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

Purpose

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

Condition

  • Arthritis, Psoriatic

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 (b) C-reactive protein (CRP) greater than or equal to (>=) 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 previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis - 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 - 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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group I: Icotrokinra Dose 1 		Participants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.
  • Drug: Icotrokinra
    Icotrokinra will be administered.
    Other names:
    • JNJ-77242113
Experimental
Group II: Icotrokinra Dose 2 		Participants will receive icotrokinra dose 2. Participants who continue into a LTE will continue to receive icotrokinra dose 2.
  • Drug: Icotrokinra
    Icotrokinra will be administered.
    Other names:
    • JNJ-77242113
Placebo Comparator
Group III: Placebo 		Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.
  • Drug: Icotrokinra
    Icotrokinra will be administered.
    Other names:
    • JNJ-77242113
  • Drug: Placebo
    Placebo will be administered.
Active Comparator
Group IV: Active Reference Comparator 		Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.
  • Drug: Icotrokinra
    Icotrokinra will be administered.
    Other names:
    • JNJ-77242113
  • Drug: Active reference comparator
    Active reference drug will be administered.

Recruiting Locations

Arthritis and Rheumatism Associates ARA Jonesboro
Jonesboro 4116834, Arkansas 4099753 72401

Omega Research Consultants
DeBary 4152926, Florida 4155751 32713

Integral Rheumatology And Immunology Specialists
Plantation 4168782, Florida 4155751 33324

Clinical Research of West Florida
Tampa 4174757, Florida 4155751 33606

Willow Rheumatology and Wellness PLLC
Willowbrook 4916709, Illinois 4896861 60527

Joint and Muscle Research Institute
Charlotte 4460243, North Carolina 4482348 28204

Arthritis and Rheumatology Research Institute
Allen 4670300, Texas 4736286 75013

Naiara Alvarez MD Integrative Rheumatology of South TX
Harlingen 4696233, Texas 4736286 78550

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com