BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia

Phase 2 Completed 67 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindSupportive care

Summary

This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh muscle volume compared to placebo. The study will last for approximately 24 weeks.

Timeline

Start: 2012-09
Primary completion: 2014-12
Completion: 2014-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); BYM338 vs Placebo; p <0.001; Mean Difference (Net) 106.10 (90% CI 104.64 to 107.58); ANCOVA NCT01669174 ↗

paper Thigh muscle volume increased by Week 4 and remained increased at Week 24 in bimagrumab-treated patients, whereas no changes were observed with placebo PMID 30095981 ↗

Publications

Polkey MI, Praestgaard J, Berwick A, Franssen FME, Singh D, Steiner MC, Casaburi R, Tillmann HC, Lach-Trifilieff E, Roubenoff R, Rooks DS. Activin Type II Receptor Blockade for Treatment of Muscle Depletion in Chronic Obstructive Pulmonary Disease. A Randomized Trial. Am J Respir Crit Care Med. 2019 Feb 1;199(3):313-320. doi: 10.1164/rccm.201802-0286OC.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bimagrumab	Monoclonal antibody	30 mg/kg	Intravenous