Back to resultsDose Range Finding Study of Bimagrumab in Sarcopenia
Primary Purpose
Sarcopenia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bimagrumab
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia focused on measuring Sarcopenia, muscle wasting, elderly, strength, physical function, muscle, gait speed
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).
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
BYM338 70 mg
BYM338 210 mg
BYM338 700 mg
Placebo
Arm Description
BYM338 70 mg intravenous infusion
BYM338 210 mg intravenous infusion
BYM338 700 mg intravenous infusion
Placebo intravenous infusion
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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).
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.
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.
Full Information
NCT ID
NCT02333331
First Posted
December 10, 2014
Last Updated
December 9, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02333331
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 9, 2014 (Actual)
Primary Completion Date
June 26, 2018 (Actual)
Study Completion Date
June 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, muscle wasting, elderly, strength, physical function, muscle, gait speed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BYM338 70 mg
Arm Type
Experimental
Arm Description
BYM338 70 mg intravenous infusion
Arm Title
BYM338 210 mg
Arm Type
Experimental
Arm Description
BYM338 210 mg intravenous infusion
Arm Title
BYM338 700 mg
Arm Type
Experimental
Arm Description
BYM338 700 mg intravenous infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo intravenous infusion
Intervention Type
Drug
Intervention Name(s)
bimagrumab
Other Intervention Name(s)
BYM338
Intervention Description
Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
5% dextrose
Intervention Description
Placebo will be administered as an intravenous infusion starting on Day 1 until week 21.
Primary Outcome Measure Information:
Title
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25
Description
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
Time Frame
Baseline, week 25
Secondary Outcome Measure Information:
Title
Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance
Description
Change from Baseline at Week 25 in the 6 minute walk test (6MWT) distance to measure improvement in physical function
Time Frame
Baseline, week 25
Title
Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters
Description
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).
Time Frame
baseline, week 25
Title
Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)
Description
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.
Time Frame
baseline, week 25
Title
Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)
Description
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.
Time Frame
baseline, week 25
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Novartis Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Novartis Investigative Site
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Novartis Investigative Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-9405
Country
United States
Facility Name
Novartis Investigative Site
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-5215
Country
United States
Facility Name
Novartis Investigative Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Novartis Investigative Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Novartis Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Novartis Investigative Site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Novartis Investigative Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Novartis Investigative Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Novartis Investigative Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Novartis Investigative Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Novartis Investigative Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
Facility Name
Novartis Investigative Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Novartis Investigative Site
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Novartis Investigative Site
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Novartis Investigative Site
City
Opava
ZIP/Postal Code
74601
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 2
ZIP/Postal Code
12000
Country
Czechia
Facility Name
Novartis Investigative Site
City
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Novartis Investigative Site
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Novartis Investigative Site
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Novartis Investigative Site
City
Wuerzburg
ZIP/Postal Code
97074
Country
Germany
Facility Name
Novartis Investigative Site
City
Obu-city
State/Province
Aichi
ZIP/Postal Code
474-8511
Country
Japan
Facility Name
Novartis Investigative Site
City
Toyohashi-city
State/Province
Aichi
ZIP/Postal Code
440-8510
Country
Japan
Facility Name
Novartis Investigative Site
City
Mizunami-city
State/Province
Gifu
ZIP/Postal Code
509 6134
Country
Japan
Facility Name
Novartis Investigative Site
City
Nara-city
State/Province
Nara
ZIP/Postal Code
630-8581
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawachinagano-city
State/Province
Osaka
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Novartis Investigative Site
City
Kitaadachigun Inamachi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Novartis Investigative Site
City
Kitamoto-city
State/Province
Saitama
ZIP/Postal Code
364-8501
Country
Japan
Facility Name
Novartis Investigative Site
City
Yoshinogawa-city
State/Province
Tokushima
ZIP/Postal Code
776-8585
Country
Japan
Facility Name
Novartis Investigative Site
City
Itabashi ku
State/Province
Tokyo
ZIP/Postal Code
173 0015
Country
Japan
Facility Name
Novartis Investigative Site
City
Kiyose-city
State/Province
Tokyo
ZIP/Postal Code
204-0021
Country
Japan
Facility Name
Novartis Investigative Site
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
136-0075
Country
Japan
Facility Name
Novartis Investigative Site
City
Musashimurayama-city
State/Province
Tokyo
ZIP/Postal Code
208-0011
Country
Japan
Facility Name
Novartis Investigative Site
City
Bundang Gu
State/Province
Gyeonggi Do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Suwon si
State/Province
Gyeonggi Do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
101990
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Albacete
State/Province
Castilla La Mancha
ZIP/Postal Code
02006
Country
Spain
Facility Name
Novartis Investigative Site
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novartis Investigative Site
City
Basel
State/Province
CH
ZIP/Postal Code
4002
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Genève 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Citations:
PubMed Identifier
33074327
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.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=437
Description
A Plain Language Trial Summary is available on novartisclinicatrials.com
Learn more about this trial
Dose Range Finding Study of Bimagrumab in Sarcopenia
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