A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease

Who is this study for? Adult patients with Crohn's Disease
What treatments are being studied? Risankizumab
Status: Active, not recruiting
Location: See all (487) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 80
Healthy Volunteers: No
View:

• 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).

Locations
United States
Arkansas
Atria Clinical Research /ID# 164505
Little Rock
Arizona
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884
Mesa
Phoenix VA Health Care System /ID# 162264
Phoenix
University of Arizona /ID# 158502
Tucson
California
Southern California Res. Ctr. /ID# 211991
Coronado
Duplicate_Newport Huntington Medical Group /ID# 213035
Huntington Beach
UC San Diego Health Systems /ID# 155555
La Jolla
United Medical Doctors /ID# 207888
Los Alamitos
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162657
Los Angeles
TLC Clinical Research Inc /ID# 212719
Los Angeles
United Medical Doctors - Murrieta /ID# 158300
Murrieta
University of California, San Francisco /ID# 157127
San Francisco
Cedars-Sinai Medical Center-West Hollywood /ID# 163839
West Hollywood
Colorado
Peak Gastroenterology Associates, PC /ID# 165843
Colorado Springs
Rocky Mountain Pediatric Gastroenterology /ID# 207170
Lone Tree
Connecticut
Western Connecticut Medical Group /ID# 165879
Danbury
Florida
Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 162262
Brandon
Clinical Research of West Florida, Inc /ID# 205865
Clearwater
Clinical Research of West Florida, Inc /ID# 208125
Clearwater
South Lake Pain Institute, Inc /ID# 162808
Clermont
Omega Research Maitland, LLC /ID# 171082
Debary
Universal Axon Clinical Research /ID# 165428
Doral
Nature Coast Clinical Research - Inverness /ID# 159408
Inverness
SIH Research Mumtaz, Inc /ID# 163083
Kissimmee
Alliance Medical Research /ID# 163837
Lighthouse Point
Cfagi Llc /Id# 202479
Maitland
Coral Research Clinic /ID# 158456
Miami
South Florida Research Ph I-IV, Inc. /ID# 161832
Miami
Sylvester Comprehensive Cancer Center /ID# 155007
Miami
Gastroenterology Group Naples /ID# 165204
Naples
Advanced Research Institute, Inc /ID# 161966
New Port Richey
Endoscopic Research, Inc. /ID# 205906
Orlando
IMIC Inc. Medical Research /ID# 154942
Palmetto Bay
Georgia
Atlanta Gastro Assoc /ID# 154724
Atlanta
Gastroenterology Associates of Central Georgia, LLC /ID# 154850
Macon
Illinois
Northwestern University /ID# 158261
Chicago
The University of Chicago Medical Center /ID# 157124
Chicago
NorthShore University HealthSystem /ID# 158265
Evanston
Southwest Gastroenterology /ID# 164781
Oak Lawn
Kansas
Cotton-O'Neil Clinical Res Ctr /ID# 154722
Topeka
Kentucky
University of Kentucky Chandler Medical Center /ID# 157120
Lexington
University of Louisville /ID# 210525
Louisville
Louisiana
Gastroenterology Associates LLC - Jefferson Hwy /ID# 161963
Baton Rouge
Houma Digestive Health Special /ID# 158264
Houma
Delricht Research /ID# 206644
New Orleans
Nola Research Works, LLC /ID# 161317
New Orleans
Louisana Research Center, LLC /ID# 162237
Shreveport
Maryland
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154832
Chevy Chase
Gastro Center of Maryland /ID# 165001
Columbia
Michigan
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 157126
Ann Arbor
Clin Res Inst of Michigan, LLC /ID# 169179
Chesterfield
Center for Digestive Health /ID# 154683
Troy
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161313
Wyoming
Minnesota
Mayo Clinic - Rochester /ID# 163086
Rochester
Missouri
St. Louis University /ID# 161883
Saint Louis
North Carolina
Univ NC Chapel Hill /ID# 154833
Chapel Hill
Atrium Health Carolinas Medical Center /ID# 158428
Charlotte
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154873
Raleigh
North Dakota
Plains Clinical Research Center, LLC /ID# 169718
Fargo
Nebraska
University of Nebraska Medical Center /ID# 210058
Omaha
Nevada
Las Vegas Medical Research /ID# 160170
Las Vegas
Revival Research Institute, Inc /ID# 210985
Las Vegas
New York
NY Scientific /ID# 158294
Brooklyn
Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213447
Burnt Hills
Intercity Advanced Gastroentertology Center /ID# 215205
Fresh Meadows
Northwell Health Division of Gastroenterology at Great Neck /ID# 168738
Great Neck
NYU Langone Long Island Clinical Research Associates /ID# 154829
Lake Success
Digestive Disease Care /ID# 211777
New Hyde Park
Columbia Univ Medical Center /ID# 161899
New York
Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165612
New York
Lenox Hill Hospital /ID# 168467
New York
NYU Langone Medical Center /ID# 160169
New York
Weill Cornell Medicine /ID# 165878
New York
DiGiovanna Institute for Medical Education & Research /ID# 171126
North Massapequa
Ohio
Tri-State Endoscopy Center /ID# 154927
Cincinnati
Cleveland Clinic Main Campus /ID# 209226
Cleveland
Optimed Research, Ltd. /ID# 167887
Columbus
The Ohio State University /ID# 164708
Columbus
Hometown Urgent Care and Resea /ID# 170464
Dayton
Great Lakes Medical Research, LLC /ID# 201770
Mentor
Oklahoma
Digestive Disease Specialists /ID# 170775
Oklahoma City
Hightower Clinical /ID# 211993
Oklahoma City
Adult Gastroenterology Associates - Gen 1 Research /ID# 208864
Tulsa
Pennsylvania
Children's Hospital of Pittsburgh of UPMC /ID# 212544
Pittsburgh
Digestive Disease Associates, LTD /ID# 208297
Wyomissing
South Carolina
Medical University of South Carolina /ID# 212858
Charleston
Gastroenterology Associates, P.A. of Greenville /ID# 154904
Greenville
South Dakota
Rapid City Medical Center - GI Research /ID# 163838
Rapid City
Tennessee
Gastro One /ID# 154726
Germantown
East Tennessee Research Institute /ID# 168739
Johnson City
Clinical Neuroscience Solutions - Memphis /ID# 164180
Memphis
Vanderbilt University Medical Center /ID# 157121
Nashville
Texas
TX Clinical Research Institute /ID# 159404
Arlington
Inquest Clinical Research /ID# 165694
Baytown
Texas Digestive Disease Consultants /ID# 209797
Cedar Park
Texas Digestive Disease Consultants /ID# 209946
Cedar Park
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 159406
Dallas
DHAT Research Institute /ID# 158208
Garland
Baylor College of Medicine - Baylor Medical Center /ID# 158203
Houston
Centex Studies, Inc. - Houston /ID# 201219
Houston
Vilo Research Group Inc /ID# 207655
Houston
Clinical Associates in Research Therapeutics of America, LLC /ID# 161323
San Antonio
Southern Star Research Institute, LLC /ID# 168773
San Antonio
Baylor Scott & White Center for Diagnostic Medicine /ID# 204131
Temple
Tyler Research Institute, LLC /ID# 166797
Tyler
Gastro Health & Nutrition - Victoria /ID# 164290
Victoria
Utah
Advanced Research Institute /ID# 154907
Ogden
Velocity Clinical Research - Salt Lake City /ID# 161778
West Jordan
Virginia
Hunter Holmes McGuire VA Medical Center /ID# 159988
Richmond
Washington
Virginia Mason Medical Center /ID# 155556
Seattle
West Virginia
West Virginia University Hospitals /ID# 167941
Morgantown
Other Locations
Argentina
Cemic /Id# 168078
Ciudad Autonoma De Buenos Aire
Hospital Britanico de Buenos Aires /ID# 168077
Ciudad Autonoma De Buenos Aire
Hospital Privado Univesitario /ID# 168076
Cordoba
Hospital Provincial del Centenario /ID# 170886
Rosario
Australia
Emeritus Research /ID# 213512
Camberwell
Lyell McEwin Hospital /ID# 212215
Elizabeth Vale
Mater Misericordiae Limited /ID# 167220
South Brisbane
Griffith University /ID# 212635
Southport
Austria
Medizinische Universitaet Graz /ID# 158140
Graz
Universitaetsklinikum St. Poelten /ID# 166424
Sankt Poelten
Krankenhaus der Barmherzigen Brueder Wien /ID# 212060
Vienna
Medizinische Universitaet Wien /ID# 158141
Vienna
Belarus
Gomel Regional Clinical Hospital /ID# 205112
Gomel
Grodno city clinical hospital #2 /ID# 205113
Grodno
Vitebsk Regional Advanced Clin /ID# 206778
Витебск
Belgium
Imelda Ziekenhuis /ID# 157403
Bonheiden
Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 157408
Brussels
AZ Maria Middelares /ID# 213532
Gent
UZ Gent /ID# 157405
Gent
CHU UCL Namur - site Godinne /ID# 157412
Godinne
AZ Groeninge /ID# 211513
Kortrijk
Universitair Ziekenhuis Leuven /ID# 157407
Leuven
CHU de Liege /ID# 157409
Liege
Groupe Sante CHC - Clinique du MontLegia /ID# 157404
Liege
AZ Sint-Maarten /ID# 212876
Mechelen
ZNA - Jan Palfijn /ID# 212877
Merksem
AZ-Delta /ID# 157402
Roeselare
UCL Saint-Luc /ID# 157406
Woluwe-saint-lambert
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 164513
Banja Luka
Clinical Center University of Sarajevo /ID# 165139
Sarajevo
Bulgaria
UMHAT Dr Georgi Stranski EAD /ID# 203976
Pleven
University Multiprofile Hospit /ID# 165700
Plovdiv
Second Multiprofile Hospital f /ID# 165702
Sofia
Tokuda Hospital Sofia /ID# 165701
Sofia
UMHAT Sveti Ivan Rilski /ID# 204815
Sofia
UMHAT Tsaritsa Joanna - ISUL /ID# 211242
Sofia
MHAT Trakia /ID# 201668
Stara Zagora
Canada
University of Calgary /ID# 157155
Calgary
Allen Whey Khye Lim Professional Corporation /ID# 169763
Edmonton
Covenant Health /ID# 161632
Edmonton
University of Alberta - Zeidler Ledcor Centre /ID# 157099
Edmonton
CISSS de la Monteregie /ID# 161630
Greenfield Park
IWK Health Center /ID# 165905
Halifax
QEII - Health Sciences Centre /ID# 157088
Halifax
Hamilton Health Sciences - McMaster University Medical Centre /ID# 157184
Hamilton
Hotel Dieu de Levis /ID# 214377
Lévis
London Health Sciences Center /ID# 157161
London
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159056
Montreal
Royal Victoria Hospital / McGill University Health Centre /ID# 157085
Montreal
Fraser Clinical Trials Inc /ID# 159055
New Westminster
Scott Shulman Medicine Professional Corporation /ID# 165906
North Bay
Medicor Research Inc /ID# 157150
Sudbury
Mount Sinai Hospital /ID# 169764
Toronto
GIRI Gastrointestinal Research Institute /ID# 157096
Vancouver
Toronto Digestive Disease Asso /ID# 157158
Vaughan
Percuro Clinical Research, Ltd /ID# 161631
Victoria
Chile
Hospital Guillermo Grant Benavente de Concepción /ID# 210760
Concepción
Complejo Asistencial Dr. Sotero del Rio /ID# 169384
Santiago
Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171122
Santiago
Hospital Las Higueras /ID# 167092
Talcahuano
China
The Second Xiangya Hospital of Central South University /ID# 211700
Changsha
West China Hospital, Sichuan University /ID# 210890
Chengdu
Guangdong Provincial People's Hospital /ID# 212949
Guangzhou
The Sixth Affiliated Hosp Sun /ID# 210784
Guangzhou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210625
Hangzhou
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 210724
Hangzhou
Jinhua Municipal Central Hospital /ID# 215628
Jinhua
The First Affiliated Hospital of Nanchang University /ID# 211036
Nanchang
Shanghai East Hospital /ID# 212684
Pudong New District
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210705
Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210840
Shanghai
The Second Hospital of Hebei Medical University /ID# 212738
Shijiazhuang
Tianjin Medical University General Hospital /ID# 210926
Tianjin
Renmin Hospital of Wuhan University /ID# 214874
Wuhan
Tongji Hospital Tongji Medical College of HUST /ID# 210858
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211039
Wuhan
Colombia
Hospital Univ San Ignacio /ID# 158734
Bogota
Hospital Universitario San Vic /ID# 171486
Medellin
Instituto de Coloproctologia /ID# 158743
Medellin
Hospital Pablo Tobon Uribe /ID# 158730
Medellín
Croatia
UHC Osijek /ID# 157559
Osijek
Klinicki bolnicki centar Split /ID# 157562
Split
Zadar General Hospital /ID# 157563
Zadar
Klinicka bolnica Dubrava Zagreb /ID# 157560
Zagreb
Klinicki bolnicki centar Sestre milosrdnice /ID# 157728
Zagreb
Klinicki bolnicki centar Zagreb /ID# 157561
Zagreb
Denmark
Aarhus University Hospital /ID# 155664
Aarhus N
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155530
Hvidovre
Sygehusenheden Nyborg - OUH /ID# 161525
Nyborg
Odense Universitets Hospital /ID# 155531
Odense C
Sjællands Universitetshospital /ID# 155532
Roskilde
Egypt
Zagazig University Hospitals /ID# 164539
Al Sharqia
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157187
Alexandria
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164540
Alexandria
Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157175
Cairo
Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 157506
Cairo
National Hepatology and Tropical Medicine Research Institute /ID# 157874
Cairo
Estonia
North Estonia Medical Centre /ID# 164326
Mustamäe Linnaosa
East Tallinn Central Hospital /ID# 157074
Tallinn
West Tallinn Central Hospital /ID# 157075
Tallinn
France
CHU Amiens-Picardie Site Sud /ID# 165058
Amiens Cedex 1
Hopital Beaujon /ID# 166284
Clichy
CHU Grenoble - Hopital Michallon /ID# 212834
La Tronche
CHRU Lille - Hopital Claude Huriez /ID# 162559
Lille
CHU Montpellier - Hôpital Saint Eloi /ID# 215147
Montpellier Cedex 5
Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249858
Neuilly Sur Seine
Chu de Nice-Hopital L'Archet Ii /Id# 162557
Nice
CHU Bordeaux - Hopital Haut Leveque /ID# 162558
Pessac
HCL - Hopital Lyon Sud /ID# 162560
Pierre Benite Cedex
CHRU Pontchaillou /ID# 213209
Rennes
CHU de SAINT ETIENNE - Hopital Nord /ID# 162562
St. Priest En Jarez
CHRU Nancy - Hopitaux de Brabois /ID# 162561
Vandoeuvre-les-nancy
Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212220
Berlin
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212894
Berlin
DRK Kliniken Berlin Westend /ID# 166151
Berlin
Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211974
Berlin
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159350
Berlin
Krankenhaus Waldfriede /ID# 212727
Berlin-zehlendorf
Stadtisches Klinikum Braunschweig /ID# 163680
Braunschweig
Evangelisches Krankenhaus Kalk /ID# 212726
Cologne
Medizinisches Versorgunszentrum Dachau /ID# 211555
Dachau
Universitaetsklinikum Erlangen /ID# 159343
Erlangen
Agaplesion Markus Krankenhaus /ID# 159345
Frankfurt Am Main
Universitaetsklinikum Frankfurt /ID# 212979
Frankfurt Am Main
Universitaetsklinikum Freiburg /ID# 162030
Freiburg
Praxiszentrum fuer Gastroenterologie /ID# 211966
Grevenbroich
Medizinische Hochschule Hannover /ID# 162032
Hannover
Praxis fuer Gastroenterologie /ID# 166150
Heidelberg
Universitaetsklinikum Jena /ID# 159351
Jena
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159349
Kiel
Universitaetsklinikum Koeln /ID# 164989
Köln
EUGASTRO GmbH /ID# 212078
Leipzig
Klinikum Lueneburg /ID# 163678
Lueneburg
Universitaetsklinikum Magdeburg /ID# 211843
Magdeburg
Universitatsklinikum Mannheim /ID# 162031
Mannheim
Gastroenterologische Gemeinschaftspraxis Minden /ID# 162029
Minden
Universitatsklinikum Munster /ID# 159344
Munster
Universitaetsklinikum Regensburg /ID# 163813
Regensburg
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210528
Saarbrücken
Universitaetsklinikum Ulm /ID# 164990
Ulm
Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157423
Athens
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170914
Athens
University General Hospital of Heraklion PA.G.N.I /ID# 157422
Heraklion
University General Hospital of Ioannina /ID# 157420
Ioannina
Tzaneio general hospital of Piraeus /ID# 206443
Piraeus
General Hospital of Nikaia-Piraeus Agios Panteleimon- general hospital dytikis /ID# 157424
Pireaus
Theageneio Anticancer Hospital /ID# 163897
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital /ID# 163923
Hong Kong
Tuen Mun Hospital /ID# 163905
Hong Kong
Ireland
Beaumont Hospital /ID# 157543
Beaumont
St Vincent's University Hospital /ID# 157540
Elm Park
University Hospital Galway /ID# 157541
Galway
Israel
Soroka University Medical Center /ID# 157794
Be'er Sheva
Duplicate_Rambam Medical Center /ID# 171067
Haifa
The Edith Wolfson Medical Center /ID# 217331
Holon
Hadassah Medical Center-Hebrew University /ID# 165914
Jerusalem
Shaare Zedek Medical Center /ID# 163541
Jerusalem
Shaare Zedek Medical Center /ID# 171068
Jerusalem
The Chaim Sheba Medical Center /ID# 157793
Ramat Gan
The Chaim Sheba Medical Center /ID# 171069
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 157792
Tel Aviv-yafo
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 155643
Bologna
A.O. Per L'Emergenza Cannizzaro /ID# 161300
Catania
University of Catanzaro /ID# 212016
Catanzaro
Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 167992
Florence
Ospedale Policlinico San Martino /ID# 162439
Genova
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155641
Milan
ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155639
Milano
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212028
Modena
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161299
Negrar
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 155645
Palermo
Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212031
Pavia
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 212227
Rho
Azienda Ospedaliera San Camillo Forlanini /ID# 155644
Rome
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166912
Rome
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 162438
Rome
Fondazione PTV Policlinico Tor Vergata /ID# 158022
Rome
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155640
Rome
Istituto Clinico Humanitas /ID# 155642
Rozzano
Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162436
Torrette
Japan
Tokatsu Tsujinaka Hospital /ID# 163352
Abiko-shi
Asahikawa Medical University Hospital /ID# 162848
Asahikawa-shi
Tokyo Medical And Dental University Hospital /ID# 160095
Bunkyo-ku
Chiba University Hospital /ID# 217533
Chiba-shi
Fukuoka University Hospital /ID# 217793
Fukuoka-shi
NHO Fukuyama Medical Center /ID# 163577
Fukuyama-shi
Tokai University Hachioji Hospital /ID# 160098
Hachioji-shi
Hamamatsu University Hospital /ID# 205690
Hamamatsu-shi
National Hospital Organization Mito Medical Center /ID# 160092
Higashi Ibaraki-gun
Hiroshima University Hospital /ID# 160109
Hiroshima-shi
Gokeikai Ofuna Chuo Hospital /ID# 171066
Kamakura-shi
Kanazawa University Hospital /ID# 202258
Kanazawa-shi
The Jikei University Kashiwa Hospital /ID# 200030
Kashiwa-shi
Tsujinaka Hospital Kashiwanoha /ID# 213848
Kashiwa-shi
Saitama Medical Center /ID# 160093
Kawagoe-shi
Yamanashi Prefectural Central Hospital /ID# 160094
Kofu-shi
Kurume University Hospital /ID# 160106
Kurume-shi
Kitasato University Kitasato Institute Hospital /ID# 160105
Minato-ku
The Jikei University Hospital /ID# 163209
Minato-ku
Kyorin University Hospital /ID# 160114
Mitaka-shi
Aichi Medical University Hospital /ID# 160097
Nagakute-shi
Nagoya City University Hospital /ID# 160100
Nagoya Shi
Daido Clinic /ID# 211476
Nagoya-shi
Nagoya University Hospital /ID# 160116
Nagoya-shi
Hyogo Medical University Hospital /ID# 160107
Nishinomiya-shi
Nishinomiya Municipal Central Hospital /ID# 210103
Nishinomiya-shi
Osaka Metropolitan University Hospital /ID# 160117
Osaka-shi
Shiga University of Medical Science Hospital /ID# 164025
Otsu-shi
Kitasato University Hospital /ID# 171065
Sagamihara-shi
Tokitokai Tokito clinic /ID# 160110
Saitama-shi
Toho University Sakura Medical Center /ID# 160099
Sakura-shi
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 160096
Sapporo-shi
Sapporo Medical University Hospital /ID# 163056
Sapporo-shi
Sapporo Tokushukai Hospital /ID# 213492
Sapporo-shi
Tohoku Rosai Hospital /ID# 163229
Sendai-shi
Tohoku University Hospital /ID# 162847
Sendai-shi
Tokyo Women's Medical University Hospital /ID# 205974
Shinjuku-ku
NHO Shizuoka Medical Center /ID# 163057
Sunto-gun
Fujita Health University Hospital /ID# 163234
Toyoake-shi
Mie University Hospital /ID# 203640
Tsu-shi
Wakayama Medical University Hospital /ID# 202561
Wakayama-shi
Yamagata University Hospital /ID# 200159
Yamagata-shi
Yokkaichi Hazu Medical Center /ID# 163764
Yokkaichi-shi
Yokohama City University Medical Center /ID# 163907
Yokohama Shi
Yokohama Municipal Citizen's Hospital /ID# 207161
Yokohama-shi
Latvia
Digestive Disease Center Gastro /ID# 163107
Riga
Pauls Stradins Clinical University Hospital /ID# 159612
Riga
VCA Polyclinic Aura /ID# 159611
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162583
Kaunas
Vilnius University Hospital Santaros Klinikos /ID# 162514
Vilnius
Malaysia
Queen Elizabeth Hospital /ID# 160664
Division Pantai Barat Utara
Universiti Sains Malaysia /ID# 160666
Kelantan
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201363
Kuala Lumpur
Mexico
JM Research SC /ID# 170729
Cuernavaca
Health Pharma Professional Research S.A de C.V /ID# 170730
Del. Benito Juárez
Unidad de Atencion Medica e Investigacion en Salud /ID# 170732
Merida
Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170734
Zapopan
Netherlands
Academisch Medisch Centrum /ID# 157956
Amsterdam
Elisabeth Tweesteden Ziekenhuis /ID# 163632
Tilburg
New Zealand
Christchurch Hospital /ID# 167224
Christchurch
Dunedin Hospital /ID# 167227
Otago
Middlemore Clinical Trials /ID# 167226
Papatoetoe
Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167225
Wellington
Norway
Helse More og Romsdal HF, Alesund sjukehus /ID# 212810
Ålesund
Vestre viken - Baerum Sykehus /ID# 212996
Gjettum
Sykehuset Levanger Helse NT /ID# 201669
Levanger
Akershus universitetssykehus /ID# 169379
Nordbyhagen
Poland
Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212478
Chojnice
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212477
Lodz
1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 210940
Lublin
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 210941
Lublin
Wojewodzki Szpital Specjalistyczny /ID# 212474
Olsztyn
Solumed Centrum Medyczne /ID# 163569
Poznan
Centrum Medyczne Medyk /ID# 212891
Rzeszów
Gastromed /Id# 212476
Torun
H-T. Centrum Medyczne - Endoterapia /ID# 212475
Tychy
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163582
Warszawa
Centrum Zdrowia MDM /ID# 163570
Warszawa
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213580
Warszawa
NZOZ Vivamed /ID# 202800
Warszawa
Planetmed Sp. z o.o. /ID# 202799
Wroclaw
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212601
Wroclaw
Portugal
Hospital Garcia de Orta, EPE /ID# 160745
Almada
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160713
Faro
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160737
Guimaraes
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167751
Lisboa
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160692
Lisboa
Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160673
Lisboa
Hospital de Loures, E.P.E /ID# 207759
Loures
Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167752
Portimão
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160693
Porto
Centro Hospitalar de Entre Douro e Vouga /ID# 160672
Santa Maria Da Feira
Centro Hosp de Tondela-Viseu /ID# 160699
Viseu
Republic of Korea
Dong-A University Hospital /ID# 158699
Busan
Inje University Haeundae Hospital /ID# 202518
Busan
Pusan National University Hospital /ID# 158695
Busan
Yeungnam University Medical Center /ID# 158691
Daegu
The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213554
Daejeon
Hayang University GuriHospital /ID# 158690
Guri
CHA University Bundang Medical Center /ID# 158698
Seongnam Si
Asan Medical Center /ID# 158696
Seoul
Kangbuk Samsung Hospital /ID# 158694
Seoul
Samsung Medical Center /ID# 158692
Seoul
Yonsei University Health System Severance Hospital /ID# 158689
Seoul
The Catholic University of Korea, ST. Vincent's Hospital /ID# 158693
Suwon
Romania
Fundeni Clinical Institute /ID# 170899
Bucharest
Tvm Med Serv Srl /Id# 170902
Cluj
Duplicate_Centrul Medical Tuculanu SRL /ID# 170903
Timisoara
Cabinet Particular Policlinic Algomed /ID# 170900
Timișoara
Russian Federation
Alliance Biomedical Ural Group /ID# 200972
Izhevsk
Kuzbass Regional Clinical Hospital /ID# 200962
Kemerovo
National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204808
Moscow
Novosibirski Gastrocenter /ID# 217552
Novosibirsk
Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207439
Perm
Duplicate_St. Petersburg State Pediatric Medical University /ID# 211978
Saint Petersburg
City Clinical Hospital No. 31 /ID# 208872
St. Petersburg
Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200970
Stavropol
Tver Regional Clinical Hospital /ID# 206858
Tver
Regional Clinical Hospital #1 /ID# 200973
Tyumen
Ulyanovsk Regional Clinical Hospital /ID# 200964
Ulyanovsk
Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 157050
Belgrade
Clinical Hosp Center Zvezdara /ID# 157052
Belgrade
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212799
Belgrade
Military Medical Academy /ID# 157053
Belgrade
University Children's Hospital 'Tirsova' /ID# 211482
Belgrade
University Clinical Center Serbia /ID# 157047
Belgrade
University Clinical Center Kragujevac /ID# 157049
Kragujevac
General Hospital Leskovac /ID# 209575
Leskovac
Clinical Center Vojvodina /ID# 157046
Novi Sad
Singapore
KL Ling Gastroenterology and Liver Clinic /ID# 205741
Singapore
National University Hospital /ID# 160667
Singapore
Singapore General Hospital /ID# 160668
Singapore
Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156468
Banska Bystrica
KM Management, spol. s.r.o. /ID# 206764
Nitra
GASTRO I., s.r.o. /ID# 156469
Presov
South Africa
Private Practice Dr MN Rajabally /ID# 163112
Cape Town
Spoke Research Inc /ID# 158116
Cape Town Milnerton
Clinresco Centers /ID# 163865
Johannesburg
Wits Clinical Research Site /ID# 158114
Johannesburg
Spain
Hospital Clinic de Barcelona /ID# 157552
Barcelona
Hospital Universitario Basurto /ID# 205190
Bilbao
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157553
Ferrol
Hospital Universitario de Bellvitge /ID# 208207
L'hospitalet De Llobregat
Hospital General Universitario Gregorio Maranon /ID# 161145
Madrid
Hospital Universitario La Paz /ID# 159235
Madrid
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 157573
Majadahonda
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159237
Sabadell
Hospital Universitario de Salamanca /ID# 157558
Salamanca
Hospital Universitario Virgen Macarena /ID# 159967
Sevilla
Hospital Clinico Universitario de Valencia /ID# 209700
Valencia
Hospital Universitario y Politecnico La Fe /ID# 157556
Valencia
Hospital Clinico Universitario Lozano Blesa /ID# 212525
Zaragoza
Hospital Universitario Miguel Servet /ID# 157557
Zaragoza
Sweden
Sahlgrenska University Hospital /ID# 163792
Gothenburg
Sahlgrenska University Hospital /ID# 163797
Gothenburg
Skane University hospital /ID# 211745
Malmo
Karolinska University Hospital Solna /ID# 212025
Solna
Danderyd Hospital /ID# 202138
Stockholm
GHP Stockholm Gastro Center /ID# 211748
Stockholm
Medicinkliniken, Gastroenheten /ID# 163744
Stockholm
Switzerland
Universitätsspital Basel /ID# 164554
Basel
Inselspital, Universitätsspital Bern /ID# 163535
Bern
Universitatsspital Zurich /ID# 163536
Zurich
Taiwan
Taichung Veterans General Hospital /ID# 160140
Taichung
China Medical University Hospital /ID# 160141
Taichung City
National Cheng Kung University Hospital /ID# 160142
Tainan
National Taiwan University Hospital /ID# 162190
Taipei City
Taipei Veterans General Hosp /ID# 212712
Taipei City
Ukraine
Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 165657
Kharkiv
Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 212399
Kherson
Communal Noncommercial Institution Consultative and Diagnostic Center of Desnian /ID# 165659
Kyiv
Kyiv Municipal Clinical Hospital #18 /ID# 162531
Kyiv
Kyiv Railway Clinical Hosp No.2 /ID# 217366
Kyiv
Medical Center of LLC Medbud-Clinic /ID# 216998
Kyiv
Medical Center OK!Clinic+ /ID# 211998
Kyiv
Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 206789
Lutsk
Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 165658
Lviv
Transcarpathian Regional Clinical Hospital n.a. Andriy Novak /ID# 167960
Uzhgorod
Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 212000
Vinnytsia
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216474
Vinnytsia
United Kingdom
Barnsley Hospital NHS Foundation Trust /ID# 202773
Barnsley
University Hospitals Birmingham NHS Foundation Trust /ID# 157545
Birmingham
Cambridge University Hospitals NHS Foundation Trust /ID# 158034
Cambridge
Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207936
Chertsey
NHS Lothian /ID# 207448
Edinburgh
Royal Devon and Exeter NHS Trust Hospital /ID# 157544
Exeter
NHS Greater Glasgow and Clyde /ID# 202568
Glasgow
Calderdale and Huddersfield NHS Foundation Trust /ID# 209570
Huddersfield
Hull University Teaching Hospitals NHS Trust /ID# 158761
Hull
Leeds Teaching Hospitals NHS Trust /ID# 157550
Leeds
Barts Health NHS Trust /ID# 163713
London
Guys and St Thomas NHS Foundation Trust /ID# 157546
London
King's College Hospital NHS Foundation Trust /ID# 158760
London
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163708
Newcastle Upon Tyne
Oxford University Hospitals NHS Foundation Trust /ID# 158036
Oxford
Northern Care Alliance NHS Group /ID# 207766
Salford
Time Frame
Start Date: April 9, 2018
Estimated Completion Date: June 9, 2026
Participants
Target number of participants: 1336
Treatments
Placebo Comparator: Double-blind Placebo for Risankizumab (Sub-Study 1)
Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.
Experimental: Double-blind Risankizumab Dose 1 (Sub-Study 1)
Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.
Experimental: Double-blind Risankizumab Dose 2 (Sub-Study 1)
Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.
Experimental: Maintenance Risankizumab Dose 1 (Sub-Study 2)
Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Experimental: Maintenance Risankizumab Dose 2 (Sub-Study 2)
Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Experimental: Open-label Risankizumab (Sub-Study 3)
Participants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.
Experimental: Risankizumab On-Body Injector and Open Label (Sub-Study 4)
Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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