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

RecruitingPhase 3

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

Ages 18 and older · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 750 · Started: Jan 9, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06807424

Locations in the U.S.

ArizonaAARA Clinical Research, Glendale
AARA Clinical Research 1, Mesa
ArkansasArthritis and Rheumatism Associates ARA Jonesboro, Jonesboro
FloridaClinical Research of West Florida, Clearwater
Omega Research Consultants, DeBary
Suncoast Clinical Research, New Port Richey
Integral Rheumatology And Immunology Specialists, Plantation
Clinical Research of West Florida 1, Tampa
MarylandKlein And Associates M D P A, Hagerstown
New MexicoAlbuquerque Rehabilitation and Rheumatology, Albuquerque
North CarolinaJoint and Muscle Research Institute, Charlotte
OklahomaRheumatology Associates of Oklahoma, Oklahoma City
PennsylvaniaAltoona Center For Clinical Research, Duncansville
Clinical Research Philadelphia, Philadelphia
TexasUT Southwestern, Dallas
Arthritis and Rheumatology Research Institute, Frisco
AARA Clinical Research Lone Star Arthritis and Rheumatology, Irving
DM Clinical Research, Tomball
Velocity Clinical Research, Waco
WashingtonSeattle Rheumatology, Seattle
WisconsinCenter of Rheumatic Diseases, Glendale

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.