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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: EUCTR
Last refreshed on: 30 June 2019
Main ID:  EUCTR2013-000705-23-DK
Date of registration: 10/03/2014
Prospective Registration: Yes
Primary sponsor: Novartis Pharma Services AG
Public title: Study of efficacy and safety of BYM338 in sporadic inclusion body myositis patients
Scientific title: 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: 21/03/2014
Target sample size: 240
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000705-23
Study type:  Interventional clinical trial of medicinal product
Study design: 
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
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Australia Belgium Denmark France Germany Italy Japan Netherlands
Poland Switzerland United Kingdom United States
Contacts
Name: Medicinsk Information   
Address:  Edvard Thomsens Vej 14 2300 København S Denmark
Telephone: +4539168400
Email: skriv.til@novartis.com
Affiliation:  Novartis Healthcare A/S
Name: Medicinsk Information   
Address:  Edvard Thomsens Vej 14 2300 København S Denmark
Telephone: +4539168400
Email: skriv.til@novartis.com
Affiliation:  Novartis Healthcare A/S
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
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
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Intervention(s)

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

Primary Outcome(s)

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
Timepoint(s) of evaluation of this end point: 52 weeks
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.
Primary end point(s): Change from Baseline in 6 Minute Walking Distance Test (6MWD) meters to Week 52
Secondary Outcome(s)

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
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
Secondary ID(s)
NCT01925209
CBYM338B2203
2013-000705-23-IT
Source(s) of Monetary Support
Novartis Pharma Services AG
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available: Yes
Date Posted: 21/01/2017
Date Completed: 06/01/2016
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-000705-23/results
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