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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

Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Intravenous BYM338 in Patients With Sporadic Inclusion Body Myositis

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223024
Enrollment
240
Registered
2015-11-25
Start date
2015-11-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sporadic Inclusion Body Myositis

Interventions

investigational material(s) Generic name etc : BYM338 INN of investigational material : Bimagrumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Inv

Sponsors

Novartis Pharma K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Safety Assessment, incidence of Treatment-Emergent Adverse Events [ Time Frame: to end of study (2 years) ] [ Designated as safety issue: Yes ] Adverse events and serious adverse events collected will be reported Change from baseline in 6 Minute Walking Distance Test (6MWD) [ Time Frame: Baseline, 1 year ] [ Designated as safety issue: No ] The 6MWD test measures the distance (in meters) that a patient can walk in a 6 minute time frame.—

Secondary

MeasureTime frame
Change from baseline in quadriceps muscle strength [ Time Frame: Baseline, 1 and 2 years ] [ Designated as safety issue: No ] Quadriceps muscle strength will be measured. Change from baseline in patient-reported physical performance [ Time Frame: Baseline, 1 and 2 years ] [ Designated as safety issue: No ] Patients answer the patient-reported physical performance. Incidence of patients with self-reported falls and self-reported injurious falls [ Time Frame: Baseline, 1 and 2 years ] [ Designated as safety issue: Yes ] Number of self-reported falls and self-reported injurious falls Change from baseline in physical performance [ Time Frame: Baseline, 1 and 2 years ] [ Designated as safety issue: No ] Physical performance test will be measured by the Short Physical Performance Battery (SPPB).—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026