Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatients
- Conditions
- Sporadic Inclusion Body MyositisMedDRA version: 14.1Level: PTClassification code 10066407Term: Inclusion body myositisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-000705-23-IT
- Lead Sponsor
- ovartis Farma SpA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 251
•Diagnosed with sporadic inclusion body myositis;
•Must be able to walk (assistive aids allowed, including intermittent use of wheelchair)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170
•No 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);
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that at least one dose regimen of BYM338 will increase the 6 minute walking distance test relative to placebo at week 52.;Secondary Objective: •Change from Baseline in lean body mass (LBM) at Week 52 <br>•Change from Baseline in quadriceps Quantitative Muscle Testing (QMT) at Week 52 <br>•Change from Baseline in Patient-Reported Physical Function at Week 52<br>•Rate of Fall Events <br>•Change from Baseline in Short Physical Performance Battery score at Week 52 <br>•Dose-response relationship in the change from Baseline in 6MWD meters to Week 52;Primary end point(s): Change from Baseline in 6 Minute Walking Distance Test (6MWD) meters to Week 52 ;Timepoint(s) of evaluation of this end point: 52 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Change from Baseline in lean body mass (LBM) at Week 52 <br>•Change from Baseline in quadriceps Quantitative Muscle Testing (QMT) at Week 52 <br>•Change from Baseline in Patient-Reported Physical Function at Week 52<br>•Rate of Fall Events <br>•Change from Baseline in Short Physical Performance Battery score at Week 52 <br>•Dose-response relationship in the change from Baseline in 6MWD meters to Week 52;Timepoint(s) of evaluation of this end point: Week 52 for LBM, QMT, patient-reporter physical function, short physical performance battery and dose-response relationship for 6MWD and measured during entire study for falls , safety and tolerability