A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT03398148
Last Updated: 2025-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
1558 participants
INTERVENTIONAL
2018-03-07
2023-05-11
Brief Summary
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The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
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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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Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab
placebo for risankizumab
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV
risankizumab intravenous (IV) infusion
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV
risankizumab intravenous (IV) infusion
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
risankizumab IV
risankizumab intravenous (IV) infusion
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
risankizumab IV
risankizumab intravenous (IV) infusion
Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
risankizumab SC
risankizumab subcutaneous (SC) injection
Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
risankizumab SC
risankizumab subcutaneous (SC) injection
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
risankizumab IV
risankizumab intravenous (IV) infusion
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo
Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
risankizumab IV
risankizumab intravenous (IV) infusion
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab
placebo for risankizumab
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV
risankizumab intravenous (IV) infusion
Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
risankizumab SC
risankizumab subcutaneous (SC) injection
Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
risankizumab SC
risankizumab subcutaneous (SC) injection
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
risankizumab IV
risankizumab intravenous (IV) infusion
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
risankizumab IV
risankizumab intravenous (IV) infusion
Interventions
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risankizumab IV
risankizumab intravenous (IV) infusion
placebo for risankizumab
placebo for risankizumab
risankizumab SC
risankizumab subcutaneous (SC) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
* Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
* Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
* Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.
Exclusion Criteria
* Participant receiving prohibited medications and treatment.
* Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
* Participant with currently known complications of UC (e.g., megacolon).
* No 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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Southern California Res. Ctr. /ID# 169660
Coronado, California, United States
Hoag Memorial Hosp Presbyterian /ID# 218348
Irvine, California, United States
UC San Diego Health System /ID# 160452
La Jolla, California, United States
United Medical Doctors /ID# 158528
Los Alamitos, California, United States
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200931
Los Angeles, California, United States
UCSF Center for Colitis and Crohn's Disease /ID# 201210
San Francisco, California, United States
Cedars-Sinai Medical Center-West Hollywood /ID# 163851
West Hollywood, California, United States
Peak Gastroenterology Associates, PC /ID# 165841
Colorado Springs, Colorado, United States
Rocky Mountain Pediatric Gastroenterology /ID# 207174
Lone Tree, Colorado, United States
Medical Research Center of CT /ID# 160311
Hamden, Connecticut, United States
Yale Univ Digestive Diseases /ID# 213179
New Haven, Connecticut, United States
South Lake Pain Institute, Inc /ID# 162878
Clermont, Florida, United States
Ctr for Advanced Gastroenterol /ID# 202811
Maitland, Florida, United States
University of Miami /ID# 160471
Miami, Florida, United States
Coral Research Clinic /ID# 158584
Miami, Florida, United States
South Florida Research Ph I-IV, Inc. /ID# 161848
Miami, Florida, United States
Gastroenterology Group Naples /ID# 165212
Naples, Florida, United States
Advanced Research Institute, Inc /ID# 161938
New Port Richey, Florida, United States
Advent Health /ID# 160433
Orlando, Florida, United States
Endoscopic Research, Inc. /ID# 206711
Orlando, Florida, United States
Omega Research Group /ID# 203059
Orlando, Florida, United States
Lenus Research & Medical Group /ID# 169730
Sweetwater, Florida, United States
Clinical Research Trials of Florida, Inc. /ID# 201783
Tampa, Florida, United States
AdventHealth Tampa /ID# 170503
Tampa, Florida, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 160523
Macon, Georgia, United States
Atlanta Gastroenterology Spec /ID# 161372
Suwanee, Georgia, United States
The University of Chicago Medical Center /ID# 160521
Chicago, Illinois, United States
DM Clinical Research/Southwest /ID# 165012
Oak Lawn, Illinois, United States
Indiana University /ID# 167252
Indianapolis, Indiana, United States
Univ Kansas Med Ctr /ID# 226602
Kansas City, Kansas, United States
Cotton-O'Neil Clinical Res Ctr /ID# 160412
Topeka, Kansas, United States
Robley Rex VA Medical Center /ID# 218648
Louisville, Kentucky, United States
Houma Digestive Health Special /ID# 158317
Houma, Louisiana, United States
Delricht Research /ID# 206815
New Orleans, Louisiana, United States
Nola Research Works, LLC /ID# 161368
New Orleans, Louisiana, United States
Louisana Research Center, LLC /ID# 201204
Shreveport, Louisiana, United States
Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164255
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 158524
Ann Arbor, Michigan, United States
Clin Res Inst of Michigan, LLC /ID# 160327
Chesterfield, Michigan, United States
Mayo Clinic - Rochester /ID# 200458
Rochester, Minnesota, United States
Quality Clinical Research Inc. /ID# 167313
Omaha, Nebraska, United States
Weill Cornell Medicine /ID# 165887
New York, New York, United States
Columbia Univ Medical Center /ID# 161934
New York, New York, United States
Lenox Hill Hospital /ID# 168470
New York, New York, United States
Manhattan Clinical Research, LLC /ID# 211805
New York, New York, United States
DiGiovanna Institute for Medical Education & Research /ID# 171129
North Massapequa, New York, United States
University of Rochester Medical Center /ID# 161664
Rochester, New York, United States
Atrium Health Carolinas Medical Center /ID# 158512
Charlotte, North Carolina, United States
Carolina Research /ID# 201090
Greenville, North Carolina, United States
Plains Clinical Research Center, LLC /ID# 169732
Fargo, North Dakota, United States
Cleveland Clinic Main Campus /ID# 209232
Cleveland, Ohio, United States
The Ohio State University /ID# 164714
Columbus, Ohio, United States
Optimed Research, Ltd. /ID# 167113
Columbus, Ohio, United States
Great Lakes Gastroenterology Research, LLC /ID# 201777
Mentor, Ohio, United States
ProMedica Physicians Digestive Healthcare /ID# 215623
Sylvania, Ohio, United States
Digestive Disease Specialists /ID# 170779
Oklahoma City, Oklahoma, United States
Adult Gastroenterology Associates - Gen 1 Research /ID# 208867
Tulsa, Oklahoma, United States
Penn State Milton S. Hershey Medical Center /ID# 223563
Hershey, Pennsylvania, United States
University of Pennsylvania /ID# 166266
Philadelphia, Pennsylvania, United States
Digestive Disease Associates, LTD /ID# 232407
Wyomissing, Pennsylvania, United States
Gastroenterology Associates, P.A. of Greenville /ID# 160472
Greenville, South Carolina, United States
Gastro One /ID# 160418
Cordova, Tennessee, United States
East Tennessee Research Institute /ID# 168747
Johnson City, Tennessee, United States
Vanderbilt University Medical Center /ID# 160580
Nashville, Tennessee, United States
Inquest Clinical Research /ID# 165685
Baytown, Texas, United States
Texas Digestive Disease Consultants /ID# 209950
Cedar Park, Texas, United States
GI Alliance /ID# 209798
Cedar Park, Texas, United States
DHAT Research Institute /ID# 158226
Garland, Texas, United States
Vilo Research Group Inc /ID# 207656
Houston, Texas, United States
CliniCore International, LLC /ID# 158218
Houston, Texas, United States
Baylor College of Medicine - Baylor Medical Center /ID# 158221
Houston, Texas, United States
Precision Research Institute, LLC /ID# 201351
Houston, Texas, United States
Centex Studies, Inc. - Houston /ID# 201222
Houston, Texas, United States
Caprock Gastro Research, LLC /ID# 215432
Lubbock, Texas, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 161376
San Antonio, Texas, United States
Southern Star Research Institute, LLC /ID# 168776
San Antonio, Texas, United States
Baylor Scott & White Center for Diagnostic Medicine /ID# 204130
Temple, Texas, United States
Tyler Research Institute, LLC /ID# 166800
Tyler, Texas, United States
Gastro Health & Nutrition - Victoria /ID# 164321
Victoria, Texas, United States
Advanced Research Institute /ID# 160480
Ogden, Utah, United States
Gastroenterology Consultants of Southwest Virginia /ID# 218143
Roanoke, Virginia, United States
Virginia Mason Medical Center /ID# 160466
Seattle, Washington, United States
Gedyt /ID# 243423
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina
Cemic /Id# 167782
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina
Hospital Provincial del Centenario /ID# 170898
Rosario, Santa Fe Province, Argentina
Sanatorio 9 de Julio /ID# 167780
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital Privado Univesitario /ID# 167779
Córdoba, , Argentina
Duplicate_Universitaetsklinikum St.Poelten /ID# 169048
Sankt Pölten, Lower Austria, Austria
Medizinische Universitaet Graz /ID# 169053
Graz, Styria, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 215320
Linz, Upper Austria, Austria
Medizinische Universitaet Wien /ID# 169050
Vienna, Vienna, Austria
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 200685
Salzburg, , Austria
Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 200252
Brussels, Brussels Capital, Belgium
UCL Saint-Luc /ID# 200039
Woluwe-Saint-Lambert, Brussels Capital, Belgium
CHU UCL Namur - site Godinne /ID# 200254
Godinne, Namur, Belgium
Universitair Ziekenhuis Leuven /ID# 170812
Leuven, Vlaams-Brabant, Belgium
AZ-Delta /ID# 200040
Roeselare, West-Vlaanderen, Belgium
Imelda Ziekenhuis /ID# 211100
Bonheiden, , Belgium
CHU de Liege /ID# 200253
Liège, , Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 200250
Liège, , Belgium
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157679
Goiânia, Goiás, Brazil
Hospital Nossa Senhora das Graças /ID# 157671
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre /ID# 157662
Porto Alegre, Rio Grande do Sul, Brazil
Upeclin Fmb - Unesp /Id# 157690
Botucatu, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157660
Ribeirão Preto, São Paulo, Brazil
Faculdade de Medicina do ABC /ID# 163995
Santo André, São Paulo, Brazil
Kaiser Clinica e Hospital Dia /ID# 157680
São José do Rio Preto, São Paulo, Brazil
UMHAT Kaspela EOOD /ID# 200797
Plovdiv, , Bulgaria
MHAT Hadzhi Dimitar /ID# 207945
Sliven, , Bulgaria
Second MHAT Sofia /ID# 200799
Sofia, , Bulgaria
UMHAT Sveti Ivan Rilski /ID# 210797
Sofia, , Bulgaria
UMHAT Tsaritsa Joanna - ISUL /ID# 209977
Sofia, , Bulgaria
University of Calgary /ID# 169111
Calgary, Alberta, Canada
Allen Whey Khye Lim Professional Corporation /ID# 169767
Edmonton, Alberta, Canada
Covenant Health /ID# 169114
Edmonton, Alberta, Canada
Fraser Clinical Trials Inc /ID# 169102
New Westminster, British Columbia, Canada
Percuro Clinical Research, Ltd /ID# 169109
Victoria, British Columbia, Canada
London Health Sciences Center- University Hospital /ID# 169103
London, Ontario, Canada
Scott Shulman Medicine Professional Corporation /ID# 169113
North Bay, Ontario, Canada
Toronto Digestive Disease Asso /ID# 169106
Vaughan, Ontario, Canada
Hotel Dieu de Levis /ID# 214378
Lévis, Quebec, Canada
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169108
Montreal, Quebec, Canada
Royal Victoria Hospital / McGill University Health Centre /ID# 169104
Montreal, Quebec, Canada
Complejo Asistencial Dr. Sotero del Rio /ID# 169385
Santiago, Region Metropolitana Santiago, Chile
Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171125
Santiago, Region Metropolitana Santiago, Chile
Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213151
Victoria, Región de la Araucanía, Chile
Hospital Guillermo Grant Benavente de Concepción /ID# 210761
Concepción, , Chile
Hospital Las Higueras /ID# 167093
Talcahuano, , Chile
The First Affiliated Hospital of Anhui Medical University /ID# 211228
Hefei, Anhui, China
Beijing Friendship Hospital /ID# 211066
Beijing, Beijing Municipality, China
The Sixth Affiliated Hosp Sun /ID# 211231
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University /ID# 213018
Shijiazhuang, Hebei, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211071
Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of HUST /ID# 211072
Wuhan, Hubei, China
Renmin Hospital of Wuhan University /ID# 212868
Wuhan, Hubei, China
Huai'an First People's Hospital /ID# 239196
Huaian, Jiangsu, China
Nanjing Drum Tower Hospital /ID# 227439
Nanjing, Jiangsu, China
Jiangsu Province Hospital /ID# 211232
Nanjing, Jiangsu, China
Wuxi People's Hospital /ID# 218798
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 212183
Nanchang, Jiangxi, China
The First Hospital of Jilin University /ID# 212278
Changchun, Jilin, China
General Hospital of Ningxia Medical University /ID# 213911
Yinchuan, Ningxia, China
Xijing Hospital /ID# 211639
Xi'an, Shaanxi, China
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215504
Xi'an, Shaanxi, China
Shanghai East Hospital /ID# 218791
Pudong New District, Shanghai Municipality, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210962
Shanghai, Shanghai Municipality, China
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211233
Shanghai, Shanghai Municipality, China
Shanghai General Hospital /ID# 226190
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University /ID# 211276
Chengdu, Sichuan, China
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 211025
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 211064
Hangzhou, Zhejiang, China
The Second Xiangya Hospital of Central South University /ID# 211198
Changsha, , China
Shengjing Hospital of China Medical University /ID# 211646
Shenyang, , China
Oncomédica SAS /ID# 206937
Montería, Departamento de Córdoba, Colombia
Hospital Universitario San Vic /ID# 171490
Medellín, , Colombia
Clinical Hospital Dubrava /ID# 157475
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 157471
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 201917
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Osijek /ID# 157472
Osijek, County of Osijek-Baranja, Croatia
Klinicki bolnicki centar Split /ID# 157473
Split, Split-Dalmatia County, Croatia
Fakultni nemocnice u sv. Anny v Brne /ID# 239157
Brno, , Czechia
Nemocnice Ceske Budejovice a.s. /ID# 225226
České Budějovice, , Czechia
Hepato-Gastroenterologie HK, s.r.o. /ID# 163395
Hradec Králové, , Czechia
Fakultni nemocnice Ostrava /ID# 225567
Ostrava, , Czechia
Bispebjerg and Frederiksberg Hospital /ID# 208945
Copenhagen NV, Capital Region, Denmark
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202266
Hvidovre, Capital Region, Denmark
Sjællands Universitetshospital /ID# 200033
Roskilde, Region Sjælland, Denmark
Odense University Hospital /ID# 205602
Odense C, Region Syddanmark, Denmark
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 200848
Alexandria, , Egypt
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226793
Alexandria, , Egypt
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226794
Alexandria, , Egypt
Air Force Specialized Hospital /ID# 170986
Cairo, , Egypt
National Liver Institute /ID# 171040
Menoufiya, , Egypt
Chu de Nice-Hopital L'Archet Ii /Id# 171577
Nice, Alpes-Maritimes, France
APHM - Hopital Nord /ID# 225825
Marseille, Bouches-du-Rhone, France
CHU Bordeaux - Hopital Haut Leveque /ID# 171579
Pessac, Gironde, France
CHU Montpellier - Hôpital Saint Eloi /ID# 223779
Montpellier, Herault, France
CHRU Nancy - Hopitaux de Brabois /ID# 200095
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU de SAINT ETIENNE - Hopital Nord /ID# 171580
Saint Priest EN Jarez, Pays de la Loire Region, France
CHU Amiens-Picardie Site Sud /ID# 171576
Amiens, Somme, France
Clinique Jules Verne /ID# 240976
Nantes, , France
Hopital Beaujon /ID# 200092
Clichy, Île-de-France Region, France
Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249860
Neuilly-sur-Seine, Île-de-France Region, France
Universitaetsklinikum Freiburg /ID# 162034
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Praxis fuer Gastroenterologie /ID# 166152
Heidelberg, Baden-Wurttemberg, Germany
Universitatsklinikum Mannheim /ID# 162035
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm /ID# 164992
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen /ID# 159354
Erlangen, Bavaria, Germany
Universitaetsklinikum Koeln /ID# 164991
Cologne, North Rhine-Westphalia, Germany
Praxiszentrum fuer Gastroenterologie /ID# 219069
Grevenbroich, North Rhine-Westphalia, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159360
Kiel, Schleswig-Holstein, Germany
Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219145
Berlin, , Germany
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159361
Berlin, , Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 210510
Berlin, , Germany
DRK Kliniken Berlin Westend /ID# 166153
Berlin, , Germany
Stadtisches Klinikum Braunschweig /ID# 163687
Braunschweig, , Germany
Agaplesion Markus Krankenhaus /ID# 159356
Frankfurt am Main, , Germany
Gastroenterologie Opernstrasse /ID# 163683
Kassel, , Germany
EUGASTRO GmbH /ID# 219070
Leipzig, , Germany
Klinikum Lueneburg /ID# 163685
Lüneburg, , Germany
Gastroenterologische Gemeinschaftspraxis Minden /ID# 162033
Minden, , Germany
LMU Klinikum Campus Grosshadern /ID# 210481
München, , Germany
Universitaetsklinikum Regensburg /ID# 163686
Regensburg, , Germany
General Hospital of Athens Ippokratio /ID# 229189
Athens, Attica, Greece
General Hospital of Athens Laiko /ID# 206440
Athens, Attica, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170915
Athens, Attica, Greece
Tzaneio general hospital of Piraeus /ID# 206439
Piraeus, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 165216
Heraklion, Crete, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217480
Athens, , Greece
General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 165218
Pireaus, , Greece
Theageneio Anticancer Hospital /ID# 165217
Thessaloniki, , Greece
Hadassah Medical Center-Hebrew University /ID# 171099
Jerusalem, Jerusalem, Israel
Soroka University Medical Center /ID# 171100
Beersheba, Southern District, Israel
The Chaim Sheba Medical Center /ID# 211278
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus /ID# 171103
Haifa, , Israel
Shaare Zedek Medical Center /ID# 163544
Jerusalem, , Israel
Rabin Medical Center /ID# 167403
Petah Tikva, , Israel
University of Catanzaro /ID# 200125
Catanzaro, Calabria, Italy
Ospedale Sant Orsola Malpighi /ID# 155611
Bologna, Emilia-Romagna, Italy
Ospedale Policlinico San Martino /ID# 164031
Genoa, Genova, Italy
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 163992
Rome, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini /ID# 155612
Rome, Lazio, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 171226
Rome, Lazio, Italy
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211449
Rho, Milano, Italy
Istituto Clinico Humanitas /ID# 155610
Rozzano, Milano, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158018
Rome, Roma, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 164041
Negrar, Verona, Italy
A.O. Per L'Emergenza Cannizzaro /ID# 164036
Catania, , Italy
ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155607
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 170947
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 201819
Modena, , Italy
UOC Medicina Interna e Gastroe /ID# 155608
Rome, , Italy
Aichi Medical University Hospital /ID# 164332
Nagakute-shi, Aichi-ken, Japan
Daido Clinic /ID# 211479
Nagoya, Aichi-ken, Japan
Nagoya University Hospital /ID# 164271
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 164331
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital /ID# 164261
Toyoake-shi, Aichi-ken, Japan
National Hospital Organization Hirosaki General Medical Center /ID# 164252
Hirosaki-shi, Aomori, Japan
Tokatsu Tsujinaka Hospital /ID# 164438
Abiko-shi, Chiba, Japan
Chiba University Hospital /ID# 209632
Chiba, Chiba, Japan
Tsujinaka Hospital Kashiwanoha /ID# 208964
Kashiwa-shi, Chiba, Japan
Toho University Sakura Medical Center /ID# 164254
Sakura-shi, Chiba, Japan
Fukuoka University Chikushi Hospital /ID# 209055
Chikushino-shi, Fukuoka, Japan
Saiseikai Fukuoka Genaral Hospital /ID# 225639
Fukuoka, Fukuoka, Japan
Fukuoka University Hospital /ID# 226189
Fukuoka, Fukuoka, Japan
Kurume University Hospital /ID# 164427
Kurume-shi, Fukuoka, Japan
Gifu University Hospital /ID# 208081
Gifu, Gifu, Japan
Ogaki Municipal Hospital /ID# 226010
Ogaki-shi, Gifu, Japan
National Hospital Organization Takasaki General Medical Center /ID# 164437
Takasaki-shi, Gunma, Japan
NHO Fukuyama Medical Center /ID# 164439
Fukuyama-shi, Hiroshima, Japan
Hiroshima University Hospital /ID# 164426
Hiroshima, Hiroshima, Japan
Asahikawa Medical University Hospital /ID# 164433
Asahikawa-shi, Hokkaido, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164251
Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital /ID# 164432
Sapporo, Hokkaido, Japan
Sapporo IBD Clinic /ID# 225923
Sapporo, Hokkaido, Japan
Sapporo Higashi Tokushukai Hospital /ID# 208488
Sapporo, Hokkaido, Japan
Aoyama Clinic /ID# 164425
Kobe, Hyōgo, Japan
Hyogo Medical University Hospital /ID# 164424
Nishinomiya-shi, Hyōgo, Japan
Kanazawa University Hospital /ID# 169224
Kanazawa, Ishikawa-ken, Japan
Sameshima Hospital /ID# 211181
Kagoshima, Kagoshima-ken, Japan
Tokai University Hospital /ID# 209204
Isehara-shi, Kanagawa, Japan
Gokeikai Ofuna Chuo Hospital /ID# 169300
Kamakura-shi, Kanagawa, Japan
St. Marianna University Hospital /ID# 226728
Kawasaki-shi, Kanagawa, Japan
Kitasato University Hospital /ID# 169226
Sagamihara-shi, Kanagawa, Japan
Colo-proctology Center Matsushima Clinic /ID# 225914
Yokohama, Kanagawa, Japan
Showa University Fujigaoka Hospital /ID# 209555
Yokohama, Kanagawa, Japan
Mie University Hospital /ID# 203633
Tsu, Mie-ken, Japan
Yokkaichi Hazu Medical Center /ID# 164441
Yokkaichi-shi, Mie-ken, Japan
Tohoku University Hospital /ID# 164430
Sendai, Miyagi, Japan
Nagasaki University Hospital /ID# 202674
Nagasaki, Nagasaki, Japan
Nara Medical University Hospital /ID# 169225
Kashihara-shi, Nara, Japan
Kinshukai Infusion Clinic /ID# 226747
Osaka, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital /ID# 226035
Takatsuki-shi, Osaka, Japan
Saga University Hospital /ID# 209396
Saga, Saga-ken, Japan
Tokitokai Tokito clinic /ID# 164253
Saitama-shi, Saitama, Japan
Shiga University of Medical Science Hospital /ID# 164440
Ōtsu, Shiga, Japan
Hamamatsu University Hospital /ID# 226727
Hamamatsu, Shizuoka, Japan
Matsuda Hospital /ID# 226616
Hamamatsu, Shizuoka, Japan
NHO Shizuoka Medical Center /ID# 164435
Sunto-gun, Shizuoka, Japan
Tokyo Medical And Dental University Hospital /ID# 164258
Bunkyo-ku, Tokyo, Japan
St.Luke's International Hospital /ID# 225822
Chuo-ku, Tokyo, Japan
Tokai University Hachioji Hospital /ID# 226899
Hachioji-shi, Tokyo, Japan
Teikyo University Hospital /ID# 225588
Itabashi-ku, Tokyo, Japan
The Jikei University Hospital /ID# 164434
Minato-ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital /ID# 164256
Minato-ku, Tokyo, Japan
Kyorin University Hospital /ID# 164259
Mitaka-shi, Tokyo, Japan
NTT Medical Center Tokyo /ID# 225587
Shinagawa-ku, Tokyo, Japan
Keio University Hospital /ID# 203629
Shinjuku-ku, Tokyo, Japan
Japanese Red Cross Wakayama Medical Center /ID# 171195
Wakayama, Wakayama, Japan
Wakayama Medical University Hospital /ID# 169487
Wakayama, Wakayama, Japan
Yamagata University Hospital /ID# 171474
Yamagata, Yamagata, Japan
Tokuyama Central Hospital /ID# 226011
Shunan-shi, Yamaguchi, Japan
VCA Polyclinic Aura /ID# 163802
Riga, , Latvia
Pauls Stradins Clinical University Hospital /ID# 163803
Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 170714
Kaunas, , Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 170614
Vilnius, , Lithuania
Universiti Sains Malaysia /ID# 221971
Kelantan, Kelantan, Malaysia
JM Research SC /ID# 203593
Cuernavaca, Morelos, Mexico
Unidad de Atencion Medica e Investigacion en Salud /ID# 203595
Mérida, Yucatán, Mexico
Health Pharma Professional Research S.A de C.V /ID# 203597
Del. Benito Juárez, , Mexico
Academisch Medisch Centrum /ID# 157959
Amsterdam, , Netherlands
Elisabeth Tweesteden Ziekenhuis /ID# 163767
Tilburg, , Netherlands
Tauranga Hospital /ID# 212792
Tauranga South, Bay of Plenty, New Zealand
Christchurch Hospital /ID# 205342
Christchurch, Canterbury, New Zealand
Dunedin Hospital /ID# 212790
Otago, Otago, New Zealand
Waikato Hospital /ID# 212789
Hamilton, Waikato Region, New Zealand
Wellington Regional Hospital /ID# 205343
Newtown, Wellington Region, New Zealand
Hutt Hospital /ID# 212786
Lower Hutt, , New Zealand
Vitamed Gałaj i Cichomski Sp.j. /ID# 213283
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Gastromed Sp. z o.o /ID# 230978
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne Plejady /ID# 170633
Krakow, Lesser Poland Voivodeship, Poland
Vistamed /ID# 210105
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Zdrowia MDM /ID# 170597
Warsaw, Masovian Voivodeship, Poland
WIP Warsaw IBD Point Profesor Kierkus /ID# 216102
Warsaw, Masovian Voivodeship, Poland
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 170601
Warsaw, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Panstwowy Instytut Bada /ID# 170600
Warsaw, Masovian Voivodeship, Poland
NZOZ Vivamed Jadwiga Miecz /ID# 216307
Warsaw, Masovian Voivodeship, Poland
Endoskopia Sp. z o.o. /ID# 170598
Sopot, Pomeranian Voivodeship, Poland
NZOZ All-Medicus /ID# 170596
Katowice, Silesian Voivodeship, Poland
H-T. Centrum Medyczne - Endoterapia /ID# 230979
Tychy, Silesian Voivodeship, Poland
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 165580
Guimarães, Braga District, Portugal
Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166551
Portimão, Faro District, Portugal
Centro Hospitalar de Entre Douro e Vouga /ID# 166052
Santa Maria DA Feira, Porto District, Portugal
Hospital Garcia de Orta, EPE /ID# 165583
Almada, , Portugal
Centro Hospitalar e Universitario de Coimbra, EPE /ID# 166054
Coimbra, , Portugal
Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 165582
Lisbon, , Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 165581
Porto, , Portugal
Centro Hosp de Tondela-Viseu /ID# 166053
Viseu, , Portugal
Ponce Medical School Foundation /ID# 221244
Ponce, , Puerto Rico
San Jorge Children Hospital /ID# 166954
San Juan, , Puerto Rico
VA Caribbean Healthcare System /ID# 221245
San Juan, , Puerto Rico
Clinica GASTRO MED SRL /ID# 224169
Cluj-Napoca, Cluj, Romania
Sana Monitoring /Id# 224166
Bucharest, , Romania
Fundeni Clinical Institute /ID# 171264
Bucharest, , Romania
Fundeni Clinical Institute /ID# 224168
Bucharest, , Romania
Cabinet Particular Policlinic Algomed /ID# 171266
Timișoara, , Romania
Duplicate_Centrul Medical Tuculanu SRL /ID# 171268
Timișoara, , Romania
Interdisctrict Multidisciplinary Hospital /ID# 203335
Anzorey, Kabardino-Balkarskaya Respublika, Russia
GBUZ Allergology and Immunology Center of Ministry of Health of Kabardino-Bal /ID# 233973
Nal'chik, Kabardino-Balkarskaya Respublika, Russia
Immanuel Kant Baltic Federal University /ID# 204888
Kaliningrad, Kaliningrad Oblast, Russia
Kuzbass Regional Clinical Hospital /ID# 165750
Kemerovo, Kemerovo Oblast, Russia
Uninova Medical Center /ID# 229216
Saint Petersburg, Leningradskaya Oblast', Russia
Arsvita Clinic /ID# 208946
Korolyov, Moscow Oblast, Russia
Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227457
Perm, Permskiy Kray, Russia
City Clinical Hospital #40 /ID# 203370
Sestroretsk, Sankt-Peterburg, Russia
Regional Clinical Hospital #1 /ID# 165754
Tyumen, Tyumen Oblast, Russia
Clinic of New Technologies of Medicine /ID# 203369
Dzerzhinskiy, , Russia
First Moscow State Medical University n.a I.M. Sechenov /ID# 204978
Moscow, , Russia
National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203512
Moscow, , Russia
Central Clinical Hospital RZHD Medicine /ID# 204917
Moscow, , Russia
Novosibirski Gastrocenter /ID# 229855
Novosibirsk, , Russia
Euromedservice /ID# 204892
Pushkin, , Russia
International Medical Center SOGAZ /ID# 206727
Saint Petersburg, , Russia
Ulyanovsk Regional Clinical Hospital /ID# 203368
Ulyanovsk, , Russia
Clinical Hosp Center Zvezdara /ID# 200151
Belgrade, Beograd, Serbia
University Clinical Center Serbia /ID# 200152
Belgrade, Beograd, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 202059
Belgrade, Beograd, Serbia
Clinical Center Vojvodina /ID# 156910
Novi Sad, Vojvodina, Serbia
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224926
Belgrade, , Serbia
General Hospital Leskovac /ID# 207226
Leskovac, , Serbia
KL Ling Gastroenterology and Liver Clinic /ID# 205738
Singapore, , Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164347
Banská Bystrica, , Slovakia
KM Management, spol. s.r.o. /ID# 206602
Nitra, , Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224099
Nové Zámky, , Slovakia
GASTRO I., s.r.o. /ID# 164346
Prešov, , Slovakia
Univ Medical Ctr Ljubljana /ID# 210627
Ljubljana, , Slovenia
Farmovs (Pty) Ltd /Id# 207537
Bloemfontein, Free State, South Africa
Clinresco Centers /ID# 239824
Johannesburg, Gauteng, South Africa
Allergy & Immunology (AIU) /ID# 171441
Cape Town, Western Cape, South Africa
Dr JP Wright /ID# 171138
Cape Town, Western Cape, South Africa
Private Practice Dr MN Rajabally /ID# 171137
Cape Town, Western Cape, South Africa
Spoke Research Inc /ID# 229905
CAPE TOWN Milnerton, Western Cape, South Africa
Hanyang University Gurihospital /ID# 158702
Guri-si, Gyeonggido, South Korea
CHA University Bundang Medical Center /ID# 158710
Seongnam-si, Gyeonggido, South Korea
The Catholic University of Korea, ST. Vincent's Hospital /ID# 158706
Suwon, Gyeonggido, South Korea
Kangbuk Samsung Hospital /ID# 158707
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 158701
Seoul, Seoul Teugbyeolsi, South Korea
Inje University Haeundae Hospital /ID# 203028
Busan, , South Korea
Dong-A University Hospital /ID# 158705
Busan, , South Korea
Pusan National University Hospital /ID# 158711
Busan, , South Korea
Yeungnam University Medical Center /ID# 158703
Daegu, , South Korea
The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 242378
Daejeon, , South Korea
Samsung Medical Center /ID# 158704
Seoul, , South Korea
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159440
Ferrol, A Coruna, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159461
Sabadell, Barcelona, Spain
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 159443
Majadahonda, Madrid, Spain
Hospital Alvaro Cunqueiro CHUVI /ID# 167360
Vigo, Pontevedra, Spain
Hospital de Cabuenes /ID# 170748
Gijón, Principality of Asturias, Spain
Hospital Clinic de Barcelona /ID# 159439
Barcelona, , Spain
Hospital Universitario Reina Sofia /ID# 167058
Córdoba, , Spain
Hospital Universitario La Paz /ID# 159459
Madrid, , Spain
Complejo Hospitalario Universitario de Pontevedra /ID# 216182
Pontevedra, , Spain
Hospital Universitario de Salamanca /ID# 159446
Salamanca, , Spain
Hospital Universitario Virgen Macarena /ID# 159968
Seville, , Spain
Hospital Universitario Miguel Servet /ID# 159445
Zaragoza, , Spain
Alingsas lasarett /ID# 202074
Alingsås, Västra Götaland County, Sweden
Sahlgrenska University Hospital Molndal /ID# 202843
Mölndal, Västra Götaland County, Sweden
Danderyds sjukhus AB /ID# 202035
Stockholm, , Sweden
Universitatsspital Zurich /ID# 202910
Zurich, Canton of Zurich, Switzerland
Inselspital, Universitätsspital Bern /ID# 202911
Bern, , Switzerland
Chung Shan Medical University Hospital /ID# 163651
Taichung, , Taiwan
China Medical University Hospital /ID# 160189
Taichung, , Taiwan
Taichung Veterans General Hospital /ID# 163649
Taichung, , Taiwan
National Taiwan University Hospital /ID# 162187
Taipei, , Taiwan
Taipei Veterans General Hosp /ID# 163650
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 222877
Taoyuan, , Taiwan
Acibadem Kozyatagi Hospital /ID# 213276
Kadıköy, Istanbul, Turkey (Türkiye)
Erciyes University Medical Fac /ID# 171291
Melikgazi, Kayseri, Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 167210
Ankara, , Turkey (Türkiye)
Inonu Universitesi Turgut Ozal /ID# 203981
Battalgazi/malatya, , Turkey (Türkiye)
Uludag University Medical Faculty /ID# 204182
Bursa, , Turkey (Türkiye)
Fırat University Medical Facul /ID# 171292
Elâzığ, , Turkey (Türkiye)
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 167207
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171293
Istanbul, , Turkey (Türkiye)
Sisli Etfal Train & Res Hosp /ID# 171409
Şişli, , Turkey (Türkiye)
CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203367
Ivano-Frankivsk, , Ukraine
Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224350
Kherson, , Ukraine
Kyiv Municipal Clinical Hospital #18 /ID# 224348
Kyiv, , Ukraine
Medical Center "OK!Clinic+" /ID# 205482
Kyiv, , Ukraine
CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224343
Kyiv, , Ukraine
Royal Devon University Healthcare NHS Foundation Trust /ID# 157587
Exeter, Devon, United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 210813
Southampton, Hampshire, United Kingdom
Barts Health NHS Trust /ID# 157590
London, London, City of, United Kingdom
Barnsley Hospital NHS Foundation Trust /ID# 202770
Barnsley, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust /ID# 158040
Cambridge, , United Kingdom
NHS Lothian /ID# 208802
Edinburgh, , United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 203858
Liverpool, , United Kingdom
King's College Hospital NHS Foundation Trust /ID# 158766
London, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158041
Newcastle upon Tyne, , United Kingdom
St George's University Hospitals NHS Foundation Trust /ID# 208378
Tooting, , United Kingdom
Countries
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References
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Panaccione R, Melmed GY, Drobne D, Kaur M, Danese S, Hisamatsu T, Kalabic J, Chen S, Cheng L, Duan WR, Shah S, Louis E. Impact of Extended Risankizumab Treatment in Patients With Ulcerative Colitis Who Did Not Respond to Induction Treatment. Clin Gastroenterol Hepatol. 2025 Sep 13:S1542-3565(25)00797-9. doi: 10.1016/j.cgh.2025.09.007. Online ahead of print.
Reinisch W, Loftus EV Jr, Schreiber S, Rubin DT, Louis E, Hecht PM, Barrachina EM, Kalabic J, Vladea R, Sharma D, Duan WR, Zhang Y, Panaccione R. Corticosteroid-sparing effects of risankizumab efficacy and safety in patients with moderately to severely active ulcerative colitis. J Crohns Colitis. 2025 Apr 4;19(4):jjaf025. doi: 10.1093/ecco-jcc/jjaf025.
Panaccione R, Louis E, Colombel JF, D'Haens G, Peyrin-Biroulet L, Dubinsky M, Takeuchi K, Rubin DT, Kalabic J, Chien KB, Chen S, Cheng L, Zhang Y, Duan WR, Vladea R, Hecht PM, Morisset P, Schreiber S, Ferrante M. Risankizumab efficacy and safety based on prior inadequate response or intolerance to advanced therapy: post hoc analysis of the INSPIRE and COMMAND phase 3 studies. J Crohns Colitis. 2025 Jan 11;19(1):jjaf005. doi: 10.1093/ecco-jcc/jjaf005.
Louis E, Schreiber S, Panaccione R, Bossuyt P, Biedermann L, Colombel JF, Parkes G, Peyrin-Biroulet L, D'Haens G, Hisamatsu T, Siegmund B, Wu K, Boland BS, Melmed GY, Armuzzi A, Levine P, Kalabic J, Chen S, Cheng L, Shu L, Duan WR, Pivorunas V, Sanchez Gonzalez Y, D'Cunha R, Neimark E, Wallace K, Atreya R, Ferrante M, Loftus EV Jr; INSPIRE and COMMAND Study Group. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials. JAMA. 2024 Sep 17;332(11):881-897. doi: 10.1001/jama.2024.12414.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2016-004677-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-067
Identifier Type: -
Identifier Source: org_study_id
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