A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Arthritis, Psoriatic

Treatments: Drug: Placebo; Drug: Guselkumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04882098

CNTO1959PSA3004 (Other Identifier)

CR108957

2020-004981-20 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Enrollment: 950 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
• Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
• Have active PsA as defined by: at least 3 swollen joints and 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
• Have >= 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read
• Have at least one 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

Exclusion criteria

• Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients
• Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr-axSpA), systemic lupus erythematosus, or Lyme disease
• Has previously received any biologic treatment
• Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor
• Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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950 participants in 3 patient groups

Group 1: Guselkumab and Placebo

Experimental group

Description:

Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.

Treatment:

Drug: Guselkumab

Drug: Placebo

Group 2: Guselkumab

Experimental group

Description:

Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.

Treatment:

Drug: Guselkumab

Group 3: Placebo Followed by Guselkumab

Experimental group

Description:

Participants will receive placebo SC and will cross over to receive SC guselkumab. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.

Treatment:

Drug: Guselkumab

Drug: Placebo