Extension Study of the Long-term Efficacy and Safety of BYM338 in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203
Phase 2
- Conditions
- Sporadic Inclusion Body Myositis
- Registration Number
- JPRN-jRCT2080223024
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
Patients who completed the core study
-Willing to participate for the entire duration of the extension study with commitment to follow study requirements and procedures.
Exclusion Criteria
-Current use of prohibited treatments
-History of severe hypersensitivity reaction in the core study
-History of something prior to the start of study drug in the extension study 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Assessment, incidence of Treatment-Emergent Adverse Events [ Time Frame: to end of study (2 years) ] [ Designated as safety issue: Yes ]<br>Adverse events and serious adverse events collected will be reported<br> Change from baseline in 6 Minute Walking Distance Test (6MWD) [ Time Frame: Baseline, 1 year ] [ Designated as safety issue: No ]<br>The 6MWD test measures the distance (in meters) that a patient can walk in a 6 minute time frame.
- Secondary Outcome Measures
Name Time Method Change from baseline in quadriceps muscle strength [ Time Frame: Baseline, 1 and 2 years ] [ Designated as safety issue: No ]<br>Quadriceps muscle strength will be measured.<br>Change from baseline in patient-reported physical performance [ Time Frame: Baseline, 1 and 2 years ] [ Designated as safety issue: No ]<br>Patients answer the patient-reported physical performance.<br>Incidence of patients with self-reported falls and self-reported injurious falls [ Time Frame: Baseline, 1 and 2 years ] [ Designated as safety issue: Yes ]<br>Number of self-reported falls and self-reported injurious falls<br>Change from baseline in physical performance [ Time Frame: Baseline, 1 and 2 years ] [ Designated as safety issue: No ]<br>Physical performance test will be measured by the Short Physical Performance Battery (SPPB).