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Активно (без набиране) Фаза 3 NCT03105102

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

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

Спонсор: AbbVie

Налично на: БГ
Обобщение
The study consists of 4 sub-studies, as follows: * Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; * Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; * Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; * Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab. * OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.
Кой може да участва
Inclusion Criteria: * Participants who have entered and completed Study M16-006 or Study M15-991 or other AbbVie risankizumab Crohn's disease study. * Participants have completed the study M16-006 or M15-991 and have achieved clinical response. * Sub-Study 4: * Participants receiving maintenance treatment in Sub-study 3 and willing to comply with the requirements of Sub-study 4, including self-administration of sub-cutaneous injections using the on-body injector (OBI). * Participant has received at least 16 weeks of stable dosing with risankizumab in Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the 72-week mark). Exclusion Criteria: * Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter Study M16-000 OR is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. * Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an adverse event (AE) during Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study that in the Investigator's judgment makes the participant unsuitable for this study. * Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study. * Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study. * Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly. * Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.
Места на провеждане 42
Argentina (1)
Cemic /Id# 168078
Ciudad Autonoma Buenos Aires , Buenos Aires
Австралия (1)
Mater Misericordiae Limited /ID# 167220
South Brisbane , Queensland
Belarus (1)
Grodno city clinical hospital #2 /ID# 205113
Hrodna , Grodnenskaya
Bosnia and Herzegovina (1)
Klinicki centar Banja Luka /ID# 164513
Banja Luka , Republika Srpska
България (1)
UMHAT Dr Georgi Stranski EAD /ID# 203976
Pleven
Канада (1)
University of Calgary /ID# 157155
Calgary , Alberta
Chile (1)
Hospital Guillermo Grant Benavente de Concepción /ID# 210760
Concepción , Biobio
Китай (1)
Guangdong Provincial People's Hospital /ID# 212949
Guangzhou , Guangdong
Colombia (1)
Instituto de Coloproctologia /ID# 158743
Medellín , Antioquia
Хърватия (1)
Klinicka bolnica Dubrava Zagreb /ID# 157560
Zagreb , City of Zagreb
Чехия (1)
Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165465
Prague , Praha 4
Дания (1)
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155530
Hvidovre , Capital Region
Egypt (1)
Alexandria University /ID# 157187
Alexandria , Alexandria Governorate
Estonia (1)
North Estonia Medical Centre /ID# 164326
Mustamäe , Harju
Франция (1)
Chu de Nice-Hopital L'Archet Ii /Id# 162557
Nice , Alpes-Maritimes
Гърция (1)
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170914
Athens , Attica
Hong Kong (1)
Queen Mary Hospital /ID# 163923
Hong Kong
Ireland (1)
Duplicate_Beaumont Hospital /ID# 157543
Beaumont , Dublin
Израел (1)
Shaare Zedek Medical Center /ID# 163541
Jerusalem , Jerusalem
Италия (1)
Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162436
Torrette , Ancona
Япония (1)
Aichi Medical University Hospital /ID# 160097
Nagakute , Aichi-ken
Latvia (1)
VCA Polyclinic Aura /ID# 159611
Riga
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162583
Kaunas
Malaysia (1)
Universiti Sains Malaysia /ID# 160666
Kelantan , Kelantan
Mexico (1)
Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170734
Zapopan , Jalisco
Нидерландия (1)
Elisabeth Tweesteden Ziekenhuis /ID# 163632
Tilburg , North Brabant
New Zealand (1)
Aotearoa Clinical Trials /ID# 167226
Papatoetoe , Auckland
Норвегия (1)
Duplicate_Vestre viken - Baerum Sykehus /ID# 212996
Gjettum , Akershus
Полша (1)
Solumed Centrum Medyczne /ID# 163569
Poznan , Greater Poland Voivodeship
Румъния (1)
Fundeni Clinical Institute /ID# 170899
Bucharest
Russia (1)
Kuzbass Regional Clinical Hospital /ID# 200962
Kemerovo , Kemerovo Oblast
Сърбия (1)
Clinical Hosp Center Zvezdara /ID# 157052
Belgrade , Beograd
Сингапур (1)
Mount Elizabeth Hospital /ID# 205741
Singapore , Central Singapore
Словакия (1)
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156468
Banská Bystrica , Banská Bystrica Region
South Africa (1)
Clinresco Centers /ID# 163865
Johannesburg , Gauteng
Южна Корея (1)
Inje University Haeundae Hospital /ID# 202518
Busan , Busan Gwang Yeogsi
Испания (1)
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157553
Ferrol , A Coruna
Швеция (1)
Skane University hospital /ID# 211745
Malmo , Skåne County
Taiwan (1)
National Taiwan University Hospital /ID# 162190
Taipei City , Taipei
Ukraine (1)
Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 165658
Lviv , Lviv Oblast
Великобритания (1)
Addenbrooke's Hospital /ID# 158034
Cambridge , Cambridgeshire
САЩ (1)
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884
Mesa , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
16 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
09.04.2018
Крайна дата
01.05.2026
Регистрационен номер
NCT03105102
Източник
anzctr
Запитване за медицински туризъм

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