A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
NCT ID: NCT03104413
Last Updated: 2022-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
618 participants
INTERVENTIONAL
2017-12-18
2021-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Risankizumab Dose 1 (Induction Period 1)
Participants randomized to receive risankizumab dose 1 in Induction Period 1.
risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Risankizumab Dose 2 (Induction Period 1)
Participants randomized to receive risankizumab dose 2 in Induction Period 1.
risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Placebo (Induction Period 1)
Participants randomized to receive placebo for risankizumab in Induction Period 1.
placebo for risankizumab IV
placebo for risankizumab administered as intravenous (IV) infusion.
Risankizumab Dose 1 (Induction Period 2)
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Risankizumab Dose 2 (Induction Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Risankizumab Dose 3 (Induction period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Interventions
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placebo for risankizumab IV
placebo for risankizumab administered as intravenous (IV) infusion.
risankizumab SC
risankizumab administered by subcutaneous (SC) injection
risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of 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 CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
* Demonstrated intolerance or inadequate response to biologic therapy for CD.
* If female, participant must meet the contraception recommendations.
Exclusion Criteria
* Participants with unstable doses of concomitant Crohn's disease therapy.
* Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.
* Prior exposure to p19 inhibitors (e.g., risankizumab).
* Complications of Crohn's disease.
* Having an ostomy or ileoanal pouch.
* Known active Coronavirus Disease 2019 (COVID-19) infection.
16 Years
80 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Phoenix VA Health Care System /ID# 162261
Phoenix, Arizona, United States
HonorHealth Research Institute - Shea /ID# 165825
Scottsdale, Arizona, United States
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882
Tempe, Arizona, United States
University of Arizona /ID# 158305
Tucson, Arizona, United States
Duplicate_Atria Clinical Research /ID# 164504
Little Rock, Arkansas, United States
Southern California Res. Ctr. /ID# 211989
Coronado, California, United States
Newport Huntington Medica /ID# 213034
Huntington Beach, California, United States
UC San Diego Health Systems /ID# 155576
La Jolla, California, United States
United Medical Doctors /ID# 207887
Los Alamitos, California, United States
TLC Clinical Research Inc /ID# 212501
Los Angeles, California, United States
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162655
Los Angeles, California, United States
United Medical Doctors - Murrieta /ID# 158278
Murrieta, California, United States
Peak Gastroenterology Associates, PC /ID# 165832
Colorado Springs, Colorado, United States
Rocky Mountain Pediatric Gastroenterology /ID# 207171
Lone Tree, Colorado, United States
Western Connecticut Medical Group /ID# 165874
Danbury, Connecticut, United States
Seffner Premier Health Care, PA /ID# 162259
Brandon, Florida, United States
Clinical Research of West Florida, Inc /ID# 205864
Clearwater, Florida, United States
Clinical Research of West Florida, Inc /ID# 208127
Clearwater, Florida, United States
South Lake Pain Institute, Inc /ID# 162798
Clermont, Florida, United States
Omega Research Maitland, LLC /ID# 171080
DeBary, Florida, United States
Universal Axon Clinical Research /ID# 165426
Doral, Florida, United States
SIH Research Mumtaz, Inc /ID# 163081
Kissimmee, Florida, United States
Alliance Medical Research /ID# 163834
Lighthouse PT, Florida, United States
Cfagi Llc /Id# 202482
Maitland, Florida, United States
University of Miami /ID# 155011
Miami, Florida, United States
Vista Health Research, LLC /ID# 212828
Miami, Florida, United States
ITB Research /ID# 161278
Miami, Florida, United States
Coral Research Clinic /ID# 158330
Miami, Florida, United States
South Florida Research Ph I-IV, Inc. /ID# 161825
Miami, Florida, United States
Gastroenterology Group Naples /ID# 165192
Naples, Florida, United States
Advanced Research Institute, Inc /ID# 161973
New Port Richey, Florida, United States
Endoscopic Research, Inc. /ID# 205903
Orlando, Florida, United States
IMIC Inc. Medical Research /ID# 154944
Palmetto Bay, Florida, United States
Clinical Research Trials of Florida, Inc. /ID# 201606
Tampa, Florida, United States
Atlanta Gastro Assoc /ID# 154755
Atlanta, Georgia, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 154865
Macon, Georgia, United States
Northwestern University Division of GI/Hepatology /ID# 158250
Chicago, Illinois, United States
The University of Chicago Medical Center /ID# 157113
Chicago, Illinois, United States
NorthShore University HealthSystem /ID# 158254
Evanston, Illinois, United States
Southwest Gastroenterology /ID# 164764
Oak Lawn, Illinois, United States
Cotton-O'Neil Clinical Res Ctr /ID# 154753
Topeka, Kansas, United States
University of Kentucky Chandler Medical Center /ID# 157109
Lexington, Kentucky, United States
University of Louisville /ID# 210523
Louisville, Kentucky, United States
Gastroenterology Associates LLC - Jefferson Hwy /ID# 161970
Baton Rouge, Louisiana, United States
Houma Digestive Health Special /ID# 158253
Houma, Louisiana, United States
Delricht Research /ID# 206567
New Orleans, Louisiana, United States
Nola Research Works, LLC /ID# 161271
New Orleans, Louisiana, United States
Louisana Research Center, LLC /ID# 162239
Shreveport, Louisiana, United States
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154846
Chevy Chase, Maryland, United States
Gastro Center of Maryland /ID# 164766
Columbia, Maryland, United States
Center for Digestive Health /ID# 154697
Troy, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161267
Wyoming, Michigan, United States
Mayo Clinic - Rochester /ID# 163084
Rochester, Minnesota, United States
University of Nebraska Medical Center /ID# 210056
Omaha, Nebraska, United States
Las Vegas Medical Research /ID# 160167
Las Vegas, Nevada, United States
Revival Research Institute, Inc /ID# 210986
Las Vegas, Nevada, United States
NY Scientific /ID# 158272
Brooklyn, New York, United States
Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213446
Burnt Hills, New York, United States
Intercity Advanced Gastroentertology Center /ID# 215204
Fresh Meadows, New York, United States
Duplicate_Long Island Clinical Research /ID# 154843
Great Neck, New York, United States
Digestive Disease Care /ID# 211776
New Hyde Park, New York, United States
North Shore University Hospital /ID# 168734
New Hyde Park, New York, United States
NYU Langone Medical Center /ID# 160166
New York, New York, United States
Weill Cornell Medicine /ID# 165856
New York, New York, United States
Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165610
New York, New York, United States
Columbia Univ Medical Center /ID# 167545
New York, New York, United States
Lenox Hill Hospital /ID# 168466
New York, New York, United States
DiGiovanna Institute for Medical Education & Research /ID# 171130
North Massapequa, New York, United States
Atrium Health Carolinas Medical Center /ID# 158364
Charlotte, North Carolina, United States
Vidant Multispecialty Clinic - Kinston /ID# 161109
Kinston, North Carolina, United States
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154891
Raleigh, North Carolina, United States
Plains Clinical Research Center, LLC /ID# 169712
Fargo, North Dakota, United States
Tri-State Endoscopy /ID# 154939
Cincinnati, Ohio, United States
Cleveland Clinic Main Campus /ID# 209225
Cleveland, Ohio, United States
The Ohio State University /ID# 164706
Columbus, Ohio, United States
Optimed Research, Ltd. /ID# 167877
Columbus, Ohio, United States
Hometown Urgent Care and Resea /ID# 170447
Dayton, Ohio, United States
Great Lakes Medical Research, LLC /ID# 201774
Mentor, Ohio, United States
Hightower Clinical /ID# 211992
Oklahoma City, Oklahoma, United States
Digestive Disease Specialists /ID# 170772
Oklahoma City, Oklahoma, United States
Adult Gastroenterology Associates - Gen 1 Research /ID# 208857
Tulsa, Oklahoma, United States
Northwest Gastroenterology Clinic /ID# 158255
Portland, Oregon, United States
PennState Milton S.Hershey Med /ID# 154894
Hershey, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC /ID# 212543
Pittsburgh, Pennsylvania, United States
Digestive Disease Associates, LTD /ID# 208296
Wyomissing, Pennsylvania, United States
Medical University of South Carolina /ID# 212859
Charleston, South Carolina, United States
Gastroenterology Associates, P.A. of Greenville /ID# 154919
Greenville, South Carolina, United States
Rapid City Medical Center - GI Research /ID# 163835
Rapid City, South Dakota, United States
Gastro One /ID# 154757
Germantown, Tennessee, United States
East Tennessee Research Institute /ID# 168735
Johnson City, Tennessee, United States
Duplicate_Clinical Neuroscience Solutions, Inc /ID# 164179
Memphis, Tennessee, United States
Vanderbilt University Medical Center /ID# 157110
Nashville, Tennessee, United States
TX Clinical Research Institute /ID# 159396
Arlington, Texas, United States
Inquest Clinical Research /ID# 165696
Baytown, Texas, United States
Texas Digestive Disease Consultants /ID# 209781
Cedar Park, Texas, United States
Texas Digestive Disease Consultants /ID# 209945
Cedar Park, Texas, United States
DHAT Research Institute /ID# 158199
Garland, Texas, United States
Vilo Research Group Inc /ID# 207654
Houston, Texas, United States
CliniCore International, LLC /ID# 158191
Houston, Texas, United States
Baylor College of Medicine - Baylor Medical Center /ID# 158194
Houston, Texas, United States
Precision Research Institute, LLC /ID# 201072
Houston, Texas, United States
Centex Studies, Inc. - Houston /ID# 201218
Houston, Texas, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 161307
San Antonio, Texas, United States
Southern Star Research Institute, LLC /ID# 168772
San Antonio, Texas, United States
Baylor Scott & White Medical Center- Temple /ID# 204129
Temple, Texas, United States
Tyler Research Institute, LLC /ID# 166795
Tyler, Texas, United States
Gastro Health & Nutrition - Victoria /ID# 164284
Victoria, Texas, United States
HP Clinical Research /ID# 162992
Bountiful, Utah, United States
Advanced Research Institute /ID# 154922
Ogden, Utah, United States
Velocity Clinical Research - Salt Lake City /ID# 161775
West Jordan, Utah, United States
Hunter Holmes McGuire VA Medical Center /ID# 159977
Richmond, Virginia, United States
Washington Gastroenterology Associates /ID# 162101
Bellevue, Washington, United States
Virginia Mason - Seattle Orthapedics /ID# 155577
Seattle, Washington, United States
WVU Medicine /ID# 167942
Morgantown, West Virginia, United States
Hospital Britanico de Buenos Aires /ID# 168081
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina
Cemic /Id# 168082
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina
Hospital Provincial del Centenario /ID# 170904
Rosario, Santa Fe Province, Argentina
Hospital Privado Univesitario /ID# 168080
Córdoba, , Argentina
Mater Misericordiae Limited /ID# 167216
South Brisbane, Queensland, Australia
Griffith University /ID# 212631
Southport, Queensland, Australia
Lyell McEwin Hospital /ID# 211364
Elizabeth Vale, South Australia, Australia
Emeritus Research /ID# 213510
Camberwell, Victoria, Australia
Footscray Hospital /ID# 211362
Footscray, Victoria, Australia
Universitaetsklinikum St. Poelten /ID# 166423
Sankt Pölten, Lower Austria, Austria
Duplicate_LKH-Univ. Klinikum Graz /ID# 158134
Graz, Styria, Austria
Krankenhaus der Barmherzigen Brueder Wien /ID# 211418
Vienna, Vienna, Austria
Duplicate_Medical University of Vienna /ID# 158135
Vienna, Vienna, Austria
Vitebsk Regional Advanced Clin /ID# 204807
Vitebsk, , Belarus
AZ Sint-Maarten /ID# 212280
Mechelen, Antwerpen, Belgium
ULB Hospital Erasme /ID# 157386
Brussels, Brussels Capital, Belgium
UCL Saint-Luc /ID# 157384
Woluwe-Saint-Lambert, Brussels Capital, Belgium
UZ Gent /ID# 157383
Ghent, Oost-Vlaanderen, Belgium
Imelda Ziekenhuis /ID# 157381
Bonheiden, , Belgium
AZ Maria Middelares /ID# 212871
Ghent, , Belgium
AZ Groeninge /ID# 212571
Kortrijk, , Belgium
ZNA - Jan Palfijn /ID# 212822
Merksem, , Belgium
University Clinical Centre of the Republic of Srpska /ID# 157710
Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 165018
Banja Luka, Republika Srpska, Bosnia and Herzegovina
Clinical Center University of Sarajevo /ID# 165132
Sarajevo, , Bosnia and Herzegovina
UMHAT Dr Georgi Stranski EAD /ID# 203975
Pleven, , Bulgaria
University Multiprofile Hospit /ID# 165697
Plovdiv, , Bulgaria
Second Multiprofile Hospital f /ID# 165699
Sofia, , Bulgaria
Acibadem City Clinic UMHAT Tokuda /ID# 165698
Sofia, , Bulgaria
UMHAT Sveti Ivan Rilski /ID# 204713
Sofia, , Bulgaria
UMHAT Tsaritsa Joanna - ISUL /ID# 211241
Sofia, , Bulgaria
MHAT Trakia /ID# 201665
Stara Zagora, , Bulgaria
University Multiprofile Hospit /ID# 167576
Varna, , Bulgaria
University of Calgary - Heritage Medical Research Clinic /ID# 157156
Calgary, Alberta, Canada
Allen Whey Khye Lim Professional Corporation /ID# 169766
Edmonton, Alberta, Canada
University of Alberta - Zeidler Ledcor Centre /ID# 157100
Edmonton, Alberta, Canada
Covenant Health /ID# 161636
Edmonton, Alberta, Canada
Fraser Clinical Trials Inc /ID# 159057
New Westminster, British Columbia, Canada
GIRI Gastrointestinal Research Institute /ID# 157097
Vancouver, British Columbia, Canada
Percuro Clinical Research, Ltd /ID# 161635
Victoria, British Columbia, Canada
QEII - Health Sciences Centre /ID# 157089
Halifax, Nova Scotia, Canada
IWK Health Center /ID# 165909
Halifax, Nova Scotia, Canada
Medicor Research Inc /ID# 157151
Greater Sudbury, Ontario, Canada
London Health Sciences Center /ID# 157162
London, Ontario, Canada
Scott Shulman Medicine Professional Corporation /ID# 165910
North Bay, Ontario, Canada
Toronto Digestive Disease Asso /ID# 157159
Vaughan, Ontario, Canada
CISSS de la Monteregie /ID# 161634
Greenfield Park, Quebec, Canada
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159058
Montreal, Quebec, Canada
CHUM - Centre hospitalier de l'Universite de Montréal /ID# 167070
Montreal, Quebec, Canada
Montreal General Hospital - McGill University Health Center /ID# 157086
Montreal, Quebec, Canada
Centro de Investigaciones Clínicas Viña del Mar /ID# 203585
Viña del Mar, Región de Valparaíso, Chile
Complejo Asistencial Dr. Sotero del Rio /ID# 169383
Santiago, Santiago Metropolitan, Chile
Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171121
Santiago, Santiago Metropolitan, Chile
Hospital Guillermo Grant Benavente de Concepción /ID# 210758
Concepción, , Chile
Hospital Las Higueras /ID# 167091
Talcahuano, , Chile
The Sixth Affiliated Hosp Sun /ID# 210783
Guangzhou, Guangdong, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 210857
Wuhan, Hubei, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211040
Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University /ID# 211035
Nanchang, Jiangxi, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210842
Shanghai, Shanghai Municipality, China
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210706
Shanghai, Shanghai Municipality, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210626
Hangzhou, Zhejiang, China
West China Hospital, Sichuan University /ID# 210888
Chengdu, , China
Shanghai East Hospital /ID# 212671
Pudong New District, , China
Duplicate_Tianjin Med Univ General Hosp /ID# 210925
Tianjin, , China
Instituto de Coloproctologia /ID# 158740
Medellín, Antioquia, Colombia
Hospital Pablo Tobon Uribe /ID# 158732
Medellín, Antioquia, Colombia
Hospital Univ San Ignacio /ID# 158737
Bogota, Cundinamarca, Colombia
Duplicate_Klinicka bolnica Dubrava Zagreb /ID# 157719
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Sestre milosrdnice /ID# 157720
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 157703
Zagreb, City of Zagreb, Croatia
UHC Osijek /ID# 157704
Osijek, County of Osijek-Baranja, Croatia
Klinicki bolnicki centar Split /ID# 157705
Split, Split-Dalmatia County, Croatia
Zadar General Hospital /ID# 157706
Zadar, , Croatia
Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165479
Prague, Praha 4, Czechia
Hepato-Gastroenterologie HK, s.r.o. /ID# 163218
Hradec Králové, , Czechia
CTCenter MaVe s.r.o. /ID# 163215
Olomouc, , Czechia
Nemocnice Pardubickeho kraje, a.s. /ID# 163219
Pardubice, , Czechia
Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211304
Prague, , Czechia
Axon Clinical, s.r.o. /ID# 163216
Prague, , Czechia
Thomayerova nemocnice /ID# 162942
Prague, , Czechia
ResTrial s.r.o. /ID# 211074
Prague, , Czechia
NH Hospital a.s. /ID# 211073
Prague, , Czechia
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155535
Hvidovre, Capital Region, Denmark
Aarhus University Hospital /ID# 155534
Aarhus N, Central Jutland, Denmark
Sjællands Universitetshospital, Roskilde /ID# 155537
Roskilde, Region Sjælland, Denmark
Sygehusenheden Nyborg - OUH /ID# 161591
Nyborg, Region Syddanmark, Denmark
Aalborg Universitets Hospital /ID# 160685
Aalborg, , Denmark
Odense Universitets Hospital /ID# 155536
Odense C, , Denmark
Zagazig University Hospitals /ID# 164018
Al Sharqia, , Egypt
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157876
Alexandria, , Egypt
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164423
Alexandria, , Egypt
Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157176
Cairo, , Egypt
National Hepatology and Tropical Medicine Research Institute /ID# 157875
Cairo, , Egypt
Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 158630
Cairo, , Egypt
East Tallinn Central Hospital /ID# 157072
Tallinn, Harju, Estonia
West Tallinn Central Hospital /ID# 157073
Tallinn, , Estonia
Chu de Nice-Hopital L'Archet Ii /Id# 162545
Nice, Alpes-Maritimes, France
HCL - Hôpital Lyon Sud /ID# 162548
Pierre-Bénite, Auvergne-Rhône-Alpes, France
CHU Bordeaux - Hopital Haut Lévêque /ID# 162546
Pessac, Gironde, France
CHRU Lille - Hopital Claude Huriez /ID# 162547
Lille, Hauts-de-France, France
CHU Montpellier - Hôpital Saint Eloi /ID# 215146
Montpellier, Herault, France
CHRU Nancy - Hôpitaux de Brabois /ID# 162549
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU de SAINT ETIENNE - Hopital Nord /ID# 162550
Saint Priest EN Jarez, Pays de la Loire Region, France
CHU Amiens-Picardie Site Sud /ID# 165056
Amiens, Somme, France
CHU Grenoble - Hopital Michallon /ID# 211980
La Tronche, , France
Hospital Pontchaillou /ID# 213207
Rennes, , France
Hapital Beaujon /ID# 166287
Clichy, Île-de-France Region, France
Praxis fuer Gastroenterologie /ID# 166148
Heidelberg, Baden-Wurttemberg, Germany
Universitatsklinikum Mannheim /ID# 162026
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen /ID# 159341
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm /ID# 164988
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen /ID# 159332
Erlangen, Bavaria, Germany
Universitaetsklinikum Frankfurt /ID# 212977
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Koeln /ID# 164987
Cologne, North Rhine-Westphalia, Germany
Evangelisches Krankenhaus Kalk /ID# 212724
Cologne, North Rhine-Westphalia, Germany
Praxiszentrum fuer Gastroenterologie /ID# 211965
Grevenbroich, North Rhine-Westphalia, Germany
Universitaetsklinikum Muenster /ID# 159333
Münster, North Rhine-Westphalia, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210527
Saarbrücken, Saarland, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159338
Kiel, Schleswig-Holstein, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212218
Berlin, , Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212892
Berlin, , Germany
Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211976
Berlin, , Germany
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159339
Berlin, , Germany
DRK Kliniken Berlin Westend /ID# 166149
Berlin, , Germany
Krankenhaus Waldfriede /ID# 212729
Berlin-Zehlendorf, , Germany
Stadtisches Klinikum Braunschweig /ID# 163673
Braunschweig, , Germany
Medizinisches Versorgunszentrum Dachau /ID# 211550
Dachau, , Germany
Agaplesion Markus Krankenhaus /ID# 159334
Frankfurt am Main, , Germany
Duplicate_Universitaetsklinikum Freiburg /ID# 162025
Freiburg im Breisgau, , Germany
Asklepios Westklinikum Hamburg /ID# 159336
Hamburg, , Germany
Medizinische Hochschule Hannover /ID# 162027
Hanover, , Germany
EUGASTRO GmbH /ID# 212077
Leipzig, , Germany
Klinikum Lueneburg /ID# 163671
Lüneburg, , Germany
Universitaetsklinikum Magdeburg /ID# 211840
Magdeburg, , Germany
Gastroenterologische Gemeinschaftspraxis Minden /ID# 162024
Minden, , Germany
Universitaetsklinikum Regensburg /ID# 163812
Regensburg, , Germany
Duplicate_Gastro-Praxis Wiesbaden /ID# 159335
Wiesbaden, , Germany
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170905
Athens, Attica, Greece
Tzaneio general hospital of Piraeus /ID# 206441
Piraeus, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 157417
Heraklion, Crete, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157418
Athens, , Greece
University General Hospital of Ioannina /ID# 157415
Ioannina, , Greece
General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157419
Pireaus, , Greece
Theageneio Anticancer Hospital /ID# 163922
Thessaloniki, , Greece
Beaumont Hospital /ID# 157572
Beaumont, Dublin, Ireland
St Vincent's University Hospital /ID# 157569
Elm Park, Dublin, Ireland
University Hospital Galway /ID# 157570
Galway, , Ireland
Soroka University Medical Center /ID# 157789
Beersheba, Southern District, Israel
Sheba Medical Center /ID# 171059
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 157787
Tel Aviv, Tel Aviv, Israel
Duplicate_Rambam Medical Center /ID# 171056
Haifa, , Israel
Shaare Zedek Medical Center /ID# 163539
Jerusalem, , Israel
Shaare Zedek Medical Center /ID# 171055
Jerusalem, , Israel
Hadassah Medical Center-Hebrew University /ID# 171062
Jerusalem, , Israel
Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162431
Torrette, Ancona, Italy
Duplicate_Universita di Catanzaro Magna Graecia /ID# 212017
Catanzaro, Calabria, Italy
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212018
Modena, Emilia-Romagna, Italy
Duplicate_Policlinico Universitario Campus Bio-Medico /ID# 162433
Rome, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini /ID# 155660
Rome, Lazio, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166910
Rome, Lazio, Italy
Duplicate_Ospedale Policlinico San Martino/ Università Degli Studi Di Genova /ID# 162434
Genoa, Liguria, Italy
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211453
Rho, Milano, Italy
Istituto Clinico Humanitas /ID# 155658
Rozzano, Milano, Italy
Fondazione PTV Policlinico Tor Vergata /ID# 158023
Rome, Roma, Italy
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155656
Rome, Roma, Italy
Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 168049
Florence, Tuscany, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161302
Negrar, Verona, Italy
A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 155659
Bologna, , Italy
A.O. Per L'Emergenza Cannizzaro /ID# 161303
Catania, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155657
Milan, , Italy
ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155655
Milan, , Italy
Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212030
Pavia, , Italy
Pauls Stradins Clinical University Hospital /ID# 159616
Riga, , Latvia
Riga East Clinical University Hospital /ID# 159615
Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162584
Kaunas, , Lithuania
Vinius University Hospital Santaros Klinikos /ID# 162524
Vilnius, , Lithuania
Universiti Sains Malaysia /ID# 160661
Kelantan, Kelantan, Malaysia
Queen Elizabeth Hospital /ID# 160659
Division Pantai Barat Utara, Sabah, Malaysia
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201362
Kuala Lumpur, Selangor, Malaysia
Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170766
Zapopan, Jalisco, Mexico
JM Research SC /ID# 170762
Cuernavaca, Morelos, Mexico
Unidad de Atencion Medica e Investigacion en Salud /ID# 170765
Mérida, Yucatán, Mexico
Health Pharma Professional Research S.A de C.V /ID# 170763
Del. Benito Juárez, , Mexico
Academisch Medisch Centrum /ID# 157953
Amsterdam, , Netherlands
Elisabeth Tweesteden Ziekenhuis /ID# 163620
Tilburg, , Netherlands
Christchurch Hospital /ID# 167212
Christchurch, Canterbury, New Zealand
Dunedin Hospital /ID# 167215
Dunedin, Otago, New Zealand
Middlemore Clinical Trials /ID# 167214
Auckland, , New Zealand
Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167213
Wellington, , New Zealand
Planetmed Sp. z o.o. /ID# 205159
Wroclaw, Lower Silesian Voivodeship, Poland
1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 209984
Lublin, Lublin Voivodeship, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 209980
Lublin, Lublin Voivodeship, Poland
Centrum Zdrowia MDM /ID# 163602
Warsaw, Masovian Voivodeship, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163604
Warsaw, Masovian Voivodeship, Poland
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213578
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Medyk /ID# 212888
Rzeszów, Podkarpackie Voivodeship, Poland
Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212079
Chojnice, Pomeranian Voivodeship, Poland
H-T. Centrum Medyczne - Endoterapia /ID# 212458
Tychy, Silesian Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny /ID# 212400
Olsztyn, Warmian-Masurian Voivodeship, Poland
Duplicate_Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz /ID# 202434
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212534
Wroclaw, , Poland
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212290
Lodz, Łódź Voivodeship, Poland
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160691
Guimarães, Braga District, Portugal
Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167754
Portimão, Faro District, Portugal
Centro Hospitalar de Entre Douro e Vouga /ID# 160676
Santa Maria DA Feira, Porto District, Portugal
Hospital Garcia de Orta, EPE /ID# 160688
Almada, , Portugal
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160732
Faro, , Portugal
Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160677
Lisbon, , Portugal
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167753
Lisbon, , Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160741
Lisbon, , Portugal
Hospital Beatriz Ângelo /ID# 207758
Loures, , Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160742
Porto, , Portugal
Centro Hosp de Tondela-Viseu /ID# 160731
Viseu, , Portugal
Institutul Clinic Fundeni /ID# 170890
Sector 2, București, Romania
Duplicate_Institutul Clinic Fundeni /ID# 170888
Bucharest, , Romania
Tvm Med Serv Srl /Id# 170891
Cluj-Napoca, , Romania
Cabinet Particular Policlinic Algomed /ID# 170889
Timișoara, , Romania
Duplicate_Centrul Medical Tuculanu SRL /ID# 170892
Timișoara, , Romania
Kuzbass Regional Clinical Hospital /ID# 200707
Kemerovo, Kemerovo Oblast, Russia
Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207438
Perm, Permskiy Kray, Russia
Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200701
Stavropol, Stavropol Kray, Russia
Tver Regional Clinical Hospital /ID# 206586
Tver', Tver Oblast, Russia
Regional Clinical Hospital #1 /ID# 200708
Tyumen, Tyumen Oblast, Russia
Alliance Biomedical Ural Group /ID# 200703
Izhevsk, Udmurtiya Republic, Russia
National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204806
Moscow, , Russia
City Clinical Hospital No. 31 /ID# 208865
Saint Petersburg, , Russia
Ulyanovsk Regional Clinical Hospital /ID# 200700
Ulyanovsk, , Russia
Clinical Hosp Center Zvezdara /ID# 156956
Belgrade, Beograd, Serbia
Military Medical Academy /ID# 156963
Belgrade, Beograd, Serbia
University Clinical Center Serbia /ID# 156957
Belgrade, Beograd, Serbia
Duplicate_Clin Hosp Ctr Bezanijska Kosa /ID# 156959
Belgrade, Beograd, Serbia
University Clinical Center Kragujevac /ID# 156961
Kragujevac, Sumadijski Okrug, Serbia
Clinical Center Vojvodina /ID# 156958
Novi Sad, Vojvodina, Serbia
University Children's Hospital 'Tirsova' /ID# 211480
Belgrade, , Serbia
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212798
Belgrade, , Serbia
National University Hospital /ID# 160662
Singapore, , Singapore
Singapore General Hospital /ID# 160663
Singapore, , Singapore
KL Ling Gastroenterology and Liver Clinic /ID# 205736
Singapore, , Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156453
Banská Bystrica, , Slovakia
Univerzitna nemocnica Martin /ID# 163205
Martin, , Slovakia
KM Management, spol. s.r.o. /ID# 206762
Nitra, , Slovakia
GASTRO I., s.r.o. /ID# 156455
Prešov, , Slovakia
Wits Clinical Research Site /ID# 171169
Johannesburg, Gauteng, South Africa
Kingsbury Hospital /ID# 171158
Cape Town, Western Cape, South Africa
Private Practice Dr MN Rajabally /ID# 171159
Cape Town, Western Cape, South Africa
Spoke Research Inc /ID# 171172
CAPE TOWN Milnerton, Western Cape, South Africa
Hanyang University Guri Hospital /ID# 163351
Guri-si, Gyeonggido, South Korea
CHA Bundang Medical center CHA University /ID# 163377
Seongnam-si, Gyeonggido, South Korea
The Catholic University of Korea, ST. Vincent's Hospital /ID# 163365
Suwon, Gyeonggido, South Korea
Kangbuk Samsung Hospital /ID# 163354
Seoul, Seoul Teugbyeolsi, South Korea
Severance Hospital /ID# 163374
Seoul, Seoul Teugbyeolsi, South Korea
Inje University Haeundae Hospital /ID# 202516
Busan, , South Korea
Duplicate_Dong-A University Hospital /ID# 163370
Busan, , South Korea
Pusan National University Hospital /ID# 163376
Busan, , South Korea
Yeungnam University Medical Center /ID# 163366
Daegu, , South Korea
The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213553
Daejeon, , South Korea
Samsung Medical Center /ID# 163426
Seoul, , South Korea
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157534
Ferrol, A Coruna, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159234
Sabadell, Barcelona, Spain
Hospital Universitario Basurto /ID# 205188
Bilbao, Vizcaya, Spain
Hospital Clinic de Barcelona /ID# 157533
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 161144
Madrid, , Spain
Hospital Universitario La Paz /ID# 159232
Madrid, , Spain
Hospital Clinico Universitario de Salamanca /ID# 157539
Salamanca, , Spain
Hospital Universitario Virgen Macarena /ID# 159966
Seville, , Spain
Hospital Clinico Universitario de Valencia /ID# 209699
Valencia, , Spain
Hospital Universitario y Politecnico La Fe /ID# 157537
Valencia, , Spain
Hospital Universitario Miguel Servet /ID# 157538
Zaragoza, , Spain
Universitätsspital Basel /ID# 166321
Basel, Canton of Basel-City, Switzerland
Universitätsspital Zürich /ID# 163528
Zurich, Canton of Zurich, Switzerland
China Medical University Hosp /ID# 160130
Taichung, , Taiwan
Taichung Veterans General Hosp /ID# 160134
Taichung, , Taiwan
National Cheng Kung University Hospital /ID# 160129
Tainan City, , Taiwan
National Taiwan University Hospital /ID# 162189
Taipei, , Taiwan
Taipei Veterans General Hosp /ID# 212711
Taipei, , Taiwan
Kyiv Municipal Clinical Hospital #18 /ID# 162527
Kyiv, , Ukraine
Duplicate_Transcarpathian Regional Clin. /ID# 167958
Uzhhorod, , Ukraine
NHS Greater Glasgow and Clyde /ID# 202314
Glasgow, Scotland, United Kingdom
Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207938
Chertsey, Surrey, United Kingdom
Barnsley Hospital NHS Foundation Trust /ID# 202772
Barnsley, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 157577
Birmingham, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust /ID# 158037
Cambridge, , United Kingdom
NHS Lothian /ID# 207446
Edinburgh, , United Kingdom
Hull University Teaching Hospitals NHS Trust /ID# 158759
Hull, , United Kingdom
King's College Hospital NHS Foundation Trusts /ID# 158758
London, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163889
Newcastle upon Tyne, , United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 158039
Oxford, , United Kingdom
Duplicate_Northern Care Alliance NHS Group /ID# 207765
Salford, , United Kingdom
Countries
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References
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Feagan BG, Colombel JF, Panaccione R, Schreiber S, Ferrante M, Kamikozuru K, Ma C, Lee WJ, Griffith J, Joshi N, Kligys K, Kalabic J, Xuan S, Dubinsky M. Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn's Disease. Gastro Hep Adv. 2024 Sep 5;4(1):100544. doi: 10.1016/j.gastha.2024.08.022. eCollection 2025.
Atreya R, Ferrante M, Panaccione R, Feagan B, Shchukina O, Jairath V, Rieder F, Hisamatsu T, Siegmund B, Kligys K, Song A, Zambrano J, Mallick M, Zhang Y, Armuzzi A, D'Haens G. Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn's Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies. J Crohns Colitis. 2025 Apr 4;19(4):jjae164. doi: 10.1093/ecco-jcc/jjae164.
Peyrin-Biroulet L, Colombel JF, Louis E, Ferrante M, Motoya S, Panaccione R, Torres J, Ungaro RC, Kligys K, Kalabic J, Zambrano J, Zhang Y, D'Haens G. Shorter Crohn's Disease Duration Is Associated With Better Clinical and Endoscopic Outcomes With Risankizumab in Phase 3 Studies. Gastro Hep Adv. 2024 Mar 7;3(4):539-550. doi: 10.1016/j.gastha.2024.02.008. eCollection 2024.
Dubinsky M, Ma C, Griffith J, Crowell M, Neimark E, Kligys K, O'Connell T. Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. Adv Ther. 2023 Sep;40(9):3896-3911. doi: 10.1007/s12325-023-02546-6. Epub 2023 Jun 27.
D'Haens G, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, Ferrante M. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May 28;399(10340):2015-2030. doi: 10.1016/S0140-6736(22)00467-6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Related info
Other Identifiers
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2016-003190-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-991
Identifier Type: -
Identifier Source: org_study_id
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