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Clinical Trials in India / NCT06807424
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
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2025-01-09
Last updated
2026-08-28

Condition(s) studied

Arthritis, Psoriatic

Investigational drug(s) / intervention(s)

IcotrokinraPlacebo

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)

Trial sites (236)

FacilityCityRegionStatus
AARA Clinical Research Glendale Arizona Recruiting
AARA Clinical Research 1 Mesa Arizona Recruiting
Arthritis and Rheumatism Associates ARA Jonesboro Jonesboro Arkansas Recruiting
Clinical Research of West Florida Clearwater Florida Recruiting
Omega Research Consultants DeBary Florida Recruiting
Suncoast Clinical Research New Port Richey Florida Recruiting
Integral Rheumatology And Immunology Specialists Plantation Florida Recruiting
Clinical Research of West Florida 1 Tampa Florida Recruiting
Clinic of Robert Hozman Skokie Illinois Completed
Klein And Associates M D P A Hagerstown Maryland Recruiting
DM Clinical Research 1 Brookline Massachusetts Completed
St Paul Rheumatology PA Eagan Minnesota Completed
Albuquerque Rehabilitation and Rheumatology Albuquerque New Mexico Recruiting
Joint and Muscle Research Institute Charlotte North Carolina Recruiting
Rheumatology Associates of Oklahoma Oklahoma City Oklahoma Recruiting
Altoona Center For Clinical Research Duncansville Pennsylvania Recruiting
Clinical Research Philadelphia Philadelphia Pennsylvania Recruiting
UT Southwestern Dallas Texas Recruiting
Arthritis and Rheumatology Research Institute Frisco Texas Recruiting
Naiara Alvarez MD Integrative Rheumatology of South TX Harlingen Texas Suspended
AARA Clinical Research Lone Star Arthritis and Rheumatology Irving Texas Recruiting
DM Clinical Research Tomball Texas Recruiting
Velocity Clinical Research Waco Texas Recruiting
Seattle Rheumatology Seattle Washington Recruiting
Center of Rheumatic Diseases Glendale Wisconsin Recruiting
Instituto Medico De Alta Complejidad (IMAC) Buenos Aires Argentina Recruiting
ARCIS Salud SRL Aprillus asistencia e investigacion Buenos Aires Argentina Recruiting
Hospital Militar Central Cir. My. Dr. Cosme Argerich Buenos Aires Argentina Recruiting
Arsema Ciudad de Buenos Aires Argentina Recruiting
Centro Medico Privado de Reumatologia Tucuman Ciudad de San Miguel de Tucuman Argentina Recruiting
MR Medicina Reumatologica San Fernando Argentina Recruiting
Ipswich Hospital Ipswich Australia Recruiting
Rheumatology Research Unit Maroochydore Australia Recruiting
Queen Elizabeth Hospital South Woodville Australia Recruiting
Royal North Shore Hospital St Leonards Australia Recruiting
Royal Darwin Hospital Tiwi Australia Recruiting
Faculdade de Medicina Universidade Federal de Minas Gerais Belo Horizonte Brazil Completed
LMK Servicos Medicos S S Porto Alegre Brazil Active Not Recruiting
Funfarme Sjrp São José do Rio Preto Brazil Active Not Recruiting
BR Trials São Paulo Brazil Active Not Recruiting

+ 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