Recruiting
Phase 3

Icotrokinra

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06807424

Conditions

Arthritis, Psoriatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Icotrokinra

Placebo

Study Details

Brief summary:

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.

Conditions

Arthritis, Psoriatic

Study ID

NCT06807424

Start date

Jan 9, 2025

Status verified date

Aug, 2026

Completion date

Oct 18, 2028

Anticipated

Primary completion date

Feb 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

Icotrokinra

Icotrokinra will be administered.

Placebo

Placebo will be administered.

Primary outcome measure

  • Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

AARA Clinical Research

Recruiting

Glendale, Arizona, United States, 85306

AARA Clinical Research 1

Recruiting

Mesa, Arizona, United States, 85210

Arthritis and Rheumatism Associates ARA Jonesboro

Recruiting

Jonesboro, Arkansas, United States, 72401

Clinical Research of West Florida

Recruiting

Clearwater, Florida, United States, 33765

Omega Research Consultants

Recruiting

DeBary, Florida, United States, 32713

Suncoast Clinical Research

Recruiting

New Port Richey, Florida, United States, 34652

Integral Rheumatology And Immunology Specialists

Recruiting

Plantation, Florida, United States, 33324

Clinical Research of West Florida 1

Recruiting

Tampa, Florida, United States, 33606

Klein And Associates M D P A

Recruiting

Hagerstown, Maryland, United States, 21740

Albuquerque Rehabilitation and Rheumatology

Recruiting

Albuquerque, New Mexico, United States, 87102

Joint and Muscle Research Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Rheumatology Associates of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73116

Altoona Center For Clinical Research

Recruiting

Duncansville, Pennsylvania, United States, 16635

Clinical Research Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19114

UT Southwestern

Recruiting

Dallas, Texas, United States, 75390

Arthritis and Rheumatology Research Institute

Recruiting

Frisco, Texas, United States, 75035

AARA Clinical Research Lone Star Arthritis and Rheumatology

Recruiting

Irving, Texas, United States, 75039

DM Clinical Research

Recruiting

Tomball, Texas, United States, 77375

Velocity Clinical Research

Recruiting

Waco, Texas, United States, 76710

Seattle Rheumatology

Recruiting

Seattle, Washington, United States, 98104

Center of Rheumatic Diseases

Recruiting

Glendale, Wisconsin, United States, 53217

Eastern Regional Health Authority St Clares Mercy Hospital

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1C 5B8

The Waterside Clinic

Recruiting

Orillia, Ontario, Canada, L3V 1T5

Womens College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B1

Dr Sabeen Anwar Medicine Professional Corporation

Recruiting

Windsor, Ontario, Canada, N8X 1T3

Hospital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Centre de Recherche Musculo Squelettique

Recruiting

Trois-Rivières, Quebec, Canada, G9A 3X2

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.