Back to Trials
NCT06807424PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

1/9/2025

Completion Date

10/18/2028

Summary

The purpose of this study is to evaluate the efficacy of icotrokinra (JNJ-77242113) compared to placebo in biologic-experienced and biologic-naive participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Have active psoriatic arthritis (PsA) despite current or previous use of greater than or equal to (\>=) 1 of the following: a. Non-biologic disease-modifying antirheumatic drug (DMARD) therapy; b. Apremilast therapy; c. Biologic-agent (limited to only 1) * Have a diagnosis of 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) \>= 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

Interventions

DRUG

Icotrokinra

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Arthritis, Psoriatic

Locations

AARA Clinical Research

Glendale, Arizona 85306

United States

AARA Clinical Research 1

Mesa, Arizona 85210

United States

Arthritis and Rheumatism Associates ARA Jonesboro

Jonesboro, Arkansas 72401

United States

Clinical Research of West Florida

Clearwater, Florida 33765

United States

Omega Research Consultants

DeBary, Florida 32713

United States

Suncoast Clinical Research

New Port Richey, Florida 34652

United States

Integral Rheumatology And Immunology Specialists

Plantation, Florida 33324

United States

Clinical Research of West Florida 1

Tampa, Florida 33606

United States

Clinic of Robert Hozman

Skokie, Illinois 60076

United States

Klein And Associates M D P A

Hagerstown, Maryland 21740

United States

DM Clinical Research 1

Brookline, Massachusetts 02446

United States

St Paul Rheumatology PA

Eagan, Minnesota 55123

United States

Albuquerque Rehabilitation and Rheumatology

Albuquerque, New Mexico 87102

United States

Joint and Muscle Research Institute

Charlotte, North Carolina 28204

United States

Rheumatology Associates of Oklahoma

Oklahoma City, Oklahoma 73116

United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania 16635

United States

Clinical Research Philadelphia

Philadelphia, Pennsylvania 19114

United States

UT Southwestern

Dallas, Texas 75390

United States

Arthritis and Rheumatology Research Institute

Frisco, Texas 75035

United States

Naiara Alvarez MD Integrative Rheumatology of South TX

Harlingen, Texas 78550

United States

AARA Clinical Research Lone Star Arthritis and Rheumatology

Irving, Texas 75039

United States

DM Clinical Research

Tomball, Texas 77375

United States

Velocity Clinical Research

Waco, Texas 76710

United States

Seattle Rheumatology

Seattle, Washington 98104

United States

Center of Rheumatic Diseases

Glendale, Wisconsin 53217

United States

Instituto Medico De Alta Complejidad (IMAC)

Buenos Aires, B1643CRO

Argentina

ARCIS Salud SRL Aprillus asistencia e investigacion

Buenos Aires, C1406AGA

Argentina

Hospital Militar Central Cir. My. Dr. Cosme Argerich

Buenos Aires, C1426

Argentina

Arsema

Ciudad de Buenos Aires, C1431

Argentina

Centro Medico Privado de Reumatologia Tucuman

Ciudad de San Miguel de Tucuman, T4000AXL

Argentina

MR Medicina Reumatologica

San Fernando, B1646GHP

Argentina

Ipswich Hospital

Ipswich, 4305

Australia

Rheumatology Research Unit

Maroochydore, 4558

Australia

Queen Elizabeth Hospital

South Woodville, 5011

Australia

Royal North Shore Hospital

St Leonards, 2065

Australia

Royal Darwin Hospital

Tiwi, 0810

Australia

Universidade Federal de Minas Gerais UFMG Faculdade de Medicina

Belo Horizonte, 30130 100

Brazil

LMK Servicos Medicos S S

Porto Alegre, 90480 000

Brazil

Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base

São José do Rio Preto, 15090-000

Brazil

BR TRIALS Ensaios Clinicos e Consultoria Ltda

São Paulo, 01236030

Brazil

CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos

São Paulo, 04266 010

Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, 05403 900

Brazil

UMHAT Kaspela

Plovdiv, 4001

Bulgaria

Multiprofile Hospital for Active Treatment Plovdiv

Plovdiv, 4003

Bulgaria

Diagnostic Consulting Center I Sliven

Sliven, 8801

Bulgaria

Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD

Sofia, 1336

Bulgaria

MC Ekselsior

Sofia, 1407

Bulgaria

Diagnostic-Consultative Center (DCC) Aleksandrovska

Sofia, 1431

Bulgaria

UMHAT St. Ivan Rilski

Sofia, 1612

Bulgaria

ASIMP Rheumatology Centre St Irina EOOD

Sofia, 1750

Bulgaria

Eastern Regional Health Authority St Clares Mercy Hospital

St. John's, Newfoundland and Labrador A1C 5B8

Canada

The Waterside Clinic

Orillia, Ontario L3V 1T5

Canada

Womens College Hospital

Toronto, Ontario M5S 1B1

Canada

Alliance Clinical Trials

Waterloo, Ontario N2J 1C4

Canada

Dr Sabeen Anwar Medicine Professional Corporation

Windsor, Ontario N8X 1T3

Canada

Hospital Maisonneuve-Rosemont

Montreal, Quebec H1T 2M4

Canada

Centre de Recherche Musculo Squelettique

Trois-Rivières, Quebec G9A 3X2

Canada

Peking University Third Hospital

Beijing, 100191

China

Beijing Tong Ren Hospital Capital Medical University

Beijing, 100730

China

The First Bethune Hospital of Jilin University

Changchun, 130021

China

Xiangya Hospital Central South University

Changsha, 410008

China

West China Hospital Sichuan University

Chengdu, 610041

China

Sichuan Provincial Peoples Hospital

Chengdu, 610072

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016

China

Dongguan People s Hospital

Dongguan, 523109

China

Nanfang Hospital of Southern Medical Hospital

Guangzhou, 510515

China

The Affiliated Hospital of Guizhou Medical University

Guiyang, 550004

China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310018

China

The First Hospital of Jiaxing

Jiaxing, 314001

China

Jinhua municipal central hospital

Jinhua, 321013

China

Linfen Central Hospital

Linfen, 041000

China

Linyi City People Hospital

Linyi, 276002

China

The Second Affiliated Hospital of Nanchang University

Nanchang, 330008

China

Affiliated Hospital of Nantong University

Nantong, 226001

China

Pingxiang People's Hospital

Pingxiang, 337055

China

Huashan Hospital Fudan University

Shanghai, 200040

China

Shanghai skin disease hospital

Shanghai, 200443

China

Shenzhen People s Hospital

Shenzhen, 518020

China

Second Affiliated Hospital of Soochow University

Suzhou, 215004

China

Shanxi Bethune Hospital

Taiyuan, 030032

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000

China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710006

China

Revmacentrum MUDr Mostera s r o

Brno, 615 00

Czechia

Revmatologie s r o

Brno, 63800

Czechia

RHEUMA s r o

Břeclav, 690 02

Czechia

L K N Arthrocentrum

Hlučín, 748 01

Czechia

CCR Ostrava S R O

Ostrava, 70200

Czechia

MUDr Rosypalova s r o

Ostrava, 708 00

Czechia

Pratia Czech s r o

Prague, 13000

Czechia

FN Motol

Prague, 15000

Czechia

Medical Plus S R O

Uherské Hradiště, 68601

Czechia

PV Medical S R O

Zlín, 76001

Czechia

Aarhus University Hospital

Aarhus N, 8200

Denmark

Sydvestjysk Sygehus

Esbjerg, 6700

Denmark

Frederiksberg Hospital

Frederiksberg, 2000

Denmark

Regionshospitalet Godstrup

Herning, 7400

Denmark

Svendborg Hospital Odense University Hospital

Svendborg, 5700

Denmark

Vejle Sygehus

Vejle, 7100

Denmark

Charite - Campus Mitte

Berlin, 10117

Germany

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789

Germany

Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Dresden, 01307

Germany

Medizinische Fakultaet Der Albert Ludwigs Universitaet Freiburg

Freiburg im Breisgau, 79106

Germany

Hamburger Rheuma Forschungszentrum II

Hamburg, 20095

Germany

Rheumazentrum Ruhrgebiet

Herne, 44649

Germany

Praxis Dr. med. Beate Schwarz - Germany

Langenau, 89129

Germany

Rheumaforschung - Studienambulanz Dr. Wassenberg

Ratingen, 40878

Germany

Universitatsklinikum Tubingen

Tübingen, 72076

Germany

Prince of Wales Hospital

Hong Kong, 000000

Hong Kong

Queen Mary Hospital

Hong Kong,

Hong Kong

Trial Pharma Kft

Békéscsaba, 5600

Hungary

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

Budapest, 1023

Hungary

Revita Kft

Budapest, 1027

Hungary

Qualiclinic Kft

Budapest, 1134

Hungary

Uno Medical Trials Ltd.

Budapest, 1152

Hungary

Debreceni Egyetem Reumatologiai Klinika

Debrecen, 4032

Hungary

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, 5700

Hungary

Porcika Klinika - Vasarhelyi Sarkanyfu Kft.

Hódmezővásárhely, 6800

Hungary

Obudai Egeszsegugyi Centrum Kft

Kaposvár, 7400

Hungary

Bacs Kiskun Varmegyei Oktatokorhaz

Kecskemét, 6000

Hungary

University of Szeged

Szeged, 6725

Hungary

Complex Rendelo Med Zrt

Székesfehérvár, 8000

Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

Székesfehérvár, 8000

Hungary

MAV Korhaz es Rendelointezet

Szolnok, 5000

Hungary

Vital Medical Center Orvosi es Fogaszati Kozpont

Veszprém, 8200

Hungary

Marengo Cims Hospital

Ahmedabad, 380060

India

Apollo Hospitals

Bhubaneswar, 751005

India

Sushruta Multispeciality Hospital

Hubballi, 580021

India

Apollo Multispeciality Hospital Ltd

Kolkata, 700054

India

JSS Hospital

Mysuru, 570004

India

All India Institute of Medical Sciences

New Delhi, 110029

India

Indraprastha Apollo Hospital

New Delhi, 1100776

India

Fortis Hospital

Noida, 201301

India

SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre

Surat, 395002

India

A.O. Universitaria Ospedali Riuniti di Ancona

Ancona, 60126

Italy

ASST Spedali Civili Brescia

Brescia, 25123

Italy

Policlinico San Marco

Catania, 95124

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Azienda Ospedaliero Universitaria Luigi Vanvitelli

Naples, 80138

Italy

IRCCS Policlinico San Matteo

Pavia, 27100

Italy

Universita Degli Studi di Roma Tor Vergata

Roma, 00133

Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

A O Universitaria Senese Ospedale Santa Maria alle Scotte

Siena, 53100

Italy

Ospedale S. Maria Della Misericordia

Udine, 33100

Italy

NHO Chiba Medical Center Chibahigashi National Hospital

Chiba, 260-8712

Japan

St. Luke's International Hospital

Chūōku, 104 8560

Japan

Kansai Medical University Hospital

Hirakata, 573 1191

Japan

Kita-harima Medical Center

Hyōgo, 6751392

Japan

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, 807-8556

Japan

Nagoya City University Hospital

Nagoya, 467 8602

Japan

Osaka Metropolitan University Hospital

Osaka, 545 8586

Japan

Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

Osaka, 550 0006

Japan

Maeshima Rheumatology Clinic

Ōita, 870 0030

Japan

Sanuki Municipal Hospital

Sanuki, 7692393

Japan

Sasebo Chuo Hospital

Sasebo, 857 1195

Japan

Tohoku University Hospital

Sendai, 980 8574

Japan

Dokkyo Medical University Hospital

Shimotsuga Gun, 321 0293

Japan

Kyorin University Hospital

Tokyo, 181 8611

Japan

Mie University Hospital

Tsu, 514 8507

Japan

National Hospital Organization Yokohama Medical Center

Yokohama, 245-8575

Japan

Hospital Sultanah Bahiyah

Alor Star, 05460

Malaysia

Hospital Selayang

Batu Caves, 68100

Malaysia

Hospital Raja Permaisuri Bainun

Ipoh, 30450

Malaysia

Hospital Sultan Ismail

Johor Bahru, 81100

Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, 50586

Malaysia

Hospital Tuanku Jaafar

Seremban, 70300

Malaysia

Centro de Investigacion de Tratamientos Innovadores de Sinaloa

Culiacán, 80000

Mexico

Grupo Clinico CATEI

Guadalajara, 44630

Mexico

Centro Medico del Angel

Mexicali, 45116

Mexico

RM Pharma Specialists

Mexico City, 03100

Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, 64460

Mexico

Centro de Alta Especialidad en Reumatologia e Investigacion

San Luis Potosí City, 78213

Mexico

Osteo-Medic s.c A. Racewicz, J Supronik

Bialystok, 15-351

Poland

Specderm Poznanska sp j

Bialystok, 15-375

Poland

ClinicMed Daniluk Nowak Spolka Komandytowa

Bialystok, 15-879

Poland

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168

Poland

Ambulatorium sp. z o.o.

Elblag, 82-300

Poland

Centrum Kliniczno Badawcze

Elblag, 82-300

Poland

Centrum Medyczne Pratia Gdynia

Gdynia, 81-338

Poland

Malopolskie Badania Kliniczne Sp z o o

Krakow, 30-002

Poland

Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna

Krakow, 30-002

Poland

Centrum Medyczne All Med

Krakow, 30-033

Poland

Pratia MCM Krakow

Krakow, 30-727

Poland

Dermed Centrum Medyczne Sp z o o

Lodz, 90-265

Poland

Zespol Poradni Specjalistycznych Reumed Filia nr 1

Lublin, 20-607

Poland

NZOZ Lecznica MAK MED S C

Nadarzyn, 05-830

Poland

MICS Centrum Medyczne Torun

Torun, 87-100

Poland

MICS Centrum Medyczne Warszawa

Warsaw, 00-874

Poland

Centrum Medyczne Reuma Park

Warsaw, 02-665

Poland

DermMedica Sp z o o

Wroclaw, 51-503

Poland

Centrum Medyczne Oporow

Wroclaw, 52-416

Poland

Quantum Medical Center Srl

Bucharest, 012071

Romania

S C Delta Health Care S R L

Bucharest, 014142

Romania

CCBR Clinical Research

Bucharest, 030463

Romania

Hiperdia Piata Sudului

Bucharest, 041312

Romania

Ecomed Research SRL

Craiova, 200400

Romania

Centrul Medical Unirea

Iași, 700259

Romania

Medaudio Optica S R L

Râmnicu Vâlcea, 247065

Romania

Hosp Univ A Coruna

A Coruña, 15006

Spain

Hosp Reina Sofia

Córdoba, 14004

Spain

Hosp. Univ. de Bellvitge

L'Hospitalet de Llobregat, 08907

Spain

Hosp. Univ. Infanta Leonor

Madrid, 28031

Spain

Hosp Regional Univ de Malaga

Málaga, 29009

Spain

Hosp. Univ. Marques de Valdecilla

Santander, 39008

Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706

Spain

Hosp. Virgen Macarena

Seville, 41009

Spain

Hosp. Infanta Luisa

Seville, 41010

Spain

Hosp. Virgen Del Rocio

Seville, 41013

Spain

Hosp. Ntra. Sra. de Valme

Seville, 41014

Spain

National Taiwan University Hospital Hsin Chu Branch

Hsinchu, 300

Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301

Taiwan

Chi Mei Medical Center

Tainan, 710

Taiwan

Taipei Veterans General Hospital

Taipei, 112

Taiwan

Phramongkutklao Hospital

Bangkok, 10400

Thailand

Rajavithi Hospital

Bangkok, 10400

Thailand

Siriraj Hospital

Bangkok, 10700

Thailand

Saraburi Hospital

Changwat Sara Buri, 18000

Thailand

Songklanagarind hospital

Songkhla, 90110

Thailand

Gulhane Egitim ve Arastirma Hastanesi

Ankara, 06010

Turkey (Türkiye)

Gazi Universitesi Tip Fakultesi

Ankara, 06570

Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, 41001

Turkey (Türkiye)

Necmettin Erbakan Universitesi Tip Fakultesi

Konya, 42080

Turkey (Türkiye)

Royal Free London NHS Foundation Trust

Barnet, EN5 3DJ

United Kingdom

Basingstoke And North Hampshire Hospital

Basingstoke, RG24 9NA

United Kingdom

University Hospitals Dorset NHS Foundation Trust

Christchurch, BH23 2JX

United Kingdom

Western General Hospital

Edinburgh, EH4 2XU

United Kingdom

Glasgow Royal Infirmary

Glasgow, G31 2ER

United Kingdom

Hereford County Hospital

Hereford, HR1 2ER

United Kingdom

Forth Valley Royal Hospital

Larbert, FK5 4WR

United Kingdom

Haywood Hospital

Staffordshire, ST6 7AG

United Kingdom

Torbay Hospital-Devon

Torquay, TQ2 7AA

United Kingdom

New Cross Hospital

Wolverhampton, WV10 0QP

United Kingdom

Betsi Cadwaladr University Health Board BCUHB

Wrexham, LL13 7TD

United Kingdom