Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients
NCT ID: NCT01925209
Last Updated: 2017-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
251 participants
INTERVENTIONAL
2013-09-26
2016-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BYM338/bimagrumab 10 mg/kg
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
BYM338/bimagrumab
BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
BYM338/bimagrumab 3 mg/kg
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
BYM338/bimagrumab
BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
BYM338/bimagrumab 1 mg/kg
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
BYM338/bimagrumab
BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
Placebo
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
Placebo
Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
Interventions
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BYM338/bimagrumab
BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
Placebo
Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
Eligibility Criteria
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Inclusion Criteria
* Must be able to walk (assistive aids allowed, including intermittent use of wheelchair);
Exclusion Criteria
* 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.);
36 Years
85 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Orange, California, United States
Novartis Investigative Site
Sacramento, California, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Kansas City, Kansas, United States
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Baltimore, Maryland, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Columbus, Ohio, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
St Leonards, New South Wales, Australia
Novartis Investigative Site
Cauldfield, Victoria, Australia
Novartis Investigative Site
Nedlands, Western Australia, Australia
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Edegem, , Belgium
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative Site
Copenhagen, , Denmark
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Brescia, BS, Italy
Novartis Investigative Site
Rome, Lazio, Italy
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Messina, ME, Italy
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Milan, MI, Italy
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Padua, PD, Italy
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Kumamoto, Kumamoto, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Osaka, Osaka, Japan
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Tokushima, Tokushima, Japan
Novartis Investigative Site
Kodaira, Tokyo, Japan
Novartis Investigative Site
Wakayama, Wakayama, Japan
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Leiden, , Netherlands
Novartis Investigative Site
Zurich, , Switzerland
Novartis Investigative Site
Salford, Manchester, United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Hanna MG, Badrising UA, Benveniste O, Lloyd TE, Needham M, Chinoy H, Aoki M, Machado PM, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Oskarsson B, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AI, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Katsuno M, Murata K, Nodera H, Nishino I, Romano CD, Williams VSL, Vissing J, Auberson LZ, Wu M, de Vera A, Papanicolaou DA, Amato AA; RESILIENT Study Group. Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial. Lancet Neurol. 2019 Sep;18(9):834-844. doi: 10.1016/S1474-4422(19)30200-5.
Other Identifiers
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CBYM338B2203
Identifier Type: -
Identifier Source: org_study_id
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