Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease
NCT ID: NCT02574637
Last Updated: 2021-05-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
29 participants
INTERVENTIONAL
2016-01-05
2018-01-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab IV Infusion
Brazikumab IV infusion as per protocol specified dosing schedule.
Brazikumab SC Injection
Brazikumab IV infusion as per protocol specified dosing schedule.
Placebo
Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.
Brazikumab High Dose
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab IV Infusion
Brazikumab IV infusion as per protocol specified dosing schedule.
Brazikumab SC Injection
Brazikumab IV infusion as per protocol specified dosing schedule.
Placebo
Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.
Brazikumab High-Medium Dose
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab IV Infusion
Brazikumab IV infusion as per protocol specified dosing schedule.
Brazikumab SC Injection
Brazikumab IV infusion as per protocol specified dosing schedule.
Placebo
Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.
Brazikumab Low-Medium Dose
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab IV Infusion
Brazikumab IV infusion as per protocol specified dosing schedule.
Brazikumab SC Injection
Brazikumab IV infusion as per protocol specified dosing schedule.
Placebo
Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.
Brazikumab Low Dose
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab IV Infusion
Brazikumab IV infusion as per protocol specified dosing schedule.
Brazikumab SC Injection
Brazikumab IV infusion as per protocol specified dosing schedule.
Placebo
Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.
Interventions
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Brazikumab IV Infusion
Brazikumab IV infusion as per protocol specified dosing schedule.
Brazikumab SC Injection
Brazikumab IV infusion as per protocol specified dosing schedule.
Placebo
Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men or women age 18 - 80 years at the time of screening
* Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI) and endoscopic demonstration of inflammation
* Stable dose of medications for Crohn's disease therapy
* Prior treatment failure or intolerance with at least one Anti-Tumor Necrosis Factor-Alpha Therapy (anti-TNF α) agent
* Effective contraception from screening, and for 36 weeks after the last dose of investigational product
* No known history of active tuberculosis (TB) \& negative assessment for TB/latent TB
Exclusion Criteria
* Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation
* Significant infections at screening; Infected abscess, positive for Clostridium difficile, recent infectious hospitalization
* Recent treatment with approved or investigational biologic therapy for Crohn's disease
* Recent or planned live attenuated vaccine
* History of cancer, except for basal cell carcinoma or carcinoma in situ (CIS) of the cervix with apparent cure ≥ 12 months before screening
* Pregnancy/breast feeding
* Drug abuse
18 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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, Haute Garonne, France
CHU Rennes - Hôpital Pontchaillou
Rennes, Ille Et Vilaine, France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, Meurthe Et Moselle, France
CHU Saint Etienne - Hôpital Nord
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
Research Site
Rennes, , France
Research Site
Saint-Priez En Jarez, , France
Research Site
Toulouse, , France
Research Site
Vandœuvre-lès-Nancy, , France
Medizinische Hochschule Hannover
Marburg, Hesse, Germany
St. Johannes Hospital
Dortmund, North Rhine-Westphalia, Germany
Research Site
Dortmund, , Germany
Research Site
Hanover, , 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
Rehovot, , 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, , Russia
TSBIH "Territorial Clinical Hospital"
Krasnoyarsk, , Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Research Site
Barcelona, , Spain
Research Site
L'Hospitalet de Llobregat, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015-000609-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5170C00002
Identifier Type: -
Identifier Source: org_study_id
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