Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 3 NCT04524611

Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Crohn's Disease (CD)

Спонсор: AbbVie

Налично на: БГ
Обобщение
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Кой може да участва
Inclusion Criteria: * Confirmed diagnosis of Crohn's disease (CD) for at least 3 months prior to Baseline. * Crohn's disease activity index (CDAI) score 220 - 450 at Baseline. * Confirmed diagnosis of moderate to severe Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD). * Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies. Exclusion Criteria: * Current diagnosis of ulcerative colitis or indeterminate colitis. * Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol). * Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab). * Currently know complications of CD (strictures, short bowel, etc).
Места на провеждане 29
Argentina (1)
Hospital Britanico de Buenos Aires /ID# 223432
Ciudad Autonoma de Buenos Aire , Buenos Aires
Австралия (1)
Wollongong Hospital /ID# 224688
Wollongong , New South Wales
Белгия (1)
ZAS Palfijn /ID# 223907
Merksem , Antwerpen
Бразилия (1)
Faculdade de Medicina do ABC /ID# 223231
Santo André , La Spezia
България (1)
Hospital Tsaritsa Yoanna /ID# 223822
Sofiya , Sofia
Канада (1)
Duplicate_University of Calgary /ID# 223750
Calgary , Alberta
Chile (1)
Hospital Guillermo Grant Benavente de Concepción /ID# 223668
Concepción , Biobio
Китай (1)
Anhui Provincial Hospital /ID# 224832
Hefei , Anhui
Чехия (1)
Iscare Klinické Centrum /ID# 223279
Prague , Praha 9
Франция (1)
Chu de Nice-Hopital Larchet Ii /Id# 223763
Nice , Alpes-Maritimes
Германия (1)
Universitaetsklinikum Freiburg /ID# 223406
Freiburg im Breisgau , Baden-Wurttemberg
Гърция (1)
General Hospital of Athens Ippokratio /ID# 223344
Athens , Attica
Унгария (1)
Duplicate_Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 223774
Szeged , Csongrád megye
Израел (1)
Yitzhak Shamir Medical Center /ID# 224686
Ẕerifin , Central District
Италия (1)
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 223330
Bologna , Emilia-Romagna
Mexico (1)
Centro de Investigacion en Artritis y Osteoporosis S.C. /ID# 227179
Mexicali , Estado de Baja California
Нидерландия (1)
Radboud Universitair Medisch Centrum /ID# 233750
Nijmegen , Gelderland
Полша (1)
Gastromed Sp. z o.o /ID# 223705
Torun , Kuyavian-Pomeranian Voivodeship
Румъния (1)
Duplicate_Institutul Clinic Fundeni /ID# 223914
Bucharest , Bucharest
Russia (1)
Immanuel Kant Baltic Federal University /ID# 224224
Kaliningrad , Kaliningrad Oblast
Словакия (1)
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 223302
Banská Bystrica , Banská Bystrica Region
South Africa (1)
Lenasia Clinical Trial Centre /ID# 224306
Johannesburg , Gauteng
Южна Корея (1)
Duplicate_The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456
Junggu , Daejeon Gwang Yeogsi
Испания (1)
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 223356
Ferrol , A Coruna
Швеция (1)
Karolinska University Hospital Solna /ID# 223423
Solna , Stockholm County
Турция (1)
Gazi Universitesi Tip Fakultes /ID# 223386
Yenimahalle , Ankara
Ukraine (1)
Lviv Regional Clinical Hospital /ID# 223661
Lviv , Lviv Oblast
Великобритания (1)
Addenbrookes Hospital /ID# 223648
Cambridge , Cambridgeshire
САЩ (1)
Advanced Gastroenterology, P.C /ID# 224396
Chandler , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
30.09.2020
Крайна дата
01.02.2028
Регистрационен номер
NCT04524611
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.