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Trial record 13 of 148 for:    "idiopathic inflammatory myopathy"

An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203

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ClinicalTrials.gov Identifier: NCT02573467
Recruitment Status : Completed
First Posted : October 9, 2015
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sporadic Inclusion Body Myositis
Interventions Drug: Bimagrumab
Drug: Placebo
Enrollment 211
Recruitment Details Participants entered extension study treatment period after completing the core study and continued on the study drug to which they were randomized in the core study (one of 3 bimagrumab doses (1mg/kg, 3mg/kg or 10mg/kg) or placebo). Participants discontinued from the treatment period were to enter a 6-month, treatment-free Follow-up Period (FUP).
Pre-assignment Details All participants (N=211) were discontinued from the double-blind treatment period, 178 of whom entered the FUP. Overall 154 participants completed the FUP and 20 discontinued due to subject/guardian decision and 1 for technical reasons. Three discontinued FUP due to death (one each in the 10mg/kg, 3mg/kg, and placebo groups).
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 BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.. Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Period Title: Double-blind Treatment Epoch
Started [1] 53 52 51 55
Full Analysis Set 53 52 51 55
Completed 0 0 0 0
Not Completed 53 52 51 55
Reason Not Completed
Lack of Efficacy             0             0             1             0
Adverse Event             1             0             1             0
Withdrawal by Subject             2             1             1             0
Study Terminated by sponsor             50             51             48             55
[1]
Mean duration of exposure during the extension double-blind treatment period was 197.2 to 212.3 days
Period Title: Post-treatment Follow up Epoch
Started 41 46 44 47
Completed 35 41 34 44
Not Completed 6 5 10 3
Reason Not Completed
Death             1             1             0             1
Withdrawal by Subject             5             4             9             2
Technical problems             0             0             1             0
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 BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.. Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. Total of all reporting groups
Overall Number of Baseline Participants 53 52 51 55 211
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 52 participants 51 participants 55 participants 211 participants
69.2  (8.19) 67.3  (9.04) 70.0  (7.69) 69.9  (7.95) 69.1  (8.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 52 participants 51 participants 55 participants 211 participants
Female
18
  34.0%
19
  36.5%
17
  33.3%
19
  34.5%
73
  34.6%
Male
35
  66.0%
33
  63.5%
34
  66.7%
36
  65.5%
138
  65.4%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.
Hide Description Safety monitoring was conducted throughout the study. AEs starting on or after the day of first administration of extension study drug until last administration of study drug + 56 days are considered. SAEs starting on or after the day of first administration of extension study drug are considered. Deaths which occurred on or after the day of first administration of extension study drug are considered.
Time Frame to end of study (up to 14 months, including the 6-month treatment-free follow-up period)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set: The safety set consisted of all participants who received at least one dose of study drug during the extension study.
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 BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Overall Number of Participants Analyzed 53 52 51 55
Measure Type: Number
Unit of Measure: Participants
Adverse events 48 50 44 49
Serious adverse events 12 10 7 8
Deaths 1 1 1 2
2.Primary Outcome
Title Change From Core Study Baseline in 6 Minute Walking Distance Test (6MWD)
Hide Description The 6MWD test measures the distance (in meters) that a participant can walk in a 6 minute time frame. A positive change from baseline indicates improvement. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
Time Frame Core study baseline, weeks 52, 78, 104, and >=117
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.
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 BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Overall Number of Participants Analyzed 53 52 51 55
Mean (Standard Deviation)
Unit of Measure: meters
Week 52 (n=53,52,51,54) Number Analyzed 53 participants 52 participants 51 participants 54 participants
6.88  (68.948) 9.48  (81.676) -14.26  (81.029) -5.98  (78.817)
Week 78 Number Analyzed 52 participants 52 participants 50 participants 54 participants
-5.25  (122.002) -9.73  (68.302) -18.66  (81.536) -32.78  (96.494)
Week 104 Number Analyzed 32 participants 34 participants 37 participants 39 participants
-22.68  (102.549) -50.58  (118.012) -25.08  (95.737) -61.30  (107.399)
>=Week 117 Number Analyzed 2 participants 1 participants 4 participants 1 participants
-206.65  (281.923) -5.0 [1]   (NA) -53.65  (114.322) 31.60 [2]   (NA)
[1]
Standard deviation (SD) does not apply when n = 1.
[2]
SD does not apply when n = 1.
3.Secondary Outcome
Title Change From Core Study Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side
Hide Description Quantitative Muscle Testing (QMT) was used to describe the long-term evolution of quadriceps muscle strength on the right side. The QMT was performed using the same portable fixed dynamometry (PFD) used in the core study. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
Time Frame Core study baseline, week 52, week 78, week 104 and >=week 117
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.
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 BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Overall Number of Participants Analyzed 53 52 51 55
Mean (Standard Deviation)
Unit of Measure: newtons
Week 52 Number Analyzed 48 participants 49 participants 51 participants 55 participants
-6.29  (31.121) -19.70  (77.820) -5.62  (32.245) -14.22  (27.577)
Week 78 Number Analyzed 46 participants 49 participants 49 participants 53 participants
-9.43  (41.285) -23.76  (73.729) -17.04  (25.696) -21.02  (31.391)
Week 104 Number Analyzed 33 participants 33 participants 37 participants 37 participants
-11.92  (35.243) -16.99  (34.379) -18.63  (37.968) -21.91  (39.985)
>=Week 117 Number Analyzed 1 participants 1 participants 4 participants 1 participants
67.64 [1]   (NA) 33.38 [1]   (NA) -19.36  (18.475) -18.24 [1]   (NA)
[1]
SD does not apply when n = 1.
4.Secondary Outcome
Title Change From Core Study Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score
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. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
Time Frame Core study baseline, week 52, week 78, week 104, and >=week 117
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.
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 BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Overall Number of Participants Analyzed 53 52 51 55
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 52 Number Analyzed 53 participants 52 participants 49 participants 52 participants
-1.34  (15.249) 1.80  (11.910) 3.17  (11.380) 5.16  (13.889)
Week 78 Number Analyzed 53 participants 51 participants 48 participants 54 participants
-0.27  (13.745) 5.33  (13.099) 6.52  (12.918) 7.41  (14.410)
Week 104 Number Analyzed 38 participants 37 participants 35 participants 40 participants
3.54  (14.998) 8.04  (16.861) 5.97  (12.849) 7.39  (15.580)
>=Week 117 Number Analyzed 2 participants 1 participants 4 participants 1 participants
-16.37  (21.857) 10.91 [1]   (NA) 1.37  (17.655) 6.36 [1]   (NA)
[1]
SD does not apply when n = 1.
5.Secondary Outcome
Title Estimated Annual Number of Falls Per Participant Within Treatment Group
Hide Description Participants documented any fall occurrences in a paper diary during the study.
Time Frame Core baseline to end of extension double-blind treatment (up to a maximum of 32 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set: The safety set consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension.
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 BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Overall Number of Participants Analyzed 53 52 51 55
Measure Type: Number
Unit of Measure: Annual number of falls per participant
4.164 3.879 3.480 3.835
6.Secondary Outcome
Title Change From Core Study Baseline in Short Physical Performance Battery (SPPB) Score
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. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
Time Frame Core study baseline, week 52, week 78, week 104 and >=week 117
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.
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 BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Overall Number of Participants Analyzed 53 52 51 55
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 52 Number Analyzed 53 participants 52 participants 51 participants 55 participants
0.3  (1.73) 0.2  (1.61) -0.4  (1.74) -0.3  (1.31)
Week 78 Number Analyzed 53 participants 52 participants 50 participants 55 participants
-0.5  (2.58) -0.1  (1.54) -0.4  (1.69) -0.9  (1.92)
Week 104 Number Analyzed 38 participants 38 participants 39 participants 41 participants
-1.4  (3.29) -0.9  (2.77) -1.1  (2.56) -1.3  (2.35)
>=Week 117 Number Analyzed 2 participants 1 participants 4 participants 1 participants
-3.0  (4.24) 0.0 [1]   (NA) 0.3  (2.06) 0.0 [1]   (NA)
[1]
SD does not apply when n = 1.
7.Secondary Outcome
Title Change in Muscles of the Thigh
Hide Description Magnetic resonance imaging (MRI) was planned to be used to characterize changes in muscles of the thigh in a subset of patients.
Time Frame up to 1 year, up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed. The optional MRI assessment was not initiated as the study was stopped.
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 BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Patients With Anti-BYM338 Antibodies
Hide Description Investigated the development of immunogenicity against BYM338.
Time Frame end of double-blind treatment (up to 8 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set: The safety set consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension. Only those participants who provided a sample 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 BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Overall Number of Participants Analyzed 38 40 38 39
Measure Type: Number
Unit of Measure: Participants
0 1 0 2
Time Frame Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
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 Pooled Active Treatment Groups
Hide Arm/Group Description Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.. Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. Participants from all 3 BYM338 groups
All-Cause Mortality
BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo Pooled Active Treatment Groups
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/53 (1.89%)   1/52 (1.92%)   1/51 (1.96%)   2/55 (3.64%)   3/156 (1.92%) 
Show Serious Adverse Events Hide Serious Adverse Events
BYM338/Bimagrumab 10 mg/kg BYM338/Bimagrumab 3 mg/kg BYM338/Bimagrumab 1 mg/kg Placebo Pooled Active Treatment Groups
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/53 (22.64%)   10/52 (19.23%)   7/51 (13.73%)   8/55 (14.55%)   29/156 (18.59%) 
Blood and lymphatic system disorders           
Anaemia  1  0/53 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/55 (1.82%)  0/156 (0.00%) 
Gastrointestinal disorders           
Colitis  1  0/53 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/55 (1.82%)  0/156 (0.00%) 
Diarrhoea  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Dysphagia  1  0/53 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/55 (1.82%)  0/156 (0.00%) 
Oesophageal achalasia  1  0/53 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
General disorders           
Asthenia  1  0/53 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/55 (1.82%)  0/156 (0.00%) 
Infections and infestations           
Cellulitis  1  0/53 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Pneumonia  1  1/53 (1.89%)  1/52 (1.92%)  1/51 (1.96%)  1/55 (1.82%)  3/156 (1.92%) 
Sepsis  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  2/55 (3.64%)  1/156 (0.64%) 
Urosepsis  1  0/53 (0.00%)  0/52 (0.00%)  1/51 (1.96%)  0/55 (0.00%)  1/156 (0.64%) 
Injury, poisoning and procedural complications           
Ankle fracture  1  1/53 (1.89%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  2/156 (1.28%) 
Avulsion fracture  1  0/53 (0.00%)  0/52 (0.00%)  1/51 (1.96%)  0/55 (0.00%)  1/156 (0.64%) 
Fall  1  0/53 (0.00%)  0/52 (0.00%)  1/51 (1.96%)  1/55 (1.82%)  1/156 (0.64%) 
Head injury  1  0/53 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/55 (1.82%)  0/156 (0.00%) 
Hip fracture  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Lower limb fracture  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Patella fracture  1  0/53 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Pelvic fracture  1  0/53 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/55 (1.82%)  0/156 (0.00%) 
Subarachnoid haemorrhage  1  0/53 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/55 (1.82%)  0/156 (0.00%) 
Subdural haemorrhage  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Ulna fracture  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Metabolism and nutrition disorders           
Dehydration  1  0/53 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/55 (1.82%)  0/156 (0.00%) 
Hyperkalaemia  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/53 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Inclusion body myositis  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Joint effusion  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Mobility decreased  1  0/53 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Muscle haemorrhage  1  0/53 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/55 (1.82%)  0/156 (0.00%) 
Rotator cuff syndrome  1  0/53 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Basal cell carcinoma  1  0/53 (0.00%)  0/52 (0.00%)  1/51 (1.96%)  2/55 (3.64%)  1/156 (0.64%) 
Bladder cancer  1  0/53 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Bowen's disease  1  0/53 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Haemangioma  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Skin cancer  1  0/53 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Squamous cell carcinoma  1  1/53 (1.89%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  2/156 (1.28%) 
Nervous system disorders           
Headache  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Migraine  1  0/53 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Presyncope  1  0/53 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Respiratory, thoracic and mediastinal disorders           
Pneumonia aspiration  1  1/53 (1.89%)  0/52 (0.00%)  2/51 (3.92%)  1/55 (1.82%)  3/156 (1.92%) 
Pulmonary embolism  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  0/55 (0.00%)  1/156 (0.64%) 
Respiratory failure  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  1/55 (1.82%)  1/156 (0.64%) 
Vascular disorders           
Peripheral arterial occlusive disease  1  0/53 (0.00%)  0/52 (0.00%)  1/51 (1.96%)  0/55 (0.00%)  1/156 (0.64%) 
Peripheral venous disease  1  0/53 (0.00%)  0/52 (0.00%)  1/51 (1.96%)  0/55 (0.00%)  1/156 (0.64%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events 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 Pooled Active Treatment Groups
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/53 (75.47%)   46/52 (88.46%)   38/51 (74.51%)   43/55 (78.18%)   124/156 (79.49%) 
Gastrointestinal disorders           
Abdominal pain upper  1  0/53 (0.00%)  4/52 (7.69%)  0/51 (0.00%)  0/55 (0.00%)  4/156 (2.56%) 
Diarrhoea  1  9/53 (16.98%)  5/52 (9.62%)  9/51 (17.65%)  5/55 (9.09%)  23/156 (14.74%) 
Immune system disorders           
Seasonal allergy  1  0/53 (0.00%)  0/52 (0.00%)  3/51 (5.88%)  1/55 (1.82%)  3/156 (1.92%) 
Infections and infestations           
Nasopharyngitis  1  0/53 (0.00%)  4/52 (7.69%)  1/51 (1.96%)  0/55 (0.00%)  5/156 (3.21%) 
Upper respiratory tract infection  1  3/53 (5.66%)  3/52 (5.77%)  4/51 (7.84%)  4/55 (7.27%)  10/156 (6.41%) 
Injury, poisoning and procedural complications           
Contusion  1  9/53 (16.98%)  7/52 (13.46%)  12/51 (23.53%)  8/55 (14.55%)  28/156 (17.95%) 
Fall  1  30/53 (56.60%)  36/52 (69.23%)  30/51 (58.82%)  34/55 (61.82%)  96/156 (61.54%) 
Foot fracture  1  3/53 (5.66%)  1/52 (1.92%)  0/51 (0.00%)  4/55 (7.27%)  4/156 (2.56%) 
Injury  1  3/53 (5.66%)  1/52 (1.92%)  0/51 (0.00%)  1/55 (1.82%)  4/156 (2.56%) 
Joint injury  1  3/53 (5.66%)  0/52 (0.00%)  0/51 (0.00%)  0/55 (0.00%)  3/156 (1.92%) 
Laceration  1  1/53 (1.89%)  7/52 (13.46%)  4/51 (7.84%)  6/55 (10.91%)  12/156 (7.69%) 
Ligament sprain  1  5/53 (9.43%)  2/52 (3.85%)  2/51 (3.92%)  3/55 (5.45%)  9/156 (5.77%) 
Limb injury  1  3/53 (5.66%)  1/52 (1.92%)  1/51 (1.96%)  0/55 (0.00%)  5/156 (3.21%) 
Skin abrasion  1  6/53 (11.32%)  7/52 (13.46%)  4/51 (7.84%)  5/55 (9.09%)  17/156 (10.90%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/53 (1.89%)  5/52 (9.62%)  6/51 (11.76%)  6/55 (10.91%)  12/156 (7.69%) 
Back pain  1  2/53 (3.77%)  4/52 (7.69%)  3/51 (5.88%)  1/55 (1.82%)  9/156 (5.77%) 
Muscle spasms  1  4/53 (7.55%)  8/52 (15.38%)  3/51 (5.88%)  1/55 (1.82%)  15/156 (9.62%) 
Muscular weakness  1  1/53 (1.89%)  3/52 (5.77%)  0/51 (0.00%)  3/55 (5.45%)  4/156 (2.56%) 
Musculoskeletal chest pain  1  3/53 (5.66%)  2/52 (3.85%)  0/51 (0.00%)  1/55 (1.82%)  5/156 (3.21%) 
Musculoskeletal pain  1  2/53 (3.77%)  2/52 (3.85%)  4/51 (7.84%)  2/55 (3.64%)  8/156 (5.13%) 
Myalgia  1  2/53 (3.77%)  4/52 (7.69%)  2/51 (3.92%)  0/55 (0.00%)  8/156 (5.13%) 
Neck pain  1  0/53 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  5/55 (9.09%)  0/156 (0.00%) 
Pain in extremity  1  1/53 (1.89%)  5/52 (9.62%)  3/51 (5.88%)  2/55 (3.64%)  9/156 (5.77%) 
Nervous system disorders           
Dizziness  1  1/53 (1.89%)  0/52 (0.00%)  0/51 (0.00%)  3/55 (5.45%)  1/156 (0.64%) 
Headache  1  1/53 (1.89%)  2/52 (3.85%)  4/51 (7.84%)  3/55 (5.45%)  7/156 (4.49%) 
Respiratory, thoracic and mediastinal disorders           
Productive cough  1  0/53 (0.00%)  1/52 (1.92%)  1/51 (1.96%)  3/55 (5.45%)  2/156 (1.28%) 
Skin and subcutaneous tissue disorders           
Acne  1  2/53 (3.77%)  1/52 (1.92%)  3/51 (5.88%)  1/55 (1.82%)  6/156 (3.85%) 
Pruritus  1  3/53 (5.66%)  0/52 (0.00%)  2/51 (3.92%)  3/55 (5.45%)  5/156 (3.21%) 
Rash  1  2/53 (3.77%)  3/52 (5.77%)  3/51 (5.88%)  1/55 (1.82%)  8/156 (5.13%) 
Vascular disorders           
Haematoma  1  2/53 (3.77%)  0/52 (0.00%)  2/51 (3.92%)  4/55 (7.27%)  4/156 (2.56%) 
Hypertension  1  5/53 (9.43%)  2/52 (3.85%)  2/51 (3.92%)  1/55 (1.82%)  9/156 (5.77%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
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
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02573467     History of Changes
Other Study ID Numbers: CBYM338B2203E1
2015-001411-12 ( EudraCT Number )
First Submitted: July 9, 2015
First Posted: October 9, 2015
Results First Submitted: February 12, 2018
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018