Trials / Terminated
TerminatedNCT02574637
Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brazikumab IV Infusion | Brazikumab IV infusion as per protocol specified dosing schedule. |
| DRUG | Brazikumab SC Injection | Brazikumab IV infusion as per protocol specified dosing schedule. |
| DRUG | Placebo | Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule. |
Timeline
- Start date
- 2016-01-05
- Primary completion
- 2017-07-28
- Completion
- 2018-01-29
- First posted
- 2015-10-14
- Last updated
- 2021-05-26
- Results posted
- 2020-05-15
Locations
97 sites across 12 countries: United States, Australia, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Russia, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02574637. Inclusion in this directory is not an endorsement.