Overview

This trial is active, not recruiting.

Condition sporadic inclusion body myositis
Treatments bimagrumab, placebo
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date November 2015
End date February 2017
Trial size 203 participants
Trial identifier NCT02573467, 2015-001411-12, CBYM338B2203E1

Summary

This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. Patients who complete the core study and qualify for this extension study will enter Treatment Period 1, during which they will continue on the study drug which they were receiving in the core study (either one of the three BYM338 doses or placebo). Treatment Period 1 will continue until the dose of BYM338 with the best benefit-risk profile is determined and selected. The duration of Treatment Period 1 could be up to one year (but estimated to be between 6 and 8 months) and the total duration of Treatment Period 1 will depend upon the timing of selection of the dose for Treatment Period 2. Once the dose with the best benefit-risk profile is selected, all ongoing subjects (including those who have been receiving placebo) will enter Treatment Period 2 and will be switched to open-label treatment with BYM338 at the selected dose. Treatment Period 2 will continue until BYM338 is approved and commercially available in the country of the investigational site.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Approximately 60 patients who meet all inclusion criteria and none of the exclusion criteria will be treated in Treatment Period 1 with the BYM338 10 mg/kg dose administered via intravenous infusion every 4 weeks. In Treatment Period 2, patients will be treated with open-label BYM338 at the selected dose, administered via intravenous infusion every 4 weeks.
bimagrumab BYM338
(Experimental)
Approximately 60 patients who meet all inclusion criteria and none of the exclusion criteria will be treated in Treatment Period 1 with the BYM338 3 mg/kg dose administered via intravenous infusion every 4 weeks. In Treatment Period 2, patients will be treated with open-label BYM338 at the selected dose, administered via intravenous infusion every 4 weeks.
bimagrumab BYM338
(Experimental)
Approximately 60 patients who meet all inclusion criteria and none of the exclusion criteria will be treated in Treatment Period 1 with the BYM338 1 mg/kg dose administered via intravenous infusion every 4 weeks. In Treatment Period 2, patients will be treated with open-label BYM338 at the selected dose, administered via intravenous infusion every 4 weeks.
bimagrumab BYM338
(Placebo Comparator)
Approximately 60 patients who meet all inclusion criteria and none of the exclusion criteria will be treated in Treatment Period 1 with Placebo administered via intravenous infusion every 4 weeks. In Treatment Period 2, patients will be treated with open-label BYM338 at the selected dose, administered via intravenous infusion every 4 weeks.
placebo

Primary Outcomes

Measure
Safety Assessment, incidence of Treatment-Emergent Adverse Events
time frame: to end of study (2 years)
Change from baseline in 6 Minute Walking Distance Test (6MWD)
time frame: Baseline, 1 year

Secondary Outcomes

Measure
Change from baseline in quadriceps muscle strength
time frame: Baseline, 1 and 2 years
Change from baseline in patient-reported physical performance
time frame: Baseline, 1 and 2 years
Incidence of patients with self-reported falls and self-reported injurious falls
time frame: Baseline, 1 and 2 years
Change from baseline in physical performance
time frame: Baseline, 1 and 2 years
Change in muscles of the thigh
time frame: 1 and 2 years
Number of patients who develop immunogenicity against BYM338
time frame: 2 years

Eligibility Criteria

Male or female participants at least 36 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Novartis.