Ireland
--:--IST
Active, not recruiting Phase 3

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

NCT06807424 · tracked via the Priya Life Science India tracker
Phase
Phase 3
Started
2025-01-09
Last updated
2026-11-03

Condition(s) studied

Arthritis, Psoriatic

Investigational drug(s) / intervention(s)

Icotrokinra →Placebo

Icotrokinra: Icotrokinra will be administered.

Placebo: Placebo will be administered.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 — Week 16
    The ACR 20 responders are participants with an improvement of greater than or equal to (\>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity \[arthritis, VAS\] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).

Trial sites (236)

FacilityCityRegionStatus
AARA Clinical Research Glendale Arizona
AARA Clinical Research 1 Mesa Arizona
Arthritis and Rheumatism Associates ARA Jonesboro Jonesboro Arkansas
Clinical Research of West Florida Clearwater Florida
Omega Research Consultants DeBary Florida
Suncoast Clinical Research New Port Richey Florida
Integral Rheumatology And Immunology Specialists Plantation Florida
Clinical Research of West Florida 1 Tampa Florida
Clinic of Robert Hozman Skokie Illinois
Klein And Associates M D P A Hagerstown Maryland
DM Clinical Research 1 Brookline Massachusetts
St Paul Rheumatology PA Eagan Minnesota
Albuquerque Rehabilitation and Rheumatology Albuquerque New Mexico
Joint and Muscle Research Institute Charlotte North Carolina
Rheumatology Associates of Oklahoma Oklahoma City Oklahoma
Altoona Center For Clinical Research Duncansville Pennsylvania
Clinical Research Philadelphia Philadelphia Pennsylvania
UT Southwestern Dallas Texas
Arthritis and Rheumatology Research Institute Frisco Texas
Naiara Alvarez MD Integrative Rheumatology of South TX Harlingen Texas
AARA Clinical Research Lone Star Arthritis and Rheumatology Irving Texas
DM Clinical Research Tomball Texas
Velocity Clinical Research Waco Texas
Seattle Rheumatology Seattle Washington
Center of Rheumatic Diseases Glendale Wisconsin
Instituto Medico De Alta Complejidad (IMAC) Buenos Aires Argentina
ARCIS Salud SRL Aprillus asistencia e investigacion Buenos Aires Argentina
Hospital Militar Central Cir. My. Dr. Cosme Argerich Buenos Aires Argentina
Arsema Ciudad de Buenos Aires Argentina
Centro Medico Privado de Reumatologia Tucuman Ciudad de San Miguel de Tucuman Argentina
MR Medicina Reumatologica San Fernando Argentina
Ipswich Hospital Ipswich Australia
Rheumatology Research Unit Maroochydore Australia
Queen Elizabeth Hospital South Woodville Australia
Royal North Shore Hospital St Leonards Australia
Royal Darwin Hospital Tiwi Australia
Faculdade de Medicina Universidade Federal de Minas Gerais Belo Horizonte Brazil
LMK Servicos Medicos S S Porto Alegre Brazil
Funfarme Sjrp São José do Rio Preto Brazil
BR Trials São Paulo Brazil

+ 196 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06807424 on ClinicalTrials.gov ↗ ← All trials in India