Trial · NCT02250443
Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
NCT02250443, Phase 2, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2018-04-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis. Trials, record NCT02250443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02250443
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
- NCT number
- NCT02250443
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 10 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Sporadic Inclusion Body Myositis (sIBM)
- Interventions
- BYM338 (Bimagrumab)
- First posted
- 2014-09-26
- Last updated
- 2020-12-30
- Results first posted
- 2018-04-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to 29 month | Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity |
| Secondary | Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) | Baseline, Day 1, 57, 113, 169, 365, 533, and day 729 | To assess the effect of multiple doses of BYM338 on lean body mass as measured by DXA in terms of change from baseline. |
| Secondary | Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing | Day 29, 85, 169, 253, 337, 421, 505, 589, 673, 757, 1177 | To obtain pharmacokinetic data from multiple i.v. dosing of BYM338 in this patient population. Pre-dose, 30 mins \& 4 hours post-dose on Day 1. Pre-dose only on each subsequent administration |
| Secondary | Changes From Baseline in Physical Function Reported by Patients | Baseline, Week 104 | 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. Due to the no-signal this analysis was cancelled. |
| Secondary | Changes From Baseline in Muscle Strength. | Baseline, Day 1, 113, 169, 365, 533, 729 | Quadriceps muscle strength was measured, Quadriceps Quantitative Muscle Testing (QMT) by portable fixed dynamometry (PFD). A negative change from baseline indicates deterioration |
| Secondary | Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry) | Baseline,Day 1, 113, 169, 365, 533, 729 | The effect of BYM338 on additional muscle function measures (hand-grip and pinch-grip dynamometry). |
| Secondary | Changes From Baseline in Muscle Function 6 Minute Walking Distance | Baseline,Day 1, 113, 169, 365, 533, 729 | The effect of BYM338 on additional muscle function measures (6 minute walking distance). The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement. |
| Secondary | Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan | Baseline, Day 1, 57, 113 | Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was equal or more than 2% at Week 8 and 16 were considered responders |
| Secondary | Pharmacokinetics (PK) Parameter of Cmax | Day 1 | To obtain pharmacokinetic data from multiple i.v. dosing of BYM338 in this patient population. Pre-dose, 30 mins \& 4 hours post-dose on Day 1. |
| Secondary | Time to Reach the Maximum Concentration After Drug Administration (Tmax) | Day 1 | The time to reach the maximum concentration after drug administration |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to 29 month | safety analysis set - included all patients that received at least one dose of study drug. No statistical analysis provided for Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During this extension study | Participants | NUMBER |
| SECONDARY | Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) | Baseline, Day 1, 57, 113, 169, 365, 533, and day 729 | Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data | Percentage Change in LBM | MEAN |
| SECONDARY | Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing | Day 29, 85, 169, 253, 337, 421, 505, 589, 673, 757, 1177 | Pharmacokinetics (PK) Analysis set: Patients with available PK data and no protocol deviations with relevant impact on PK data | ng/mL | MEAN |
| SECONDARY | Changes From Baseline in Physical Function Reported by Patients | Baseline, Week 104 | Due to the early study termination and the small sample size in this open-label trial, this PRO analysis was cancelled. | ||
| SECONDARY | Changes From Baseline in Muscle Strength. | Baseline, Day 1, 113, 169, 365, 533, 729 | Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data | Newtons | MEAN |
| SECONDARY | Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry) | Baseline,Day 1, 113, 169, 365, 533, 729 | Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data | Newtons | MEAN |
| SECONDARY | Changes From Baseline in Muscle Function 6 Minute Walking Distance | Baseline,Day 1, 113, 169, 365, 533, 729 | Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data | Meters | MEAN |
| SECONDARY | Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan | Baseline, Day 1, 57, 113 | Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data | Percentage Change | MEAN |
| SECONDARY | Pharmacokinetics (PK) Parameter of Cmax | Day 1 | Pharmacokinetics (PK) Analysis set: Patients with available PK data and no protocol deviations with relevant impact on PK data | ug/mL | MEAN |
| SECONDARY | Time to Reach the Maximum Concentration After Drug Administration (Tmax) | Day 1 | Pharmacokinetics (PK) Analysis set: Patients with available PK data and no protocol deviations with relevant impact on PK data | hr | MEDIAN |
Source ClinicalTrials.gov
Results by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | BYM338 | Death | 0 | Participants | |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | BYM338 | Serious adverse events (SAE) | 2 | Participants | |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | BYM338 | Adverse Events (AE) | 10 | Participants | |
| Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) | BYM338 | Day 1 | 0 | Standard Deviation 0 | Percentage Change in LBM |
| Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) | BYM338 | Day 57 | 4.292 | Standard Deviation 2.7480 | Percentage Change in LBM |
| Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) | BYM338 | Day 113 | 5.552 | Standard Deviation 3.6066 | Percentage Change in LBM |
| Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) | BYM338 | Day 169 | 7.463 | Standard Deviation 4.5687 | Percentage Change in LBM |
| Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) | BYM338 | Day 365 | 6.919 | Standard Deviation 2.9669 | Percentage Change in LBM |
| Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) | BYM338 | Day 533 | 6.885 | Standard Deviation 3.7894 | Percentage Change in LBM |
| Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) | BYM338 | Day 729 | 0.727 | Standard Deviation NA | Percentage Change in LBM |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BYM338 | 10 | |
| Overall Study | COMPLETED | BYM338 | 0 | |
| Overall Study | NOT COMPLETED | BYM338 | 10 |
Source ClinicalTrials.gov
Adverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | BYM338 10mg/kg i.v. | 1 | 10 | |
| other | Atrial fibrillation | Cardiac disorders | BYM338 10mg/kg i.v. | 1 | 10 | |
| other | Myocardial infarction | Cardiac disorders | BYM338 10mg/kg i.v. | 1 | 10 | |
| other | Tinnitus | Ear and labyrinth disorders | BYM338 10mg/kg i.v. | 1 | 10 | |
| other | Abdominal pain | Gastrointestinal disorders | BYM338 10mg/kg i.v. | 1 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | BYM338 10mg/kg i.v. | 6 | 10 | |
| other | Frequent bowel movements | Gastrointestinal disorders | BYM338 10mg/kg i.v. | 1 | 10 | |
| other | Haemorrhoidal haemorrhage | Gastrointestinal disorders | BYM338 10mg/kg i.v. | 1 | 10 | |
| other | Inguinal hernia | Gastrointestinal disorders | BYM338 10mg/kg i.v. | 1 | 10 | |
| other | Nausea | Gastrointestinal disorders | BYM338 10mg/kg i.v. | 2 | 10 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BYM338 10mg/kg i.v. | ||
| Total, other adverse events | BYM338 10mg/kg i.v. | 10 | 10 |
| Total, serious adverse events | BYM338 10mg/kg i.v. | 2 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32690797 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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