Dose Range Finding Study of Bimagrumab in Sarcopenia

Sarcopenia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333331
• Other study ID #: CBYM338E2202
• Status: Completed
• Phase: Phase 2
• Start date: December 9, 2014
• Est. completion date: June 28, 2018

Study information

• Verified date: July 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: June 28, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Drug:
• bimagrumab
Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.

Other:
• placebo
Placebo will be administered as an intravenous infusion starting on Day 1 until week 21.

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	St Albans	Victoria
Belgium	Novartis Investigative Site	Brussel
Belgium	Novartis Investigative Site	Leuven
Czechia	Novartis Investigative Site	Brno
Czechia	Novartis Investigative Site	Opava
Czechia	Novartis Investigative Site	Praha 2
Denmark	Novartis Investigative Site	Copenhagen
Denmark	Novartis Investigative Site	Copenhagen NV
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Pessac
France	Novartis Investigative Site	Toulouse
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Wuerzburg
Japan	Novartis Investigative Site	Itabashi ku	Tokyo
Japan	Novartis Investigative Site	Kawachinagano-city	Osaka
Japan	Novartis Investigative Site	Kitaadachigun Inamachi	Saitama
Japan	Novartis Investigative Site	Kitamoto-city	Saitama
Japan	Novartis Investigative Site	Kiyose-city	Tokyo
Japan	Novartis Investigative Site	Koto-ku	Tokyo
Japan	Novartis Investigative Site	Mizunami-city	Gifu
Japan	Novartis Investigative Site	Musashimurayama-city	Tokyo
Japan	Novartis Investigative Site	Nara-city	Nara
Japan	Novartis Investigative Site	Obu-city	Aichi
Japan	Novartis Investigative Site	Toyohashi-city	Aichi
Japan	Novartis Investigative Site	Yoshinogawa-city	Tokushima
Korea, Republic of	Novartis Investigative Site	Bundang Gu	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Suwon si	Gyeonggi Do
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	Yaroslavl
Spain	Novartis Investigative Site	Albacete	Castilla La Mancha
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Getafe	Madrid
Spain	Novartis Investigative Site	Madrid
Switzerland	Novartis Investigative Site	Basel	CH
Switzerland	Novartis Investigative Site	Genève 14
Taiwan	Novartis Investigative Site	Taipei
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Cypress	California
United States	Novartis Investigative Site	Farmington	Connecticut
United States	Novartis Investigative Site	Gainesville	Florida
United States	Novartis Investigative Site	Gainesville	Georgia
United States	Novartis Investigative Site	High Point	North Carolina
United States	Novartis Investigative Site	La Jolla	California
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Madison	Wisconsin
United States	Novartis Investigative Site	Mesquite	Texas
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	Rochester	Minnesota
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Czechia,  Denmark,  France,  Germany,  Japan,  Korea, Republic of,  Russian Federation,  Spain,  Switzerland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25	Change from Baseline in total Short Physical Performance Battery (SPPB) Score to week 25; SPPB is a series of six activities involving three domains of physical function - balance, usual walking speed and rising from a chair , is commonly used globally to assess and quantify (score 0-12) lower extremity function and has been shown to predict future adverse health events. A decline of one or more points in the SPPB total score is predictive of a decrease in lower extremity function and future adverse clinical outcomes in older adults, including falls, hospitalizations, institutionalization, incident disability and death	Baseline, week 25
Secondary	Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance	Change from Baseline at Week 25 in the 6 minute walk test (6MWT) distance to measure improvement in physical function	Baseline, week 25
Secondary	Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters	Change from Baseline to Week 25 in usual Gait speed (GS) over 4 meters Gait speed in this study was assessed as part of the SPPB, over a 4 meter distance of a 6 meter course. This test assessed a person's usual walking speed, which was defined as the speed a person normally walks from one place to another without urgency (e.g., walking down a hallway).	baseline, week 25
Secondary	Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)	Change from Baseline to Week 25 on appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) Appendicular skeletal muscle index (ASMI) is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m^2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.	baseline, week 25
Secondary	Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)	Change from Baseline to Week 25 on Total lean body mass and appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(LBM at Visit - LBM at Baseline) / LBM at Baseline] * 100.	baseline, week 25

External Links

•   A Plain Language Trial Summary is available on novartisclinicatrials.com