A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

Study Purpose

The purpose of this study is to evaluate the pharmacokinetics (PK) and efficacy of ustekinumab and guselkumab in juvenile psoriatic arthritis (jPsA).

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 5 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion of enthesitis-related arthritis (ERA).
Diagnosis made at least 12 weeks prior to screening.
  • - Active disease in at least greater than or equal to (>=) 3 joints at screening and at week 0 (defined as swelling or loss of motion with pain and/or tenderness.
Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint.
  • - Inadequate response (>= 4 weeks) or intolerance to >=1 non-steroidal anti-inflammatory drug (NSAID) - Inadequate response (>=12 weeks) or intolerance to >=1 non-biological disease modifying anti-rheumatic drug (DMARD) - If using corticosteroids; must be on a stable dose of less than or equal to (<=) 10 milligrams (mg) prednisone equivalent or 0.20 mg per kilograms (kg) per day (whichever is less) for >=4 weeks before first administration of study intervention.
If currently not using corticosteroids, the participant must have not received corticosteroids (intra articular, intramuscular, or intravenous [IV] corticosteroids [including intramuscular corticotropin]) for >=4 weeks before the first dose administration.

Exclusion Criteria:

  • - Participants with ERA.
  • - Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screening.
  • - Have a history of, or ongoing, chronic or recurrent infectious disease.
  • - Has evidence of herpes zoster infection within 8 weeks prior to Week 0.
- Have a known history of hepatitis C infection or test positive at screening

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.

NCT05083182
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 Argentina, France, Germany, Italy, Poland, Spain, Turkey, United Kingdom, United States
Conditions

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

Arthritis, Juvenile
Additional Details

Juvenile psoriatic arthritis is a complex, chronic, progressive, debilitating musculoskeletal disease with significant remaining medical need. There is a need for medications which have a similar efficacy profile and a similar safety profile relative to currently available treatment for jPsA which include anti-tumor necrosis factor alpha (TNF alpha) inhibitors (though mostly off-label) and secukinumab. STELARA (ustekinumab) is a fully human immunoglobulin G (IgG) 1 kappa monoclonal antibody (mAb) which binds with high affinity to the p40 subunit common to both interleukin (IL)-12 and IL 23 preventing IL-12/23p40 binding to the IL 12 Rb1 cell surface receptor shared by both cytokines. Through this mechanism of action, ustekinumab effectively neutralizes IL-12 T helper 1- and IL-23 T helper 17-mediated cellular responses. TREMFYA (guselkumab) is a fully human IgG1 lambda (G1 lambda) mAb that binds to the p19 subunit of human IL-23 with high affinity. The binding of guselkumab to IL-23 blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-specific intracellular signaling and subsequent activation and cytokine production. This study consists of Screening period (up to 6 weeks), Treatment period (up to 52 weeks) and a final safety visit at Week 68. The total duration of the study is up to 68 weeks.

Arms & Interventions

Arms

Experimental: Cohort 1: Ustekinumab

Participants will receive a weight-based dose of ustekinumab subcutaneously (SC) at Week 0, Week 4 and then every 12 weeks up to Week 52.

Experimental: Cohort 2: Guselkumab

Participants without evidence of joint damage will be dosed with guselkumab at Week 0, Week 4 and then every 8 weeks up to Week 52. Participants with radiographic evidence of joint damage will be dosed with guselkumab every 4 weeks from Week 0 through Week 52. Participants at high risk of joint damage according to clinical judgement but should be considered for dosing every 4 weeks, depending upon the judgement of the study doctor.

Interventions

Drug: - Ustekinumab

Ustekinumab will be administered as subcutaneous injection.

Drug: - Guselkumab

Guselkumab will be administered as subcutaneous injection.

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.

Childrens Hospital Los Angeles, Los Angeles, California

Status

Recruiting

Address

Childrens Hospital Los Angeles

Los Angeles, California, 90027

UCLA, Los Angeles, California

Status

Not yet recruiting

Address

UCLA

Los Angeles, California, 90095-3075

Orlando, Florida

Status

Withdrawn

Address

Nemours Children's Hospital/Endocrinology

Orlando, Florida, 32827

University of Chicago Medical Center, Chicago, Illinois

Status

Not yet recruiting

Address

University of Chicago Medical Center

Chicago, Illinois, 60637-1447

Boston, Massachusetts

Status

Not yet recruiting

Address

Harvard Medical School - Boston Children&#39;s Hospital

Boston, Massachusetts, 02215-5450

Montefiore Medical Center, Bronx, New York

Status

Recruiting

Address

Montefiore Medical Center

Bronx, New York, 10467-2403

Northwell Health, New York, New York

Status

Recruiting

Address

Northwell Health

New York, New York, 11040

University of North Carolina, Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina

Chapel Hill, North Carolina, 27514

Legacy Emanuel Medical Center, Portland, Oregon

Status

Recruiting

Address

Legacy Emanuel Medical Center

Portland, Oregon, 97227

University of Utah, Salt Lake City, Utah

Status

Not yet recruiting

Address

University of Utah

Salt Lake City, Utah, 84132

Seattle Children's Hospital, Seattle, Washington

Status

Withdrawn

Address

Seattle Children's Hospital

Seattle, Washington, 98105

International Sites

STAT Research S.A., Ciudad Autonoma Buenos Aires, Argentina

Status

Recruiting

Address

STAT Research S.A.

Ciudad Autonoma Buenos Aires, , C1013AAAB

Hospital de Ninos de Cordoba, Cordoba, Argentina

Status

Recruiting

Address

Hospital de Ninos de Cordoba

Cordoba, , 5000

Instituto Medico Platense, La Plata, Argentina

Status

Recruiting

Address

Instituto Medico Platense

La Plata, , B1900

Centro Medico Privado de Reumatologia, San Miguel De Tucuman, Argentina

Status

Recruiting

Address

Centro Medico Privado de Reumatologia

San Miguel De Tucuman, , T4000AXL

CHU de Caen, Caen, France

Status

Not yet recruiting

Address

CHU de Caen

Caen, , 14033

Hopital de Bicetre, Le Kremlin Bicêtre, France

Status

Not yet recruiting

Address

Hopital de Bicetre

Le Kremlin Bicêtre, , 94270

CHU de Toulouse Hopital des Enfants, Toulouse cedex 9, France

Status

Not yet recruiting

Address

CHU de Toulouse Hopital des Enfants

Toulouse cedex 9, , 31059

Hôpital D'Enfants, Vandoeuvre les Nancy, France

Status

Not yet recruiting

Address

Hôpital D'Enfants

Vandoeuvre les Nancy, , 54511

Helios Kliniken Berlin Buch Gmbh, Berlin, Germany

Status

Withdrawn

Address

Helios Kliniken Berlin Buch Gmbh

Berlin, , 13125

Berlin, Germany

Status

Not yet recruiting

Address

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, , 13353

Schön Klinik Hamburg Eilbek, Hamburg, Germany

Status

Not yet recruiting

Address

Schön Klinik Hamburg Eilbek

Hamburg, , 22081

Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany

Status

Not yet recruiting

Address

Asklepios Klinik Sankt Augustin

Sankt Augustin, , 53757

Brescia, Italy

Status

Not yet recruiting

Address

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

Brescia, , 25100

Istituto Giannina Gaslini, Genova, Italy

Status

Not yet recruiting

Address

Istituto Giannina Gaslini

Genova, , 16147

Milano, Italy

Status

Not yet recruiting

Address

Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Milano, , 20122

Milano, Italy

Status

Not yet recruiting

Address

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, , 20122

Lodz, Poland

Status

Not yet recruiting

Address

CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej

Lodz, , 91-738

Hosp. Univ. Vall D Hebron, Barcelona, Spain

Status

Not yet recruiting

Address

Hosp. Univ. Vall D Hebron

Barcelona, , 08035

Hosp. Gral. Univ. Gregorio Marañon, Madrid, Spain

Status

Not yet recruiting

Address

Hosp. Gral. Univ. Gregorio Marañon

Madrid, , 28007

Hosp. Univ. La Paz, Madrid, Spain

Status

Not yet recruiting

Address

Hosp. Univ. La Paz

Madrid, , 28046

Hosp. Clinico Univ. de Santiago, Santiago de Compostela, Spain

Status

Not yet recruiting

Address

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , 15706

Hosp. Infanta Luisa, Sevilla, Spain

Status

Not yet recruiting

Address

Hosp. Infanta Luisa

Sevilla, , 41010

Hosp. Univ. I Politecni La Fe, Valencia, Spain

Status

Not yet recruiting

Address

Hosp. Univ. I Politecni La Fe

Valencia, , 46026

Hacettepe Universitesi Hastanesi, Ankara, Turkey

Status

Not yet recruiting

Address

Hacettepe Universitesi Hastanesi

Ankara, , 6230

Istanbul, Turkey

Status

Not yet recruiting

Address

Istanbul University Cerrahpasa Medical Faculty

Istanbul, , 34098

Umraniye Training and Research Hospital, Istanbul, Turkey

Status

Not yet recruiting

Address

Umraniye Training and Research Hospital

Istanbul, , 34766

Birmingham Children's Hospital, Birmingham, United Kingdom

Status

Not yet recruiting

Address

Birmingham Children's Hospital

Birmingham, , B4 6NH

Great Ormond Street Hospital, London, United Kingdom

Status

Not yet recruiting

Address

Great Ormond Street Hospital

London, , WC1N 3JH

Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom

Status

Not yet recruiting

Address

Royal Victoria Infirmary

Newcastle upon Tyne, , NE1 4LP

Nottingham, United Kingdom

Status

Not yet recruiting

Address

Nottingham University Hospitals NHS Trust

Nottingham, , NG7 2UH

Sheffield Children's Hospital, Sheffield, United Kingdom

Status

Not yet recruiting

Address

Sheffield Children's Hospital

Sheffield, , S1 0 2TH