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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
6/12/2018

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: bimagrumab low dose - bimagrumab low dose infusion

Experimental: bimagrumab moderate dose - bimagrumab moderate dose infusion

Experimental: bimagrumab high dose - bimagrumab high dose infusion

Placebo Comparator: Placebo - Placebo 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
Short Physical Performance Battery - Change from baseline to week 25.
Timepoint [1] 0 0
Baseline, week 25
Secondary outcome [1] 0 0
Safety and tolerability as assessed by various measures such as adverse events - Assessed by various measures such as adverse events over 24 weeks.
Timepoint [1] 0 0
baseline, weeks 1, 5, 9, 13, 17, 21 and 25
Secondary outcome [2] 0 0
6-minute walk test - Change from baseline to week 25
Timepoint [2] 0 0
baseline, week 25
Secondary outcome [3] 0 0
Gait speed - Change from baseline to Week 25
Timepoint [3] 0 0
baseline, week 25
Secondary outcome [4] 0 0
Total lean body mass and appendicular skeletal muscle index measured by DXA - Change from baseline to Week 25
Timepoint [4] 0 0
baseline, week 25

Eligibility
Key inclusion criteria
- Low muscle mass as confirmed by DXA;

- Low gait speed;

- 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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
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
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Wisconsin
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Belgium
State/province [13] 0 0
Brussel
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Belgium
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Leuven
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Czechia
State/province [15] 0 0
Brno
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Czechia
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Opava
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Czechia
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Praha 2
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Denmark
State/province [18] 0 0
Copenhagen NV
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Denmark
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Copenhagen
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France
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Montpellier
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France
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Paris
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France
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Pessac
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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
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Russian Federation
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St Petersburg
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Russian Federation
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Yaroslavl
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Spain
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Castilla La Mancha
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Spain
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Madrid
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Spain
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Barcelona
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Switzerland
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CH
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Switzerland
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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 is 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 will generate 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