Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
217 participants
INTERVENTIONAL
2014-12-09
2018-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BYM338 70 mg
BYM338 70 mg intravenous infusion
bimagrumab
Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
BYM338 210 mg
BYM338 210 mg intravenous infusion
bimagrumab
Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
BYM338 700 mg
BYM338 700 mg intravenous infusion
bimagrumab
Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
Placebo
Placebo intravenous infusion
placebo
Placebo will be administered as an intravenous infusion starting on Day 1 until week 21.
Interventions
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bimagrumab
Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
placebo
Placebo will be administered as an intravenous infusion starting on Day 1 until week 21.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Low gait speed \<0.8 m/s
* SPPB score less than or equal to 9;
* Weigh at least 35 kg;
* Adequate dietary intake;
Exclusion Criteria
* 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).
70 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Little Rock, Arkansas, United States
Novartis Investigative Site
Cypress, California, United States
Novartis Investigative Site
La Jolla, California, United States
Novartis Investigative Site
Farmington, Connecticut, United States
Novartis Investigative Site
Gainesville, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Miami Lakes, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Gainesville, Georgia, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Rochester, Minnesota, United States
Novartis Investigative Site
High Point, North Carolina, United States
Novartis Investigative Site
Columbus, Ohio, United States
Novartis Investigative Site
Spartanburg, South Carolina, United States
Novartis Investigative Site
Mesquite, Texas, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Madison, Wisconsin, United States
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
St Albans, Victoria, Australia
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Brno, , Czechia
Novartis Investigative Site
Opava, , Czechia
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Copenhagen, , Denmark
Novartis Investigative Site
Copenhagen NV, , Denmark
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Pessac, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Würzburg, , Germany
Novartis Investigative Site
Ōbu, Aichi-ken, Japan
Novartis Investigative Site
Toyohashi, Aichi-ken, Japan
Novartis Investigative Site
Mizunami, Gifu, Japan
Novartis Investigative Site
Nara, Nara, Japan
Novartis Investigative Site
Kawachi-Nagano, Osaka, Japan
Novartis Investigative Site
Kitaadachigun Inamachi, Saitama, Japan
Novartis Investigative Site
Kitamoto, Saitama, Japan
Novartis Investigative Site
Yoshinogawa, Tokushima, Japan
Novartis Investigative Site
Itabashi Ku, Tokyo, Japan
Novartis Investigative Site
Kiyose, Tokyo, Japan
Novartis Investigative Site
Koto-ku, Tokyo, Japan
Novartis Investigative Site
Musashimurayama, Tokyo, Japan
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Yaroslavl, , Russia
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, South Korea
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Albacete, Castille-La Mancha, Spain
Novartis Investigative Site
Getafe, Madrid, Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Basel, CH, Switzerland
Novartis Investigative Site
Geneva, , Switzerland
Novartis Investigative Site
Taipei, , Taiwan
Countries
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References
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Rooks D, Swan T, Goswami B, Filosa LA, Bunte O, Panchaud N, Coleman LA, Miller RR, Garcia Garayoa E, Praestgaard J, Perry RG, Recknor C, Fogarty CM, Arai H, Chen LK, Hashimoto J, Chung YS, Vissing J, Laurent D, Petricoul O, Hemsley S, Lach-Trifilieff E, Papanicolaou DA, Roubenoff R. Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020836. doi: 10.1001/jamanetworkopen.2020.20836.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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A Plain Language Trial Summary is available on novartisclinicatrials.com
Other Identifiers
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CBYM338E2202
Identifier Type: -
Identifier Source: org_study_id
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