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

Purpose

The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in biologic-experienced 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

  • Participants must have been previously treated with 1 biologic agent for psoriatic arthritis (PsA) or psoriasis and have discontinued treatment for any reason. The reason for discontinuation must be documented - 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 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 5295985, Arizona 5551752 85306

AARA Clinical Research
Mesa 5304391, Arizona 5551752 85210

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

Clinical Research of West Florida
Clearwater 4151316, Florida 4155751 33765

Omega Research Consultants
DeBary 4152926, Florida 4155751 32713

Suncoast Clinical Research
New Port Richey 4165869, Florida 4155751 34652

Integral Rheumatology And Immunology Specialists
Plantation 4168782, Florida 4155751 33324

Clinical Research of West Florida
Tampa 4174757, Florida 4155751 33606

Clinic of Robert Hozman
Skokie 4911600, Illinois 4896861 60076

Klein And Associates M D P A
Hagerstown 4357141, Maryland 4361885 21740

DM Clinical Research
Brookline 4931482, Massachusetts 6254926 02446

St Paul Rheumatology PA
Eagan 5024825, Minnesota 5037779 55121

Albuquerque Rehabilitation and Rheumatology
Albuquerque 5454711, New Mexico 5481136 87102

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

Rheumatology Associates of Oklahoma
Oklahoma City 4544349, Oklahoma 4544379 73116

Altoona Center For Clinical Research
Duncansville 5187508, Pennsylvania 6254927 16635

Arthritis and Rheumatology Research Institute
Allen 4670300, Texas 4736286 75013

UT Southwestern
Dallas 4684888, Texas 4736286 75390

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

AARA Clinical Research Lone Star Arthritis and Rheumatology
Irving 4700168, Texas 4736286 75039

DM Clinical Research
Tomball 4737094, Texas 4736286 77375

Velocity Clinical Research
Waco 4739526, Texas 4736286 76710

More Details

NCT ID
NCT06807424
Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center