A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-88545223 in Participants with Active Psoriatic Arthritis

Trial ID: 2025-523141-10-00
Protocol: 88545223PSA2001
Sponsor: Janssen Cilag International

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Diseases & Conditions

Psoriatic arthropathy

Objectives

The primary objective of this study is to evaluate the efficacy of JNJ-88545223 compared to a placebo in patients with active psoriatic arthritis. 5, 4.

Participants

This study includes 74 participants diagnosed with active psoriatic arthritis. The study population consists of both male and female patients. Eligible individuals are aged 18 years or older and must meet the CASPAR classification criteria. Participants must present with active psoriatic plaques or nail changes and exhibit specific clinical markers, including a minimum number of swollen and tender joints and elevated C-reactive protein levels. The cohort includes patients with disease activity despite the prior or current use of conventional DMARDs, apremilast, or anti-TNF agents. Specific requirements regarding the stability and dosage of concomitant medications, such as NSAIDs or oral corticosteroids, are applied to the study population.

Plans and Procedures

This Phase 2b, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study is designed to evaluate the efficacy and safety of JNJ-88545223 in participants with active psoriatic arthritis. The primary objective is to assess the ACR50 response at Week 16. Participants will undergo a screening visit to confirm eligibility based on specific clinical criteria, including a diagnosis of the disease for at least 3 months, active joint involvement, and specific C-reactive protein levels. Following screening, participants will be administered either the test substance or a placebo via oral tablet. The study includes a baseline assessment at Week 0 and subsequent monitoring to evaluate the treatment response. The overall recruitment and study activities are estimated to occur between March 2026 and June 2027.

Treatment

The experimental medication is JNJ-88545223, which is administered in a tablet pharmaceutical form. The oral route of administration is utilized for this investigational product.

The control group receives a placebo to facilitate a double-blind assessment of the efficacy and safety of the test substance in participants with active psoriatic arthritis.

Efficacy

The efficacy of JNJ-88545223 in participants with active psoriatic arthritis is evaluated by comparing the study drug against a placebo. The primary efficacy endpoint is the ACR50 response measured at week 16.

Inclusion and Exclusion Criteria

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Inclusion Criteria

At the time of informed consent, be ≥18 years of age.
Have a diagnosis of PsA for ≥3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening.
Have active APs as defined by: At least 3 swollen joints and 3 tender joints at screening and at baseline (Week 0/Day 1); and CRP ≥0.1 mg/dL at screening ≥0.1 mg/dL
Have active plaque psoriasis, with ≥1 psoriatic plaque of ≥2 cm diameter or nail changes consistent with psoriasis
Have active PsA despite current or previous use of ≥1 of the following: a. Conventional DMARDs Conventional DMARD (limited to MTX, SSZ, HCQ, and/or LEF) therapy is defined as taking a conventional DMARD for ≥12 weeks before first administration of study intervention, or evidence of conventional DMARD intolerance. b. Apremilast Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for ≥12 weeks before first administration of study intervention, or evidence of apremilast intolerance. c. Anti-TNF agents Must have experienced either: i. Inadequate response to TNFi treatment at an approved dose, as assessed by the treating physician, after ≥12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar) or ≥14 weeks of infliximab (or biosimilar); OR ii. Stopped TNFi treatment due to safety/tolerability reasons, as assessed by the treating physician. Limited to prior use of up to 2 different TNFi
If currently using conventional DMARDs (limited to MTX, SSZ, HCQ, or LEF), participants should have started treatment ≥12 weeks and the dose must be stable for ≥4 weeks before first administration of study intervention and should have no serious toxic side effects attributable to the conventional DMARD. If currently not using MTX, SSZ, or HCQ, must have been off such medication(s) for at least 4 weeks before first the administration of study intervention. If currently not using LEF, must have been off this medication for at least 12 weeks before the first administration of study intervention. a. If using MTX, the route of administration and dose must be stable at ≤25 mg/week b. If receiving SSZ, the dose must be stable at ≤3 g/day c. If receiving HCQ, the dose must be stable at ≤400 mg/day d. If receiving LEF, the dose must be stable at ≤20 mg/day
If using apremilast at baseline (Week 0/Day 1), participants must be on a stable dose at ≤30 mg twice daily for ≥12 weeks before first administration of study intervention. If currently not using apremilast, must have been off this medication for at least 4 weeks before the first administration of study intervention.
If using NSAIDs or other analgesics for PsA at baseline, participants must be on a stable dose for ≥2 weeks before first administration of study intervention. If currently not using NSAIDs or other analgesics for PsA, must have been off such medication(s) for at least 2 weeks before first administration of study intervention.
If using oral corticosteroids at baseline (Week 0/Day 1), participants must be on a stable dose equivalent to ≤10 mg of prednisone/day for ≥2 weeks before first administration of study intervention. If currently not using oral corticosteroids, must have been off such medication(s) for at least 2 weeks before the first administration of study intervention

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Exclusion Criteria

Has a history or current signs and symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except PsA), psychiatric, genitourinary, and/or metabolic disturbances.
Currently has a malignancy or has a history of malignancy within 5 years prior to screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for ≥12 weeks prior to the first study intervention administration or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for ≥12 weeks prior to the first study intervention administration).
Has other inflammatory diseases that might confound the evaluations of benefit of JNJ 88545223 therapy
Have rheumatoid factor or anti-CCP antibody levels at screening that are above the ULN
Active hepatitis of infectious origin
History of chronic or recurrent infectious disease