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

Официальное название

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

Обзор

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).

Вмешательства

• Препарат Guselkumab
  Guselkumab will be administered as subcutaneous injection.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Япония · 7 центров

• 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

Китай · 6 центров

• Capital Center For Children's health Capital Medical University — Пекин
• Changzhou No 2 Peoples Hospital — Changzhou
• The Childrens Hospital Zhejiang University School Of Medicine — Ханчжоу
• Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Ханчжоу
• Ruijin Hospital Shanghai Jiao Tong University — Шанхай
• Shengjing Hospital Of China Medical University — Шэньян

США · 5 центров

• 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

Италия · 5 центров

• 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

Польша · 4 центра

• 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

Австралия · 3 центра

• 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 центра

• Gazi University Medical Faculty — Ankara
• Umraniye Training and Research Hospital — Istanbul
• Kocaeli Universitesi Hastanesi — Kocaeli

Великобритания · 3 центра

• Sheffield Children's Hospital — Sheffield
• Royal Stoke University Hospital — Stoke-on-Trent
• Haywood Hospital — Stoke-on-Trent

Бразилия · 2 центра

• Universidade Federal de Goias - Hospital das Clinicas da UFG — Goiânia
• INTEGRAL Pesquisa e Ensino — Votuporanga

Германия · 2 центра

• Schon Klinik Hamburg Eilbek — Hamburg
• Asklepios Klinik Sankt Augustin — Sankt Augustin

Португалия · 2 центра

• Uls Braga - Hosp. Braga — Braga
• Uls Sao Joao - Hosp. Sao Joao — Porto

South Korea · 2 центра

• Severance Hospital Yonsei University Health System — Seoul
• Samsung Medical Center — Seoul

Испания · 2 центра

• Hosp. Clinico Univ. de Santiago — Santiago de Compostela
• Hosp. Univ. I Politecni La Fe — Valencia

Аргентина · 1 центр

• Instituto Caici — Rosario

Франция · 1 центр

• Hospital Center University De Lille — Lille

Норвегия · 1 центр

• Akershus Universitetssykehus — Akershus

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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