MDCO-216 Infusions Leading to Changes in Atherosclerosis: A Novel Therapy in Development to Improve Cardiovascular Outcomes - Proof of Concept Intravascular Ultrasound (IVUS), Lipids, and Other Surrogate Biomarkers Trial

Phase 1/2 Completed 126 enrolled The Medicines Company The Cleveland Clinic · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This study will be a proof-of-concept, placebo-controlled, double-blind, randomized trial in participants with a recent acute coronary syndrome (ACS) to evaluate the efficacy, pharmacokinetics, safety, tolerability, disease progression measures by IVUS, and pharmacodynamics of MDCO-216 infusion. Eligible participants will be randomized to receive 5 infusions of MDCO-216 20 milligrams/kilogram (mg/kg) or placebo in a 1:1 ratio.

Timeline

Start: 2015-12-03
Primary completion: 2016-10-26
Completion: 2016-10-26

Outcome

Missed primary endpoint

registry analysis (superiority test); MDCO-216 vs Placebo; p = 0.0738; LS mean difference 0.73 (95% CI -0.07 to 1.52) NCT02678923 ↗

paper infusing MDCO-216 did not produce an incremental plaque regression in the setting of contemporary statin therapy. PMID 30046837 ↗

Publications

Nicholls SJ, Puri R, Ballantyne CM, Jukema JW, Kastelein JJP, Koenig W, Wright RS, Kallend D, Wijngaard P, Borgman M, Wolski K, Nissen SE. Effect of Infusion of High-Density Lipoprotein Mimetic Containing Recombinant Apolipoprotein A-I Milano on Coronary Disease in Patients With an Acute Coronary Syndrome in the MILANO-PILOT Trial: A Randomized Clinical Trial. JAMA Cardiol. 2018 Sep 1;3(9):806-814. doi: 10.1001/jamacardio.2018.2112.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MDCO-216	Protein / enzyme biologic	20 mg/kg	Intravenous