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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
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.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 5, 2016
Primary Completion Date
July 28, 2017
Completion Date
January 29, 2018
Last Updated
May 26, 2021
29
ACTUAL participants
Brazikumab IV Infusion
DRUG
Brazikumab SC Injection
DRUG
Placebo
DRUG
Lead Sponsor
AstraZeneca
NCT06226883
NCT07184931
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06918808