A Randomized Withdrawal Extension Study of multiple Bimagrumab doses in Older Adults With Sarcopenia Previously Participating in the Core Study
- Conditions
- Sarcopenia
- Registration Number
- JPRN-jRCT2080223245
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 240
*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).
*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.
Other protocol defined exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>6 minute walk test [ Time Frame: Week 25, Week 49 ]<br>Change from Week 25 to Week 49
- Secondary Outcome Measures
Name Time Method safety<br>Number of participants with adverse events as a measure of Safety and Tolerability [ Time Frame: Weeks 25, 29, 37, 45, 49, 53 ]<br>Assessed by various measures such as adverse events over study<br>efficacy<br>Short Physical Performance Battery [ Time Frame: Weeks 33, 41, 49 ] <br>Change from Week 25 to Week 49<br>efficacy<br>Gait speed [ Time Frame: Weeks 33, 41, 49 ] <br>Change from Week 25 to Week 49<br>efficacy<br>Total lean body mass and appendicular skeletal muscle index measured by DXA [ Time Frame: Weeks 37, 49 ] <br>Change from Week 25 to Week 49