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Clinical Trials in India / NCT06878404
Active, not recruiting Phase 3

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

NCT06878404 · tracked via the Priya Life Science India tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2025-02-21
Last updated
2026-08-28

Condition(s) studied

Arthritis, Psoriatic

Investigational drug(s) / intervention(s)

IcotrokinraPlaceboActive reference comparator

Icotrokinra: Icotrokinra will be administered.

Placebo: Placebo will be administered.

Active reference comparator: Active reference drug will be administered.

Study summary

The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in 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 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 previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis * 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 * 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 (155)

FacilityCityRegionStatus
Arthritis and Rheumatism Associates ARA Jonesboro Jonesboro Arkansas
Omega Research Consultants DeBary Florida
Integral Rheumatology And Immunology Specialists Plantation Florida
Clinical Research of West Florida Tampa Florida
Willow Rheumatology and Wellness PLLC Willowbrook Illinois
Joint and Muscle Research Institute Charlotte North Carolina
Altoona Center For Clinical Research Duncansville Pennsylvania
Arthritis and Rheumatology Research Institute Allen Texas
Naiara Alvarez MD Integrative Rheumatology of South TX Harlingen Texas
Cosultorios Reumatologógicos Pampa Buenos Aires Argentina
Mindout Research Buenos Aires Argentina
Hospital Central Militar Cirujano Mayor 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
Consultora Integral de Salud SRL Córdoba Argentina
MR Medicina Reumatologica San Fernando Argentina
Instituto Medico De Alta Complejidad (IMAC) San Isidro Argentina
Ipswich Hospital Ipswich Australia
Rheumatology Research Unit Maroochydore Australia
BJC Health Parramatta Australia
Queen Elizabeth Hospital South Woodville Australia
Royal Darwin Hospital Tiwi Australia
MC Medtech Services Ltd Haskovo Bulgaria
Exacta Medica Pleven Bulgaria
Medical Center Artmed Plovdiv Bulgaria
Medical Center Teodora Rousse Bulgaria
Peking University Third Hospital Beijing China
Beijing Tong Ren Hospital Capital Medical University Beijing China
The First Bethune Hospital of Jilin University Changchun China
Xiangya Hospital Central South University Changsha China
West China Hospital Sichuan University Chengdu China
Sichuan Provincial Peoples Hospital Chengdu China
The First Affiliated Hospital of Chongqing Medical University Chongqing China
Nanfang Hospital of Southern Medical Hospital Guangzhou China
The Affiliated Hospital of Guizhou Medical University Guiyang China
Linyi City People Hospital Linyi China
Jiangxi Provincial Peoples Hospital Nanchang China
The Second Affiliated Hospital of Nanchang University Nanchang China
Affiliated Hospital of Nantong University Nantong China
Pingxiang People's Hospital Pingxiang China

+ 115 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 NCT06878404 on ClinicalTrials.gov ↗ ← All trials in India