Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose Range Finding Study of Bimagrumab in Sarcopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02333331
Recruitment Status : Completed
First Posted : January 7, 2015
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Sarcopenia Drug: bimagrumab Other: placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 9, 2014
Actual Primary Completion Date : June 26, 2018
Actual Study Completion Date : June 28, 2018

Arm Intervention/treatment
Experimental: BYM338 70 mg
BYM338 70 mg intravenous infusion
Drug: bimagrumab
Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
Other Name: BYM338

Experimental: BYM338 210 mg
BYM338 210 mg intravenous infusion
Drug: bimagrumab
Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
Other Name: BYM338

Experimental: BYM338 700 mg
BYM338 700 mg intravenous infusion
Drug: bimagrumab
Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
Other Name: BYM338

Placebo Comparator: Placebo
Placebo intravenous infusion
Other: placebo
Placebo will be administered as an intravenous infusion starting on Day 1 until week 21.
Other Name: 5% dextrose




Primary Outcome Measures :
  1. Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25 [ Time Frame: Baseline, 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 :
  1. Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance [ Time Frame: Baseline, week 25 ]
    Change from Baseline at Week 25 in the 6 minute walk test (6MWT) distance to measure improvement in physical function

  2. Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters [ Time Frame: baseline, week 25 ]
    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).

  3. Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA) [ Time Frame: baseline, week 25 ]
    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.

  4. Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA) [ Time Frame: baseline, week 25 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333331


  Show 58 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] July 16, 2018
Study Protocol  [PDF] October 4, 2017


Additional Information:
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02333331     History of Changes
Other Study ID Numbers: CBYM338E2202
First Posted: January 7, 2015    Key Record Dates
Results First Posted: August 6, 2019
Last Update Posted: August 6, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Sarcopenia, muscle wasting, elderly, strength, physical function, muscle, gait speed
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Antibodies, Monoclonal
Antibodies, Blocking
Immunologic Factors
Physiological Effects of Drugs