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A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
Sponsor: AbbVie
Summary
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. 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.
Official title: 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 Ulcerative Colitis
Key Details
Gender
All
Age Range
16 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1242
Start Date
2018-08-28
Completion Date
2029-02
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
risankizumab
subcutaneous (SC) injection
placebo for risankizumab
subcutaneous (SC) injection
Locations (426)
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