Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis
Sponsor: AbbVie
Summary
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult participants with moderate to severe UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed. Lutikizumab is an investigational product being developed for the treatment of moderate to severe UC. Participants are placed in groups called treatment arms. Each group receives a different treatment. In the Induction Period, participants will be randomized into 1 of 3 arms receiving lutikizumab Dose 1, lutikizumab Dose 2, or adalimumab. In the Maintenance Period, participants who responded to lutikizumab will be randomized into 1 of 2 arms of lutikizumab maintenance and participants who responded to adalimumab will continue to receive adalimumab. All participants who did not achieve clinical response per modified Mayo Score at the end of the Induction period will receive lutikizumab. Around 200 adult participants with UC will be enrolled at approximately 200 sites worldwide. During the 12 week Induction Period, participants will be randomized to receive intravenous (IV) and subcutaneous (SC) lutikizumab or SC adalimumab. At the 12 week mark, participants who are on lutikizumab who have responded to treatment will be re-randomized to receive SC lutikizumab at different intervals until Week 52. Participants who are on adalimumab who are responding to treatment will continue to receive adalimumab. Participants who do not respond to treatment will receive SC lutikizumab. Participants who complete the Week 52 visit and in whom therapeutic benefit to study drug is confirmed by the investigator may roll over into an optional, 52-week long-term extension (LTE). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Official title: A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2024-03-23
Completion Date
2027-09
Last Updated
2025-10-07
Healthy Volunteers
No
Conditions
Interventions
Lutikizumab
Subcutaneous (SC) Injection
Lutikizumab
Intravenous (IV) Infusion
Adalimumab
SC Injection
Locations (191)
Gastro SB /ID# 258331
Chula Vista, California, United States
Southern California Res. Ctr. /ID# 258391
Coronado, California, United States
Newport Huntington Medical Group /ID# 258371
Huntington Beach, California, United States
Om Research LLC /ID# 261383
Lancaster, California, United States
UC Irvine Health /ID# 259824
Orange, California, United States
University of Colorado Hospital /ID# 258388
Aurora, Colorado, United States
Research Associates of South Florida, LLC /ID# 259813
Coral Gables, Florida, United States
University of Florida College of Medicine /ID# 260402
Gainesville, Florida, United States
Auzmer Research /ID# 260940
Lakeland, Florida, United States
Atlantic Medical Research /ID# 258507
Margate, Florida, United States
Homestead Associates in Research /ID# 260392
Miami, Florida, United States
University of Miami /ID# 258396
Miami, Florida, United States
JD Medical Group, LLC /ID# 261235
Miami, Florida, United States
Gastroenterology Group Naples /ID# 258346
Naples, Florida, United States
AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 260945
Orlando, Florida, United States
GCP Clinical Research, LLC /ID# 260401
Tampa, Florida, United States
Atlanta Ctr. for Gastro /ID# 259275
Decatur, Georgia, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 258359
Macon, Georgia, United States
Gastroenterology Consultants, P.C /ID# 258352
Roswell, Georgia, United States
Northwestern Medicine - Northwestern Memorial Hospital /ID# 259592
Chicago, Illinois, United States
University of Chicago Medical Center /ID# 258491
Chicago, Illinois, United States
IU Health University Hospital /ID# 260398
Indianapolis, Indiana, United States
Univ Kansas Med Ctr /ID# 258489
Kansas City, Kansas, United States
Louisiana Research Center, LLC /ID# 258330
Shreveport, Louisiana, United States
Massachusetts General Hospital /Id# 259817
Boston, Massachusetts, United States
Clin Res Inst of Michigan, LLC /ID# 258386
Chesterfield, Michigan, United States
Clin Res Inst of Michigan, LLC /ID# 259267
Chesterfield, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 258493
Wyoming, Michigan, United States
Mayo Clinic - Rochester /ID# 258402
Rochester, Minnesota, United States
Univ New Mexico /ID# 258490
Albuquerque, New Mexico, United States
NY Scientific /ID# 260937
Brooklyn, New York, United States
NYU Langone Long Island Clinical Research Associates /ID# 258504
Lake Success, New York, United States
Weill Cornell Medicine/NYP /ID# 258953
New York, New York, United States
Columbia University Medical Center /ID# 258496
New York, New York, United States
Atrium Health /ID# 258506
Charlotte, North Carolina, United States
DJL Clinical Research, PLLC /ID# 259465
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 260387
Winston-Salem, North Carolina, United States
Plains Clinical Research Center, LLC /ID# 258502
Fargo, North Dakota, United States
Digestive Disease Specialists /ID# 258499
Oklahoma City, Oklahoma, United States
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 258358
Garland, Texas, United States
Baylor College of Medicine /ID# 258394
Houston, Texas, United States
BioStar Clinical Research Group - Houston - Katy Freeway /ID# 261164
Houston, Texas, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 258403
San Antonio, Texas, United States
Southern Star Research Institute, LLC /ID# 258347
San Antonio, Texas, United States
Tyler Research Institute, LLC /ID# 258383
Tyler, Texas, United States
Texas Digestive Disease Consultants - Webster /ID# 258718
Webster, Texas, United States
University Physicians and Surgeons Inc. /ID# 260399
Huntington, West Virginia, United States
Wisconsin Center for Advanced Research /ID# 258949
Milwaukee, Wisconsin, United States
Bankstown-Lidcombe Hospital /ID# 259089
Bankstown, New South Wales, Australia
Lyell McEwin Hospital /ID# 260580
Elizabeth Vale, South Australia, Australia
The Queen Elizabeth Hospital /ID# 259482
Woodville South, South Australia, Australia
St Vincent's Hospital Melbourne /ID# 259473
Fitzroy Melbourne, Victoria, Australia
Fiona Stanley Hospital /ID# 259480
Murdoch, Western Australia, Australia
Universitaetsklinikum St. Poelten /ID# 258256
Sankt Pölten, Lower Austria, Austria
Medizinische Universitaet Wien /ID# 258026
Vienna, Vienna, Austria
Universite Libre de Bruxelles - Hopital Erasme /ID# 258214
Anderlecht, Brussels Capital, Belgium
UZ Gent /ID# 258210
Ghent, Oost-Vlaanderen, Belgium
Vitaz /Id# 258222
Sint-Niklaas, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 258226
Leuven, Vlaams-Brabant, Belgium
AZ Maria Middelares /ID# 258219
Ghent, Belgium
CHU de Liege /ID# 258212
Liège, Belgium
Hospital Tsaritsa Yoanna /ID# 258338
Sofiya, Sofia, Bulgaria
Medical Center - Doverie /ID# 261936
Sofiya, Sofia, Bulgaria
ACIBADEM City Clinic Diagnostic-Consultative Center /ID# 258339
Sofiya, Sofia, Bulgaria
Umbal Kaspela /ID# 258336
Plovdiv, Bulgaria
2nd Mhat /ID# 258337
Sofia, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 261417
Sofia, Bulgaria
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 258878
Varna, Bulgaria
Gastroenterology and Internal Medicine Research Institution /ID# 258765
Edmonton, Alberta, Canada
Covenant Health /ID# 258799
Edmonton, Alberta, Canada
Toronto Digestive Disease Associates /ID# 260460
Vaughan, Ontario, Canada
Klinicki bolnicki centar Zagreb /ID# 258145
Zagreb, City of Zagreb, Croatia
Poliklinika Solmed /ID# 258147
Zagreb, City of Zagreb, Croatia
POLIKLINIKA BORZAN d.o.o. /ID# 258146
Osijek, County of Osijek-Baranja, Croatia
Specialty Hospital Medico /ID# 258169
Rijeka, Primorje-Gorski Kotar County, Croatia
Klinicki Bolnicki Centar (KBC) Split /ID# 258153
Split, Split-Dalmatia County, Croatia
West Tallinn Central Hospital /ID# 262035
Tallinn, Harju, Estonia
Medicum /ID# 268320
Tallinn, Harju, Estonia
Parnu Hospital /ID# 261783
Pärnu, Estonia
Tartu University Hospital /ID# 261782
Tartu, Estonia
Chu de Nice-Hopital L'Archet Ii /Id# 258041
Nice, Alpes-Maritimes, France
CHU Toulouse - Hopital Rangueil /ID# 258044
Toulouse, Haute-Garonne, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 258555
Créteil, Paris, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 258042
Nantes, Pays de la Loire Region, France
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 258040
St-Priest-en-Jarez, Pays de la Loire Region, France
Universitaetsklinikum Ulm /ID# 258616
Ulm, Baden-Wurttemberg, Germany
Klinikum rechts der Isar /ID# 260228
Munich, Bavaria, Germany
St. Marien- und St. Annastiftskrankenhaus /ID# 264691
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Eugastro /ID# 260229
Leipzig, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 258614
Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 258617
Hamburg, Germany
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 257831
Athens, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 257832
Heraklion, Crete, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 257829
Athens, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 260810
Thessaloniki, Greece
Clinfan /ID# 258094
Szekszárd, Tolna County, Hungary
Clinexpert Kft /ID# 258449
Budapest, Hungary
Synexus Hungary Clinical Research Centre - Budapest /ID# 258915
Budapest, Hungary
Semmelweis Egyetem /ID# 258527
Budapest, Hungary
Szegedi Tudományegyetem /ID# 258095
Szeged, Hungary