Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.

Summary

The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection in open-label period

Timeline

Start

2013-02-01

Primary completion

2014-05-20

Completion

2016-12-14

Publications

• Background Sands BE, Chen J, Feagan BG, Penney M, Rees WA, Danese S, Higgins PDR, Newbold P, Faggioni R, Patra K, Li J, Klekotka P, Morehouse C, Pulkstenis E, Drappa J, van der Merwe R, Gasser RA Jr. Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn's Disease: A Phase 2a Study. Gastroenterology. 2017 Jul;153(1):77-86.e6. doi: 10.1053/j.gastro.2017.03.049. Epub 2017 Apr 5.
• Danese S, Beaton A, Duncan EA, Mercier AK, Neisen J, Seth H, Zetterstrand S, Sands BE. Long-term safety of brazikumab in the open-label period of a randomized phase 2a study of patients with Crohn's disease. BMC Gastroenterol. 2023 Dec 20;23(1):451. doi: 10.1186/s12876-023-03078-7.

Drugs

Indications