Psoriasis Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

91

Study ID:

NCT05071664

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 82 Locations for this study

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Arizona Arthritis and Rheumatology Research PLLC
Phoenix Arizona, 85032, United States
Arizona Arthritis and Rheumatology Research PLLC
Phoenix Arizona, 85037, United States
Unity Health-White County Medical Center
Searcy Arkansas, 72143, United States
HARAC Research Corp
Avon Park Florida, 33825, United States
Bay Pines VA Healthcare System
Bay Pines Florida, 33744, United States
Omega Research Consultants
DeBary Florida, 32713, United States
South Coast Research Center
Miami Florida, 33136, United States
Advanced Clinical Research of Orlando
Ocoee Florida, 34761, United States
Millennium Research
Ormond Beach Florida, 32174, United States
Atlanta Research Center for Rheumatology
Marietta Georgia, 30060, United States
Great Lakes Center of Rheumatology
Lansing Michigan, 48911, United States
Clinvest
Springfield Missouri, 65807, United States
Jacobi Medical Center
Bronx New York, 10461, United States
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn New York, 11201, United States
NYU School of Medicine
New York New York, 10016, United States
University of Rochester
Rochester New York, 14642, United States
STAT Research, Inc.
Vandalia Ohio, 45377, United States
Trinity Universal Research Associates, LLC
Plano Texas, 75024, United States
DM Clinical Research
Tomball Texas, 77375, United States
Swedish Medical Center
Seattle Washington, 98122, United States
Frederiksberg Hospital
Frederiksberg , 2000, Denmark
Rigshospitalet Glostrup
Glostrup , 2600, Denmark
Køge Sygehus Region Sjaelland
Køge , 4600, Denmark
Silkeborg Hospital
Silkeborg , 8600, Denmark
Vejle Sygehus
Vejle , 7100, Denmark
Centre Hospitalier Le Mans
Le Mans , 72037, France
Hopital Larrey CHU de Toulouse
Toulouse Cedex 9 , 31059, France
CHU Trousseau - Service de Rhumatologie
Tours , 37044, France
Obudai Egeszsegugyi Centrum Kft
Budapest , 1036, Hungary
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula , 5700, Hungary
Complex Rendelo Med Zrt
Szekesfehervar , 8000, Hungary
Vital Medical Center
Veszprem , 8200, Hungary
Azienda Ospedaliero-Universitaria di Cagliari
Cagliari , 09124, Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milano , 20122, Italy
Ospedale San Raffaele
Milano , 20132, Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia , 27100, Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia , 42123, Italy
A.O.U.Policlinico Tor Vergata
Roma , 00133, Italy
Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy
Università Campus Biomedico di Roma
Rome , 00128, Italy
AO Ordine Mauriziano
Torino , 10128, Italy
Centrum Kliniczno Badawcze
Elblag , 82-30, Poland
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz , 90-24, Poland
NZOZ Lecznica MAK MED S C
Nadarzyn , 05 83, Poland
Centrum Medyczne
Poznan , 61-11, Poland
Medycyna Kliniczna
Warsaw , 00-87, Poland
Centrum Medyczne AMED Targowek
Warszawa , 03-29, Poland
WroMedica I.Bielicka, A.Strzałkowska s.c.
Wrocław , 51-68, Poland
Kemerovo State Medical University
Kemerovo , 65000, Russian Federation
LLL Medical Center Revma-Med
Kemerovo , 65007, Russian Federation
LLC Family Outpatient Clinic # 4
Korolev , 14106, Russian Federation
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
Moscow , 12911, Russian Federation
Orenburg State Medical Academy
Orenburg , 46000, Russian Federation
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov , 34400, Russian Federation
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan , 39004, Russian Federation
Smolensk regional hospital on Smolensk railway station
Smolensk , 21402, Russian Federation
X7 Clinical Research Company Limited
St. Petersburg , 19415, Russian Federation
Republican Clinical Hospital - G.G. Kuvatov
Ufa , 45000, Russian Federation
Clinical Hospital #3
Yaroslavl , 15000, Russian Federation
Hosp. Univ. A Coruna
A Coruna , 15006, Spain
Hosp. Univ. Germans Trias I Pujol
Barcelona , 08916, Spain
Hosp. Univ. de Basurto
Bilbao , 48013, Spain
Hosp. Reina Sofia
Cordoba , 14004, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Corporacio Sanitari Parc Tauli
Sabadell , 08208, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela , 15706, Spain
Hosp. Virgen Macarena
Sevilla , 41009, Spain
Hosp. Infanta Luisa
Sevilla , 41010, Spain
Hosp. Ntra. Sra. de Valme
Sevilla , 41014, Spain
Skanes universitetssjukhus
Malmo , 205 0, Sweden
Karolinska Universitetssjukhuset Solna
Solna , 171 7, Sweden
State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
Kharkiv , 61039, Ukraine
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Kharkiv , 61204, Ukraine
Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
Kyiv , 03037, Ukraine
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Kyiv , 03049, Ukraine
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Kyiv , 03680, Ukraine
Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'
Kyiv , 04107, Ukraine
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
Poltava , 36011, Ukraine
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil , 46002, Ukraine
MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
Uzhgorod , 88000, Ukraine
Health Clinic Limited Liability Company
Vinnytsia , 21009, Ukraine
Medical Center LLC 'Modern Clinic'
Zaporizhzhya , 69600, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

91

Study ID:

NCT05071664

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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