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

Ведущий спонсор: Janssen Research & Development, LLC

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 a prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy by assessing clinical response compared with guselkumab monotherapy.

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.

• Arthritis, Psoriatic

Тип вмешательства: Drug

Название вмешательства: Guselkumab

Описание: Guselkumab will be administered as a SC injection.

Тип вмешательства: Drug

Название вмешательства: Golimumab

Описание: Golimumab will be administered as a SC injection.

Этикетка Arm Group: Group 1: Guselkumab and Golimumab

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Placebo will be administered as a SC injection.

Этикетка Arm Group: Group 2: Guselkumab and Placebo

Критерии:

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: at least 3 swollen joints and at least 3 tender joints at screening and at baseline; and high-sensitivity C-reactive protein (hsCRP) >= 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory - 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 1 anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite previous treatment with only 1 prior anti-TNF-alpha agent and the following: a. Lack of benefit to 1 prior anti-TNF-alpha therapy, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, 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 screening visit (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 1 prior anti-TNF-alpha agent (or biosimilars) - Positive human immunodeficiency virus (HIV) antibody test

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

65 Years

Здоровые волонтеры:

No

Фамилия: Study Contact

Телефон: 844-434-4210

Poland

Russian Federation

Spain

Ukraine

United States

2022-01-01

Тип: Sponsor

• Arthritis
• Arthritis, Psoriatic

Метка: Group 1: Guselkumab and Golimumab

Тип: Experimental

Описание: Participants will receive subcutaneous (SC) guselkumab and golimumab.

Метка: Group 2: Guselkumab and Placebo

Тип: Active Comparator

Описание: Participants will receive SC guselkumab and placebo.

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: Double (Participant, Investigator)