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Trial record 24 of 140 for:    "idiopathic inflammatory myopathy"

Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients (RESILIENT)

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ClinicalTrials.gov Identifier: NCT01925209
Recruitment Status : Completed
First Posted : August 19, 2013
Results First Posted : May 12, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Sporadic Inclusion Body Myositis
Interventions: Drug: BYM338/bimagrumab
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were randomized into one of the four treatment arms in a 1:1:1:1 ratio.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study included 4 epochs: screening (up to 28 days pre-treatment), treatment (from day 1 up to 52 weeks), treatment maintenance (from week 52 up to 104 weeks) and follow-up (28 days after last dose administration).

Reporting Groups
  Description
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 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 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.
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.

Participant Flow for 3 periods

Period 1:   Treatment Epoch
    BYM338/Bimagrumab 10 mg/kg   BYM338/Bimagrumab 3 mg/kg   BYM338/Bimagrumab 1 mg/kg   Placebo
STARTED   63   63   63   62 
Full Analysis Set   63   63   63   62 
COMPLETED   54   55   56   57 
NOT COMPLETED   9   8   7   5 
Physician Decision                1                0                0                0 
Non-compliance with study treatment                0                0                0                1 
Death                1                0                0                0 
Protocol deviation                0                0                1                1 
Withdrawal by Subject                4                3                3                2 
Adverse Event                3                5                3                1 

Period 2:   Maintenance Treatment Epoch
    BYM338/Bimagrumab 10 mg/kg   BYM338/Bimagrumab 3 mg/kg   BYM338/Bimagrumab 1 mg/kg   Placebo
STARTED   49   46   52   50 
COMPLETED   49   45   50   48 
NOT COMPLETED   0   1   2   2 
Withdrawal by Subject                0                1                1                2 
Adverse Event                0                0                1                0 

Period 3:   Follow-up
    BYM338/Bimagrumab 10 mg/kg   BYM338/Bimagrumab 3 mg/kg   BYM338/Bimagrumab 1 mg/kg   Placebo
STARTED   57   61   56   58 
COMPLETED   56   55   55   54 
NOT COMPLETED   1   6   1   4 
Adverse Event                1                4                0                1 
Physician Decision                0                0                1                0 
Non-compliance with study treatment                0                0                0                1 
Withdrawal by Subject                0                2                0                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was analyzed.

Reporting Groups
  Description
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 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 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.
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.
Total Total of all reporting groups

Baseline Measures
   BYM338/Bimagrumab 10 mg/kg   BYM338/Bimagrumab 3 mg/kg   BYM338/Bimagrumab 1 mg/kg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 63   63   63   62   251 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.0  (7.93)   66.5  (8.72)   69.4  (7.91)   68.4  (8.12)   68.1  (8.20) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      22  34.9%      21  33.3%      23  36.5%      23  37.1%      89  35.5% 
Male      41  65.1%      42  66.7%      40  63.5%      39  62.9%      162  64.5% 


  Outcome Measures

1.  Primary:   Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52   [ Time Frame: Baseline, Week 52 ]

2.  Secondary:   Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52   [ Time Frame: Baseline, Week 52 ]

3.  Secondary:   Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52   [ Time Frame: Baseline, Week 52 ]

4.  Secondary:   Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52   [ Time Frame: Baseline, Week 52 ]

5.  Secondary:   Estimated Annual Number of Falls Per Patient Within Treatment Group   [ Time Frame: Week 52 ]

6.  Secondary:   Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52   [ Time Frame: Baseline, Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01925209     History of Changes
Other Study ID Numbers: CBYM338B2203
First Submitted: August 15, 2013
First Posted: August 19, 2013
Results First Submitted: January 5, 2017
Results First Posted: May 12, 2017
Last Update Posted: August 11, 2017