Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients

What Was Tested

The trial (phase 2, phase 3) is built around Bimagrumab.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 251 actual participants took part.

It was open to people of any sex aged from 36 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosed with sporadic inclusion body myositis;. Must be able to walk (assistive aids allowed, including intermittent use of wheelchair);.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: must meet cardiovascular requirements;; must not be pregnant or nursing;; must not have a chronic active infection (e.g., hiv, hepatitis b or c, tuberculosis, etc.);.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Bimagrumab study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Bimagrumab group and the comparison group ran side by side rather than switching.

As a double-blind Bimagrumab study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2013-09-26 with completion listed for 2016-01-06.

It ran at 38 sites in United States (12), Japan (7), Italy (5), Australia (3), Belgium (3) and United Kingdom (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52 (time frame: Baseline, Week 52).

It also tracked 5 secondary outcomes, for example Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52, Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52, Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52, Estimated Annual Number of Falls Per Patient Within Treatment Group and Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Bimagrumab in 251 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Bimagrumab compound page, all human trials.