Phase 2
N=217
Dose Range Finding Study of Bimagrumab in Sarcopenia
Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT02333331 ↗Enrolled (actual)
217
Serious AEs
10.1%
Results posted
Aug 2019
Primary outcome: Primary: Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25 — 7.1; 7.3; 7.2; 7.3 Score on a scale — p=0.274
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bimagrumab (Drug); placebo (Other)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25 |
7.1; 7.3; 7.2; 7.3; 8.5; 8.7 | 0.274 |
| SECONDARY Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance |
293.30; 291.81; 294.30; 312.43; 304.98; 340.71 | 0.576 |
| SECONDARY Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters |
2.37; 2.72; 2.58; 2.70; 3.12; 3.60 | 0.488 |
| SECONDARY Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA) |
5.99; 5.87; 5.70; 5.55; 6.04; 6.42 | 0.213 |
| SECONDARY Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA) |
37.44; 35.84; 35.39; 33.65; 38.26; 39.52 | 0.458 |
Summary
The purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. In addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.
Eligibility Criteria
Inclusion Criteria
- Low muscle mass as confirmed by DXA;
- Low gait speed 2 on the Medical Research Council Dyspnea Scale;
- Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids >10 mg/d prednisone equivalent;
- Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis);
- Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g. angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of screening;
- Active cancer (i.e., under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (e.g., early stage prostate or breast cancer, carcinoma in situ of the uterine cervix);
- Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc).
Data sourced from ClinicalTrials.gov (NCT02333331). 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.