Phase 3
N=251
Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients
Sporadic Inclusion Body Myositis
Bottom Line
View on ClinicalTrials.gov: NCT01925209 ↗Enrolled (actual)
251
Serious AEs
27.9%
Results posted
May 2017
Primary outcome: Primary: Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52 — 8.63; 9.63; -10.27; -8.96 meters — p=0.2210
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BYM338/bimagrumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 36+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52 |
8.63; 9.63; -10.27; -8.96 | 0.2210 |
| SECONDARY Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52 |
102.8; 100.4; 98.3; 97.2 | — |
| SECONDARY Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52 |
-12.44; -20.36; -14.89; -16.48 | — |
| SECONDARY Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52 |
1.74; 3.56; 6.12; 6.85 | — |
| SECONDARY Estimated Annual Number of Falls Per Patient Within Treatment Group |
4.33; 4.02; 4.70; 5.13 | — |
| SECONDARY Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52 |
0.0; 0.0; -0.5; -0.5 | — |
Summary
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).
Eligibility Criteria
Key Inclusion Criteria
- Diagnosed with sporadic inclusion body myositis;
- Must be able to walk (assistive aids allowed, including intermittent use of wheelchair);
Key Exclusion Criteria
- Must not have other conditions that significantly limit ability to move around;
- Must not be using corticosteroids. Must not have used systemic corticosteroid (at daily dose >=10mg prednisone) for the past 3 months;
- 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.);
Data sourced from ClinicalTrials.gov (NCT01925209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.