Sarcopenia MedDRA version: 18.0 Level: PT Classification code 10063024 Term: Sarcopenia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: bimagrumab
Product Code: BYM338
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Bimagrumab
CAS Number: 1356922-05-8
Current Sponsor code: BYM338
Other des
Sponsors
Novartis Farmacéutica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and postmenopausal women aged 70 years or older that have participated in, and have completed the full study treatment period per protocol (24 weeks/EOT visit) in the preceding core study (CBYM338E2202). Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: - Use of prohibited treatments as per recommendations outlined in protocol - History of severe hypersensitivity reaction in the core study (CBYM338E2202) - History of breaking of the blind (inadvertently or for emergency reasons) in the core study (CBYM338E2202) - History of adverse event(s) in the core study (CBYM338E2202) that in the judgment of the investigator, taking into account the subject?s overall status, prevent the subject from entering the extension study - Clinically significant abnormal liver function tests that would have resulted in discontinuation of study drug while participating in the core study (CBYM338E2202) as per protocol - Any medical condition or laboratory finding, which, in the opinion of the investigator prevents the subject from continuing participation in the study, may interfere with participation in the study, might confound the results of the study, or pose an additional safety risk to the subject in administering bimagrumab - Concurrent enrollment in a clinical trial involving an investigational drug or off- label use of a drug, or any other type of medical research judged to be scientifically or medically incompatible with this study (not including enrollment in BYM338E2202 core study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the durability of effect of bimagrumab (BYM) by comparing withdrawal of BYM (i.e., BYM/placebo PBO switch) treatment with continued BYM administration every 4 weeks for 24 additional weeks of treatment (following participation in the core study) in older adults with sarcopenia as measured by change from week 25 to week 49 on the 6MWT;Secondary Objective: - Evaluate the effect of BYM given intravenously every 4 weeks for 24 additional weeks of treatment (following completion of 24 weeks of treatment in the core study) on safety and tolerability as assessed by measures such as vital signs, clinical laboratory variables, electrocardiogram, echocardiogram, and adverse events as compared to treatment with PBO in older adults with sarcopenia - Evaluate the durability of effect of BYM by comparing withdrawal of BYM (i.e. BYM/PBO switch) treatment with continued BYM administration every 4 weeks for 24 additional weeks of treatment (following completion of 24 weeks of treatment in the core study) in older adults with sarcopenia as measured by change from week 25 to week 49 on: - performance on the Short Physical Performance Battery score mobility as measured in gait speed (GS measured as a component of the SPPB) over 4 meters - total lean body mass and appendicular skeletal muscle index measured by dual energy X-ray absorptiometry;Primary end point(s): 6 minute walk test;Timepoint(s) of evaluation of this end point: Week 25, 49 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety and tolerability - Short Physical Performance Battery - Gait speed - Total lean body mass and appendicular skeletal muscle index measured by DXA;Timepoint(s) of evaluation of this end point: - Safety and tolerability: Weeks 25, 29, 37, 45, 49, 53 - Short Physical Performance Battery, Gait speed: Weeks 33, 41, 49 - Total lean body mass and appendicular skeletal muscle index measured by DXA: Weeks 37,49 | — |
Countries
Belgium, Denmark, European Union, Japan, Spain, Switzerland, Taiwan, United States
Contacts
Public ContactDepartamento Medico (ICRO)
Novartis Farmacéutica, S.A.
Outcome results
None listed