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

NCT05071664 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: CR109054CNTO1959PSA20032021-002012-31
• Study Type: interventional
• Target: 91
• Locations: 10 countries
• Sites: 82

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.

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Achieve Minimal Disease Activity (MDA) at Week 24

  MDA defines a satisfactory state of disease activity that includes the 5 domains of psoriatic arthritis (PsA; joint symptoms, skin psoriasis, participant's assessment of pain and disease activity, physical function, and enthesitis). Participants are classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count less than or equal to (\<=) 1; swollen joint count \<=1; psoriasis area and severity index (PASI) \<=1 or body surface area (BSA) \<=3 percent (%); participant's pain visual analog scale (VAS) score of \<=15; participant's global disease activity VAS (arthritis and psoriasis) score of \<=20; disability index of the health assessment questionnaire (HAQ-DI) score \<=0.5; and tender entheseal points \<=1.

  Week 24

Secondary Outcomes (15)

• Percentage of Participants who Achieve American College of Rheumatology (ACR) 50 at Week 24

  Week 24

• Percentage of Participants who Achieve MDA at Week 16

  Week 16

• Percentage of Participants who Achieve PASI 90 at Week 24 Among the Participants with >=3% BSA Psoriatic involvement and an IGA Score of >=2 (Mild) at Baseline

  Week 24

• Percentage of Participants who Achieve PASI 100 at Week 24 Among the Participants with >=3% BSA Psoriatic involvement and an IGA Score of >=2 (Mild) at Baseline

  Week 24

• Percentage of Participants with an IGA-psoriasis Response of IGA Psoriasis Score of 0 or 1 AND >=2 Grade Reduction From Baseline at Week 24 Among Participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline

  Week 24

Study Arms (2)

Group 1: Guselkumab and Golimumab

EXPERIMENTAL

Participants will receive subcutaneous (SC) guselkumab and golimumab.

Drug: Guselkumab; Drug: Golimumab

Group 2: Guselkumab and Placebo

ACTIVE COMPARATOR

Participants will receive SC guselkumab and placebo.

Drug: Guselkumab; Drug: Placebo

Interventions

Guselkumab DRUG

Guselkumab will be administered as a SC injection.

Also known as: TREMFYA, CNTO1959

Group 1: Guselkumab and Golimumab; Group 2: Guselkumab and Placebo

Golimumab DRUG

Golimumab will be administered as a SC injection.

Also known as: SIMPONI, CNTO148

Group 1: Guselkumab and Golimumab

Placebo DRUG

Placebo will be administered as a SC injection.

Group 2: Guselkumab and Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (82)

Arizona Arthritis and Rheumatology Research PLLC

Phoenix, Arizona, 85032, United States

Location

Arizona Arthritis and Rheumatology Research PLLC 1

Phoenix, Arizona, 85037, United States

Location

Unity Health-White County Medical Center

Searcy, Arkansas, 72143, United States

Location

HARAC Research Corp

Avon Park, Florida, 33825, United States

Location

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744, United States

Location

Omega Research Consultants

DeBary, Florida, 32713, United States

Location

South Coast Research Center

Miami, Florida, 33136, United States

Location

Advanced Clinical Research of Orlando

Ocoee, Florida, 34761, United States

Location

Millennium Research

Ormond Beach, Florida, 32174, United States

Location

Atlanta Research Center for Rheumatology

Marietta, Georgia, 30060, United States

Location

Great Lakes Center of Rheumatology

Lansing, Michigan, 48911, United States

Location

Clinvest

Springfield, Missouri, 65807, United States

Location

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, 11201, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

STAT Research, Inc.

Vandalia, Ohio, 45377, United States

Location

Trinity Universal Research Associates, LLC

Plano, Texas, 75024, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

Køge Sygehus Region Sjaelland

Køge, 4600, Denmark

Location

Silkeborg Hospital

Silkeborg, 8600, Denmark

Location

Vejle Sygehus

Vejle, 7100, Denmark

Location

Centre Hospitalier Le Mans

Le Mans, 72037, France

Location

Hopital Larrey CHU de Toulouse

Toulouse, 31059, France

Location

CHU Trousseau - Service de Rhumatologie

Tours, 37044, France

Location

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036, Hungary

Location

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, 5700, Hungary

Location

Complex Rendelo Med Zrt

Székesfehérvár, 8000, Hungary

Location

Vital Medical Center

Veszprém, 8200, Hungary

Location

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, 09124, Italy

Location

Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

Milan, 20122, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, 27100, Italy

Location

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, 42123, Italy

Location

A.O.U.Policlinico Tor Vergata

Roma, 00133, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Università Campus Biomedico di Roma

Rome, 00128, Italy

Location

AO Ordine Mauriziano

Torino, 10128, Italy

Location

Centrum Kliniczno Badawcze

Elblag, 82-300, Poland

Location

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, 90-242, Poland

Location

NZOZ Lecznica MAK MED S C

Nadarzyn, 05-830, Poland

Location

Centrum Medyczne

Poznan, 61 113, Poland

Location

Medycyna Kliniczna

Warsaw, 00-874, Poland

Location

Centrum Medyczne AMED Targowek

Warsaw, 03 291, Poland

Location

WroMedica I Bielicka A Strzalkowska s c

Wroclaw, 51 685, Poland

Location

Kemerovo State Medical University

Kemerovo, 650000, Russia

Location

LLL Medical Center Revma-Med

Kemerovo, 650070, Russia

Location

LLC Family Outpatient Clinic # 4

Korolyov, 141060, Russia

Location

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

Moscow, 129110, Russia

Location

Orenburg State Medical Academy

Orenburg, 460000, Russia

Location

Rostov Regional Clinical Dermatovenerological Dispensary

Rostov-on-Don, 344007, Russia

Location

Ryazan Regional Clinical Dermatovenerological Dispensary

Ryazan, 390046, Russia

Location

X7 Clinical Research Company Limited

Saint Petersburg, 194156, Russia

Location

Smolensk regional hospital on Smolensk railway station

Smolensk, 214025, Russia

Location

Republican Clinical Hospital - G.G. Kuvatov

Ufa, 450005, Russia

Location

Clinical Hospital #3

Yaroslavl, 150007, Russia

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Hosp. Univ. Germans Trias I Pujol

Barcelona, 08916, Spain

Location

Hosp. Univ. de Basurto

Bilbao, 48013, Spain

Location

Hosp Reina Sofia

Córdoba, 14004, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Corporacio Sanitari Parc Tauli

Sabadell, 08208, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Hosp. Virgen Macarena

Seville, 41009, Spain

Location

Hosp. Infanta Luisa

Seville, 41010, Spain

Location

Hosp. Ntra. Sra. de Valme

Seville, 41014, Spain

Location

Skanes universitetssjukhus

Malmo, 205 02, Sweden

Location

Karolinska Universitetssjukhuset Solna

Solna, 171 76, Sweden

Location

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

Kharkiv, 61039, Ukraine

Location

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

Kharkiv, 61204, Ukraine

Location

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

Kyiv, 03037, Ukraine

Location

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

Kyiv, 03049, Ukraine

Location

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

Kyiv, 03680, Ukraine

Location

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

Kyiv, 04107, Ukraine

Location

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

Poltava, 36011, Ukraine

Location

Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

Ternopil, 46002, Ukraine

Location

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

Uzhhorod, 88000, Ukraine

Location

Health Clinic Limited Liability Company

Vinnytsia, 21009, Ukraine

Location

Medical Center LLC 'Modern Clinic'

Zaporizhzhya, 69600, Ukraine

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

guselkumab; golimumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 8, 2021
• Study Start: October 25, 2021
• Primary Completion: May 14, 2024
• Study Completion: August 6, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (9); DK (5); ES (10); PL (7); RU (11); SE (2); HU (4); US (20); UA (11); FR (3)