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

Purpose

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.

Condition

  • Arthritis, Psoriatic

Eligibility

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

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 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 have not discontinued will be eligible to enter a long term extension (LTE) and 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 have not discontinued will be eligible to enter a LTE and 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 at Week 16. Participants who have not discontinued will be eligible to enter a LTE and 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.

Recruiting Locations

AARA Clinical Research
Glendale, Arizona 85306

AARA Clinical Research 1
Mesa, Arizona 85210

Arthritis and Rheumatism Associates ARA Jonesboro
Jonesboro, Arkansas 72401

Clinical Research of West Florida
Clearwater, Florida 33765

Omega Research Consultants
DeBary, Florida 32713

Suncoast Clinical Research
New Port Richey, Florida 34652

Integral Rheumatology And Immunology Specialists
Plantation, Florida 33324

Clinical Research of West Florida 1
Tampa, Florida 33606

Klein And Associates M D P A
Hagerstown, Maryland 21740

St Paul Rheumatology PA
Eagan, Minnesota 55123

Albuquerque Rehabilitation and Rheumatology
Albuquerque, New Mexico 87102

Joint and Muscle Research Institute
Charlotte, North Carolina 28204

Rheumatology Associates of Oklahoma
Oklahoma City, Oklahoma 73116

Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635

Arthritis and Rheumatology Research Institute
Allen, Texas 75013

UT Southwestern
Dallas, Texas 75390

AARA Clinical Research Lone Star Arthritis and Rheumatology
Irving, Texas 75039

DM Clinical Research
Tomball, Texas 77375

Velocity Clinical Research
Waco, Texas 76710

Seattle Rheumatology
Seattle, Washington 98104

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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