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)
Phase 3 – large-scale trial before approval
Conditions:
Crohn's Disease (CD)
Sponsor: AbbVie
trial.available_in:
БГ
Overview
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.
Who can participate
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).
Locations
29
Argentina (1)
Hospital Britanico de Buenos Aires /ID# 223432
Ciudad Autonoma de Buenos Aire , Buenos Aires
Australia (1)
Wollongong Hospital /ID# 224688
Wollongong , New South Wales
Belgium (1)
ZAS Palfijn /ID# 223907
Merksem , Antwerpen
Brazil (1)
Faculdade de Medicina do ABC /ID# 223231
Santo André , La Spezia
Bulgaria (1)
Hospital Tsaritsa Yoanna /ID# 223822
Sofiya , Sofia
Canada (1)
Duplicate_University of Calgary /ID# 223750
Calgary , Alberta
Chile (1)
Hospital Guillermo Grant Benavente de Concepción /ID# 223668
Concepción , Biobio
China (1)
Anhui Provincial Hospital /ID# 224832
Hefei , Anhui
Czech Republic (1)
Iscare Klinické Centrum /ID# 223279
Prague , Praha 9
France (1)
Chu de Nice-Hopital Larchet Ii /Id# 223763
Nice , Alpes-Maritimes
Germany (1)
Universitaetsklinikum Freiburg /ID# 223406
Freiburg im Breisgau , Baden-Wurttemberg
Greece (1)
General Hospital of Athens Ippokratio /ID# 223344
Athens , Attica
Hungary (1)
Duplicate_Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 223774
Szeged , Csongrád megye
Israel (1)
Yitzhak Shamir Medical Center /ID# 224686
Ẕerifin , Central District
Italy (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
Netherlands (1)
Radboud Universitair Medisch Centrum /ID# 233750
Nijmegen , Gelderland
Poland (1)
Gastromed Sp. z o.o /ID# 223705
Torun , Kuyavian-Pomeranian Voivodeship
Romania (1)
Duplicate_Institutul Clinic Fundeni /ID# 223914
Bucharest , Bucharest
Russia (1)
Immanuel Kant Baltic Federal University /ID# 224224
Kaliningrad , Kaliningrad Oblast
Slovakia (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
South Korea (1)
Duplicate_The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456