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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02333331
Ethics application status
Date submitted
10/12/2014
Date registered
7/01/2015

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
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
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
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)
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)
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
Sex
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
9/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/06/2018
Sample size
Target
Accrual to date
Final
217
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
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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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
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Brussel
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Belgium
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Leuven
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Czechia
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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
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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
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Toulouse
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Germany
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Berlin
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Germany
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Wuerzburg
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Japan
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Aichi
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Japan
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Gifu
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Japan
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Nara
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokushima
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Japan
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Tokyo
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Korea, Republic of
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Gyeonggi Do
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Korea
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Russian Federation
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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
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
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


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02333331