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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06878404
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, China, Japan, Taiwan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Psoriatic
Arms & Interventions

Arms

Experimental: Group I: Icotrokinra Dose 1

Participants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.

Experimental: Group II: Icotrokinra Dose 2

Participants will receive icotrokinra dose 2. Participants who continue into a LTE 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. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.

Active Comparator: Group IV: Active Reference Comparator

Participants will receive active reference drug, ustekinumab. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.

Interventions

Drug: - Icotrokinra

Icotrokinra will be administered.

Drug: - Placebo

Placebo will be administered.

Drug: - Active reference comparator

Active reference comparator drug will be administered.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Omega Research Consultants, DeBary, Florida

Status

Recruiting

Address

Omega Research Consultants

DeBary, Florida, 32713

Plantation, Florida

Status

Recruiting

Address

Integral Rheumatology And Immunology Specialists

Plantation, Florida, 33324

International Sites

Ipswich Hospital, Ipswich, Australia

Status

Recruiting

Address

Ipswich Hospital

Ipswich, , 4305

Rheumatology Research Unit, Maroochydore, Australia

Status

Recruiting

Address

Rheumatology Research Unit

Maroochydore, , 4558

BJC Health, Parramatta, Australia

Status

Recruiting

Address

BJC Health

Parramatta, , 2150

Peking University Third Hospital, Beijing, China

Status

Recruiting

Address

Peking University Third Hospital

Beijing, , 100191

Sichuan Provincial Peoples Hospital, Chengdu, China

Status

Recruiting

Address

Sichuan Provincial Peoples Hospital

Chengdu, , 610072

Guangzhou, China

Status

Recruiting

Address

Nanfang Hospital of Southern Medical Hospital

Guangzhou, , 510515

Guiyang, China

Status

Recruiting

Address

The Affiliated Hospital of Guizhou Medical University

Guiyang, , 561113

Linyi City People Hospital, Linyi City, China

Status

Recruiting

Address

Linyi City People Hospital

Linyi City, , 276002

Nantong, China

Status

Recruiting

Address

Affiliated Hospital of Nantong University

Nantong, , 226001

Pingxiang People's Hospital, Pingxiang, China

Status

Recruiting

Address

Pingxiang People's Hospital

Pingxiang, , 337055

Huashan Hospital Fudan University, Shanghai, China

Status

Recruiting

Address

Huashan Hospital Fudan University

Shanghai, , 200040

Shanxi Bethune Hospital, Taiyuan, China

Status

Recruiting

Address

Shanxi Bethune Hospital

Taiyuan, , 030032

Wenzhou, China

Status

Recruiting

Address

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , 325000

Teikyo University Hospital, Itabashi Ku, Japan

Status

Recruiting

Address

Teikyo University Hospital

Itabashi Ku, , 173 8606

Maeshima Rheumatology Clinic, Oita, Japan

Status

Recruiting

Address

Maeshima Rheumatology Clinic

Oita, , 870 0823

Osaka, Japan

Status

Recruiting

Address

Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

Osaka, , 550 0006

Sasebo Chuo Hospital, Sasebo, Japan

Status

Recruiting

Address

Sasebo Chuo Hospital

Sasebo, , 857 1195

Mie University Hospital, Tsu, Japan

Status

Recruiting

Address

Mie University Hospital

Tsu, , 514 8507

Hsin Chu, Taiwan

Status

Recruiting

Address

National Taiwan University Hospital Hsin Chu Branch

Hsin Chu, , 300

Chang Gung Memorial Hospital, Kaohsiung City, Taiwan

Status

Recruiting

Address

Chang Gung Memorial Hospital

Kaohsiung City, , 833

Taipei Veterans General Hospital, Taipei, Taiwan

Status

Recruiting

Address

Taipei Veterans General Hospital

Taipei, , 112

Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan

Status

Recruiting

Address

Linkou Chang Gung Memorial Hospital

Taoyuan, , 333