RightFit
RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced and Biologic-naive 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 how well icotrokinra (JNJ-77242113) reduces symptoms of active psoriatic arthritis, a joint disease linked to psoriasis, and checks its safety. It compares the drug with a placebo, which has no active medicine. It is for people who have or have not used a biologic medicine, a treatment made from living cells.

The purpose of this study is to evaluate the efficacy of icotrokinra (JNJ-77242113) compared to placebo in biologic-experienced and biologic-naive participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

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

Eligibility

Who can join

  • Still have active psoriatic arthritis despite current or past treatment with at least one of these: a non-biologic drug that slows arthritis, apremilast, or one biologic medicine only.
  • Have had a psoriatic arthritis diagnosis for at least 3 months before the first study dose and meet the study’s diagnosis rules at screening.
  • Have at least 3 swollen joints and 3 tender joints at screening and at the start of the study.
  • Have a C-reactive protein (CRP) blood test result of at least 0.1 mg/dL at screening. CRP is a sign of inflammation.
  • Have one of the listed arthritis patterns: joints near the fingertips; many joints without rheumatoid lumps; severe joint damage; uneven joint symptoms on the two sides of the body; or spine arthritis plus arthritis in other joints.
  • Have at least one raised psoriasis skin patch at least 2 cm across, 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 dose at Week 0.

Who can't join

  • Have a history or signs of severe, worsening, or uncontrolled health problems affecting organs, blood, hormones, nerves, mental health, or how the body uses energy, or another rheumatic disease besides psoriatic arthritis.
  • Have cancer now or have had cancer within 5 years before screening.
  • Have a known allergy, sensitivity, or inability to tolerate icotrokinra or any of its ingredients.
  • Have another disease that causes inflammation and could make the study results hard to judge, such as rheumatoid arthritis, lupus, or Lyme disease.
  • Have symptoms of fibromyalgia (widespread pain) or osteoarthritis (joint wear and damage) that the study doctor thinks could make treatment results hard to judge.

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

Official eligibility criteria

Inclusion Criteria: * Have active psoriatic arthritis (PsA) despite current or previous use of greater than or equal to (\>=) 1 of the following: a. Non-biologic disease-modifying antirheumatic drug (DMARD) therapy; b. Apremilast therapy; c. Biologic-agent (limited to only 1) * Have a diagnosis of 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 (b) C-reactive protein (CRP) \>= 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory * Have at least 1 of the 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 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 history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances * Currently has a malignancy or has a history of malignancy within 5 years prior to screening * Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients * Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or Lyme disease * Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments

Study sites (25)

AR

AZ

FL

IL

MA

MD

MN

NC

NM

OK

PA

TX

WA

WI