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Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis

A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body Myositis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01423110
Enrollment
14
Registered
2011-08-25
Start date
2011-08-31
Completion date
2012-05-31
Last updated
2020-12-17

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

Conditions

Sporadic Inclusion Body Myositis

Keywords

sporadic Inclusion Body Myositis

Brief summary

This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis

Interventions

BIOLOGICALBYM338
BIOLOGICALPlacebo

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

\- Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body Myositis

Exclusion criteria

* Unable to walk at least 3 meters without assistance from another person * Use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months * patients with a history or presence of renal impairment and/or liver disease Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Effect of BYM338 on Thigh Muscle Volume by MRI8 weeksChange in thigh muscle volume

Secondary

MeasureTime frameDescription
Effect of BYM338 on muscle function by 'Timed Get Up and Go' test8 weeksChange in muscle function measured on scale by test results

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026