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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
Enrollment 251
Recruitment Details Participants were randomized into one of the four treatment arms in a 1:1:1:1 ratio.
Pre-assignment Details 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).
Arm/Group Title BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Treatment Epoch
Started 63 63 63 62
Full Analysis Set 63 63 63 62
Completed 54 55 56 57
Not Completed 9 8 7 5
Reason Not Completed
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 Title: Maintenance Treatment Epoch
Started 49 46 52 50
Completed 49 45 50 48
Not Completed 0 1 2 2
Reason Not Completed
Withdrawal by Subject             0             1             1             2
Adverse Event             0             0             1             0
Period Title: Follow-up
Started 57 61 56 58
Completed 56 55 55 54
Not Completed 1 6 1 4
Reason Not Completed
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
Arm/Group Title BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 63 63 63 62 251
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 63 participants 63 participants 62 participants 251 participants
68.0  (7.93) 66.5  (8.72) 69.4  (7.91) 68.4  (8.12) 68.1  (8.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 63 participants 63 participants 62 participants 251 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%
1.Primary Outcome
Title Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52
Hide Description The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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 considered for the analysis. Only those participants from the FAS who had both baseline and week 52 6MWD measurements were analyzed.
Arm/Group Title BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 61 63 63 62
Least Squares Mean (Standard Error)
Unit of Measure: meters
8.63  (10.934) 9.63  (10.770) -10.27  (10.718) -8.96  (10.765)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BYM338/Bimagrumab 10 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2210
Comments [Not Specified]
Method mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 17.59
Confidence Interval (2-Sided) 99%
-19.63 to 54.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.331
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BYM338/Bimagrumab 3 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1909
Comments [Not Specified]
Method mixed model repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 18.59
Confidence Interval (2-Sided) 99%
-18.21 to 55.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.176
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BYM338/Bimagrumab 1 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9263
Comments [Not Specified]
Method mixed models repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.31
Confidence Interval (2-Sided) 99%
-37.97 to 35.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.121
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52
Hide Description LBM was measured via dual energy x-ray absorptiometry (DXA) and calculated as (LBM at Week 52/LBM at baseline)*100 . A positive change from baseline indicates improvement.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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 considered for the analysis. Only those participants from the FAS who had both baseline and week 52 LBM measurements were analyzed.
Arm/Group Title BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 62 61 63 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
102.8
(101.4 to 104.2)
100.4
(99.1 to 101.8)
98.3
(97.0 to 99.6)
97.2
(95.9 to 98.5)
3.Secondary Outcome
Title Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52
Hide Description Quadriceps muscle strength was measured by portable fixed dynamometry (PFD) on the right side. A negative change from baseline indicates deterioration.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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 considered for the analysis. Only those participants from the FAS who had both baseline and week 52 QMT measurements were analyzed.
Arm/Group Title BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 60 63 63 61
Least Squares Mean (Standard Error)
Unit of Measure: newtons
-12.44  (6.021) -20.36  (5.843) -14.89  (5.828) -16.48  (5.830)
4.Secondary Outcome
Title Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52
Hide Description Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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 considered for the analysis. Only those participants from the FAS who had both baseline and week 52 sIFA measurements were analyzed.
Arm/Group Title BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 61 63 60 61
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
1.74  (1.915) 3.56  (1.876) 6.12  (1.899) 6.85  (1.895)
5.Secondary Outcome
Title Estimated Annual Number of Falls Per Patient Within Treatment Group
Hide Description Participants documented any fall occurrences in a paper diary during the study.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 63 63 63 62
Measure Type: Number
Unit of Measure: Annual number of falls per participant
4.33 4.02 4.70 5.13
6.Secondary Outcome
Title Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52
Hide Description The SPPB evaluated lower extremities function by testing gait speed, ability to keep standing balance and time to rise from a chair five times. The sub-score for each test ranged from 0 to 4. The summary score, which was a summation of scores from the 3 tests, ranged from 0 to 12. An increase in score indicates improvement in physical performance. A negative change from baseline indicates deterioration.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 62 63 63 62
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.0  (0.24) 0.0  (0.23) -0.5  (0.23) -0.5  (0.23)
Time Frame up to 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/63 (33.33%)   11/63 (17.46%)   18/63 (28.57%)   20/62 (32.26%) 
Blood and lymphatic system disorders         
ANAEMIA † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
IRON DEFICIENCY ANAEMIA † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
Cardiac disorders         
ACUTE MYOCARDIAL INFARCTION † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
ATRIAL FIBRILLATION † 1  1/63 (1.59%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
ATRIOVENTRICULAR BLOCK † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
ATRIOVENTRICULAR BLOCK SECOND DEGREE † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
MYOCARDIAL INFARCTION † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
PALPITATIONS † 1  0/63 (0.00%)  1/63 (1.59%)  1/63 (1.59%)  0/62 (0.00%) 
Ear and labyrinth disorders         
VERTIGO † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  1/62 (1.61%) 
Eye disorders         
RETINAL ARTERY OCCLUSION † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
Gastrointestinal disorders         
ABDOMINAL DISTENSION † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
ABDOMINAL HERNIA † 1  0/63 (0.00%)  1/63 (1.59%)  0/63 (0.00%)  0/62 (0.00%) 
ABDOMINAL PAIN UPPER † 1  1/63 (1.59%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
DIARRHOEA † 1  3/63 (4.76%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
DYSPHAGIA † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  2/62 (3.23%) 
INGUINAL HERNIA † 1  1/63 (1.59%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
VOLVULUS † 1  0/63 (0.00%)  1/63 (1.59%)  0/63 (0.00%)  0/62 (0.00%) 
General disorders         
INJURY ASSOCIATED WITH DEVICE † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
Infections and infestations         
DIVERTICULITIS † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
PNEUMONIA † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
STREPTOCOCCAL BACTERAEMIA † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
Injury, poisoning and procedural complications         
ANKLE FRACTURE † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
CARBON MONOXIDE POISONING † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
CERVICAL VERTEBRAL FRACTURE † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
ENDOTRACHEAL INTUBATION COMPLICATION † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
EYE INJURY † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
FACIAL BONES FRACTURE † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
FALL † 1  2/63 (3.17%)  2/63 (3.17%)  4/63 (6.35%)  1/62 (1.61%) 
FEMUR FRACTURE † 1  0/63 (0.00%)  1/63 (1.59%)  0/63 (0.00%)  0/62 (0.00%) 
FIBULA FRACTURE † 1  1/63 (1.59%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
FOOT FRACTURE † 1  0/63 (0.00%)  1/63 (1.59%)  1/63 (1.59%)  1/62 (1.61%) 
HAND FRACTURE † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
HIP FRACTURE † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
INTENTIONAL OVERDOSE † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
LACERATION † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
PATELLA FRACTURE † 1  0/63 (0.00%)  1/63 (1.59%)  1/63 (1.59%)  1/62 (1.61%) 
SPINAL CORD INJURY CERVICAL † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
THORACIC VERTEBRAL FRACTURE † 1  0/63 (0.00%)  1/63 (1.59%)  0/63 (0.00%)  0/62 (0.00%) 
TIBIA FRACTURE † 1  1/63 (1.59%)  0/63 (0.00%)  2/63 (3.17%)  0/62 (0.00%) 
TRAUMATIC HAEMATOMA † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
VASCULAR PSEUDOANEURYSM † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
WRIST FRACTURE † 1  0/63 (0.00%)  1/63 (1.59%)  1/63 (1.59%)  0/62 (0.00%) 
Investigations         
ALANINE AMINOTRANSFERASE INCREASED † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
BLOOD ALKALINE PHOSPHATASE INCREASED † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
Metabolism and nutrition disorders         
DEHYDRATION † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
HYPONATRAEMIA † 1  1/63 (1.59%)  1/63 (1.59%)  0/63 (0.00%)  0/62 (0.00%) 
Musculoskeletal and connective tissue disorders         
BACK PAIN † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
MYALGIA † 1  0/63 (0.00%)  1/63 (1.59%)  0/63 (0.00%)  0/62 (0.00%) 
VERTEBRAL FORAMINAL STENOSIS † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
BASAL CELL CARCINOMA † 1  3/63 (4.76%)  3/63 (4.76%)  1/63 (1.59%)  3/62 (4.84%) 
LUNG ADENOCARCINOMA † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
SQUAMOUS CELL CARCINOMA † 1  2/63 (3.17%)  2/63 (3.17%)  2/63 (3.17%)  0/62 (0.00%) 
SQUAMOUS CELL CARCINOMA OF SKIN † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
Nervous system disorders         
CAROTID ARTERY STENOSIS † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
PRESYNCOPE † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
SYNCOPE † 1  1/63 (1.59%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
TRANSIENT GLOBAL AMNESIA † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
TRANSIENT ISCHAEMIC ATTACK † 1  0/63 (0.00%)  1/63 (1.59%)  0/63 (0.00%)  1/62 (1.61%) 
Psychiatric disorders         
DEPRESSION † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
SUICIDE ATTEMPT † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
Renal and urinary disorders         
BLADDER MASS † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
HAEMATURIA † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
URINARY RETENTION † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
ASPIRATION † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
PNEUMONIA ASPIRATION † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  1/62 (1.61%) 
PULMONARY EMBOLISM † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
Skin and subcutaneous tissue disorders         
RASH † 1  0/63 (0.00%)  0/63 (0.00%)  1/63 (1.59%)  0/62 (0.00%) 
RASH PRURITIC † 1  0/63 (0.00%)  0/63 (0.00%)  0/63 (0.00%)  1/62 (1.61%) 
Vascular disorders         
AORTIC ANEURYSM † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
PERIPHERAL ISCHAEMIA † 1  1/63 (1.59%)  0/63 (0.00%)  0/63 (0.00%)  0/62 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   63/63 (100.00%)   63/63 (100.00%)   63/63 (100.00%)   61/62 (98.39%) 
Blood and lymphatic system disorders         
ANAEMIA † 1  5/63 (7.94%)  3/63 (4.76%)  0/63 (0.00%)  1/62 (1.61%) 
Gastrointestinal disorders         
ABDOMINAL PAIN † 1  3/63 (4.76%)  4/63 (6.35%)  0/63 (0.00%)  0/62 (0.00%) 
ABDOMINAL PAIN UPPER † 1  2/63 (3.17%)  6/63 (9.52%)  1/63 (1.59%)  0/62 (0.00%) 
CONSTIPATION † 1  6/63 (9.52%)  3/63 (4.76%)  6/63 (9.52%)  3/62 (4.84%) 
DIARRHOEA † 1  32/63 (50.79%)  28/63 (44.44%)  20/63 (31.75%)  11/62 (17.74%) 
DRY MOUTH † 1  5/63 (7.94%)  1/63 (1.59%)  3/63 (4.76%)  4/62 (6.45%) 
DYSPHAGIA † 1  5/63 (7.94%)  4/63 (6.35%)  1/63 (1.59%)  5/62 (8.06%) 
NAUSEA † 1  11/63 (17.46%)  4/63 (6.35%)  9/63 (14.29%)  5/62 (8.06%) 
VOMITING † 1  4/63 (6.35%)  1/63 (1.59%)  2/63 (3.17%)  3/62 (4.84%) 
General disorders         
ASTHENIA † 1  1/63 (1.59%)  3/63 (4.76%)  4/63 (6.35%)  6/62 (9.68%) 
FATIGUE † 1  9/63 (14.29%)  4/63 (6.35%)  14/63 (22.22%)  7/62 (11.29%) 
OEDEMA PERIPHERAL † 1  5/63 (7.94%)  9/63 (14.29%)  9/63 (14.29%)  7/62 (11.29%) 
PYREXIA † 1  3/63 (4.76%)  1/63 (1.59%)  3/63 (4.76%)  5/62 (8.06%) 
Infections and infestations         
FOLLICULITIS † 1  4/63 (6.35%)  2/63 (3.17%)  0/63 (0.00%)  1/62 (1.61%) 
INFLUENZA † 1  2/63 (3.17%)  4/63 (6.35%)  4/63 (6.35%)  2/62 (3.23%) 
NASOPHARYNGITIS † 1  6/63 (9.52%)  11/63 (17.46%)  9/63 (14.29%)  6/62 (9.68%) 
RHINITIS † 1  0/63 (0.00%)  1/63 (1.59%)  1/63 (1.59%)  4/62 (6.45%) 
SINUSITIS † 1  1/63 (1.59%)  4/63 (6.35%)  1/63 (1.59%)  4/62 (6.45%) 
UPPER RESPIRATORY TRACT INFECTION † 1  11/63 (17.46%)  11/63 (17.46%)  14/63 (22.22%)  10/62 (16.13%) 
URINARY TRACT INFECTION † 1  4/63 (6.35%)  4/63 (6.35%)  2/63 (3.17%)  4/62 (6.45%) 
Injury, poisoning and procedural complications         
CONTUSION † 1  14/63 (22.22%)  23/63 (36.51%)  22/63 (34.92%)  22/62 (35.48%) 
FALL † 1  47/63 (74.60%)  55/63 (87.30%)  54/63 (85.71%)  52/62 (83.87%) 
FOOT FRACTURE † 1  3/63 (4.76%)  3/63 (4.76%)  4/63 (6.35%)  4/62 (6.45%) 
HEAD INJURY † 1  4/63 (6.35%)  4/63 (6.35%)  3/63 (4.76%)  3/62 (4.84%) 
INJURY † 1  4/63 (6.35%)  0/63 (0.00%)  7/63 (11.11%)  3/62 (4.84%) 
JOINT INJURY † 1  5/63 (7.94%)  3/63 (4.76%)  6/63 (9.52%)  5/62 (8.06%) 
LACERATION † 1  6/63 (9.52%)  5/63 (7.94%)  12/63 (19.05%)  9/62 (14.52%) 
LIGAMENT SPRAIN † 1  7/63 (11.11%)  10/63 (15.87%)  9/63 (14.29%)  10/62 (16.13%) 
LIMB INJURY † 1  5/63 (7.94%)  7/63 (11.11%)  2/63 (3.17%)  8/62 (12.90%) 
SKIN ABRASION † 1  14/63 (22.22%)  14/63 (22.22%)  14/63 (22.22%)  17/62 (27.42%) 
SOFT TISSUE INJURY † 1  3/63 (4.76%)  5/63 (7.94%)  1/63 (1.59%)  1/62 (1.61%) 
Investigations         
BLOOD CREATINE PHOSPHOKINASE INCREASED † 1  3/63 (4.76%)  5/63 (7.94%)  4/63 (6.35%)  0/62 (0.00%) 
VITAMIN D DECREASED † 1  4/63 (6.35%)  2/63 (3.17%)  3/63 (4.76%)  1/62 (1.61%) 
WEIGHT DECREASED † 1  9/63 (14.29%)  4/63 (6.35%)  8/63 (12.70%)  3/62 (4.84%) 
Metabolism and nutrition disorders         
DECREASED APPETITE † 1  10/63 (15.87%)  3/63 (4.76%)  3/63 (4.76%)  1/62 (1.61%) 
GOUT † 1  3/63 (4.76%)  0/63 (0.00%)  4/63 (6.35%)  2/62 (3.23%) 
HYPERCHOLESTEROLAEMIA † 1  2/63 (3.17%)  4/63 (6.35%)  2/63 (3.17%)  1/62 (1.61%) 
HYPOMAGNESAEMIA † 1  4/63 (6.35%)  2/63 (3.17%)  0/63 (0.00%)  0/62 (0.00%) 
VITAMIN D DEFICIENCY † 1  6/63 (9.52%)  12/63 (19.05%)  3/63 (4.76%)  11/62 (17.74%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA † 1  15/63 (23.81%)  14/63 (22.22%)  19/63 (30.16%)  15/62 (24.19%) 
BACK PAIN † 1  10/63 (15.87%)  8/63 (12.70%)  14/63 (22.22%)  9/62 (14.52%) 
JOINT SWELLING † 1  5/63 (7.94%)  4/63 (6.35%)  1/63 (1.59%)  6/62 (9.68%) 
MUSCLE SPASMS † 1  32/63 (50.79%)  43/63 (68.25%)  25/63 (39.68%)  13/62 (20.97%) 
MUSCLE TWITCHING † 1  2/63 (3.17%)  4/63 (6.35%)  2/63 (3.17%)  4/62 (6.45%) 
MUSCULAR WEAKNESS † 1  2/63 (3.17%)  4/63 (6.35%)  3/63 (4.76%)  3/62 (4.84%) 
MUSCULOSKELETAL PAIN † 1  5/63 (7.94%)  4/63 (6.35%)  7/63 (11.11%)  4/62 (6.45%) 
MUSCULOSKELETAL STIFFNESS † 1  4/63 (6.35%)  0/63 (0.00%)  1/63 (1.59%)  2/62 (3.23%) 
MYALGIA † 1  5/63 (7.94%)  11/63 (17.46%)  7/63 (11.11%)  8/62 (12.90%) 
PAIN IN EXTREMITY † 1  5/63 (7.94%)  4/63 (6.35%)  13/63 (20.63%)  7/62 (11.29%) 
Nervous system disorders         
DIZZINESS † 1  6/63 (9.52%)  10/63 (15.87%)  6/63 (9.52%)  8/62 (12.90%) 
DYSGEUSIA † 1  5/63 (7.94%)  1/63 (1.59%)  0/63 (0.00%)  1/62 (1.61%) 
HEADACHE † 1  12/63 (19.05%)  4/63 (6.35%)  14/63 (22.22%)  9/62 (14.52%) 
HYPOAESTHESIA † 1  2/63 (3.17%)  1/63 (1.59%)  3/63 (4.76%)  5/62 (8.06%) 
MUSCLE CONTRACTIONS INVOLUNTARY † 1  3/63 (4.76%)  6/63 (9.52%)  0/63 (0.00%)  2/62 (3.23%) 
PARAESTHESIA † 1  0/63 (0.00%)  2/63 (3.17%)  2/63 (3.17%)  5/62 (8.06%) 
Psychiatric disorders         
ANXIETY † 1  4/63 (6.35%)  2/63 (3.17%)  1/63 (1.59%)  2/62 (3.23%) 
DEPRESSED MOOD † 1  4/63 (6.35%)  1/63 (1.59%)  0/63 (0.00%)  1/62 (1.61%) 
DEPRESSION † 1  4/63 (6.35%)  1/63 (1.59%)  5/63 (7.94%)  0/62 (0.00%) 
INSOMNIA † 1  5/63 (7.94%)  0/63 (0.00%)  2/63 (3.17%)  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders         
COUGH † 1  3/63 (4.76%)  3/63 (4.76%)  4/63 (6.35%)  8/62 (12.90%) 
DYSPNOEA † 1  2/63 (3.17%)  0/63 (0.00%)  1/63 (1.59%)  4/62 (6.45%) 
RHINORRHOEA † 1  4/63 (6.35%)  3/63 (4.76%)  5/63 (7.94%)  5/62 (8.06%) 
Skin and subcutaneous tissue disorders         
ACNE † 1  12/63 (19.05%)  19/63 (30.16%)  8/63 (12.70%)  6/62 (9.68%) 
DRY SKIN † 1  1/63 (1.59%)  2/63 (3.17%)  1/63 (1.59%)  5/62 (8.06%) 
PRURITUS † 1  6/63 (9.52%)  6/63 (9.52%)  6/63 (9.52%)  1/62 (1.61%) 
RASH † 1  13/63 (20.63%)  8/63 (12.70%)  9/63 (14.29%)  8/62 (12.90%) 
ROSACEA † 1  0/63 (0.00%)  4/63 (6.35%)  0/63 (0.00%)  0/62 (0.00%) 
Vascular disorders         
HAEMATOMA † 1  1/63 (1.59%)  2/63 (3.17%)  7/63 (11.11%)  2/62 (3.23%) 
HYPERTENSION † 1  7/63 (11.11%)  7/63 (11.11%)  5/63 (7.94%)  9/62 (14.52%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
[Not Specified]
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01925209    
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