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Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients
Phase 2, PHASE3 trial testing BYM338/bimagrumab in Sporadic Inclusion Body Myositis in 251 participants. Completed in 6 January 2016.
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 251 |
| Start date | 26 September 2013 |
| Primary completion | 6 January 2016 |
| Estimated completion | 6 January 2016 |
| Sites | 38 locations across Denmark, France, Italy, Japan, Netherlands, Belgium, United Kingdom, Switzerland |
Novartis Pharmaceuticals — full company profile →
Adults 36 to 85, any sex, with Sporadic Inclusion Body Myositis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.
| Group | Value | 95% CI |
|---|---|---|
| BYM338/Bimagrumab 10 mg/kg | 8.63 | ± 10.934 |
| BYM338/Bimagrumab 3 mg/kg | 9.63 | ± 10.770 |
| BYM338/Bimagrumab 1 mg/kg | -10.27 | ± 10.718 |
| Placebo | -8.96 | ± 10.765 |
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.
| Group | Value | 95% CI |
|---|---|---|
| BYM338/Bimagrumab 10 mg/kg | 102.8 | 101.4 – 104.2 |
| BYM338/Bimagrumab 3 mg/kg | 100.4 | 99.1 – 101.8 |
| BYM338/Bimagrumab 1 mg/kg | 98.3 | 97.0 – 99.6 |
| Placebo | 97.2 | 95.9 – 98.5 |
Quadriceps muscle strength was measured by portable fixed dynamometry (PFD) on the right side. A negative change from baseline indicates deterioration.
| Group | Value | 95% CI |
|---|---|---|
| BYM338/Bimagrumab 10 mg/kg | -12.44 | ± 6.021 |
| BYM338/Bimagrumab 3 mg/kg | -20.36 | ± 5.843 |
| BYM338/Bimagrumab 1 mg/kg | -14.89 | ± 5.828 |
| Placebo | -16.48 | ± 5.830 |
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 value
| Group | Value | 95% CI |
|---|---|---|
| BYM338/Bimagrumab 10 mg/kg | 1.74 | ± 1.915 |
| BYM338/Bimagrumab 3 mg/kg | 3.56 | ± 1.876 |
| BYM338/Bimagrumab 1 mg/kg | 6.12 | ± 1.899 |
| Placebo | 6.85 | ± 1.895 |
Participants documented any fall occurrences in a paper diary during the study.
| Group | Value | 95% CI |
|---|---|---|
| BYM338/Bimagrumab 10 mg/kg | 4.33 | |
| BYM338/Bimagrumab 3 mg/kg | 4.02 | |
| BYM338/Bimagrumab 1 mg/kg | 4.70 | |
| Placebo | 5.13 |
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.
| Group | Value | 95% CI |
|---|---|---|
| BYM338/Bimagrumab 10 mg/kg | 0.0 | ± 0.24 |
| BYM338/Bimagrumab 3 mg/kg | 0.0 | ± 0.23 |
| BYM338/Bimagrumab 1 mg/kg | -0.5 | ± 0.23 |
| Placebo | -0.5 | ± 0.23 |
Time frame: up to 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | BYM338/Bimagrumab 10 mg/kg | BYM338/Bimagrumab 3 mg/kg | BYM338/Bimagrumab 1 mg/kg | Placebo |
|---|---|---|---|---|---|
| FALL | Injury, poisoning and procedural complications | — | — | — | — |
| DIARRHOEA | Gastrointestinal disorders | — | — | — | — |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| DYSPHAGIA | Gastrointestinal disorders | — | — | — | — |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | — | — | — | — |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| ANAEMIA | Blood and lymphatic system disorders | — | — | — | — |
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | — | — | — | — |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | — | — | — | — |
| ATRIAL FIBRILLATION | Cardiac disorders | — | — | — | — |
| ATRIOVENTRICULAR BLOCK | Cardiac disorders | — | — | — | — |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | — | — | — | — |
| MYOCARDIAL INFARCTION | Cardiac disorders | — | — | — | — |
| PALPITATIONS | Cardiac disorders | — | — | — | — |
| VERTIGO | Ear and labyrinth disorders | — | — | — | — |
| RETINAL ARTERY OCCLUSION | Eye disorders | — | — | — | — |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | — | — | — | — |
| ABDOMINAL HERNIA | Gastrointestinal disorders | — | — | — | — |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | — | — | — | — |
| INGUINAL HERNIA | Gastrointestinal disorders | — | — | — | — |
| VOLVULUS | Gastrointestinal disorders | — | — | — | — |
| INJURY ASSOCIATED WITH DEVICE | General disorders | — | — | — | — |
| DIVERTICULITIS | Infections and infestations | — | — | — | — |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | — | — | — | — |
| PNEUMONIA | Infections and infestations | — | — | — | — |
| Reaction | System | BYM338/Bimagrumab 10 mg/kg | BYM338/Bimagrumab 3 mg/kg | BYM338/Bimagrumab 1 mg/kg | Placebo |
|---|---|---|---|---|---|
| FALL | Injury, poisoning and procedural complications | — | — | — | — |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | — | — | — | — |
| DIARRHOEA | Gastrointestinal disorders | — | — | — | — |
| CONTUSION | Injury, poisoning and procedural complications | — | — | — | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — | — | — | — |
| ACNE | Skin and subcutaneous tissue disorders | — | — | — | — |
| SKIN ABRASION | Injury, poisoning and procedural complications | — | — | — | — |
| FATIGUE | General disorders | — | — | — | — |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | — | — | — | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — | — | — | — |
| HEADACHE | Nervous system disorders | — | — | — | — |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | — | — | — | — |
| RASH | Skin and subcutaneous tissue disorders | — | — | — | — |
| LACERATION | Injury, poisoning and procedural complications | — | — | — | — |
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | — | — | — | — |
| NAUSEA | Gastrointestinal disorders | — | — | — | — |
| NASOPHARYNGITIS | Infections and infestations | — | — | — | — |
| MYALGIA | Musculoskeletal and connective tissue disorders | — | — | — | — |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | — | — | — | — |
| DECREASED APPETITE | Metabolism and nutrition disorders | — | — | — | — |
| DIZZINESS | Nervous system disorders | — | — | — | — |
| OEDEMA PERIPHERAL | General disorders | — | — | — | — |
| WEIGHT DECREASED | Investigations | — | — | — | — |
| HYPERTENSION | Vascular disorders | — | — | — | — |
| LIMB INJURY | Injury, poisoning and procedural complications | — | — | — | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| INJURY | Injury, poisoning and procedural complications | — | — | — | — |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | — | — | — | — |
| HAEMATOMA | Vascular disorders | — | — | — | — |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | — | — | — | — |
| CONSTIPATION | Gastrointestinal disorders | — | — | — | — |
| ASTHENIA | General disorders | — | — | — | — |
| JOINT INJURY | Injury, poisoning and procedural complications | — | — | — | — |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | — | — | — | — |
| MUSCLE CONTRACTIONS INVOLUNTARY | Nervous system disorders | — | — | — | — |
| PRURITUS | Skin and subcutaneous tissue disorders | — | — | — | — |
| ANAEMIA | Blood and lymphatic system disorders | — | — | — | — |
| DRY MOUTH | Gastrointestinal disorders | — | — | — | — |
| DYSPHAGIA | Gastrointestinal disorders | — | — | — | — |
| PYREXIA | General disorders | — | — | — | — |
Most-reported serious reactions: FALL, DIARRHOEA, BASAL CELL CARCINOMA, DYSPHAGIA, TIBIA FRACTURE, SQUAMOUS CELL CARCINOMA, ANAEMIA, IRON DEFICIENCY ANAEMIA.
Data from ClinicalTrials.gov NCT01925209 adverse events section.
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).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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