A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn

Название протокола
Клинические исследование Crohn Disease: Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3, Placebo - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Janssen Research & Development, LLC

Источник Janssen Research & Development, LLC
Краткое содержание

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Подробное описание

Crohn's disease is a chronic, progressive and potentially life-threatening disorder which may affect any part of the gastrointestinal (GI) tract. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody that binds to human interleukin (IL)-23, thereby blocking the binding of extracellular IL-23 to the cell surface IL-23 receptor. This binding results in inhibition of IL-23 mediated intracellular signaling, activation and cytokine production. The purpose of the study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn's disease. The overall study duration is up to 109 weeks.

Общий статус Recruiting
Дата начала 2022-01-17
Дата завершения 2026-02-13
Дата первичного завершения 2023-07-06
Фаза Phase 3
Тип исследования Interventional
Первичный результат
Мера Временное ограничение
Clinical Remission at Week 12 Week 12
Endoscopic Response at Week 12 Week 12
Вторичный результат
Мера Временное ограничение
Clinical Remission at Week 24 Week 24
Patient-reported Outcome (PRO)-2 Remission at Week 12 Week 12
Clinical Response at Week 12 Week 12
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention Up to 109 Weeks
Регистрация 318
Состояние
  • Crohn Disease
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Guselkumab Dose 1

Описание: Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Тип вмешательства: Drug

Название вмешательства: Guselkumab Dose 2

Описание: Guselkumab (Dose 2) will be administered by SC injection.

Этикетка Arm Group: Group 1: Guselkumab

Тип вмешательства: Drug

Название вмешательства: Guselkumab Dose 3

Описание: Guselkumab (Dose 3) will be administered by SC injection.

Этикетка Arm Group: Group 2: Guselkumab

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Placebo will be administered by SC injection.

Этикетка Arm Group: Group 3: Placebo

Приемлемость

Критерии:

Inclusion Criteria: - Diagnosis of Crohn's disease (CD) of at least 3 months in duration - Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD). - Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD Exclusion Criteria: - Current diagnosis of ulcerative colitis or indeterminate colitis - Complications of Crohn's disease that require surgical intervention or confound efficacy assessments - Unstable doses of concomitant Crohn's disease therapy

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

N/A

Здоровые волонтеры:

No

Общий Официальный
Фамилия Роль Присоединение
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Общий контакт

Фамилия: Study Contact

Телефон: 844-434-4210

Расположение
Объект: Положение дел:
Om Research LLC | Lancaster, California, 93534, United States Not yet recruiting
Harmony Medical Research Institute, Inc. | Hialeah, Florida, 33016, United States Not yet recruiting
Florida Hospital | Orlando, Florida, 32803, United States Not yet recruiting
Synexus Clinical Research US, Inc | Pinellas Park, Florida, 33781, United States Not yet recruiting
Gastroenterolgy Associates of Central GA | Macon, Georgia, 31201, United States Recruiting
Tri-State Gastroenterology Assoc | Crestview Hills, Kentucky, 41017, United States Recruiting
Clinical Research Institute of Michigan, LLC | Chesterfield, Michigan, 48047, United States Not yet recruiting
University of Rochester | Rochester, New York, 14642, United States Withdrawn
Dayton Gastroenterology, Inc | Dayton, Ohio, 45440, United States Not yet recruiting
Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania, 17033, United States Not yet recruiting
Synexus Clinical Research US, Inc | Anderson, South Carolina, 29621-2062, United States Not yet recruiting
Wellness Clinical Research | San Antonio, Texas, 78232, United States Not yet recruiting
Monash Health, Monash Medical Centre | Clayton, 3168, Australia Not yet recruiting
Grodno University Hospital | Grodno, 230017, Belarus Not yet recruiting
Vitebsk Regional Clinical Hospital | Vitebsk, 210037, Belarus Not yet recruiting
GZA Ziekenhuizen | Antwerpen, 2018, Belgium Not yet recruiting
Imelda Ziekenhuis | Bonheiden, 2820, Belgium Not yet recruiting
University hospital Clinical centre Banja Luka | Banja Luka, 78000, Bosnia and Herzegovina Not yet recruiting
Universidade Federal Do Ceara | Fortaleza, 60430-370, Brazil Not yet recruiting
Hospital Moinhos de Vento | Porto Alegre, 90035-901, Brazil Not yet recruiting
Hospital Ernesto Dornelles | Porto Alegre, 90160-092, Brazil Not yet recruiting
Universidade Federal da Bahia (UFBA) - Complexo Hospitalar U | Salvador, 40110-060, Brazil Not yet recruiting
FMUSP - ICHC - Centro de Pesquisas Clínicas | São Paulo, 01246-000, Brazil Not yet recruiting
BR Trials | São Paulo, 03325-050, Brazil Not yet recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou, 310016, China Not yet recruiting
Wuxi People's Hospital | Wuxi, 214023, China Not yet recruiting
Opca bolnica Zadar | Zadar, 23000, Croatia Not yet recruiting
Fakultni nemocnice Brno | Brno, 636 00, Czechia Not yet recruiting
Fakultni nemocnice Hradec Kralove | Hradec Kralove, 500 05, Czechia Not yet recruiting
Oblastni nemocnice Kladno a.s. | Kladno, 27259, Czechia Not yet recruiting
Synexus Czech s.r.o. | Prague 2, 120 00, Czechia Not yet recruiting
Fakultni nemocnice Kralovske Vinohrady | Praha 10, 100 34, Czechia Not yet recruiting
CHU de Nice Hopital de l Archet | Nice, 06202, France Not yet recruiting
CHU Rangueil | Toulouse, 31059, France Not yet recruiting
Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center | Berlin, 10117, Germany Not yet recruiting
DRK Kliniken Westend | Berlin, 14050, Germany Not yet recruiting
Krankenhaus Waldfriede Mitte | Berlin, 14163, Germany Not yet recruiting
Synexus Clinical Research GmbH | Frankfurt, 60313, Germany Not yet recruiting
Synexus Clinical Research GmbH | Leipzig, 04103, Germany Not yet recruiting
Synexus Magyarorszag Kft | Budapest, 1036, Hungary Not yet recruiting
Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú | Budapest, 1125, Hungary Not yet recruiting
Synexus Magyarorszag Kft | Gyula, 5700, Hungary Not yet recruiting
Mohacsi Korhaz | Mohacs, 7700, Hungary Not yet recruiting
Università Campus Biomedico di Roma | Roma, 00128, Italy Not yet recruiting
Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata' | Roma, 00133, Italy Not yet recruiting
Toyota Kosei Hospital | Toyota, 470-0396, Japan Not yet recruiting
Khalidi Hospital and Medical Center | Amman, 11183, Jordan Not yet recruiting
DongA Medical Center | Busan, 602739, Korea, Republic of Not yet recruiting
Yeungnam University Medical Center | Daegu, 42415, Korea, Republic of Not yet recruiting
Kangbuk Samsung Hospital | Seoul, 03181, Korea, Republic of Not yet recruiting
Ajou University Hospital | Suwon, 16499, Korea, Republic of Not yet recruiting
Wonju Christian Hospital | Wonju, 26426, Korea, Republic of Not yet recruiting
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik | Kaunas, 44307, Lithuania Not yet recruiting
Vilnius University Hospital Santaros Klinikos, Public Institution | Vilnius, LT-08661, Lithuania Not yet recruiting
Elisabeth-TweeSteden Ziekenhuis | Tilburg, 5022 GC, Netherlands Not yet recruiting
Waikato Hospital - Waikato | Hamilton, 3240, New Zealand Not yet recruiting
Synexus Polska Sp. z o.o. Oddzial w Czestochowie | Czestochowa, 42-202, Poland Not yet recruiting
Synexus Polska Sp. z o.o. | Gdańsk, 80-382, Poland Not yet recruiting
Private Practice - Dr. Krzysztof Cymerman | Gdynia, 81-157, Poland Not yet recruiting
Synexus Polska Sp. z o.o. | Gdynia, 81-537, Poland Not yet recruiting
Synexus Polska Sp. z o.o. Oddzial w Katowicach | Katowice, 40-040, Poland Not yet recruiting
Globe Badania Kliniczne | Klodzko, 57-300, Poland Withdrawn
Centrum Medyczne ProMiMed | Krakow, 31-637, Poland Not yet recruiting
Allmedica | Nowy Targ, 34-400, Poland Not yet recruiting
Centrum Medyczne | Piotrkow Trybunalski, 97-300, Poland Not yet recruiting
Synexus Polska Sp. z o.o. | Poznan, 60-702, Poland Not yet recruiting
Centrum Medyczne Promed | Skorzewo, 60-185, Poland Not yet recruiting
KO-Med Centrum Medyczne | Straszów, 28-200, Poland Not yet recruiting
Endoterapia | Warsaw, 02-653, Poland Not yet recruiting
Synexus Polska Sp. z o.o. | Warszawa, 01-192, Poland Not yet recruiting
Synexus Polska Sp. z o.o. | Wroclaw, 50-381, Poland Not yet recruiting
Medical Center Meditsinskie Tekhnologii | Ekaterinburg, 620075, Russian Federation Not yet recruiting
Irkutsk State Medical Academy of Postgraduate Education | Irkutsk, 664079, Russian Federation Not yet recruiting
Kemerovo Region Clinical Hospital | Kemerovo, 650066, Russian Federation Not yet recruiting
GBUZ Regional Clinical Hospital | Tver, 170036, Russian Federation Not yet recruiting
GBUZ Respublican Clinical Hospital n.a. GG Kuvatova | Ufa, 450005, Russian Federation Not yet recruiting
GUZ Novgorod Regional Clinical Hospital | Veliky Novgorod, 173008, Russian Federation Not yet recruiting
Regional Clinical Hospital | Yaroslavl, 150062, Russian Federation Not yet recruiting
Clinical Hospital Center Bezanijska Kosa | Belgrade, 11080, Serbia Withdrawn
Hosp. Virgen Macarena | Sevilla, 41009, Spain Not yet recruiting
China Medical University Hospital | Taichung, 40447, Taiwan Withdrawn
Hacettepe University Hospital | Ankara, 06230, Turkey Not yet recruiting
Haydarpasa Numune Training and Research Hospital | Istanbul, 34668, Turkey Not yet recruiting
Dokuz Eylul Universitesi Tip Fakultesi | Izmir, 35210, Turkey Not yet recruiting
Mersin University Medical Faculty | Mersin, 33343, Turkey Not yet recruiting
Chernivtsi Regional Oncology Dispencary | Chernivtsi, 58013, Ukraine Not yet recruiting
LLC Treatment and Diagnostic Center Adonis Plus | Kyiv, 02002, Ukraine Not yet recruiting
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies' | Kyiv, 02091, Ukraine Not yet recruiting
Medical Centre IBN SINA | Kyiv, 03037, Ukraine Not yet recruiting
Medychnyi tsentr tovarystva z obmezhenoiu vidpovidalnistiu Tsentr simeinoi medytsyny plius | Kyiv, 4210, Ukraine Not yet recruiting
Communal City Clinical Emergency Hospital | Lviv, 79000, Ukraine Not yet recruiting
Lviv Railway Clinical Hospital of branch 'Health Center' 'Ukrainian Railway' | Lviv, 79000, Ukraine Not yet recruiting
Sumy State University, Sumy Regional Clinical Hospital | Sumy, 40022, Ukraine Not yet recruiting
MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council | Uzhgorod, 88018, Ukraine Not yet recruiting
Vinnytsia Yushchenko Regional Psychoneurological Hospital | Vinnytsia, 21005, Ukraine Not yet recruiting
MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council' | Vinnytsya, 21018, Ukraine Not yet recruiting
Komunalna ustanova 'Miska likarnia №1' | Zaporizhzhia, 69104, Ukraine Not yet recruiting
Fairfield General Hospital | Bury, BL9 7TD, United Kingdom Not yet recruiting
King's College Hospital | London, SE5 9RL, United Kingdom Not yet recruiting
Расположение Страны

Australia

Belarus

Belgium

Bosnia and Herzegovina

Brazil

China

Croatia

Czechia

France

Germany

Hungary

Italy

Japan

Jordan

Korea, Republic of

Lithuania

Netherlands

New Zealand

Poland

Russian Federation

Serbia

Spain

Taiwan

Turkey

Ukraine

United Kingdom

United States

Дата проверки

2022-01-01

Ответственная сторона

Тип: Sponsor

Имеет расширенный доступ No
Состояние Просмотр
  • Crohn Disease
Количество рук 3
Группа вооружений

Метка: Group 1: Guselkumab

Тип: Experimental

Описание: Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.

Метка: Group 2: Guselkumab

Тип: Experimental

Описание: Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.

Метка: Group 3: Placebo

Тип: Placebo Comparator

Описание: Participants will receive placebo injection subcutaneously.

Акроним GRAVITI
Данные пациента Yes
Информация о дизайне исследования

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: Double (Participant, Investigator)