai , Japan, 980 8574Kyorin University Hospital | Tokyo , Japan, 181 8611Mie University Hospital | Tsu , Japan, 514 8507Osteo Medic S C Artur Racewicz Jerzy Supronik | Bialystok , Poland, 15-351Specderm Poznanska sp j | Bialystok , Poland, 15-375ClinicMed Daniluk Nowak Spolka Komandytowa | Bialystok , Poland, 15-879Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy | Bydgoszcz , Poland, 85-168Ambulatorium sp. z o.o. | Elblag , Poland, 82-300Centrum Kliniczno Badawcze | Elblag , Poland, 82-300Centrum Medyczne Pratia Gdynia | Gdynia , Poland, 81-338Malopolskie Badania Kliniczne Sp z o o | Krakow , Poland, 30-002Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna | Krakow , Poland, 30-002Centrum Medyczne All Med | Krakow , Poland, 30-033Pratia MCM Krakow | Krakow , Poland, 30-727Dermed Centrum Medyczne Sp z o o | Lodz , Poland, 90-265Zespol Poradni Specjalistycznych Reumed Filia nr 1 | Lublin , Poland, 20-607NZOZ Lecznica MAK MED S C | Nadarzyn , Poland, 05-830Etyka Osrodek Badan Klinicznych | Olsztyn , Poland, 10-117MICS Centrum Medyczne Torun | Torun , Poland, 87-100MICS Centrum Medyczne Warszawa | Warsaw , Poland, 00-874Centrum Medyczne Reuma Park | Warsaw , Poland, 02-665DermMedica Sp z o o | Wroclaw , Poland, 51-503Centrum Medyczne Oporow | Wroclaw , Poland, 52-416Hosp Univ A Coruna | A Coruña , Spain, 15006Hosp Univ Vall D Hebron | Barcelona , Spain, 08035Hosp. Clinic de Barcelona | Barcelona , Spain, 8036Hosp Reina Sofia | Córdoba , Spain, 14004Hosp. Univ. 12 de Octubre | Madrid , Spain, 28041Hosp Regional Univ de Malaga | Málaga , Spain, 29009Corporacio Sanitari Parc Tauli | Sabadell , Spain, 08208Hosp. Univ. Marques de Valdecilla | Santander , Spain, 39008Hosp. Virgen Macarena | Seville , Spain, 41009Hosp. Infanta Luisa | Seville , Spain, 41010Hosp. Quiron Sagrado Corazon | Seville , Spain, 41013Hosp. Virgen Del Rocio | Seville , Spain, 41013National Taiwan University Hospital Hsin Chu Branch | Hsinchu , Taiwan, 300Chang Gung Memorial Hospital | Kaohsiung City , Taiwan, 833National Cheng Kung University Hospital | Tainan , Taiwan, 704Chi Mei Medical Center Yong Kang | Tainan , Taiwan, 710Taipei Veterans General Hospital | Taipei , Taiwan, 112Linkou Chang Gung Memorial Hospital | Taoyuan , Taiwan, 333Phramongkutklao Hospital | Bangkok , Thailand, 10400Rajavithi Hospital | Bangkok , Thailand, 10400Siriraj Hospital | Bangkok , Thailand, 10700Saraburi Hospital | Changwat Sara Buri , Thailand, 18000Phra Nakhon Si Ayutthaya Hospital | Phra Nakhon Si Ayutthaya , Thailand, 13000Songklanagarind hospital | Songkhla , Thailand, 90110
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC