Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01925209
• Date of registration: 15/08/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients RESILIENT
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Dose-finding, Pivotal, Phase 2b/3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility and Additional Long Term Safety up to 2 Years in Patients With Sporadic Inclusion Body Myositis
• Date of first enrolment: September 26, 2013
• Target sample size: 251
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01925209
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Belgium, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, Switzerland, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Diagnosed with sporadic inclusion body myositis;

- Must be able to walk (assistive aids allowed, including intermittent use of
wheelchair);

Key Exclusion Criteria:

- Must not have other conditions that significantly limit ability to move around;

- Must not be using corticosteroids. Must not have used systemic corticosteroid (at
daily dose >=10mg prednisone) for the past 3 months;

- Must meet cardiovascular requirements;

- Must not be pregnant or nursing;

- Must not have a chronic active infection (e.g., HIV, hepatitis B or C, tuberculosis,
etc.);



Age minimum: 36 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sporadic Inclusion Body Myositis

Intervention(s)

Drug: BYM338/bimagrumab

Drug: Placebo

Primary Outcome(s)

Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52 [Time Frame: Baseline, Week 52]

Secondary Outcome(s)

Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52 [Time Frame: Baseline, Week 52]

Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52 [Time Frame: Baseline, Week 52]

Estimated Annual Number of Falls Per Patient Within Treatment Group [Time Frame: Week 52]

Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52 [Time Frame: Baseline, Week 52]

Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52 [Time Frame: Baseline, Week 52]

Secondary ID(s)

CBYM338B2203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01925209