Clinical trial NCT05071664: A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis
Official title: A Phase 2a, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Psoriatic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-10-08
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants who Achieve Minimal Disease Activity (MDA) at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants who Achieve American College of Rheumatology (ACR) 50 at Week 24
timeFrame: Week 24
measure: Percentage of Participants who Achieve MDA at Week 16
timeFrame: Week 16
measure: 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
timeFrame: Week 24
measure: 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
timeFrame: Week 24
measure: 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
timeFrame: Week 24
measure: Change from Baseline in HAQ-DI at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline
timeFrame: Week 24
measure: Percentage of Participants with Resolution of Dactylitis at Week 24 Among the Participants with Dactylitis at Baseline
timeFrame: Week 24
measure: Change from Baseline in Short Form Health Survey (SF-36) Physical Component Score (PCS) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Reasonably Related AEs
timeFrame: Up to 42 weeks
measure: Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
timeFrame: Up to 42 weeks
measure: Percentage of Participants With Infections
timeFrame: Up to 42 weeks
measure: Percentage of Participants With Injection-site Reactions
timeFrame: Up to Week 20
measure: Serum Guselkumab and Golimumab Concentration
timeFrame: Up to Week 36
measure: Percentage of Participants with Antibodies to Guselkumab or Golimumab
timeFrame: Up to Week 36
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Searcy
country: United States
facility: Unity Health-White County Medical Center
state: Arkansas
city: Avon Park
country: United States
facility: HARAC Research Corp
state: Florida
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants
state: Florida
city: Miami
country: United States
facility: South Coast Research Center
state: Florida
city: Ocoee
country: United States
facility: Advanced Clinical Research of Orlando
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Marietta
country: United States
facility: Atlanta Research Center for Rheumatology
state: Georgia
city: Lansing
country: United States
facility: Great Lakes Center of Rheumatology
state: Michigan
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Brooklyn
country: United States
facility: NYU Langone Ambulatory Care Brooklyn Heights
state: New York
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Vandalia
country: United States
facility: STAT Research, Inc.
state: Ohio
city: Plano
country: United States
facility: Trinity Universal Research Associates, LLC
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup
city: Køge
country: Denmark
facility: Køge Sygehus Region Sjaelland
city: Silkeborg
country: Denmark
facility: Silkeborg Hospital
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Toulouse Cedex 9
country: France
facility: Hopital Larrey CHU de Toulouse
city: Tours
country: France
facility: CHU Trousseau - Service de Rhumatologie
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Szekesfehervar
country: Hungary
facility: Complex Rendelo Med Zrt
city: Veszprem
country: Hungary
facility: Vital Medical Center
city: Cagliari
country: Italy
facility: Azienda Ospedaliero-Universitaria di Cagliari
city: Milano
country: Italy
facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova - IRCCS
city: Roma
country: Italy
facility: A.O.U.Policlinico Tor Vergata
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Rome
country: Italy
facility: Università Campus Biomedico di Roma
city: Torino
country: Italy
facility: AO Ordine Mauriziano
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK MED S C
city: Poznan
country: Poland
facility: Centrum Medyczne
city: Warsaw
country: Poland
facility: Medycyna Kliniczna
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED Targowek
city: Wroclaw
country: Poland
facility: WroMedica I Bielicka A Strzalkowska s c
city: Kemerovo
country: Russian Federation
facility: Kemerovo State Medical University
city: Kemerovo
country: Russian Federation
facility: LLL Medical Center Revma-Med
city: Korolev
country: Russian Federation
facility: LLC Family Outpatient Clinic # 4
city: Moscow
country: Russian Federation
facility: GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
city: Orenburg
country: Russian Federation
facility: Orenburg State Medical Academy
city: Rostov
country: Russian Federation
facility: Rostov Regional Clinical Dermatovenerological Dispensary
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Dermatovenerological Dispensary
city: Smolensk
country: Russian Federation
facility: Smolensk regional hospital on Smolensk railway station
city: St. Petersburg
country: Russian Federation
facility: X7 Clinical Research Company Limited
city: Ufa
country: Russian Federation
facility: Republican Clinical Hospital - G.G. Kuvatov
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital #3
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Barcelona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Bilbao
country: Spain
facility: Hosp. Univ. de Basurto
city: Cordoba
country: Spain
facility: Hosp Reina Sofia
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Sevilla
country: Spain
facility: Hosp. Infanta Luisa
city: Sevilla
country: Spain
facility: Hosp. Ntra. Sra. de Valme
city: Malmo
country: Sweden
facility: Skanes universitetssjukhus
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: Kharkiv
country: Ukraine
facility: State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
city: Kharkiv
country: Ukraine
facility: Municipal Institution Regional hospital-center of emergency care and disasters medicine
city: Kyiv
country: Ukraine
facility: Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
city: Kyiv
country: Ukraine
facility: SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'
city: Poltava
country: Ukraine
facility: ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
city: Ternopil
country: Ukraine
facility: Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
city: Uzhgorod
country: Ukraine
facility: MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
city: Vinnytsia
country: Ukraine
facility: Health Clinic Limited Liability Company
city: Zaporizhzhya
country: Ukraine
facility: Medical Center LLC 'Modern Clinic'
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: