Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease

NCT01731990 ↗

Phase 2 Terminated 38 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg artery structure and physical activity in patients with atherosclerotic peripheral artery disease and leg pain from walking.

Timeline

Start: 2012-10-30
Primary completion: 2016-08-04
Completion: 2016-08-04

Outcome

Missed primary endpoint

Stopped: “The study got terminated based on result from primary endpoint analysis”

registry analysis (unspecified test); Canakinumab (ACZ885) vs Placebo; p = 0.284; Treatment effect for ratio to placebo 1.06 (90% CI 0.97 to 1.15); Mixed Models Analysis NCT01731990 ↗

paper Although canakinumab did not alter plaque progression in the SFA PMID 31277561 ↗

Publications

Russell KS, Yates DP, Kramer CM, Feller A, Mahling P, Colin L, Clough T, Wang T, LaPerna L, Patel A, Lawall H, Shennak MM, Fulmer J, Nikol S, Smith WB, Muller OJ, Ratchford EV, Basson CT. A randomized, placebo-controlled trial of canakinumab in patients with peripheral artery disease. Vasc Med. 2019 Oct;24(5):414-421. doi: 10.1177/1358863X19859072. Epub 2019 Jul 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Canakinumab	Monoclonal antibody	150 mg	Subcutaneous