Исследование гуселькумаба у участников педиатрического периода с умеренным и тяжелым активным язвенным колитом (QUASAR Jr)
Рандомизированный, открытый индукционный, двойной слепой поддерживающий, многоцентровый протокол фазы 3 для оценки эффективности, безопасности и фармакокинетики гуселькумаба у педиатрических участников с умеренным и тяжелым активным язвенным колитом
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Nedlands, Австралия, 6009
- The Kids Research Institute Australia on behalf of the Centre for Child Health Research
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South Brisbane, Австралия, 4101
- Mater Hospital Brisbane Inflammatory Bowel Diseases
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Westmead, Австралия, 2145
- The Children's Hospital at Westmead
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Charleroi, Бельгия, 6042
- CHU Charleroi Chimay
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Ghent, Бельгия, 9000
- UZ Gent
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Jette, Бельгия, 1090
- UZ Brussel
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Leuven, Бельгия, 3000
- UZ Leuven
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Aarhus N, Дания, 8200
- Aarhus Universitetshospital
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Hvidovre, Дания, 2650
- Hvidovre Hospital
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Madrid, Испания, 28009
- Hosp. Infantil Univ. Nino Jesus
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Sabadell, Испания, 08028
- Corporacio Sanitari Parc Tauli
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Valencia, Испания, 46026
- Hosp. Univ. I Politecni La Fe
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Bergamo, Италия, 24127
- ASST Papa Giovanni XXIII Bergamo
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Bologna, Италия, 40133
- Azienda USL di Bologna - Ospedale Maggiore
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Florence, Италия, 50139
- AOU Meyer
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Pescara, Италия, 65124
- Ospedale S. Spirito, Azienda Sanitaria Pescara
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Roma, Италия, 00161
- AOU Policlinico Umberto I
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Roma, Италия, 00165
- IRCCS Ospedale Pediatrico Bambino Gesu
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San Giovanni Rotondo, Италия, 71013
- Casa Sollievo della Sofferenza
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Trieste, Италия, 34137
- IRCCS Materno Infantile Burlo Garofolo
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Beijing, Китай, 100191
- Peking University Third Hospital
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Beijing, Китай, 100020
- Capital Center For Children's health Capital Medical University
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Changzhou, Китай, 213004
- Changzhou No 2 Peoples Hospital
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Hangzhou, Китай, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Hangzhou, Китай, 310005
- The Childrens Hospital Zhejiang University School Of Medicine
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Shanghai, Китай, 200025
- Ruijin Hospital Shanghai Jiao Tong University
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Shenyang, Китай, 110055
- Shengjing Hospital Of China Medical University
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Zhengzhou, Китай, 450052
- Henan Children's Hospital, Zhengzhou Children's Hospital
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Lørenskog, Норвегия, 1478
- Akershus Universitetssykehus
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Oslo, Норвегия, 0450
- Oslo University Hospital
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Tromsø, Норвегия, 9030
- Universitetssykehuset Nord-Norge HF
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Trondheim, Норвегия, 7030
- St. Olavs Hospital
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Gdansk, Польша, 80 803
- Copernicus Podmiot Leczniczy Sp. z o.o
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Rzeszów, Польша, 35-302
- Korczowski Bartosz Gabinet Lekarski
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Warsaw, Польша, 04 501
- Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
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Warsaw, Польша, 04 730
- Instytut Pomnik Centrum Zdrowia Dziecka
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Lisbon, Португалия, 1649-035
- Uls Santa Maria - Hosp. Santa Maria
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Porto, Португалия, 4200 319
- Uls Sao Joao - Hosp. Sao Joao
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Porto, Португалия, 4050-651
- Uls Santo Antonio - Cmin
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California
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Oakland, California, Соединенные Штаты, 94609
- Children's Hospital Oakland
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Indiana
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Indianapolis, Indiana, Соединенные Штаты, 46202
- Riley Hospital for Children
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New York
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Lake Success, New York, Соединенные Штаты, 11042
- NYU Langone Health
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Ankara, Турция (Туркие), 06560
- Gazi University Medical Faculty
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Ankara, Турция (Туркие), 6620
- Ankara University Medical Faculty
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Istanbul, Турция (Туркие), 34899
- Marmara University Pendik Training Hospital
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Istanbul, Турция (Туркие), 34098
- Istanbul University Cerrahpasa Medical Faculty
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Bron, Франция, 69677
- Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
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Dijon, Франция, 21000
- Hopital Francois Mitterand
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Lille, Франция, 59037
- CHRU Lille
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Paris, Франция, 75019
- APHP Hopital Robert Debre
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Toulouse, Франция, 31059
- CHU Toulouse
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Fuchū, Япония, 183 8561
- Tokyo Metropolitan Children's Medical Center
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Kanazawa, Япония, 920 8641
- Kanazawa University Hospital
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Kobe, Япония, 650 0017
- Kobe University Hospital
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Kumamoto, Япония, 861 8520
- Japanese Red Cross Kumamoto Hospital
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Matsumoto, Япония, 390 8621
- Shinshu University Hospital
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Saga, Япония, 849-8501
- Saga University Hospital
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Setagaya Ku, Япония, 157 8535
- National Center for Child Health and Development
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Shinjuku, Япония, 160 0023
- Tokyo Medical University Hospital
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Takatsuki, Япония, 569-8686
- Osaka Medical and Pharmaceutical University Hospital
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Yokohama, Япония, 230-8765
- Saiseikai Yokohamashi Tobu Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent for screening
- A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
- Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy
- Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
- Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids
Exclusion Criteria:
- Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon
- Presence of a stoma
- Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
- Have severe colitis or have evidence of Crohn's Disease (CD)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Open-label Induction Phase: Guselkumab Intravenously (IV)
Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase. |
Guselkumab will be administered intravenously.
Другие имена:
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Экспериментальный: Open-label Induction Phase: Guselkumab Subcutaneously (SC)
Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase. |
Guselkumab will be administered subcutaneously.
Другие имена:
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Экспериментальный: Double-blind Maintenance Phase: Guselkumab Dose Regimen 1
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56. |
Guselkumab will be administered subcutaneously.
Другие имена:
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Экспериментальный: Double-blind Maintenance Phase: Guselkumab Dose Regimen 2
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56. |
Guselkumab will be administered subcutaneously.
Другие имена:
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Экспериментальный: Open-label Maintenance Phase: Guselkumab SC
Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56. |
Guselkumab will be administered subcutaneously.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Percentage of Participants with Clinical Remission at Week 56
Временное ограничение: Week 56
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Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline. |
Week 56
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants with Clinical Response at Week 12
Временное ограничение: Week 12
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Percentage of participants with clinical response as assessed by modified Mayo score at Week 12 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. |
Week 12
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Percentage of Participants with Clinical Remission at Week 12
Временное ограничение: Week 12
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Percentage of participants with clinical remission at Week 12 as assessed by modified Mayo score will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline. |
Week 12
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Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12
Временное ограничение: Week 12
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Percentage of participants with PUCAI remission at Week 12 will be reported. It comprises 6 scales and ranges between 0 and 85 points. The scales are abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission. |
Week 12
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Percentage of Participants with Symptomatic Remission at Week 12
Временное ограничение: Week 12
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Percentage of participants with symptomatic remission at Week 12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. |
Week 12
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United States: Percentage of Participants with Endoscopic Improvement at Week 12
Временное ограничение: Week 12
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Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
Week 12
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European Union: Percentage of Participants with Endoscopic Healing at Week 12
Временное ограничение: Week 12
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Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
Week 12
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Percentage of Participants with Clinical Response at Week 56
Временное ограничение: Week 56
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Percentage of participants with clinical response as assessed by modified Mayo score at Week 56 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by >= 30 percent and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. |
Week 56
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Percentage of Participants With PUCAI Remission at Week 56
Временное ограничение: Week 56
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Percentage of participants with PUCAI remission at Week 56 will be reported. PUCAI comprises of 6 scales and ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission. |
Week 56
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Percentage of Participants with Symptomatic Remission at Week 56
Временное ограничение: Week 56
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Percentage of participants with symptomatic remission at Week 56 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. |
Week 56
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Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12
Временное ограничение: Week 56
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Percentage of participants with symptomatic remission at Week 56 among participants who had symptomatic remission at Week 12 will be reported. Symptomatic remission score is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. |
Week 56
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United States: Percentage of Participants With Endoscopic Improvement at Week 56
Временное ограничение: Week 56
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Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
Week 56
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European Union: Percentage of Participants With Endoscopic Healing at Week 56
Временное ограничение: Week 56
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Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
Week 56
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Percentage of Participants Who Achieve Endoscopic Normalization at Week 56
Временное ограничение: Week 56
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Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported. |
Week 56
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Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56
Временное ограничение: Week 56
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Percentage of participants histo-endoscopic mucosal healing per endoscopy subscore and histologic improvement at Week 56 will be reported. Histologic-endoscopic mucosal healing is defined as achieving a combination of histologic improvement and endoscopic improvement (US) or endoscopic healing (EU) (endoscopy subscore of 0 or 1). |
Week 56
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Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56
Временное ограничение: Week 56
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Percentage of participants with corticosteroid-free clinical remission at Week 56 will be reported. Corticosteroid free clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline (Week 0), and not receiving corticosteroids for at least 8 weeks prior to Week 56 |
Week 56
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Serum Concentration of Guselkumab During Induction Phase
Временное ограничение: From Week 0 to Week 12
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Serum samples will be analyzed to determine concentrations of guselkumab overtime. |
From Week 0 to Week 12
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Serum Concentration of Guselkumab During Maintenance Phase
Временное ограничение: From Week 12 to Week 56
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Serum samples will be analyzed to determine concentrations of guselkumab over time. |
From Week 12 to Week 56
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Number of Participants with Incidence of Anti-guselkumab Antibodies
Временное ограничение: Up to Week 68
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Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed. |
Up to Week 68
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Percentage of Participants with Adverse Events (AEs)
Временное ограничение: Up to Week 68
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Percentage of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. |
Up to Week 68
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Percentage of Participants with Serious Adverse Events (SAEs)
Временное ограничение: Up to Week 68
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Percentage of participants with SAEs will be reported. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. |
Up to Week 68
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Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
Временное ограничение: Up to Week 68
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Percentage of participants with AEs leading to discontinuation of study intervention will be reported. |
Up to Week 68
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Соавторы и исследователи
Следователи
- Директор по исследованиям: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CR109251
- 2022-001285-35 (Номер EudraCT)
- CNTO1959PUC3001 (Другой идентификатор: Janssen Research & Development, LLC)
- 2022-502238-22-00 (Идентификатор реестра: EUCT number)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .