Study of Muscle Effects of BYM338 in mechanically Ventilated Patients

An exploratory, randomized, double-blind, placebo-controlled study to investigate the effect of BYM338 on muscle in patients requiring prolonged mechanical ventilation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002201-66-GB

Enrollment

Registered

2013-08-27

Start date

2013-11-01

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Group III failure to wean patients MedDRA version: 16.1 Level: PT Classification code 10067221 Term: Mechanical ventilation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Product Name: BYM338 150mg Product Code: BYM338 Pharmaceutical Form: Powder for solution for infusion Current Sponsor code: BYM338 Other descriptive name: Human Monoclonal Antibody blocking ActRII Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adults on mechanical ventilation for at least 7 days with a tracheostomy in place for > 24 hours. - Expected to survive at least 14 days. - Receiving adequate nutritional support, defined as at least 20 kcal/kg and 0.6 g/kg protein per day (unless lower protein intake required by clinical status). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Patients deemed to be treminal wean patients. - Patients who have progressive neuromuscular degenerative disorders. - Patients who are comatose - Evidence of unstable medical status.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of a single intravenous (i.v.) dose of BYM338 on thigh muscle thickness at Day 14 compared to placebo in mechanically ventilated patients.;Secondary Objective: • To assess the safety and tolerability of i.v. BYM338 in mechanically ventilated patients treated with BYM338 versus placebo. • To evaluate the pharmacokinetic characteristics of i.v. BYM338 in this critically ill population.;Primary end point(s): Change in thigh muscle thickness;Timepoint(s) of evaluation of this end point: 14 days	—

Measure

Time frame

Main Objective: To assess the effect of a single intravenous (i.v.) dose of BYM338 on thigh muscle thickness at Day 14 compared to placebo in mechanically ventilated patients.;Secondary Objective: • To assess the safety and tolerability of i.v. BYM338 in mechanically ventilated patients treated with BYM338 versus placebo. • To evaluate the pharmacokinetic characteristics of i.v. BYM338 in this critically ill population.;Primary end point(s): Change in thigh muscle thickness;Timepoint(s) of evaluation of this end point: 14 days

—

Secondary

Measure	Time frame
Secondary end point(s): - Number of patients with adverse events as a measure of safety and tolerability. - Sparse sampling of BYM338 serum levels to assess pharmacokinetic profile in mechanically ventilated patients.;Timepoint(s) of evaluation of this end point: Week 12.	—

Countries

United Kingdom, United States

Contacts

Public ContactMedical Information Services

Novartis Pharmaceutials UK Ltd

medinfo.uk@novartis.com+4101276698370

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026