Clinical trial NCT02333331: Dose Range Finding Study of Bimagrumab in Sarcopenia
Official title: 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 70, 210, and 700 mg on Skeletal Muscle Strength and Function in Older Adults With Sarcopenia (InvestiGAIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcopenia
Keywords: Sarcopenia, muscle wasting, elderly, strength, physical function, muscle, gait speed
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-01-07
Enrollment: 217
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 \<0.8 m/s
* SPPB score less than or equal to 9;
* Weigh at least 35 kg;
* Adequate dietary intake;

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25
timeFrame: Baseline, week 25
Secondary outcomes:
measure: Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance
timeFrame: Baseline, week 25
measure: Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters
timeFrame: baseline, week 25
measure: Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)
timeFrame: baseline, week 25
measure: Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)
timeFrame: baseline, week 25
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Cypress
country: United States
facility: Novartis Investigative Site
state: California
city: La Jolla
country: United States
facility: Novartis Investigative Site
state: California
city: Farmington
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Gainesville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami Lakes
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Gainesville
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Rochester
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: High Point
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Spartanburg
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Mesquite
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Madison
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: St Albans
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Brussel
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Brno
country: Czechia
facility: Novartis Investigative Site
city: Opava
country: Czechia
facility: Novartis Investigative Site
city: Praha 2
country: Czechia
facility: Novartis Investigative Site
city: Copenhagen NV
country: Denmark
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Pessac
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
city: Obu-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyohashi-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Mizunami-city
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Nara-city
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Kawachinagano-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kitaadachigun Inamachi
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kitamoto-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Yoshinogawa-city
country: Japan
facility: Novartis Investigative Site
state: Tokushima
city: Itabashi ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kiyose-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Musashimurayama-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Bundang Gu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Suwon si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Albacete
country: Spain
facility: Novartis Investigative Site
state: Castilla La Mancha
city: Getafe
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
state: CH
city: Genève 14
country: Switzerland
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
References:
citation: 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.