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

Phase 3

Recruiting

• Conditions: Arthritis, Psoriatic
• Interventions: Drug: Icotrokinra; Drug: Placebo; Drug: Active reference comparator

• Registration Number: NCT06878404
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-21
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-10-02
• Study Completion: 2028-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I: Icotrokinra Dose 1	Icotrokinra	Participants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.
Group II: Icotrokinra Dose 2	Icotrokinra	Participants will receive icotrokinra dose 2. Participants who continue into a LTE 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. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.
Group III: Placebo	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.
Group IV: Active Reference Comparator	Icotrokinra	Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.
Group IV: Active Reference Comparator	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants who Achieve 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 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 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	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 Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline	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 Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline	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 who Achieve 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 VAS scale, Physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
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	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 Achieve 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 VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
Proportion of Participants who Achieve 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 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.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16	From Baseline 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 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.
Changes From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16	From Baseline 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 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).
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). Resolution is defined as participants have enteritis (LEI score \>0) at baseline and no enthesis (LEO score =0) at the visit (week 16).
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. 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).
Change From Baseline in Enthesitis Score (LEI) at Week 16 in Participants With Enthesitis at Baseline	From Baseline to 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 total scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline	From Baseline to Week 16	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.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16	From Baseline 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.

Trial Locations

Locations (127)

DermMedica Sp z o o; 🇵🇱 Wroclaw, Poland

Arthritis and Rheumatism Associates ARA Jonesboro; 🇺🇸 Jonesboro, Arkansas, United States

Consultora Integral de Salud SRL; 🇦🇷 Cordoba, Argentina

MR Medicina Reumatologica; 🇦🇷 San Fernando, Argentina

Medical Center Teodora; 🇧🇬 Ruse, Bulgaria

The Second Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xian City, China

Queen Elizabeth Hospital; 🇦🇺 South Woodville, Australia

MC Medtech Services Ltd; 🇧🇬 Haskovo, Bulgaria

Beijing Tong Ren Hospital Capital Medical University; 🇨🇳 Beijing, China

Royal Darwin Hospital; 🇦🇺 Tiwi, Australia

Shanghai skin disease hospital; 🇨🇳 Shanghai, China

Thomayerova nemocnice; 🇨🇿 Praha 4, Czechia

PV Medical S R O; 🇨🇿 Zlin, Czechia

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

The First Bethune Hospital of Jilin University; 🇨🇳 Changchun, China

Jiangxi Provincial Peoples Hospital; 🇨🇳 Nanchang, China

The Second Affiliatde Hospital To Nanchang University; 🇨🇳 Nanchang, China

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong

Uno Medical Trials Ltd.; 🇭🇺 Budapest, Hungary

Specderm Poznanska sp j; 🇵🇱 Bialystok, Poland

Centrum Medyczne Pratia Gdynia; 🇵🇱 Gdynia, Poland

Malopolskie Badania Kliniczne Sp z o o; 🇵🇱 Krakow, Poland

RHEUMA s r o; 🇨🇿 Breclav, Czechia

Revmacentrum MUDr Mostera s r o; 🇨🇿 Brno Zidenice, Czechia

Revmatologie s r o; 🇨🇿 Brno, Czechia

ISA - Interdisciplinary Study Association GmbH; 🇩🇪 Berlin, Germany

Obudai Egeszsegugyi Centrum Kft; 🇭🇺 Budapest, Hungary

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz; 🇭🇺 Gyula, Hungary

Vital Medical Center Orvosi es Fogaszati Kozpont; 🇭🇺 Veszprem, Hungary

MUDr Rosypalova s r o; 🇨🇿 Ostrava, Czechia

Revmatologicka ambulance; 🇨🇿 Praha 4, Czechia

FN Motol; 🇨🇿 Praha 5, Czechia

Medical Plus S R O; 🇨🇿 Uherske Hradiste, Czechia

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark

Revmatologicky ustav; 🇨🇿 Praha, Czechia

Regionshospitalet Godstrup; 🇩🇰 Herning, Denmark

Fachklinik Bad Bentheim; 🇩🇪 Bad Bentheim, Germany

Rheumazentrum Ruhrgebiet; 🇩🇪 Herne, Germany

Synexus Magyarorszag Kft; 🇭🇺 Budapest, Hungary

University of Debrecen; 🇭🇺 Debrecen, Hungary

Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna; 🇵🇱 Krakow, Poland

Revita Kft; 🇭🇺 Budapest, Hungary

Centrum Medyczne All Med; 🇵🇱 Krakow, Poland

Pratia MCM Krakow; 🇵🇱 Krakow, Poland

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand

Phra Nakhon Si Ayutthaya Hospital; 🇹🇭 Phra Nakhon Si Ayutthaya, Thailand

Saraburi Hospital; 🇹🇭 Saraburi, Thailand

Omega Research Consultants; 🇺🇸 DeBary, Florida, United States

Integral Rheumatology And Immunology Specialists; 🇺🇸 Plantation, Florida, United States

Willow Rheumatology and Wellness PLLC; 🇺🇸 Willowbrook, Illinois, United States

Joint and Muscle Research Institute; 🇺🇸 Charlotte, North Carolina, United States

Altoona Center For Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Cosultorios Reumatologógicos Pampa; 🇦🇷 Buenos Aires, Argentina

Hospital Central Militar Cirujano Mayor Dr Cosme Argerich; 🇦🇷 Buenos Aires, Argentina

Mindout Research; 🇦🇷 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

Zespol Poradni Specjalistycznych Reumed Filia nr 1; 🇵🇱 Lublin, Poland

MICS Centrum Medyczne Torun; 🇵🇱 Torun, Poland

MICS Centrum Medyczne Warszawa; 🇵🇱 Warszawa, Poland

Ipswich Hospital; 🇦🇺 Ipswich, Australia

Rheumatology Research Unit; 🇦🇺 Maroochydore, Australia

BJC Health; 🇦🇺 Parramatta, Australia

Peking University Third Hospital; 🇨🇳 Beijing, 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

Linyi City People Hospital; 🇨🇳 Linyi City, China

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, China

Pingxiang People's Hospital; 🇨🇳 Pingxiang, China

Huashan Hospital Fudan University; 🇨🇳 Shanghai, China

Shenzhen People s Hospital; 🇨🇳 Shenzhen, China

The Third Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, China

Soochow University, The Second Affiliated Hospital of; 🇨🇳 Suzhou, China

Shanxi Bethune Hospital; 🇨🇳 Taiyuan, China

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, China

Affiliated Hospital of Jiangsu University; 🇨🇳 Zhenjiang, China

L K N Arthrocentrum; 🇨🇿 Hlucin, Czechia

Sydvestjysk Sygehus; 🇩🇰 Esbjerg, Denmark

Frederiksberg Hospital; 🇩🇰 Frederiksberg, Denmark

Svendborg Hospital Odense University Hospital; 🇩🇰 Svendborg, Denmark

Vejle Sygehus; 🇩🇰 Vejle, Denmark

Hamburger Rheuma Forschungszentrum II; 🇩🇪 Hamburg, Germany

Studienzentrum Dr Schwarz Germany; 🇩🇪 Langenau, Germany

Universitatsklinikum Tubingen; 🇩🇪 Tubingen, Germany

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz; 🇭🇺 Budapest, Hungary

Qualiclinic Kft; 🇭🇺 Budapest, Hungary

MAV Korhaz es Rendelointezet; 🇭🇺 Szolnok, Hungary

Fukuoka University Hospital; 🇯🇵 Fukuoka, Japan

Teikyo University Hospital; 🇯🇵 Itabashi Ku, Japan

Kagawa University Hospital; 🇯🇵 Kita Gun, Japan

Maeshima Rheumatology Clinic; 🇯🇵 Oita, Japan

Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital; 🇯🇵 Osaka, Japan

Sasebo Chuo Hospital; 🇯🇵 Sasebo, Japan

Kyorin University Hospital; 🇯🇵 Tokyo, Japan

Mie University Hospital; 🇯🇵 Tsu, Japan

NZOZ Osteo Medic S C Artur Racewicz i Jerzy Supronik; 🇵🇱 Bialystok, Poland

NZOZ Lecznica MAK MED S C; 🇵🇱 Nadarzyn, Poland

Etyka Osrodek Badan Klinicznych; 🇵🇱 Olsztyn, Poland

Centrum Medyczne Reuma Park; 🇵🇱 Warszawa, Poland

Hosp Univ A Coruna; 🇪🇸 A Coruna, Spain

Hosp Univ Vall D Hebron; 🇪🇸 Barcelona, Spain

Hosp. Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hosp Reina Sofia; 🇪🇸 Cordoba, Spain

Hosp. Univ. 12 de Octubre; 🇪🇸 Madrid, Spain

Hosp Regional Univ de Malaga; 🇪🇸 Malaga, Spain

Corporacio Sanitari Parc Tauli; 🇪🇸 Sabadell, Spain

Hosp. Univ. Marques de Valdecilla; 🇪🇸 Santander, Spain

Hosp. Virgen Macarena; 🇪🇸 Sevilla, Spain

Hosp. Infanta Luisa; 🇪🇸 Sevilla, Spain

Hosp. Quiron Sagrado Corazon; 🇪🇸 Sevilla, Spain

Hosp. Virgen Del Rocio; 🇪🇸 Sevilla, Spain

National Taiwan University Hospital Hsin Chu Branch; 🇨🇳 Hsin Chu, Taiwan

Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Chi Mei Medical Center Yong Kang; 🇨🇳 Tainan, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand

Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Songklanagarind hospital; 🇹🇭 Songkhla, Thailand