Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis

What Was Tested

The trial (phase 2) is built around Bimagrumab.

It had two arms (groups): BYM338 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as biological.

Who Took Part

14 actual participants took part.

It was open to people of any sex aged from 40 years up to 80 years.

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

The full record lists 0 inclusion and 3 exclusion criteria; among the exclusions: unable to walk at least 3 meters without assistance from another person; use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months; patients with a history or presence of renal impairment and/or liver disease.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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, care provider, investigator and outcomes assessor.

It started in 2011-08 with completion listed for 2012-05.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effect of BYM338 on Thigh Muscle Volume by MRI (time frame: 8 weeks).

It also tracked 1 secondary outcome, for example Effect of BYM338 on muscle function by 'Timed Get Up and Go' test.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Bimagrumab in 14 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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