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Recruiting NCT06663332

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

Phase III Interventional Crohns Disease Colitis, Ulcerative Arthritis, Psoriatic Arthritis, Juvenile

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Guselkumab.
Who it may be relevant to
Registry conditions: Crohns Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Arthritis, Juvenile. Basic parameters: from 3 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Australia, Brazil, China +11
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

CNTO1959ISD3001: A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis

Overview

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).

Interventions

  • Drug Guselkumab
    Guselkumab will be administered as subcutaneous injection.

Primary outcome measures

  • Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety [Time frame: Up to 6 years and 9 months]

Eligibility criteria

Inclusion criteria

  • Must have completed the dosing planned in the primary pediatric guselkumab study
  • Must have received benefit from continued guselkumab therapy in the opinion of the investigator
  • Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure
  • Parent(s) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. An adolescent who provides assent will have the opportunity to sign an adult ICF upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate.

Exclusion criteria

  • Participant is greater than or equal to (>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication
  • Participant is <18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication
  • Are pregnant, nursing, or planning pregnancy or fathering a child
  • Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention
  • Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Japan · 7 centers
  • Tokyo Metropolitan Children's Medical Center — Fuchū
  • Kanazawa University Hospital — Kanazawa
  • Kobe University Hospital — Kobe
  • Japanese Red Cross Kumamoto Hospital — Kumamoto
  • Shinshu University Hospital — Matsumoto
  • Saga University Hospital — Saga
  • Yokohama City University Medical Center — Yokohama
China · 6 centers
  • Capital Center For Children's health Capital Medical University — Beijing
  • Changzhou No 2 Peoples Hospital — Changzhou
  • The Childrens Hospital Zhejiang University School Of Medicine — Hangzhou
  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou
  • Ruijin Hospital Shanghai Jiao Tong University — Shanghai
  • Shengjing Hospital Of China Medical University — Shenyang
United States · 5 centers
  • Emory University — Atlanta
  • Children's Center for Digestive Healthcare — Atlanta
  • Riley Hospital for Children — Indianapolis
  • Cincinnati Children's Hospital Medical Center — Cincinnati
  • University of Utah — Salt Lake City
Italy · 5 centers
  • ASST Papa Giovanni XXIII Bergamo — Bergamo
  • Azienda USL di Bologna - Ospedale Maggiore — Bologna
  • IRCCS Ospedale Pediatrico Bambino Gesu — Roma
  • Casa Sollievo Della Sofferenza IRCCS — San Giovanni Rotondo
  • IRCCS Materno Infantile Burlo Garofolo — Trieste
Poland · 4 centers
  • Korczowski Bartosz Gabinet Lekarski — Rzeszów
  • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o — Sosnowiec
  • Medical Network — Warsaw
  • Instytut Pomnik Centrum Zdrowia Dziecka — Warsaw
Australia · 3 centers
  • The Kids Research Institute Australia on behalf of the Centre for Child Health Research — Nedlands
  • Mater Hospital Brisbane Inflammatory Bowel Diseases — South Brisbane
  • The Children's Hospital at Westmead — Westmead
Turkey (Türkiye) · 3 centers
  • Gazi University Medical Faculty — Ankara
  • Umraniye Training and Research Hospital — Istanbul
  • Kocaeli Universitesi Hastanesi — Kocaeli
United Kingdom · 3 centers
  • Sheffield Children's Hospital — Sheffield
  • Royal Stoke University Hospital — Stoke-on-Trent
  • Haywood Hospital — Stoke-on-Trent
Brazil · 2 centers
  • Universidade Federal de Goias - Hospital das Clinicas da UFG — Goiânia
  • INTEGRAL Pesquisa e Ensino — Votuporanga
Germany · 2 centers
  • Schon Klinik Hamburg Eilbek — Hamburg
  • Asklepios Klinik Sankt Augustin — Sankt Augustin
Portugal · 2 centers
  • Uls Braga - Hosp. Braga — Braga
  • Uls Sao Joao - Hosp. Sao Joao — Porto
South Korea · 2 centers
  • Severance Hospital Yonsei University Health System — Seoul
  • Samsung Medical Center — Seoul
Spain · 2 centers
  • Hosp. Clinico Univ. de Santiago — Santiago de Compostela
  • Hosp. Univ. I Politecni La Fe — Valencia
Argentina · 1 center
  • Instituto Caici — Rosario
France · 1 center
  • Hospital Center University De Lille — Lille
Norway · 1 center
  • Akershus Universitetssykehus — Akershus

Identifiers

NCT: NCT06663332 · CNTO1959ISD3001 · CNTO1959ISD3001 · 2023-509560-16-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗