Spots Global Cancer Trial Database for Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease
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Trial Identification
Brief Title: Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease
Official Title: A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
Study ID: NCT02574637
Conditions
Study Description
Brief Summary: A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFα) therapy.
Detailed Description: This is a four-part Phase 2b study comprised of a 16-week, double-blind, placebo-controlled, Induction Period, a 12-week double-blind, placebo-controlled, Maintenance Period, a 24-week, Open-label Period and a post-treatment 28 week observational safety follow-up period designed to evaluate the short-term efficacy and the short- and long term safety of brazikumab in participants with moderate to severe, active Crohn's disease (CD) who have failed or are intolerant to anti-TNFα therapy as determined by the Investigator.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Arthritis & Rheumatology Research, PLLC, Phoenix, Arizona, United States
Research Site, Phoenix, Arizona, United States
South Denver Gastroenterology, PC, Lone Tree, Colorado, United States
Research Site, Lone Tree, Colorado, United States
Clinical Research of West Florida - Corporate, Clearwater, Florida, United States
Borland-Groover Clinic, Jacksonville, Florida, United States
Research Site, Jacksonville, Florida, United States
Advanced Pharma CR, LLC, Miami, Florida, United States
Research Site, Miami, Florida, United States
IMIC, Inc., Palmetto Bay, Florida, United States
Research Site, Chicago, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
NorthShore University HealthSystem, Evanston, Illinois, United States
Research Site, Evanston, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
Research Site, Indianapolis, Indiana, United States
Cotton-O'Neil Clinical Research Center, Digestive Health, Topeka, Kansas, United States
Research Site, Topeka, Kansas, United States
Graves Gilbert Clinic, Bowling Green, Kentucky, United States
Research Site, Bowling Green, Kentucky, United States
Research Site, Louisville, Kentucky, United States
University of Louisville, Louisville, Kentucky, United States
Clinical Trials of SW Louisiana, LLC, Lake Charles, Louisiana, United States
Research Site, Lake Charles, Louisiana, United States
Clinical Trials Management, LLC, Metairie, Louisiana, United States
Research Site, Metairie, Louisiana, United States
Research Site, Ann Arbor, Michigan, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Research Site, Southfield, Michigan, United States
Revival Research Institute, LLC, Southfield, Michigan, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Research Site, Rochester, Minnesota, United States
Ehrhardt Clinical Research, LLC, Belton, Missouri, United States
Research Site, Belton, Missouri, United States
New York University Medical Center, Great Neck, New York, United States
Premier Medical Group of the Hudson Valley, PC, Poughkeepsie, New York, United States
Research Site, Poughkeepsie, New York, United States
Research Site, Charlotte, North Carolina, United States
Clinical Inquest Center Ltd, Dayton, Ohio, United States
Research Site, Dayton, Ohio, United States
Donald Guthrie Foundation, Sayre, Pennsylvania, United States
Research Site, Sayre, Pennsylvania, United States
Erlanger Health System, Chattanooga, Tennessee, United States
Research Site, Chattanooga, Tennessee, United States
Research Site, Houston, Texas, United States
University of Texas Health Science Center at Houston, Houston, Texas, United States
Gastroenterology Research of America, Houston, Texas, United States
Research Site, Houston, Texas, United States
Baylor Research Institute, Temple, Texas, United States
Research Site, Temple, Texas, United States
Allegiance Research Specialists, LLC, Milwaukee, Wisconsin, United States
Research Site, Wauwatosa, Wisconsin, United States
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Research Site, Woolloongabba, , Australia
Imeldaziekenhuis, Bonheiden, , Belgium
Research Site, Bonheiden, , Belgium
Research Site, Leuven, , Belgium
UZ Leuven, Leuven, , Belgium
London Health Science Centre, London, Ontario, Canada
Research Site, London, Ontario, Canada
LHSC - Victoria Hospital, London, Ontario, Canada
Research Site, Saskatoon, Saskatchewan, Canada
Royal University Hospital, Saskatoon, Saskatchewan, Canada
CHU de Toulouse - Hôpital Rangueil, Toulouse Cedex 09, Haute Garonne, France
CHU Rennes - Hôpital Pontchaillou, Rennes cedex 09, Ille Et Vilaine, France
CHU Saint Etienne - Hôpital Nord, Saint Etienne, Loire, France
Hôpital de Brabois Adultes, Vandoeuvre les Nancy, Meurthe Et Moselle, France
Research Site, Rennes, , France
Research Site, Saint-Priez En Jarez, , France
Research Site, Toulouse Cedex 9, , France
Research Site, Vandoeuvre-Les-Nancy, , France
Medizinische Hochschule Hannover, Marburg, Hessen, Germany
St. Johannes Hospital, Dortmund, Nordrhein Westfalen, Germany
Research Site, Dortmund, , Germany
Research Site, Hannover, , Germany
Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Semmelweis Egyetem, Budapest, , Hungary
Research Site, Budapest, , Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak, Budapest, , Hungary
Kaplan Medical Center, Rechovot, , Israel
Research Site, Rehovot, , Israel
Istituto Clinico Humanitas, Rozzano, Milano, Italy
Research Site, Rozzano, , Italy
Maastricht University Medical Center, Maastricht, , Netherlands
Research Site, Maastricht, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Research Site, Rotterdam, , Netherlands
Research Site, Krasnoyarsk, , Russian Federation
TSBIH "Territorial Clinical Hospital", Krasnoyarsk, , Russian Federation
Pavlov First Saint Petersburg State Medical University, Saint-Petersburg, , Russian Federation
Research Site, St. Petersburg, , Russian Federation
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain
Research Site, Barcelona, , Spain
Research Site, L'Hospitalet de Llobregat, , Spain
Contact Details
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