Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2013-000705-23-DK |
Date of registration:
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10/03/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of efficacy and safety of BYM338 in sporadic inclusion body myositis patients
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Scientific title:
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A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III 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 - RESILIENT |
Date of first enrolment:
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21/03/2014 |
Target sample size:
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240 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000705-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Belgium
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Denmark
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France
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Germany
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Italy
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Japan
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Netherlands
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Poland
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Medicinsk Information
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Address:
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Edvard Thomsens Vej 14
2300
København S
Denmark |
Telephone:
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+4539168400 |
Email:
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skriv.til@novartis.com |
Affiliation:
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Novartis Healthcare A/S |
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Name:
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Medicinsk Information
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Address:
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Edvard Thomsens Vej 14
2300
København S
Denmark |
Telephone:
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+4539168400 |
Email:
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skriv.til@novartis.com |
Affiliation:
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Novartis Healthcare A/S |
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Key inclusion & exclusion criteria
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Inclusion criteria: •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
Exclusion criteria: •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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Sporadic Inclusion Body Myositis
MedDRA version: 18.1
Level: PT
Classification code 10066407
Term: Inclusion body myositis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Intervention(s)
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Product Code: BYM338 Pharmaceutical Form: Solution for injection/infusion CAS Number: 1356922-05-8 Current Sponsor code: BYM338 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Secondary Objective: •Change from Baseline in lean body mass (LBM) at Week 52 •Change from Baseline in quadriceps Quantitative Muscle Testing (QMT) at Week 52 •Change from Baseline in Patient-Reported Physical Function at Week 52 •Rate of Fall Events •Change from Baseline in Short Physical Performance Battery score at Week 52 •Dose-response relationship in the change from Baseline in 6MWD meters to Week 52
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Timepoint(s) of evaluation of this end point: 52 weeks
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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.
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Primary end point(s): Change from Baseline in 6 Minute Walking Distance Test (6MWD) meters to Week 52
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Secondary Outcome(s)
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Secondary end point(s): •Change from Baseline in lean body mass (LBM) at Week 52
•Change from Baseline in quadriceps Quantitative Muscle Testing (QMT) at Week 52
•Change from Baseline in Patient-Reported Physical Function at Week 52
•Rate of Fall Events
•Change from Baseline in Short Physical Performance Battery score at Week 52
•Dose-response relationship in the change from Baseline in 6MWD meters to Week 52
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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
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Secondary ID(s)
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NCT01925209
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CBYM338B2203
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2013-000705-23-IT
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date:
Contact:
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