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A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

Last Updated   April 10, 2025

Want to learn how to participate in this trial?

CR109101

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    5+ years
  • Phase
    phase 3
    3
  • Sites
    49 Sites
  • Status
    Recruiting

SUMMARY

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

CONDITIONS

  • Arthritis, Juvenile

ELIGIBILITY


Inclusion Criteria:

* Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion of enthesitis-related arthritis (ERA). Diagnosis made >=3 months (that is, 90 days) 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
* Have active disease despite previous non-biologic disease modifying anti-rheumatic drug (DMARD) and/or non-steroidal anti-inflammatory drug (NSAID) therapy: Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 12 weeks or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
* Concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids or NSAIDs is permitted but must be on stable dose
* Participants must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed patients
* Prior use of anti-TNFα agents, IL-17 inhibitors and other biologics (except non-responders to IL-23 inhibitors) and JAK inhibitors are permitted with sufficient washout period


Exclusion Criteria:

* Participants with enthesitis-related arthritis (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


Inclusion Criteria:

* Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion of enthesitis-related arthritis (ERA). Diagnosis made >=3 months (that is, 90 days) prior to screening
* Active disease in at least greater than or equal to (>=) 3 joints a

More...

DETAILS

LOCATIONS

Locations in:
United States, Argentina, Denmark, France, Germany, Italy, Spain, Türkiye, United Kingdom, Poland
Country (10) City or Province (49) Status
United States Los Angeles Childrens Hospital Los Angeles
RECRUITING
United States Los Angeles UCLA
RECRUITING
United States Boston Harvard Medical School - Boston Children's Hospital
RECRUITING
United States Bronx Montefiore Medical Center
RECRUITING
United States New York Northwell Health
RECRUITING
United States Chapel Hill University of North Carolina
RECRUITING
United States Portland Legacy Emanuel Medical Center
TERMINATED
United States Salt Lake City University of Utah
RECRUITING
Argentina Ciudad Autonoma Buenos Aires STAT Research S A
RECRUITING
Argentina Cordoba Hospital de Ninos de Cordoba
RECRUITING
Argentina La Plata Instituto Medico Platense
RECRUITING
Argentina Rosario Instituto Caici
RECRUITING
Argentina San Miguel De Tucuman Centro Medico Privado de Reumatologia
RECRUITING
Denmark Arhus Aarhus Universitetshospital
RECRUITING
France Caen CHU de Caen
RECRUITING
France Le Kremlin Bicêtre Hopital de Bicetre
RECRUITING
France Marseille Hopital Nord Marseille
RECRUITING
France Toulouse cedex 9 CHU de Toulouse Hopital des Enfants
RECRUITING
France Vandoeuvre les Nancy Hôpital D'Enfants
RECRUITING
Germany Sankt Augustin Asklepios Klinik Sankt Augustin
RECRUITING
Italy Brescia Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
RECRUITING
Italy Genova Istituto Giannina Gaslini
RECRUITING
Italy Milano Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
RECRUITING
Italy Milano Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
RECRUITING
Spain Barcelona Hosp Univ Vall D Hebron
RECRUITING
Spain Barcelona Hosp. de La Santa Creu I Sant Pau
RECRUITING
Spain Cordoba Hosp Reina Sofia
RECRUITING
Spain Santiago de Compostela Hosp. Clinico Univ. de Santiago
RECRUITING
Spain Valencia Hosp. Univ. I Politecni La Fe
RECRUITING
Türkiye Ankara Hacettepe Universitesi Hastanesi
RECRUITING
Türkiye Istanbul Istanbul University Cerrahpasa Medical Faculty
RECRUITING
Türkiye Istanbul Umraniye Training and Research Hospital
RECRUITING
United Kingdom London Great Ormond Street Hospital
RECRUITING
United Kingdom Nottingham Nottingham University Hospitals NHS Trust
RECRUITING
United Kingdom Sheffield Sheffield Children's Hospital
RECRUITING
United Kingdom Southampton Southampton General Hospital
RECRUITING
United Kingdom Staffordshire Haywood Hospital
RECRUITING
Türkiye Kocaeli Kocaeli University Medical Faculty
RECRUITING
United Kingdom Manchester Royal Manchester Children's Hospital
RECRUITING
United States Cincinnati Cincinnati Children's Hospital Medical Center
RECRUITING
Denmark Odense Odense Universitets Hospital
COMPLETED
Germany Berlin Charite Universitatsmedizin Berlin Campus Virchow Klinikum
RECRUITING
Germany Hamburg Schon Klinik Hamburg Eilbek
RECRUITING
Poland Lodz CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej
RECRUITING
Poland Sosnowiec Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
RECRUITING
Poland Warszawa Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
RECRUITING
Spain Sevilla Hosp. Infanta Luisa
COMPLETED
United Kingdom Newcastle upon Tyne Royal Victoria Infirmary
COMPLETED
United Kingdom Stoke on Trent Royal Stoke University Hospital
RECRUITING
Show More
Geo Locations

34.05223, -118.24368

34.05223, -118.24368

42.35843, -71.05977

40.84985, -73.86641

40.71427, -74.00597

35.9132, -79.05584

45.52345, -122.67621

40.76078, -111.89105

-34.61315, -58.37723

-31.4135, -64.18105

-34.92145, -57.95453

-32.94682, -60.63932

-26.82414, -65.2226

56.15674, 10.21076

49.18585, -0.35912

48.81471, 2.36073

43.29551, 5.38958

43.60426, 1.44367

48.65, 6.18333

50.77538, 7.197

45.53558, 10.21472

44.40478, 8.94438

45.46427, 9.18951

45.46427, 9.18951

41.38879, 2.15899

41.38879, 2.15899

37.89155, -4.77275

42.88052, -8.54569

39.46975, -0.37739

39.91987, 32.85427

41.01384, 28.94966

41.01384, 28.94966

51.50853, -0.12574

52.9536, -1.15047

53.38297, -1.4659

50.90395, -1.40428

53.056961, -2.1914135

39.62497, 27.51145

53.48095, -2.23743

39.12713, -84.51435

55.39594, 10.38831

52.52437, 13.41053

53.57532, 10.01534

51.75, 19.46667

50.28682, 19.10385

52.22977, 21.01178

37.38283, -5.97317

54.97328, -1.61396

53.00415, -2.18538

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50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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