Ведущий спонсор:
Janssen Research & Development, LLC
Источник
Janssen Research & Development, LLC
Краткое содержание
The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.
Подробное описание
This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.
Общий статус
Recruiting
Дата начала
2018-04-13
Дата завершения
2030-10-15
Дата первичного завершения
2022-06-03
Фаза
Phase 2/Phase 3
Тип исследования
Interventional
Первичный результат
Мера
Временное ограничение
Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
Baseline and Week 12
Phase 3: Clinical Remission at Week 12
Week 12
Phase 3: Endoscopic Response at Week 12
Week 12
Вторичный результат
Мера
Временное ограничение
Phase 2: Clinical Remission at Week 12
Week 12
Phase 2: Clinical Response at Week 12
Week 12
Phase 2 and Phase 3: Patient-Reported Outcome (PRO)-2 Remission at Week 12
Week 12
Phase 2: Clinical-Biomarker Response at Week 12
Week 12
Phase 2: Endoscopic Response at Week 12
Week 12
Phase 3: Clinical Remission at Week 48
Week 48
Phase 3: Endoscopic Response at Week 48
Week 48
Phase 3: Durable Clinical Remission at Week 48
Week 48
Phase 3: Corticosteroid-Free Clinical Remission at Week 48
Week 48
Phase 3: PRO-2 Remission at Week 48
Week 48
Phase 3: Endoscopic Remission at Week 12
Week 12
Phase 3: Endoscopic Remission at Week 48
Week 48
Phase 3: Fatigue Response at Week 12
Week 12
Регистрация
2000
Состояние
Crohn's Disease
Вмешательство
Тип вмешательства:
Drug
Название вмешательства:
Guselkumab Dose 1
Описание:
Guselkumab will be administered by IV infusion.
Этикетка Arm Group:
Phase 2 (GALAXI 1): Group 1 (Guselkumab)
Тип вмешательства:
Drug
Название вмешательства:
Guselkumab Dose 2
Описание:
Guselkumab will be administered by SC injection.
Тип вмешательства:
Drug
Название вмешательства:
Guselkumab Dose 3
Описание:
Guselkumab will be administered by IV infusion.
Этикетка Arm Group:
Phase 2 (GALAXI 1): Group 2 (Guselkumab)
Тип вмешательства:
Drug
Название вмешательства:
Guselkumab Dose 4
Описание:
Guselkumab will be administered by IV infusion.
Этикетка Arm Group:
Phase 2 (GALAXI 1): Group 3 (Guselkumab)
Тип вмешательства:
Drug
Название вмешательства:
Guselkumab Dose 5
Описание:
Guselkumab will be by SC injection.
Этикетка Arm Group:
Phase 2 (GALAXI 1): Group 3 (Guselkumab)
Тип вмешательства:
Drug
Название вмешательства:
Guselkumab
Описание:
Guselkumab will be administered by IV infusion and SC injection.
Этикетка Arm Group:
Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)
Тип вмешательства:
Drug
Название вмешательства:
Ustekinumab
Описание:
Ustekinumab will be administered by IV infusion and SC injection.
Тип вмешательства:
Drug
Название вмешательства:
Placebo
Описание:
Placebo will be administered as IV infusion.
Приемлемость
Критерии:
Inclusion Criteria: - Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy - Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD) - Have screening laboratory test results within the protocol specified parameters - A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline - Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD Exclusion Criteria: - Current diagnosis of ulcerative colitis or indeterminate colitis - Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation - Unstable doses of concomitant Crohn's disease therapy - Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol - Prior exposure to p40 inhibitors or p19 inhibitors - Any medical contraindications preventing study participation
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:
Northport Medical Center
| Northport, Alabama, 35476, United States
Not yet recruiting
University of Arizona
| Tucson, Arizona, 85724, United States
Recruiting
Advanced Research Center Inc
| Anaheim, California, 92805, United States
Terminated
University Of California San Diego
| La Jolla, California, 92093, United States
Recruiting
Om Research LLC
| Lancaster, California, 93534, United States
Recruiting
UCLA
| Los Angeles, California, 90095, United States
Not yet recruiting
UCI Irvine Medical Center
| Orange, California, 92868, United States
Withdrawn
Inland Empire Liver Foundation
| Rialto, California, 91106, United States
Recruiting
UC Davis Medical Center
| Sacramento, California, 95817, United States
Not yet recruiting
Clinical Applications Laboratories, Inc
| San Diego, California, 91941, United States
Not yet recruiting
Peak Gastroenterology Associates
| Colorado Springs, Colorado, 80920, United States
Recruiting
InvesClinic, LLC
| Fort Lauderdale, Florida, 33308, United States
Recruiting
Harmony Medical Research Institute, Inc.
| Hialeah, Florida, 33016, United States
Recruiting
Elite Research Network - Nature Coast Clinical Research, LLC
| Inverness, Florida, 34452, United States
Terminated
University of Florida
| Jacksonville, Florida, 32209, United States
Withdrawn
SIH Research
| Kissimmee, Florida, 34759, United States
Terminated
Community Research Foundation, Inc.
| Miami, Florida, 33155, United States
Not yet recruiting
Visionary Investigators Network
| Miami, Florida, 33180, United States
Terminated
Florida Hospital
| Orlando, Florida, 32803, United States
Recruiting
Synexus Clinical Research US, Inc
| Orlando, Florida, 32806, United States
Withdrawn
Synexus Clinical Research US, Inc
| Pinellas Park, Florida, 33781, United States
Recruiting
Theia Clincial Research, LLC
| Pinellas Park, Florida, 33781, United States
Recruiting
Clinical Research of West Florida
| Tampa, Florida, 33603, United States
Terminated
Florida Hospital Tampa
| Tampa, Florida, 33613, United States
Terminated
Cleveland Clinic Florida
| Weston, Florida, 33331, United States
Recruiting
Morehouse School of Medicine
| Atlanta, Georgia, 30310, United States
Not yet recruiting
Emory University
| Atlanta, Georgia, 30322, United States
Not yet recruiting
Atlanta Gastroenterology Associates
| Atlanta, Georgia, 30342, United States
Recruiting
Atlanta Center For Gastroenterology
| Decatur, Georgia, 30033, United States
Recruiting
Gastrointestinal Specialists of Georgia
| Marietta, Georgia, 30060, United States
Withdrawn
Gastroenterology Consultants
| Roswell, Georgia, 30076, United States
Recruiting
Atlanta Gastroenterology Specialists PC
| Suwanee, Georgia, 30024, United States
Completed
Center for Gastrointestinal Health
| Fairview Heights, Illinois, 62208, United States
Not yet recruiting
Carle Foundation Hospital
| Urbana, Illinois, 61801, United States
Recruiting
IU Health University Hospital
| Indianapolis, Indiana, 46202, United States
Recruiting
Health Science Research Center
| Pratt, Kansas, 67124, United States
Recruiting
Cotton O'Neil Digestive Health Center
| Topeka, Kansas, 66606, United States
Not yet recruiting
Robley Rex VAMC
| Louisville, Kentucky, 40206, United States
Not yet recruiting
Gastroenterology Associates
| Baton Rouge, Louisiana, 70809, United States
Recruiting
Gastroenterology Clinic of Acadiana
| Lafayette, Louisiana, 70503, United States
Terminated
Ochsner Clinic Foundation
| New Orleans, Louisiana, 70121, United States
Terminated
DelRicht Research
| New Orleans, Louisiana, 70124, United States
Completed
LSUHSC Shreveport Feist-Weiller Cancer Center
| Shreveport, Louisiana, 71103, United States
Not yet recruiting
Louisiana Research Center, LLC
| Shreveport, Louisiana, 71105, United States
Completed
Woodholme Gastroenterology Associates
| Baltimore, Maryland, 21208, United States
Suspended
Woodholme Gastroenterology Associates
| Baltimore, Maryland, 21208, United States
Not yet recruiting
Harvard Medical School-Beth Israel Deaconess Medical Center
| Boston, Massachusetts, 02215, United States
Withdrawn
Umass Memorial Medical Center
| Worcester, Massachusetts, 01655, United States
Not yet recruiting
Clinical Research Institute of Michigan, LLC
| Chesterfield, Michigan, 48047, United States
Recruiting
Associated cardiology
| Saginaw, Michigan, 48603, United States
Withdrawn
Huron Gastroenterology Associates Center for Digestive Care
| Ypsilanti, Michigan, 48197, United States
Recruiting
Las Vegas Medical Research
| Las Vegas, Nevada, 89113, United States
Recruiting
Atlantic Digestive Health Institute/ Atlantic IBD Center
| Morristown, New Jersey, 07960, United States
Recruiting
A1 Clinical Research
| Jackson Heights, New York, 11372, United States
Recruiting
Weill Cornell Medical College
| New York, New York, 10021, United States
Not yet recruiting
Care Access Research
| New York, New York, 10065, United States
Not yet recruiting
NYU Langone Medical Center
| New York, New York, 11021, United States
Recruiting
University of Rochester Medical Center
| Rochester, New York, 14642, United States
Recruiting
Syracuse VA Medical Center
| Syracuse, New York, 13210, United States
Terminated
Asheville Gastroenterology Associates
| Asheville, North Carolina, 28801, United States
Recruiting
University North Carolina at Chapel Hill
| Chapel Hill, North Carolina, 27599, United States
Recruiting
Cumberland Research Associates
| Fayetteville, North Carolina, 28304, United States
Recruiting
Carolina Research
| Greenville, North Carolina, 27834, United States
Withdrawn
Care Access Research, Kinston
| Kinston, North Carolina, 28501, United States
Not yet recruiting
PMG Research of Winston-Salem
| Winston-Salem, North Carolina, 27103, United States
Recruiting
Clinical Inquest Center, LTD
| Beavercreek, Ohio, 45432, United States
Recruiting
Wexner Medical Center at the Ohio State University
| Columbus, Ohio, 43210, United States
Recruiting
Synexus Clinical Research US, Inc
| Columbus, Ohio, 43212, United States
Recruiting
Great Lakes Gastroenterology Research, LLC
| Mentor, Ohio, 44060, United States
Not yet recruiting
Southwoods Health
| Poland, Ohio, 44514, United States
Not yet recruiting
Integris Baptist Office
| Oklahoma City, Oklahoma, 73112, United States
Recruiting
Drexel University College of Medicine
| Philadelphia, Pennsylvania, 19107, United States
Withdrawn
Allegheny-Singer Research Institute
| Pittsburgh, Pennsylvania, 15212-4756, United States
Not yet recruiting
Guthrie Medical Group, PC
| Sayre, Pennsylvania, 18840, United States
Withdrawn
Care Access Research
| Scranton, Pennsylvania, 18508, United States
Withdrawn
US Digestive Health
| Wyomissing, Pennsylvania, 19610, United States
Not yet recruiting
LifeSpan Hospital System
| Providence, Rhode Island, 02903, United States
Withdrawn
Synexus Clinical Research US, Inc
| Anderson, South Carolina, 29621-2062, United States
Recruiting
Clinical Trials of South Carolina
| Charleston, South Carolina, 29406, United States
Withdrawn
Gastroenterology Associates P.A.
| Greenville, South Carolina, 29615, United States
Not yet recruiting
Vanderbilt University Medical Center
| Nashville, Tennessee, 37212-1610, United States
Completed
Aztec Clinical Research, Inc.
| Channelview, Texas, 77530, United States
Recruiting
Baylor College of Medicine
| Houston, Texas, 77030, United States
Recruiting
Houston Methodist Hospital
| Houston, Texas, 77030, United States
Recruiting
Memorial Hermann Hospital - TMC
| Houston, Texas, 77030, United States
Withdrawn
Biopharma Informatic Research Center
| Houston, Texas, 77043, United States
Withdrawn
Houston Digestive Diseases Consultants
| Houston, Texas, 77074, United States
Not yet recruiting
CliniCore Houston
| Houston, Texas, 77079, United States
Recruiting
BI Research Center
| Houston, Texas, 77084, United States
Withdrawn
DHAT Research Institute
| Richardson, Texas, 75082, United States
Recruiting
Gastroenterology Clinic Of San Antonio P A
| San Antonio, Texas, 78229, United States
Recruiting
Gastroenterology Research of America, LLC
| San Antonio, Texas, 78229, United States
Recruiting
UT Health Science Center at San Antonio
| San Antonio, Texas, 78229, United States
Not yet recruiting
Texas Digestive Disease Consultants
| Southlake, Texas, 76092, United States
Recruiting
Baylor Scott & White Research Institute
| Temple, Texas, 76508, United States
Completed
Tyler Research Institute, LLC
| Tyler, Texas, 75701, United States
Recruiting
Victoria Gastroenterology
| Victoria, Texas, 77904, United States
Withdrawn
Val Hansen
| Bountiful, Utah, 84010, United States
Withdrawn
Care Access Research, Ogden
| Ogden, Utah, 84403, United States
Withdrawn
University of Virginia
| Charlottesville, Virginia, 22908, United States
Withdrawn
Gastroenterology Associates of Tidewater
| Chesapeake, Virginia, 23320, United States
Recruiting
Center for Gastrointestinal Health
| Petersburg, Virginia, 23805, United States
Recruiting
Clinical Research Partners, LLC
| Richmond, Virginia, 23236, United States
Withdrawn
Gastroenterology Consultants of Southwest Virginia
| Roanoke, Virginia, 24014-1372, United States
Recruiting
University of Washington
| Seattle, Washington, 98195, United States
Withdrawn
Washington Gastroenterology, PLLC
| Tacoma, Washington, 98405, United States
Not yet recruiting
The Queen Elizabeth Hospital
| Adelaide, 5011, Australia
Recruiting
Monash Health, Monash Medical Centre
| Clayton, 3168, Australia
Recruiting
Concord Hospital
| Concord, 2139, Australia
Recruiting
Western Health
| Footscray, 3011, Australia
Not yet recruiting
Austin Hospital
| Heidelberg, 3084, Australia
Recruiting
Royal Brisbane and Women's Hospital
| Herston, 4029, Australia
Withdrawn
Sir Charles Gairdner Hospital
| Nedlands, 6009, Australia
Recruiting
Royal Adelaide Hospital
| North Terrace, 5000, Australia
Recruiting
Royal Melbourne Hospital
| Parkville, 3050, Australia
Recruiting
Nepean Hospital
| Penrith, 2751, Australia
Recruiting
The Alfred Hospital
| Prahran, 3004, Australia
Recruiting
Mater Hospital Brisbane
| South Brisbane, 4101, Australia
Recruiting
Princess Alexandra Hospital
| Woolloongabba, 4102, Australia
Recruiting
Krankenhaus der Elisabethinen Linz
| Linz, A-4020, Austria
Withdrawn
Universitätsklinikum Salzburg - Landeskrankenhaus
| Salzburg, 5020, Austria
