A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
NCT ID: NCT03398135
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1242 participants
INTERVENTIONAL
2018-08-28
2029-02-28
Brief Summary
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This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Substudy 1: Double-blind Placebo
Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.
placebo for risankizumab
subcutaneous (SC) injection
Substudy 1: Double-blind Risankizumab Dose 1
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
risankizumab
subcutaneous (SC) injection
Substudy 1: Double-blind Risankizumab Dose 2
Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.
risankizumab
subcutaneous (SC) injection
Substudy 2: Open-label (OL) Clinical Assessment Risankizumab
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
risankizumab
subcutaneous (SC) injection
Substudy 2: OL Therapeutic Drug Monitoring Risankizumab
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
risankizumab
subcutaneous (SC) injection
Substudy 3: OL Extension Risankizumab
Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.
risankizumab
subcutaneous (SC) injection
OL Continuous Treatment Extension - Dose 1
Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection.
risankizumab
subcutaneous (SC) injection
OL Continuous Treatment Extension - Dose 2
Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection.
risankizumab
subcutaneous (SC) injection
Interventions
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risankizumab
subcutaneous (SC) injection
placebo for risankizumab
subcutaneous (SC) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
* Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.
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# 169659
Coronado, California, United States
Hoag Memorial Hosp Presbyterian /ID# 218347
Irvine, California, United States
UC San Diego Health System /ID# 160430
La Jolla, California, United States
United Medical Doctors /ID# 158574
Los Alamitos, California, United States
Cedars-Sinai Medical Center /ID# 163848
Los Angeles, California, United States
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934
Los Angeles, California, United States
UCSF Medical Center - Mount Zion /ID# 201209
San Francisco, California, United States
Peak Gastroenterology Associates, PC /ID# 165838
Colorado Springs, Colorado, United States
Rocky Mountain Pediatric Gastroenterology /ID# 207173
Lone Tree, Colorado, United States
Duplicate_Medical Research Center of CT /ID# 160287
Hamden, Connecticut, United States
Yale Univ Digestive Diseases /ID# 213265
New Haven, Connecticut, United States
South Lake Pain Institute, Inc /ID# 162859
Clermont, Florida, United States
Ctr for Advanced Gastroenterol /ID# 202820
Maitland, Florida, United States
University of Miami /ID# 160456
Miami, Florida, United States
Coral Research Clinic /ID# 158608
Miami, Florida, United States
South Florida Research Ph I-IV, Inc. /ID# 161844
Miami, Florida, United States
Gastroenterology Group Naples /ID# 165210
Naples, Florida, United States
Advanced Research Institute, Inc /ID# 161945
New Port Richey, Florida, United States
Advent Health /ID# 160393
Orlando, Florida, United States
Endoscopic Research, Inc. /ID# 206709
Orlando, Florida, United States
Omega Research Group /ID# 203105
Orlando, Florida, United States
Duplicate_Lenus Research & Medical Group /ID# 169727
Sweetwater, Florida, United States
Clinical Research Trials of Florida, Inc. /ID# 201794
Tampa, Florida, United States
Duplicate_AdventHealth Tampa /ID# 170482
Tampa, Florida, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 160513
Macon, Georgia, United States
The University of Chicago Medical Center /ID# 160511
Chicago, Illinois, United States
DM Clinical Research/Southwest /ID# 165009
Oak Lawn, Illinois, United States
Indiana University /ID# 167250
Indianapolis, Indiana, United States
Univ Kansas Med Ctr /ID# 226601
Kansas City, Kansas, United States
Cotton O'Neil Clinical Research Center, Digestive Health /ID# 160367
Topeka, Kansas, United States
Duplicate_Robley Rex VA Medical Center /ID# 218647
Louisville, Kentucky, United States
Houma Digestive Health Special /ID# 158377
Houma, Louisiana, United States
Delricht Research /ID# 206817
New Orleans, Louisiana, United States
Nola Research Works, LLC /ID# 161356
New Orleans, Louisiana, United States
Louisiana Research Center, LLC /ID# 201205
Shreveport, Louisiana, United States
Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164257
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 159430
Ann Arbor, Michigan, United States
Clin Res Inst of Michigan, LLC /ID# 160300
Chesterfield, Michigan, United States
Mayo Clinic - Rochester /ID# 200455
Rochester, Minnesota, United States
Quality Clinical Research Inc. /ID# 167312
Omaha, Nebraska, United States
Weill Cornell Medicine /ID# 165884
New York, New York, United States
Columbia Univ Medical Center /ID# 161929
New York, New York, United States
Lenox Hill Hospital /ID# 168469
New York, New York, United States
Manhattan Clinical Research, LLC /ID# 211803
New York, New York, United States
Duplicate_DiGiovanna Institute for Medical Education & Research /ID# 171128
North Massapequa, New York, United States
Duplicate_University of Rochester Medical Center /ID# 161660
Rochester, New York, United States
Atrium Health Carolinas Medical Center /ID# 158543
Charlotte, North Carolina, United States
Plains Clinical Research Center, LLC /ID# 169729
Fargo, North Dakota, United States
Cleveland Clinic Main Campus /ID# 209235
Cleveland, Ohio, United States
The Ohio State University /ID# 164713
Columbus, Ohio, United States
Optimed Research, Ltd. /ID# 167112
Columbus, Ohio, United States
Great Lakes Gastroenterology Research, LLC /ID# 201778
Mentor, Ohio, United States
ProMedica Physicians Digestive Healthcare /ID# 215622
Sylvania, Ohio, United States
Digestive Disease Specialists /ID# 170777
Oklahoma City, Oklahoma, United States
Adult Gastroenterology Associates - Gen 1 Research /ID# 208873
Tulsa, Oklahoma, United States
Penn State Milton S. Hershey Medical Center /ID# 230474
Hershey, Pennsylvania, United States
University of Pennsylvania /ID# 166262
Philadelphia, Pennsylvania, United States
Digestive Disease Associates, LTD - Wyomissing /ID# 232406
Wyomissing, Pennsylvania, United States
Gastroenterology Associates, P.A. of Greenville /ID# 160457
Greenville, South Carolina, United States
Gastro One /ID# 160373
Cordova, Tennessee, United States
Duplicate_East Tennessee Research Institute /ID# 168744
Johnson City, Tennessee, United States
Vanderbilt University Medical Center /ID# 160567
Nashville, Tennessee, United States
Inquest Clinical Research /ID# 165686
Baytown, Texas, United States
Texas Digestive Disease Consultants /ID# 209951
Cedar Park, Texas, United States
GI Alliance /ID# 209799
Cedar Park, Texas, United States
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 158235
Garland, Texas, United States
Vilo Research Group Inc /ID# 207657
Houston, Texas, United States
Baylor College of Medicine /ID# 158230
Houston, Texas, United States
Centex Studies, Inc. - Houston /ID# 201221
Houston, Texas, United States
Duplicate_Caprock Gastro Research, LLC /ID# 215433
Lubbock, Texas, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 161364
San Antonio, Texas, United States
Southern Star Research Institute, LLC /ID# 168774
San Antonio, Texas, United States
Baylor Scott & White Center for Diagnostic Medicine /ID# 204132
Temple, Texas, United States
Tyler Research Institute, LLC /ID# 166799
Tyler, Texas, United States
Gastro Health & Nutrition - Victoria /ID# 164308
Victoria, Texas, United States
Advanced Research Institute /ID# 160465
Ogden, Utah, United States
Gastroenterology Consultants of Southwest Virginia /ID# 218142
Roanoke, Virginia, United States
Virginia Mason Hospital & Medical Center /ID# 160432
Seattle, Washington, United States
Cemic /Id# 167805
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Gedyt /ID# 243424
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Hospital Provincial del Centenario /ID# 170896
Rosario, Santa Fe Province, Argentina
Sanatorio 9 de Julio /ID# 167803
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 167802
Córdoba, , Argentina
Duplicate_Universitaetsklinikum St.Poelten /ID# 169049
Sankt Pölten, Lower Austria, Austria
Duplicate_Medizinische Universitaet Graz /ID# 169052
Graz, Styria, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 216043
Linz, Upper Austria, Austria
Medizinische Universitaet Wien /ID# 169051
Vienna, Vienna, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 200686
Salzburg, , Austria
Imelda Ziekenhuis /ID# 211101
Bonheiden, Antwerpen, Belgium
Universite Libre de Bruxelles - Hopital Erasme /ID# 200256
Anderlecht, Brussels Capital, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 200260
Brussels, Brussels Capital, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 200255
Liège, Liege, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 200259
Yvoir, Namur, Belgium
Universitair Ziekenhuis Leuven /ID# 170829
Leuven, Vlaams-Brabant, Belgium
AZ-Delta /ID# 200258
Roeselare, West-Vlaanderen, Belgium
CHU de Liege /ID# 200257
Liège, , Belgium
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157683
Goiânia, Goiás, Brazil
Faculdade de Medicina do ABC /ID# 163993
Santo André, La Spezia, Brazil
Hospital Nossa Senhora das Graças /ID# 157677
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre /ID# 157670
Porto Alegre, Rio Grande do Sul, Brazil
Upeclin Fmb - Unesp /Id# 157691
Botucatu, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 157668
Ribeirão Preto, São Paulo, Brazil
Kaiser Clinica e Hospital Dia /ID# 157686
São José do Rio Preto, São Paulo, Brazil
Hospital Tsaritsa Yoanna /ID# 209978
Sofiya, Sofia, Bulgaria
Umbal Kaspela /ID# 200795
Plovdiv, , Bulgaria
MHAT Hadzhi Dimitar /ID# 207947
Sliven, , Bulgaria
Duplicate_Second MHAT Sofia /ID# 200794
Sofia, , Bulgaria
UMHAT Sveti Ivan Rilski /ID# 210798
Sofia, , Bulgaria
Duplicate_University of Calgary /ID# 169125
Calgary, Alberta, Canada
Allen Whey Khye Lim Professional Corporation /ID# 169770
Edmonton, Alberta, Canada
Covenant Health /ID# 169128
Edmonton, Alberta, Canada
Fraser Clinical Trials Inc /ID# 169116
New Westminster, British Columbia, Canada
Percuro Clinical Research, Ltd /ID# 169123
Victoria, British Columbia, Canada
London Health Sciences Center- University Hospital /ID# 169117
London, Ontario, Canada
Scott Shulman Medicine Professional Corporation /ID# 169127
North Bay, Ontario, Canada
Toronto Digestive Disease Associates /ID# 169120
Vaughan, Ontario, Canada
Hotel Dieu de Levis /ID# 214379
Lévis, Quebec, Canada
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169122
Montreal, Quebec, Canada
Montreal General Hospital- McGill University Health Center /ID# 169118
Montreal, Quebec, Canada
Hospital Guillermo Grant Benavente de Concepción /ID# 210762
Concepción, Bio-Bio, Chile
Hospital Las Higueras /ID# 167094
Talcahuano, Bio-Bio, Chile
Duplicate_Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213152
Victoria, Región de la Araucanía, Chile
Complejo Asistencial Dr. Sotero del Rio /ID# 169386
Santiago, Santiago Metropolitan, Chile
The First Affiliated Hospital of Anhui Medical University /ID# 211227
Hefei, Anhui, China
Beijing Friendship Hospital /ID# 211061
Beijing, Beijing Municipality, China
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 211229
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University /ID# 213019
Shijiazhuang, Hebei, China
Tongji Hospital Tongji Medical College of HUST /ID# 211069
Wuhan, Hubei, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211070
Wuhan, Hubei, China
Renmin Hospital of Wuhan University /ID# 212867
Wuhan, Hubei, China
The Second Xiangya Hospital Of Central South University /ID# 211196
Changsha, Hunan, China
Huai'an First People's Hospital /ID# 239197
Huaian, Jiangsu, China
Nanjing Drum Tower Hospital /ID# 227438
Nanjing, Jiangsu, China
Jiangsu Province Hospital /ID# 211234
Nanjing, Jiangsu, China
Wuxi People's Hospital /ID# 218797
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 212182
Nanchang, Jiangxi, China
The First Hospital of Jilin University /ID# 212277
Changchun, Jilin, China
Shengjing Hospital of China Medical University /ID# 211643
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University /ID# 213912
Yinchuan, Ningxia, China
Xijing Hospital /ID# 210708
Xi'an, Shaanxi, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210960
Shanghai, Shanghai Municipality, China
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211230
Shanghai, Shanghai Municipality, China
Shanghai East Hospital /ID# 218796
Shanghai, Shanghai Municipality, China
Shanghai General Hospital /ID# 226652
Shanghai, Shanghai Municipality, China
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215505
Xi’an, Shanxi, China
West China Hospital, Sichuan University /ID# 211275
Chengdu, Sichuan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 211024
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 211062
Hangzhou, Zhejiang, China
Fundación Hospitalaria San Vicente de Paul /ID# 171488
Medellín, Antioquia, Colombia
Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 158736
Bogota DC, Cundinamarca, Colombia
Imat Oncomedica /ID# 207041
Montería, Departamento de Córdoba, Colombia
Clinical Hospital Dubrava /ID# 157598
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 157594
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 201915
Zagreb, City of Zagreb, Croatia
Poliklinika Borzan d.o.o. /ID# 157595
Osijek, County of Osijek-Baranja, Croatia
Klinicki Bolnicki Centar (KBC) Split /ID# 157596
Split, Split-Dalmatia County, Croatia
Duplicate_Fakultni nemocnice u sv. Anny v Brne /ID# 239158
Brno, Brno-mesto, Czechia
Fakultni Nemocnice Ostrava /ID# 225568
Ostrava, Ostrava-mesto, Czechia
SurGal Clinic /ID# 252300
Brno, South Moravian, Czechia
Nemocnice Ceske Budejovice a.s. /ID# 225228
České Budějovice, , Czechia
Hepato-Gastroenterologie HK, s.r.o. /ID# 163389
Hradec Králové, , Czechia
Bispebjerg and Frederiksberg Hospital /ID# 208953
Copenhagen NV, Capital Region, Denmark
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 205093
Hvidovre, Capital Region, Denmark
Duplicate_Sjællands Universitetshospital /ID# 200073
Roskilde, Region Sjælland, Denmark
Duplicate_Odense Universitets Hospital /ID# 209502
Odense C, Region Syddanmark, Denmark
Alexandria University /ID# 226795
Alexandria, Alexandria Governorate, Egypt
Alexandria University /ID# 226796
Alexandria, Alexandria Governorate, Egypt
National Liver Institute /ID# 171042
Menoufiya, Monufia Governorate, Egypt
Duplicate_Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 201824
Alexandria, , Egypt
Air Force Specialized Hospital /ID# 170984
Cairo, , Egypt
Chu de Nice-Hopital Larchet Ii /Id# 207881
Nice, Alpes-Maritimes, France
APHM - Hopital Nord /ID# 225826
Marseille, Bouches-du-Rhone, France
CHU Montpellier - Hopital Saint Eloi /ID# 223781
Montpellier, Herault, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 207877
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Centre Hospitalier Universitaire de Bordeaux /ID# 207883
Pessac, Nouvelle-Aquitaine, France
Duplicate_CHU de SAINT ETIENNE - Hopital Nord /ID# 207882
Saint Priest EN Jarez, Pays de la Loire Region, France
Duplicate_CHU Amiens-Picardie Site Sud /ID# 207880
Amiens, Somme, France
Clinique Jules Verne /ID# 240977
Nantes, , France
Hopital Beaujon /ID# 207876
Clichy, Île-de-France Region, France
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249861
Neuilly-sur-Seine, Île-de-France Region, France
Universitaetsklinikum Freiburg /ID# 162038
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Praxis fuer Gastroenterologie /ID# 166154
Heidelberg, Baden-Wurttemberg, Germany
Universitatsklinikum Mannheim /ID# 162039
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm /ID# 164994
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen /ID# 159373
Erlangen, Bavaria, Germany
Duplicate_LMU Klinikum Campus Grosshadern /ID# 210484
Munich, Bavaria, Germany
Duplicate_Agaplesion Markus Krankenhaus /ID# 159375
Frankfurt am Main, Hesse, Germany
Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 163690
Kassel, Hesse, Germany
Klinikum Lueneburg /ID# 163692
Lüneburg, Lower Saxony, Germany
Universitaetsklinikum Koeln /ID# 164993
Cologne, North Rhine-Westphalia, Germany
Praxiszentrum fuer Gastroenterologie /ID# 219072
Grevenbroich, North Rhine-Westphalia, Germany
Gastroenterologische Gemeinschaftspraxis Minden /ID# 162037
Minden, North Rhine-Westphalia, Germany
Eugastro /ID# 219071
Leipzig, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159379
Kiel, Schleswig-Holstein, Germany
Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219146
Berlin, , Germany
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159380
Berlin, , Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 210508
Berlin, , Germany
DRK Kliniken Berlin Westend /ID# 166155
Berlin, , Germany
Stadtisches Klinikum Braunschweig /ID# 163694
Braunschweig, , Germany
Universitaetsklinikum Regensburg /ID# 163693
Regensburg, , Germany
General Hospital of Athens Ippokratio /ID# 229190
Athens, Attica, Greece
General Hospital of Athens Laiko /ID# 206438
Athens, Attica, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170910
Athens, Attica, Greece
General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 165313
Nikaia, Attica, Greece
Tzaneio general hospital of Piraeus /ID# 206437
Piraeus, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 165327
Heraklion, Crete, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217479
Athens, , Greece
Theageneio Anticancer Hospital /ID# 165329
Thessaloniki, , Greece
Shaare Zedek Medical Center /ID# 163543
Jerusalem, Jerusalem, Israel
Hadassah Medical Center-Hebrew University /ID# 171092
Jerusalem, Jerusalem, Israel
Soroka University Medical Center /ID# 171093
Beersheba, Southern District, Israel
The Chaim Sheba Medical Center /ID# 211279
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus /ID# 171096
Haifa, , Israel
Rabin Medical Center. /ID# 167402
Petah Tikva, , Israel
Ospedale San Martino /ID# 164030
Genoa, Genova, Italy
IRCCS Istituto Clinico Humanitas /ID# 155626
Rozzano, Lombardy, Italy
ASST Fatebenefratelli Sacco /ID# 155623
Milan, Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 170959
Milan, Milano, Italy
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211450
Rho, Milano, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158020
Rome, Roma, Italy
Azienda Ospedaliera San Camillo Forlanini /ID# 155628
Rome, Roma, Italy
Duplicate_Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 171223
Rome, Roma, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 164029
Negrar, Verona, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 155627
Bologna, , Italy
Ospedale Cannizzaro /ID# 164039
Catania, , Italy
Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 200124
Catanzaro, , Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 201818
Modena, , Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 163994
Roma, , Italy
UOC Medicina Interna e Gastroe /ID# 155624
Rome, , Italy
Aichi Medical University Hospital /ID# 164227
Nagakute, Aichi-ken, Japan
Daido Clinic - Nagoya /ID# 211478
Nagoya, Aichi-ken, Japan
Duplicate_Nagoya University Hospital /ID# 164230
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 164229
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital /ID# 164313
Toyoake, Aichi-ken, Japan
National Hospital Organization Hirosaki General Medical Center /ID# 164216
Hirosaki-shi, Aomori, Japan
Tokatsu Tsujinaka Hospital /ID# 164310
Abiko-shi, Chiba, Japan
Chiba University Hospital /ID# 209633
Chiba, Chiba, Japan
Tsujinaka Hospital - Kashiwanoha /ID# 225968
Kashiwa-shi, Chiba, Japan
Toho University Sakura Medical Center /ID# 164219
Sakura-shi, Chiba, Japan
Fukuoka University Chikushi Hospital /ID# 209056
Chikushino-shi, Fukuoka, Japan
Saiseikai Fukuoka Genaral Hospital /ID# 225640
Fukuoka, Fukuoka, Japan
Fukuoka University Hospital /ID# 226723
Fukuoka, Fukuoka, Japan
Kurume University Hospital /ID# 164237
Kurume-shi, Fukuoka, Japan
Gifu University Hospital /ID# 208490
Gifu, Gifu, Japan
Ogaki Municipal Hospital /ID# 226009
Ogaki-shi, Gifu, Japan
National Hospital Organization Takasaki General Medical Center /ID# 164312
Takasaki-shi, Gunma, Japan
National Hospital Organization Fukuyama Medical Center /ID# 164315
Fukuyama-shi, Hiroshima, Japan
Hiroshima University Hospital /ID# 164240
Hiroshima, Hiroshima, Japan
Duplicate_Asahikawa Medical University Hospital /ID# 164324
Asahikawa-shi, Hokkaido, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164215
Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital /ID# 164278
Sapporo, Hokkaido, Japan
Sapporo IBD Clinic /ID# 225967
Sapporo, Hokkaido, Japan
Sapporo Higashi Tokushukai Hospital /ID# 208493
Sapporo, Hokkaido, Japan
Aoyama Clinic /ID# 164236
Kobe, Hyōgo, Japan
Hyogo Medical University Hospital /ID# 164238
Nishinomiya-shi, Hyōgo, Japan
Kanazawa University Hospital /ID# 169221
Kanazawa, Ishikawa-ken, Japan
Sameshima Hospital /ID# 211182
Kagoshima, Kagoshima-ken, Japan
Tokai University Hospital /ID# 209207
Isehara, Kanagawa, Japan
Gokeikai Ofuna Chuo Hospital /ID# 169296
Kamakura-shi, Kanagawa, Japan
St Marianna University School Of Medicine /ID# 226730
Kawasaki-shi, Kanagawa, Japan
Kitasato University Hospital /ID# 169223
Sagamihara-shi, Kanagawa, Japan
Matsushima Hospital /ID# 254448
Yokohama, Kanagawa, Japan
Colo-proctology Center Matsushima Clinic /ID# 225915
Yokohama, Kanagawa, Japan
SHOWA Medical University Fujigaoka Hospital /ID# 209606
Yokohama, Kanagawa, Japan
Mie University Hospital /ID# 203635
Tsu, Mie-ken, Japan
Yokkaichi Hazu Medical Center /ID# 164316
Yokkaichi-shi, Mie-ken, Japan
Tohoku University Hospital /ID# 164276
Sendai, Miyagi, Japan
Duplicate_Nagasaki University Hospital /ID# 205326
Nagasaki, Nagasaki, Japan
Nara Medical University Hospital /ID# 169222
Kashihara-shi, Nara, Japan
Kinshukai Infusion Clinic /ID# 226992
Osaka, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital /ID# 226036
Takatsuki-shi, Osaka, Japan
Saga University Hospital /ID# 209273
Saga, Saga-ken, Japan
Tokitokai Tokito clinic /ID# 164218
Saitama-shi, Saitama, Japan
Shiga University of Medical Science Hospital /ID# 164323
Ōtsu, Shiga, Japan
Hamamatsu University Hospital /ID# 226729
Hamamatsu, Shizuoka, Japan
Matsuda Hospital - Hamamatsu /ID# 226831
Hamamatsu, Shizuoka, Japan
NHO Shizuoka Medical Center /ID# 164314
Sunto-gun, Shizuoka, Japan
Institute of Science Tokyo Hospital /ID# 164225
Bunkyo-ku, Tokyo, Japan
St. Lukes International Hospital /ID# 225969
Chuo-ku, Tokyo, Japan
Tokai University Hachioji Hospital /ID# 227102
Hachioji-shi, Tokyo, Japan
Kitasato University Kitasato Institute Hospital /ID# 164222
Minato-ku, Tokyo, Japan
Kyorin University Hospital /ID# 164226
Mitaka-shi, Tokyo, Japan
NTT Medical Center Tokyo /ID# 225595
Shinagawa-ku, Tokyo, Japan
Keio University Hospital /ID# 203630
Shinjuku-ku, Tokyo, Japan
Japanese Red Cross Wakayama Medical Center /ID# 171196
Wakayama, Wakayama, Japan
Wakayama Medical University Hospital /ID# 169485
Wakayama, Wakayama, Japan
Yamagata University Hospital /ID# 171481
Yamagata, Yamagata, Japan
Tokuyama Central Hospital /ID# 226857
Shunan-shi, Yamaguchi, Japan
The Jikei University Hospital /ID# 164279
Tokyo, , Japan
Teikyo University Hospital /ID# 225594
Tokyo, , Japan
VCA Polyclinic Aura /ID# 160204
Riga, , Latvia
Pauls Stradins Clinical University Hospital /ID# 160205
Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 201142
Kaunas, , Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 201144
Vilnius, , Lithuania
JM Research SC /ID# 206518
Cuernavaca, Morelos, Mexico
Unidad de Atencion Medica e Investigacion en Salud /ID# 206515
Mérida, Yucatán, Mexico
Health Pharma Professional Research S.A de C.V /ID# 206516
Del. Benito Juárez, , Mexico
Elisabeth Tweesteden Ziekenhuis /ID# 163738
Tilburg, North Brabant, Netherlands
Amsterdam UMC, locatie AMC /ID# 157965
Amsterdam, North Holland, Netherlands
Tauranga Hospital /ID# 212793
Tauranga South, Bay of Plenty, New Zealand
Christchurch Hospital. /ID# 205337
Christchurch, Canterbury, New Zealand
Dunedin Hospital /ID# 212791
Otago, Otago, New Zealand
Waikato Hospital /ID# 212788
Hamilton, Waikato Region, New Zealand
Hutt Hospital /ID# 212787
Lower Hutt, Wellington Region, New Zealand
Wellington Regional Hospital /ID# 205338
Newtown, Wellington Region, New Zealand
Vitamed Galaj i Cichomski Sp.j. /ID# 213358
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Gastromed Sp. z o.o /ID# 231065
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne Plejady /ID# 170635
Krakow, Lesser Poland Voivodeship, Poland
Vistamed /ID# 210106
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Zdrowia MDM /ID# 170283
Warsaw, Masovian Voivodeship, Poland
Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 216103
Warsaw, Masovian Voivodeship, Poland
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 170286
Warsaw, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie Panstwowy Instytut Bada /ID# 170285
Warsaw, Masovian Voivodeship, Poland
Vivamed Sp. z o.o. /ID# 216308
Warsaw, Masovian Voivodeship, Poland
Endoskopia Sp. z o.o. /ID# 170284
Sopot, Pomeranian Voivodeship, Poland
NZOZ All-Medicus /ID# 170282
Katowice, Silesian Voivodeship, Poland
H-T Centrum Medyczne Endoterapia /ID# 231501
Tychy, Silesian Voivodeship, Poland
Centro Hospitalar Do Alto Ave - Hospital Senhora Da Oliveira /ID# 165576
Guimarães, Braga District, Portugal
Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166563
Portimão, Faro District, Portugal
Centro Hospitalar de Entre Douro e Vouga /ID# 166048
Santa Maria DA Feira, Porto District, Portugal
Duplicate_Hospital Garcia de Orta, EPE /ID# 165579
Almada, Setúbal District, Portugal
Unidade Local de Saude de Coimbra, EPE /ID# 166050
Coimbra, , Portugal
Duplicate_Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Cap /ID# 165578
Lisbon, , Portugal
Unidade Local de Saude Sao Joao, EPE /ID# 165577
Porto, , Portugal
Centro Hosp de Tondela-Viseu /ID# 166049
Viseu, , Portugal
Ponce Medical School Foundation /ID# 222825
Ponce, , Puerto Rico
VA Caribbean Healthcare System /ID# 222779
San Juan, , Puerto Rico
Clinica Gastro Med SRL /ID# 224156
Cluj-Napoca, Cluj, Romania
Sana Monitoring /Id# 224154
Bucharest, , Romania
Fundeni Clinical Institute /ID# 171259
Bucharest, , Romania
Fundeni Clinical Institute /ID# 224155
Bucharest, , Romania
Cabinet Particular Policlinic Algomed /ID# 171260
Timișoara, , Romania
Duplicate_Centrul Medical Tuculanu SRL /ID# 171263
Timișoara, , Romania
Interdisctrict Multidisciplinary Hospital /ID# 204921
Anzorey, Kabardino-Balkarskaya Respublika, Russia
GBUZ Allergology and Immunology Center of Ministry of Health of Kabardino-Bal /ID# 233974
Nal'chik, Kabardino-Balkarskaya Respublika, Russia
Immanuel Kant Baltic Federal University /ID# 204920
Kaliningrad, Kaliningrad Oblast, Russia
Kuzbass Regional Clinical Hospital /ID# 165759
Kemerovo, Kemerovo Oblast, Russia
Uninova Medical Center /ID# 229786
Saint Petersburg, Leningradskaya Oblast', Russia
Arsvita Clinic /ID# 208947
Korolyov, Moscow Oblast, Russia
Novosibirski Gastrocenter /ID# 229852
Novosibirsk, Novosibirsk Oblast, Russia
Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227456
Perm, Permskiy Kray, Russia
City Clinical Hospital #40 /ID# 204927
Sestroretsk, Sankt-Peterburg, Russia
Regional Clinical Hospital #1 /ID# 165763
Tyumen, Tyumen Oblast, Russia
Clinic of New Technologies of Medicine /ID# 204926
Dzerzhinskiy, , Russia
First Moscow State Medical University n.a I.M. Sechenov /ID# 204981
Moscow, , Russia
National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203513
Moscow, , Russia
Central Clinical Hospital RZHD Medicine /ID# 204922
Moscow, , Russia
Euromedservice /ID# 204918
Pushkin, , Russia
International Medical Center SOGAZ /ID# 206832
Saint Petersburg, , Russia
Ulyanovsk Regional Clinical Hospital /ID# 204923
Ulyanovsk, , Russia
Clinical Hosp Center Zvezdara /ID# 200150
Belgrade, Beograd, Serbia
University Clinical Center Serbia /ID# 200153
Belgrade, Beograd, Serbia
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224927
Belgrade, Beograd, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 202060
Belgrade, Beograd, Serbia
General Hospital Leskovac /ID# 224198
Leskovac, Jablanicki Okrug, Serbia
Duplicate_Clinical Center Vojvodina /ID# 156876
Novi Sad, Vojvodina, Serbia
Mount Elizabeth Hospital /ID# 206563
Singapore, Central Singapore, Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164348
Banská Bystrica, Banská Bystrica Region, Slovakia
KM Management, spol. s.r.o. /ID# 206603
Nitra, Nitra Region, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224100
Nové Zámky, Nitra Region, Slovakia
Gastro I., s.r.o. /ID# 164345
Prešov, Presov, Slovakia
Univ Medical Ctr Ljubljana /ID# 210628
Ljubljana, , Slovenia
Farmovs (Pty) Ltd /Id# 207538
Bloemfontein, Free State, South Africa
Clinresco Centers /ID# 239825
Johannesburg, Gauteng, South Africa
Allergy & Immunology (AIU) /ID# 171439
Cape Town, Western Cape, South Africa
Dr JP Wright /ID# 171142
Cape Town, Western Cape, South Africa
Private Practice Dr MN Rajabally /ID# 171141
Cape Town, Western Cape, South Africa
Spoke Research Inc /ID# 229906
CAPE TOWN Milnerton, Western Cape, South Africa
Inje University Haeundae Hospital /ID# 203027
Busan, Busan Gwang Yeogsi, South Korea
Dong-A University Medical Center /ID# 158665
Busan, Busan Gwang Yeogsi, South Korea
Duplicate_Pusan National University Hospital /ID# 158670
Busan, Busan Gwang Yeogsi, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 242379
Daejeon, Daejeon Gwang Yeogsi, South Korea
Duplicate_Hanyang University Gurihospital /ID# 158661
Guri-si, Gyeonggido, South Korea
CHA Bundang Medical Center /ID# 158669
Seongnam, Gyeonggido, South Korea
The Catholic University Of Korea St. Vincent's Hospital /ID# 158664
Suwon, Gyeonggido, South Korea
Kangbuk Samsung Hospital /ID# 158666
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 158663
Seoul, Seoul Teugbyeolsi, South Korea
Yeungnam University Medical Center /ID# 158662
Daegu, , South Korea
Yonsei University Health System Severance Hospital /ID# 158660
Seoul, , South Korea
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159463
Ferrol, A Coruna, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159473
Sabadell, Barcelona, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 159466
Majadahonda, Madrid, Spain
Hospital Alvaro Cunqueiro CHUVI /ID# 167359
Vigo, Pontevedra, Spain
Hospital Universitario de Cabuenes /ID# 170745
Gijón, Principality of Asturias, Spain
Hospital Clinic de Barcelona /ID# 159462
Barcelona, , Spain
Duplicate_Hospital Universitario Reina Sofia /ID# 167062
Córdoba, , Spain
Hospital Universitario La Paz /ID# 159471
Madrid, , Spain
Complejo Hospitalario Universitario de Pontevedra /ID# 216183
Pontevedra, , Spain
Hospital Universitario de Salamanca /ID# 159469
Salamanca, , Spain
Hospital Universitario Virgen Macarena /ID# 159969
Seville, , Spain
Hospital Universitario Miguel Servet /ID# 159468
Zaragoza, , Spain
Alingsas lasarett /ID# 202075
Alingsås, Västra Götaland County, Sweden
Sahlgrenska University Hospital Molndal /ID# 202841
Mölndal, Västra Götaland County, Sweden
Danderyds sjukhus AB /ID# 202036
Stockholm, , Sweden
University Hospital Zurich /ID# 202908
Zurich, Canton of Zurich, Switzerland
Inselspital, Universitaetsspital Bern /ID# 202909
Bern, , Switzerland
National Taiwan University Hospital /ID# 162188
Taipei City, Taipei, Taiwan
Chung Shan Medical University Hospital /ID# 171426
Taichung, , Taiwan
China Medical University Hospital /ID# 160194
Taichung, , Taiwan
Taichung Veterans General Hospital /ID# 171433
Taichung, , Taiwan
Taipei Veterans General Hosp /ID# 171436
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 222878
Taoyuan, , Taiwan
Acibadem Kozyatagi Hospital /ID# 213277
Kadıköy, Istanbul, Turkey (Türkiye)
Sisli Etfal Train & Res Hosp /ID# 171415
Şişli, Istanbul, Turkey (Türkiye)
Duplicate_Erciyes University Medical Fac /ID# 171283
Melikgazi, Kayseri, Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 167205
Ankara, , Turkey (Türkiye)
Inonu Universitesi Turgut Ozal /ID# 203980
Battalgazi/malatya, , Turkey (Türkiye)
Uludag University Medical Faculty /ID# 204179
Bursa, , Turkey (Türkiye)
F?rat University Medical Facul /ID# 171285
Elâzığ, , Turkey (Türkiye)
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 167202
Istanbul, , Turkey (Türkiye)
Duplicate_Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171290
Istanbul, , Turkey (Türkiye)
CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203366
Ivano-Frankivsk, , Ukraine
Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224349
Kherson, , Ukraine
Medical Center OK Clinic LLC, International Institute of Clinical Research /ID# 205484
Kyiv, , Ukraine
CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224344
Kyiv, , Ukraine
Medical center of the private enterprise Sygma /ID# 224347
Kyiv, , Ukraine
Addenbrookes Hospital /ID# 158046
Cambridge, Cambridgeshire, United Kingdom
Royal Devon & Exeter Hospital /ID# 157614
Exeter, Devon, United Kingdom
Western General Hospital - NHS Lothian /ID# 208801
Edinburgh, Edinburgh, City of, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 157617
London, Greater London, United Kingdom
Kings College Hospital NHS Foundation Trust /ID# 158762
London, Greater London, United Kingdom
St George University Hospitals NHS Foundation Trust /ID# 208379
London, Greater London, United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 210814
Southampton, Hampshire, United Kingdom
Barnsley Hospital NHS Foundation Trust /ID# 202771
Barnsley, , United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 203860
Liverpool, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158047
Newcastle upon Tyne, , 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.
Related Links
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Related Info.
Other Identifiers
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2023-506994-36-00
Identifier Type: OTHER
Identifier Source: secondary_id
M16-066
Identifier Type: -
Identifier Source: org_study_id