ClinicalTrials.gov
History of Changes for Study: NCT01925209
Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients (RESILIENT)
Latest version (submitted August 7, 2017) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 August 15, 2013 None (earliest Version on record)
2 August 16, 2013 Eligibility and Study Status
3 October 7, 2013 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 October 8, 2013 Contacts/Locations, Eligibility and Study Status
5 October 9, 2013 Contacts/Locations and Study Status
6 October 11, 2013 Contacts/Locations and Study Status
7 October 12, 2013 Contacts/Locations, Oversight and Study Status
8 November 5, 2013 Study Status and Contacts/Locations
9 November 21, 2013 Study Status
10 December 9, 2013 Study Status, Contacts/Locations and Oversight
11 December 12, 2013 Contacts/Locations and Study Status
12 December 29, 2013 Contacts/Locations and Study Status
13 January 13, 2014 Study Status and Contacts/Locations
14 January 29, 2014 Contacts/Locations and Study Status
15 January 30, 2014 Contacts/Locations and Study Status
16 March 21, 2014 Contacts/Locations and Study Status
17 June 5, 2014 Contacts/Locations, Study Status and Eligibility
18 August 27, 2014 Study Status and Contacts/Locations
19 December 4, 2014 Recruitment Status, Study Status and Contacts/Locations
20 January 14, 2015 Recruitment Status, Study Status and Contacts/Locations
21 February 2, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
22 February 11, 2015 Recruitment Status and Study Status
23 March 25, 2016 Study Status
24 September 21, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
25 April 5, 2017 Study Status, Outcome Measures, Contacts/Locations, Arms and Interventions, Results, Eligibility, Study Description and Study Identification
26 August 7, 2017 Study Status
Comparison Format:
Scroll up to access the controls
Study NCT01925209
Submitted Date:  August 15, 2013 (v1)
Open or close this module Study Identification
Unique Protocol ID: CBYM338B2203
Brief Title: Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients (RESILIENT)
Official Title: Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate Efficacy, Safety, Tolerability of i.v. BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility in Sporadic Inclusion Body Myositis Patients
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2013
Overall Status: Not yet recruiting
Study Start: September 2013
Primary Completion: November 2015 [Anticipated]
Study Completion: November 2015 [Anticipated]
First Submitted: August 15, 2013
First Submitted that
Met QC Criteria:		 August 15, 2013
First Posted: August 19, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:		 August 15, 2013
Last Update Posted: August 19, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Novartis Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: To evaluate the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM)
Detailed Description:
Open or close this module Conditions
Conditions: Sporadic Inclusion Body Myositis
Keywords: sporadic inclusion body myositis,
myositis,
muscle wasting,
controlled clinical trial,
randomized,
body mass,
muscle function,
strength,
performance,
physical function
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 240 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: BYM338/bimagrumab High Dose
60 patients who meet all inclusion criteria and none of the exclusion criteria will be treated with the BYM338 High Dose administered via intravenous infusion from Day 1 to Week 52, and up to Week 104.
 Drug: BYM338/bimagrumab
BYM338 will be administered via intravenous infusion to randomized patients beginning on Day 1 through Week 52, and up to Week 104.
Experimental: BYM338/bimagrumab Mid Dose
60 patients who meet all inclusion criteria and none of the exclusion criteria will be treated with the BYM338 Mid Dose administered via intravenous infusion from Day 1 to Week 52, and up to Week 104.
 Drug: BYM338/bimagrumab
BYM338 will be administered via intravenous infusion to randomized patients beginning on Day 1 through Week 52, and up to Week 104.
Experimental: BYM338/bimagrumab Low Dose
60 patients who meet all inclusion criteria and none of the exclusion criteria will be treated with the BYM338 Low Dose administered via intravenous infusion from Day 1 to Week 52, and up to Week 104.
 Drug: BYM338/bimagrumab
BYM338 will be administered via intravenous infusion to randomized patients beginning on Day 1 through Week 52, and up to Week 104.
Placebo Comparator: Placebo
60 patients who meet all inclusion criteria and none of the exclusion criteria will be receive matching placebo administered via intravenous infusion from Day 1 to Week 52, and up to Week 104.
 Drug: Placebo
Matching placebo will be administered via intravenous infusion to 60 randomized patients beginning on Day 1 through Week 52, and up to Week 104.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from Baseline in 6 Minute Walking Distance Test (6MWD) meters to Week 52
[ Time Frame: Baseline, Week 52 ]

Change from baseline to Week 52 in the distance a patient can walk in a set timeframe. 6 Minute Walking Distance Test measures the distance (in meters) that a patient can walk in a 6 minute timeframe.
Secondary Outcome Measures:
1. Change from Baseline in lean body mass (LBM) at Week 52
[ Time Frame: Baseline, Week 52 ]

Change from baseline to Week 52 in the total and appendicular lean body mass
2. Change from Baseline in quadriceps Quantitative Muscle Testing (QMT) at Week 52
[ Time Frame: Baseline, Week 52 ]

Change from baseline to Week 52 in quadriceps QMT.
3. Change from Baseline in Patient-Reported Physical Function at Week 52
[ Time Frame: Baseline, Week 52 ]

Change from baseline to Week 52 in a patient reported outcome instrument.
4. Rate of Fall Events
[ Time Frame: Baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108 ]

Number of falls
5. Change from Baseline in Short Physical Performance Battery score at Week 52
[ Time Frame: Baseline, Week 52 ]

Change from baseline to Week 52 in physical performance as measured by the Short Physical Performance Battery (SPPB).
6. Safety and Tolerability of different i.v. BYM338 doses
[ Time Frame: Baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108 ]

Safety and tolerability
7. Change from Baseline in 6MWD meters to Week 52
[ Time Frame: Baseline, Week 52 ]

Dose-response relationship
Open or close this module Eligibility
Minimum Age: 36 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

Diagnosed with sporadic inclusion body myositis; Must be able to walk (assistive aids allowed, including intermittent use of wheelchair);

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); Other protocol-defined inclusion/exclusion criteria may apply
Open or close this module Contacts/Locations
Central Contact Person: Novartis Pharmaceuticals
Telephone: +41613241111
Central Contact Backup: Novartis Pharmaceuticals
Study Officials: Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
Scroll up to access the controls Scroll to the Study top
U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services