臨床研究等提出・公開システム

A 28 Week, Randomized, Double-blind, Placebo-controlled, Two-part, Multi-center, Parallel Group Dose Range Finding Study to Assess the Effect of Monthly Doses of Bimagrumab (higer dose level, intermediate dose level, lower dose level) on Skeletal Muscle Strength and Function in Older Adults With Sarcopenia (InvestiGAIT)

Dose Range Finding Study of Bimagrumab in Sarcopenia

Undecided

Novartis Pharma K. K.

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Novartis Pharma K. K.

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+81-120-003-293

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completed

Dec. 09, 2014

Interventional

Randomized, double-blind, placebo controlled, multi-center, parallel group study

treatment purpose

2

- Low muscle mass as confirmed by DXA
- Low gait speed
- SPPB score less than or equal to 9
- Weigh at least 35 kg
- Adequate dietary intake

Other protocol-defined inclusion criteria may apply.

- A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (e.g., stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management)
- Requires regular assistance from another person for general activities of daily living (e.g., bathing, dressing, toileting)
- Intraocular surgery and laser procedures for refractive correction within 6 months prior to screening
- Any underlying muscle disease including active myopathy or muscular dytrophy
- Confirmed diagnosis of heart failure classified as New York Heart Association Class III or IV (e.g. dilated cardiomyopathy)
- Type I diabetes or uncontrolled Type 2 diabetes;
- Chronic kidney disease [estimated glomerular filtration rate (GFR) < 30 mL/min]
- History of confirmed chronic obstructive pulmonary disease with a severity grade > 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)

Other protocol-defined exclusion criteria may apply.

Both

Sarcopenia

investigational material(s)
Generic name etc : BYM338
INN of investigational material : bimagrumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Bimagrumab (higer dose level, intermediate dose level, or lower dose level) will be administered as an intravenous infusion starting on Day 1 until 24 weeks by 4 weeks.

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Bimagrumab (higer dose level, intermediate dose level, or lower dose level) will be administered as an intravenous infusion starting on Day 1 until 24 weeks by 4 weeks.

efficacy
Short Physical Performance Battery (Time Frame: baseline, week 25)
Change from baseline to week 25

safety
Safety and tolerability as assessed by various measures such as adverse events (Time Frame: baseline, weeks 1, 5, 9, 13, 17, 21 and 25)
Assessed by various measures such as adverse events over 24 weeks
efficacy
6-minute walk test (Time Frame: Baseline, week 25)
Change from baseline to week 25
efficacy
Gait speed (Time Frame: baseline, week 25)
Change from baseline to Week 25
efficacy
Total lean body mass and appendicular skeletal muscle index measured by DXA (Time Frame: baseline, week 25)
Change from baseline to Week 25

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Jan. 09, 2015