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

Phase 3

Completed

Conditions: sporadic inclusion body myositis
10028302

Registration Number: NL-OMON42420

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

- Patients who completed the core study
- Written informed consent must be obtained before any extension study assessment is performed
- Able to communicate well with the investigator
- Willing to participate for the entire duration of the extension study with commitment to follow study requirements and procedures

Exclusion Criteria

- Women who are pregnant
- Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 6 months after the last BYM338 dose
- Current use of prohibited treatments
- History of severe hypersensitivity reaction in the core study
- History of adverse event(s) (including those from the core study) 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
- Any medical condition or laboratory finding which, in the opinion of the investigator may interfere with participation in the study, might confound the results of the study, or pose an additional safety risk in administering BYM338

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Safety and tolerabilty of different i.v. BYM338 doses<br /><br>- Change from baseline in 6 Minute Walking Distance Test (6MWD)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* To describe the long-term evolution of quadriceps muscle strength using<br /><br>quadriceps Quantitative Muscle Testing (QMT)<br /><br>* To describe physical function reported by patients using the Sporadic<br /><br>Inclusion Body Myositis Functional Assessment (sIFA)<br /><br>* To report the incidence of self-reported falls and self-reported injurious<br /><br>falls (falls that result in any subject injury) which are a subset of all<br /><br>self-reported falls<br /><br>* To describe physical performance using the Short Physical Performance Battery<br /><br>(SPPB)<br /><br>* To characterize muscle changes using magnetic resonance imaging (MRI) from a<br /><br>subset of patients<br /><br>* To investigate the development of immunogenicity against BYM338</p><br>