A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

NCT ID: NCT05071664

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2024-08-06

Brief Summary

The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies by assessing clinical response compared with guselkumab monotherapy.

Detailed Description

PsA is a chronic inflammatory multi-faceted disease that impacts the peripheral and axial joints, soft tissues, and skin. Guselkumab is a fully human monoclonal antibody (mAb) directed against the p19 subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling, subsequent activation, and cytokine production. Golimumab is a fully human anti-TNF-alpha mAb that binds to TNF-alpha with high affinity, prevents binding to its receptors, thereby inhibiting the biological activity of TNF-alpha and resulting in limited production or activity of inflammatory cytokines, thereby providing therapeutic benefit in various chronic inflammatory disorders, including PsA. This study will consist of a Screening Phase (up to 6 weeks), Double-blind Phase from Weeks 0 to 24 which includes the active treatment phase and the primary efficacy visit (Week 24), and Safety Follow-up Phase from Week 24 to Week 36. Key safety assessments will include adverse events (AEs), clinical laboratory safety tests (hematology and chemistry), vital signs, monitoring for injection-site and hypersensitivity reactions, and early detection of active tuberculosis (TB). The total duration of the study is up to 42 weeks.

Conditions

Arthritis, Psoriatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Guselkumab and Golimumab

Participants will receive subcutaneous (SC) guselkumab and golimumab.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Guselkumab will be administered as a SC injection.

Golimumab

Intervention Type: DRUG

Golimumab will be administered as a SC injection.

Group 2: Guselkumab and Placebo

Participants will receive SC guselkumab and placebo.

Group Type: ACTIVE_COMPARATOR

Guselkumab

Intervention Type: DRUG

Guselkumab will be administered as a SC injection.

Placebo

Intervention Type: DRUG

Placebo will be administered as a SC injection.

Interventions

Guselkumab

Guselkumab will be administered as a SC injection.

Intervention Type: DRUG

Golimumab

Golimumab will be administered as a SC injection.

Intervention Type: DRUG

Placebo

Placebo will be administered as a SC injection.

Intervention Type: DRUG

Other Intervention Names

TREMFYA; CNTO1959; SIMPONI; CNTO148

Eligibility Criteria

Inclusion Criteria

• Have a diagnosis of psoriatic arthritis (PsA) for greater than or equal to (>=) 6 months prior to the first administration of study intervention and meet Classification criteria for PsA (CASPAR) criteria at screening
• Have active PsA as defined by having at least 3 swollen joints and at least 3 tender joints at screening and at baseline
• Have at least 1 of the following 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 centimeter (cm) diameter or nail changes consistent with psoriasis
• Have an inadequate response (IR) to anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite treatment with either 1 or 2 prior anti-TNF-alpha agent(s) and the following: a. Lack of benefit to either 1 or 2 prior anti-TNF-alpha therapies, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, or certolizumab pegol therapy, or at least 14-weeks of infliximab, or any biosimilar of these 4 therapies. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity; b. The last dose of anti-TNF-alpha therapy must have occurred greater than 5 half-lives of the drug prior to first study intervention administration (washout period)

Exclusion Criteria

• Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab and/or golimumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr AxSpA), systemic lupus erythematosus, or lyme disease
• Has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies (mAb), or antibody fragments
• Has received prior treatment with golimumab or guselkumab or has documented intolerance to prior anti-TNF-alpha therapy in the participant history by the treating physician
• Has received more than 2 prior anti-TNF-alpha agents (or biosimilars)
• Positive human immunodeficiency virus (HIV) antibody test

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Arizona Arthritis and Rheumatology Research PLLC

Phoenix, Arizona, United States

Arizona Arthritis and Rheumatology Research PLLC

Phoenix, Arizona, United States

Unity Health-White County Medical Center

Searcy, Arkansas, United States

HARAC Research Corp

Avon Park, Florida, United States

Bay Pines VA Healthcare System

Bay Pines, Florida, United States

Omega Research Consultants

DeBary, Florida, United States

South Coast Research Center

Miami, Florida, United States

Advanced Clinical Research of Orlando

Ocoee, Florida, United States

Millennium Research

Ormond Beach, Florida, United States

Atlanta Research Center for Rheumatology

Marietta, Georgia, United States

Great Lakes Center of Rheumatology

Lansing, Michigan, United States

Clinvest

Springfield, Missouri, United States

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, United States

NYU School of Medicine

New York, New York, United States

University of Rochester

Rochester, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

STAT Research, Inc.

Vandalia, Ohio, United States

Trinity Universal Research Associates, LLC

Plano, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Frederiksberg Hospital

Frederiksberg, , Denmark

Rigshospitalet Glostrup

Glostrup Municipality, , Denmark

Køge Sygehus Region Sjaelland

Køge, , Denmark

Silkeborg Hospital

Silkeborg, , Denmark

Vejle Sygehus

Vejle, , Denmark

Centre Hospitalier Le Mans

Le Mans, , France

Hopital Larrey CHU de Toulouse

Toulouse, , France

CHU Trousseau - Service de Rhumatologie

Tours, , France

Obudai Egeszsegugyi Centrum Kft

Budapest, , Hungary

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, , Hungary

Complex Rendelo Med Zrt

Székesfehérvár, , Hungary

Vital Medical Center

Veszprém, , Hungary

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, , Italy

Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

Milan, , Italy

Ospedale San Raffaele

Milan, , Italy

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, , Italy

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, , Italy

A.O.U.Policlinico Tor Vergata

Roma, , Italy

Policlinico Universitario Agostino Gemelli

Roma, , Italy

Università Campus Biomedico di Roma

Rome, , Italy

AO Ordine Mauriziano

Torino, , Italy

Centrum Kliniczno Badawcze

Elblag, , Poland

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, , Poland

NZOZ Lecznica MAK MED S C

Nadarzyn, , Poland

Centrum Medyczne

Poznan, , Poland

Medycyna Kliniczna

Warsaw, , Poland

Centrum Medyczne AMED Targowek

Warsaw, , Poland

WroMedica I Bielicka A Strzalkowska s c

Wroclaw, , Poland

Kemerovo State Medical University

Kemerovo, , Russia

LLL Medical Center Revma-Med

Kemerovo, , Russia

LLC Family Outpatient Clinic # 4

Korolyov, , Russia

GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'

Moscow, , Russia

Orenburg State Medical Academy

Orenburg, , Russia

Rostov Regional Clinical Dermatovenerological Dispensary

Rostov, , Russia

Ryazan Regional Clinical Dermatovenerological Dispensary

Ryazan, , Russia

X7 Clinical Research Company Limited

Saint Petersburg, , Russia

Smolensk regional hospital on Smolensk railway station

Smolensk, , Russia

Republican Clinical Hospital - G.G. Kuvatov

Ufa, , Russia

Clinical Hospital #3

Yaroslavl, , Russia

Hosp Univ A Coruna

A Coruña, , Spain

Hosp. Univ. Germans Trias I Pujol

Barcelona, , Spain

Hosp. Univ. de Basurto

Bilbao, , Spain

Hosp Reina Sofia

Córdoba, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Corporacio Sanitari Parc Tauli

Sabadell, , Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , Spain

Hosp. Virgen Macarena

Seville, , Spain

Hosp. Infanta Luisa

Seville, , Spain

Hosp. Ntra. Sra. de Valme

Seville, , Spain

Skanes universitetssjukhus

Malmo, , Sweden

Karolinska Universitetssjukhuset Solna

Solna, , Sweden

State Institution Institute of therapy named after L.T.Malaya AMS Ukraine

Kharkiv, , Ukraine

Municipal Institution Regional hospital-center of emergency care and disasters medicine

Kharkiv, , Ukraine

Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud

Kyiv, , Ukraine

Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

Kyiv, , Ukraine

SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

Kyiv, , Ukraine

Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'

Kyiv, , Ukraine

ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil

Poltava, , Ukraine

Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

Ternopil, , Ukraine

MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

Uzhhorod, , Ukraine

Health Clinic Limited Liability Company

Vinnytsia, , Ukraine

Medical Center LLC 'Modern Clinic'

Zaporizhzhya, , Ukraine

Countries

United States; Denmark; France; Hungary; Italy; Poland; Russia; Spain; Sweden; Ukraine

Other Identifiers

CNTO1959PSA2003

Identifier Type: OTHER

Identifier Source: secondary_id

2021-002012-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR109054

Identifier Type: -

Identifier Source: org_study_id