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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02333331




Registration number
NCT02333331
Ethics application status
Date submitted
10/12/2014
Date registered
7/01/2015
Date last updated
6/08/2019

Titles & IDs
Public title
Dose Range Finding Study of Bimagrumab in Sarcopenia
Scientific 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)
Secondary ID [1] 0 0
CBYM338E2202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bimagrumab
Other interventions - placebo

Experimental: BYM338 70 mg - BYM338 70 mg intravenous infusion

Experimental: BYM338 210 mg - BYM338 210 mg intravenous infusion

Experimental: BYM338 700 mg - BYM338 700 mg intravenous infusion

Placebo Comparator: Placebo - Placebo intravenous infusion


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

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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline, week 25
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline, week 25
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
baseline, week 25
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
baseline, week 25
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
baseline, week 25

Eligibility
Key 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;
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [2] 0 0
Novartis Investigative Site - St Albans
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
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United States of America
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Minnesota
Country [8] 0 0
United States of America
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North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussel
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Czechia
State/province [15] 0 0
Brno
Country [16] 0 0
Czechia
State/province [16] 0 0
Opava
Country [17] 0 0
Czechia
State/province [17] 0 0
Praha 2
Country [18] 0 0
Denmark
State/province [18] 0 0
Copenhagen NV
Country [19] 0 0
Denmark
State/province [19] 0 0
Copenhagen
Country [20] 0 0
France
State/province [20] 0 0
Montpellier
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
France
State/province [22] 0 0
Pessac
Country [23] 0 0
France
State/province [23] 0 0
Toulouse
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Wuerzburg
Country [26] 0 0
Japan
State/province [26] 0 0
Aichi
Country [27] 0 0
Japan
State/province [27] 0 0
Gifu
Country [28] 0 0
Japan
State/province [28] 0 0
Nara
Country [29] 0 0
Japan
State/province [29] 0 0
Osaka
Country [30] 0 0
Japan
State/province [30] 0 0
Saitama
Country [31] 0 0
Japan
State/province [31] 0 0
Tokushima
Country [32] 0 0
Japan
State/province [32] 0 0
Tokyo
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Gyeonggi Do
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Korea
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Moscow
Country [36] 0 0
Russian Federation
State/province [36] 0 0
St Petersburg
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Yaroslavl
Country [38] 0 0
Spain
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Castilla La Mancha
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
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Spain
State/province [40] 0 0
Barcelona
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Switzerland
State/province [41] 0 0
CH
Country [42] 0 0
Switzerland
State/province [42] 0 0
Genève 14
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02333331
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications