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This study evaluated 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BYM338/bimagrumab 10 mg/kg | Experimental | 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 | Experimental | 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 | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BYM338/bimagrumab | Drug | BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52 | The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement. | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52 | 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. | Baseline, Week 52 |
| Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85028 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31397289 | Derived | 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. |
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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).
Participants were randomized into one of the four treatment arms in a 1:1:1:1 ratio.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | BYM338/Bimagrumab 3 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Epoch |
|
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| Placebo | Drug | Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps. |
|
Quadriceps muscle strength was measured by portable fixed dynamometry (PFD) on the right side. A negative change from baseline indicates deterioration. |
| Baseline, Week 52 |
| Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52 | 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. | Baseline, Week 52 |
| Estimated Annual Number of Falls Per Patient Within Treatment Group | Participants documented any fall occurrences in a paper diary during the study. | Week 52 |
| Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52 | 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. | Baseline, Week 52 |
| Orange |
| California |
| 92868 |
| United States |
| Novartis Investigative Site | Sacramento | California | 95817 | United States |
| Novartis Investigative Site | Miami | Florida | 33101 | United States |
| Novartis Investigative Site | Kansas City | Kansas | 66160 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21287 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02114 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02115 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43221 | United States |
| Novartis Investigative Site | Portland | Oregon | 97239 | United States |
| Novartis Investigative Site | Dallas | Texas | 75235 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | St Leonards | New South Wales | 2065 | Australia |
| Novartis Investigative Site | Cauldfield | Victoria | 3162 | Australia |
| Novartis Investigative Site | Nedlands | Western Australia | 6009 | Australia |
| Novartis Investigative Site | Brussels | 1200 | Belgium |
| Novartis Investigative Site | Edegem | 2650 | Belgium |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Copenhagen | 2100 | Denmark |
| Novartis Investigative Site | Paris | 75013 | France |
| Novartis Investigative Site | Brescia | BS | 25123 | Italy |
| Novartis Investigative Site | Rome | Lazio | 00168 | Italy |
| Novartis Investigative Site | Messina | ME | 98125 | Italy |
| Novartis Investigative Site | Milan | MI | 20133 | Italy |
| Novartis Investigative Site | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Nagoya | Aichi-ken | 466-8560 | Japan |
| Novartis Investigative Site | Kumamoto | Kumamoto | 860-8556 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 980-8574 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 534-0021 | Japan |
| Novartis Investigative Site | Tokushima | Tokushima | 770-8503 | Japan |
| Novartis Investigative Site | Kodaira | Tokyo | 187-8551 | Japan |
| Novartis Investigative Site | Wakayama | Wakayama | 641-8510 | Japan |
| Novartis Investigative Site | Amsterdam | Netherlands |
| Novartis Investigative Site | Leiden | 2333 ZA | Netherlands |
| Novartis Investigative Site | Zurich | 8091 | Switzerland |
| Novartis Investigative Site | Salford | Manchester | M6 8HD | United Kingdom |
| Novartis Investigative Site | London | NW1 2BU | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE4 5PL | United Kingdom |
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.
| FG002 | 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. |
| FG003 | 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. |
| Full Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Treatment Epoch |
|
|
| Follow-up |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52 | The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement. | 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. | Posted | Least Squares Mean | Standard Error | meters | Baseline, Week 52 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52 | Quadriceps muscle strength was measured by portable fixed dynamometry (PFD) on the right side. A negative change from baseline indicates deterioration. | 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. | Posted | Least Squares Mean | Standard Error | newtons | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52 | 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 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Estimated Annual Number of Falls Per Patient Within Treatment Group | Participants documented any fall occurrences in a paper diary during the study. | 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. | Posted | Number | Annual number of falls per participant | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52 | 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 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
|
up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 21 | 63 | 63 | 63 | ||
| EG001 | 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. | 11 | 63 | 63 | 63 | ||
| EG002 | 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. | 18 | 63 | 63 | 63 | ||
| EG003 | 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. | 20 | 62 | 61 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
| |
| RETINAL ARTERY OCCLUSION | Eye disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| VOLVULUS | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| INJURY ASSOCIATED WITH DEVICE | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| STREPTOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| CARBON MONOXIDE POISONING | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| CERVICAL VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| ENDOTRACHEAL INTUBATION COMPLICATION | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| EYE INJURY | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| INTENTIONAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| PATELLA FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| SPINAL CORD INJURY CERVICAL | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| TRAUMATIC HAEMATOMA | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| VERTEBRAL FORAMINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| TRANSIENT GLOBAL AMNESIA | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| BLADDER MASS | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| FOLLICULITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| INJURY | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| SKIN ABRASION | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| SOFT TISSUE INJURY | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| VITAMIN D DECREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MUSCLE TWITCHING | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MUSCLE CONTRACTIONS INVOLUNTARY | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DEPRESSED MOOD | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ROSACEA | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D018979 | Myositis, Inclusion Body |
| D009220 | Myositis |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000596367 | bimagrumab |
Not provided
Not provided
Not provided
| Adverse Event |
|
| Physician Decision |
|
| Non-compliance with study treatment |
|
| Withdrawal by Subject |
|
| Male |
|
| 0.1909 |
| Mean Difference (Net) |
| 18.59 |
| Standard Error of the Mean |
| 14.176 |
| 2-Sided |
| 99 |
| -18.21 |
| 55.40 |
| Superiority or Other |
| mixed models repeated measures | 0.9263 | Mean Difference (Net) | -1.31 | Standard Error of the Mean | 14.121 | 2-Sided | 99 | -37.97 | 35.36 | Superiority or Other |
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
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. |
|
|
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.
| OG003 | 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. |
|
|