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

Conditions

• Sporadic Inclusion Body Myositis

Eligibility Criteria

Sex

ALL

Age

36 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• BYM338/bimagrumab — DRUG
  BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
• Placebo — DRUG
  Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.

Study Details

This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).

Key Dates

Start date

Sep 26, 2013

Status verified

Aug 2017

Primary completion

Jan 6, 2016

Completion

Jan 6, 2016

Study Design

Enrollment

251 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BYM338/bimagrumab 10 mg/kg
  Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
• Experimental: BYM338/bimagrumab 3 mg/kg
  Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
• Experimental: BYM338/bimagrumab 1 mg/kg
  Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
• Placebo Comparator: Placebo
  Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.

Primary Outcome Measure

Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52 [ Time Frame: Baseline, Week 52 ]

Locations (12)

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