RightFit
RecruitingPhase 2

A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-88545223 For the Treatment of Participants With Active Psoriatic Arthritis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests JNJ-88545223 in adults with active psoriatic arthritis, a disease that causes joint pain and swelling and is linked to psoriasis. It compares the study drug with a placebo (an inactive substance) to see if it helps joint and skin symptoms and to check its safety.

The purpose of this study is to evaluate how well the study drug JNJ-88545223 works compared with a placebo (an inactive substance) in adults with active psoriatic arthritis (PsA). The study aims to see whether treatment with JNJ-88545223 can help reduce the signs and symptoms of PsA and improve joint and skin health.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had psoriatic arthritis for at least 3 months before starting treatment and meet the study’s rules for this diagnosis.
  • Have at least 3 swollen joints and 3 tender joints at screening and at the first treatment visit.
  • Have a C-reactive protein (CRP) level of at least 0.1 mg/dL at screening. CRP is a blood marker of inflammation.
  • Have at least one of these arthritis patterns: affected joints near the fingertips; many affected joints without rheumatoid lumps; unevenly affected joints in the arms or legs; or spine arthritis with arthritis in the arms or legs.
  • Have active plaque psoriasis with at least one raised skin patch at least 2 cm wide, or nail changes caused by psoriasis.
  • If able to become pregnant, have a negative blood pregnancy test at screening and a negative urine pregnancy test before the first treatment.

Who can't join

  • Have a form of psoriasis other than plaque psoriasis, such as widespread redness, small drop-shaped spots, or pus-filled bumps.
  • Have a history or signs of severe, worsening, or uncontrolled health problems affecting organs, body systems, or mental health, other than psoriatic arthritis.
  • Have a known or suspected allergy or cannot tolerate the study drug, placebo, or their ingredients; or have had a severe allergic reaction to food or medicine, including severe swelling or a life-threatening reaction.
  • Have fibromyalgia (a condition causing widespread pain) or osteoarthritis (arthritis from joint wear) symptoms that the study doctor thinks could make it hard to judge whether treatment works.
  • Have cancer now or have had cancer within 5 years before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening * Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (Week 0/Day 1) based on the 66/68 joint assessment; AND (b) C-reactive protein (CRP) greater than or equal to (\>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory * Have \>= 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, 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 * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention Exclusion Criteria: * Has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular) * Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except PsA), psychiatric, genitourinary, or metabolic disturbances * Has suspected or known allergies, hypersensitivity, or intolerance to JNJ-88545223 or excipients used in the investigational medicinal product (IMP), including placebo (JNJ-88545223 investigator's brochure); or has a history of severe allergic reaction, angioedema, or anaphylaxis to drugs or food * Has fibromyalgia or osteoarthritis symptoms that, in the opinion of the investigator, would have potential to interfere with efficacy assessments * Currently has a malignancy or has a history of malignancy within 5 years prior to screening

Study sites (18)

AR

CA

FL

GA

IL

IN

NC

NM

OH

PA

TX