ACZ885 for the Treatment of Abdominal Aortic Aneurysm
Summary
This study was designed to assess the safety, tolerability and efficacy of ACZ885 on aneurysmal growth rate in subjects with abdominal aortic aneurysms (AAA). The purpose of the study was to provide data to enable decisions regarding the further development of ACZ885 for subjects with abdominal aortic aneurysms. The design of this study addressed the primary objective of evaluating the change in aneurysmal size in subjects with AAA as a result of treatment with ACZ885.
Timeline
- Start
- 2013-12
- Primary completion
- 2015-10
- Completion
- 2015-10
Outcome
Missed primary endpoint
Stopped: “The results of a third interim analysis (ad hoc) indicated a lack of efficacy and futility in continuing the trial.”
registry analysis (unspecified test); ACZ885 vs Placebo; p = 0.1037; ANCOVA NCT02007252 ↗
registry analysis (unspecified test); ACZ885 vs Placebo; p = 0.4806; ANCOVA NCT02007252 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Canakinumab | Monoclonal antibody | 150 mg | Subcutaneous |