Trial · NCT02573467

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

NCT02573467, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2018-03-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT02573467. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02573467

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT02573467
Status: Completed
Phases: Phase 3
Enrollment: 211 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Sporadic Inclusion Body Myositis
Interventions: Bimagrumab, Placebo
First posted: 2015-10-09
Last updated: 2018-03-13
Other registries' IDs: eudract:2015-001411-12
Results first posted: 2018-03-13

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.	to end of study (up to 14 months, including the 6-month treatment-free follow-up period)	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.
Primary	Change From Core Study Baseline in 6 Minute Walking Distance Test (6MWD)	Core study baseline, weeks 52, 78, 104, and >=117	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.
Secondary	Change From Core Study Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side	Core study baseline, week 52, week 78, week 104 and >=week 117	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.
Secondary	Change From Core Study Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score	Core study baseline, week 52, week 78, week 104, and >=week 117	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.
Secondary	Estimated Annual Number of Falls Per Participant Within Treatment Group	Core baseline to end of extension double-blind treatment (up to a maximum of 32 months)	Participants documented any fall occurrences in a paper diary during the study.
Secondary	Change From Core Study Baseline in Short Physical Performance Battery (SPPB) Score	Core study baseline, week 52, week 78, week 104 and >=week 117	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.
Secondary	Change in Muscles of the Thigh	up to 1 year, up to 2 years	Magnetic resonance imaging (MRI) was planned to be used to characterize changes in muscles of the thigh in a subset of patients.
Secondary	Number of Patients With Anti-BYM338 Antibodies	end of double-blind treatment (up to 8 months)	Investigated the development of immunogenicity against BYM338.

Source ClinicalTrials.gov

Outcomes8

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 (AEs), Serious Adverse Events (SAEs) and Deaths.	to end of study (up to 14 months, including the 6-month treatment-free follow-up period)	Safety set: The safety set consisted of all participants who received at least one dose of study drug during the extension study.	Participants	NUMBER
PRIMARY	Change From Core Study Baseline in 6 Minute Walking Distance Test (6MWD)	Core study baseline, weeks 52, 78, 104, and >=117	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.	meters	MEAN
SECONDARY	Change From Core Study Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side	Core study baseline, week 52, week 78, week 104 and >=week 117	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.	newtons	MEAN
SECONDARY	Change From Core Study Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score	Core study baseline, week 52, week 78, week 104, and >=week 117	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.	score on a scale	MEAN
SECONDARY	Estimated Annual Number of Falls Per Participant Within Treatment Group	Core baseline to end of extension double-blind treatment (up to a maximum of 32 months)	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.	Annual number of falls per participant	NUMBER
SECONDARY	Change From Core Study Baseline in Short Physical Performance Battery (SPPB) Score	Core study baseline, week 52, week 78, week 104 and >=week 117	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.	score on a scale	MEAN
SECONDARY	Change in Muscles of the Thigh	up to 1 year, up to 2 years	No participants were analyzed. The optional MRI assessment was not initiated as the study was stopped.
SECONDARY	Number of Patients With Anti-BYM338 Antibodies	end of double-blind treatment (up to 8 months)	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.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group84

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.	BYM338/Bimagrumab 10 mg/kg	Adverse events	48	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.	BYM338/Bimagrumab 3 mg/kg	Adverse events	50	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.	BYM338/Bimagrumab 1 mg/kg	Adverse events	44	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.	Placebo	Adverse events	49	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.	BYM338/Bimagrumab 10 mg/kg	Serious adverse events	12	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.	BYM338/Bimagrumab 3 mg/kg	Serious adverse events	10	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.	BYM338/Bimagrumab 1 mg/kg	Serious adverse events	7	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.	Placebo	Serious adverse events	8	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.	BYM338/Bimagrumab 10 mg/kg	Deaths	1	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.	BYM338/Bimagrumab 3 mg/kg	Deaths	1	Participants

1 to 10 of 84Source ClinicalTrials.gov

See all 84 results by group

Participant flow28

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double-blind Treatment Epoch	STARTED	BYM338/Bimagrumab 10 mg/kg	53
Double-blind Treatment Epoch	STARTED	BYM338/Bimagrumab 3 mg/kg	52
Double-blind Treatment Epoch	STARTED	BYM338/Bimagrumab 1 mg/kg	51
Double-blind Treatment Epoch	STARTED	Placebo	55
Double-blind Treatment Epoch	Full Analysis Set	BYM338/Bimagrumab 10 mg/kg	53
Double-blind Treatment Epoch	Full Analysis Set	BYM338/Bimagrumab 3 mg/kg	52
Double-blind Treatment Epoch	Full Analysis Set	BYM338/Bimagrumab 1 mg/kg	51
Double-blind Treatment Epoch	Full Analysis Set	Placebo	55
Double-blind Treatment Epoch	COMPLETED	BYM338/Bimagrumab 10 mg/kg	0
Double-blind Treatment Epoch	COMPLETED	BYM338/Bimagrumab 3 mg/kg	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 participant flow

Adverse events370

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
other	Abdominal pain upper	Gastrointestinal disorders	BYM338/Bimagrumab 10 mg/kg	0	53
other	Abdominal pain upper	Gastrointestinal disorders	BYM338/Bimagrumab 3 mg/kg	4	52
other	Abdominal pain upper	Gastrointestinal disorders	BYM338/Bimagrumab 1 mg/kg	0	51
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	0	55
other	Abdominal pain upper	Gastrointestinal disorders	Pooled Active Treatment Groups	4	156
other	Diarrhoea	Gastrointestinal disorders	BYM338/Bimagrumab 10 mg/kg	9	53
other	Diarrhoea	Gastrointestinal disorders	BYM338/Bimagrumab 3 mg/kg	5	52
other	Diarrhoea	Gastrointestinal disorders	BYM338/Bimagrumab 1 mg/kg	9	51
other	Diarrhoea	Gastrointestinal disorders	Placebo	5	55
other	Diarrhoea	Gastrointestinal disorders	Pooled Active Treatment Groups	23	156

1 to 10 of 370Source ClinicalTrials.gov

See all 370 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BYM338/Bimagrumab 10 mg/kg	1	53
Total, all-cause mortality	BYM338/Bimagrumab 3 mg/kg	1	52
Total, all-cause mortality	BYM338/Bimagrumab 1 mg/kg	1	51
Total, all-cause mortality	Placebo	2	55
Total, all-cause mortality	Pooled Active Treatment Groups	3	156
Total, other adverse events	BYM338/Bimagrumab 10 mg/kg	40	53
Total, other adverse events	BYM338/Bimagrumab 3 mg/kg	46	52
Total, other adverse events	BYM338/Bimagrumab 1 mg/kg	38	51
Total, other adverse events	Placebo	43	55
Total, other adverse events	Pooled Active Treatment Groups	124	156

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33597289	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

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