Trial · NCT01925209

Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients

NCT01925209, Phase 2, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-05-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients. Trials, record NCT01925209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01925209

On this page

Trial

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

Title: Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients
NCT number: NCT01925209
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 251 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Sporadic Inclusion Body Myositis
Interventions: BYM338/bimagrumab, Placebo
First posted: 2013-08-19
Last updated: 2017-08-11
Results first posted: 2017-05-12

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52	Baseline, 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.
Secondary	Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52	Baseline, 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.
Secondary	Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52	Baseline, Week 52	Quadriceps muscle strength was measured by portable fixed dynamometry (PFD) on the right side. A negative change from baseline indicates deterioration.
Secondary	Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52	Baseline, 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.
Secondary	Estimated Annual Number of Falls Per Patient Within Treatment Group	Week 52	Participants documented any fall occurrences in a paper diary during the study.
Secondary	Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52	Baseline, 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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52	Baseline, Week 52	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.	meters	LEAST_SQUARES_MEAN
SECONDARY	Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52	Baseline, Week 52	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.	Percentage	NUMBER
SECONDARY	Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52	Baseline, Week 52	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.	newtons	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52	Baseline, Week 52	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.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Estimated Annual Number of Falls Per Patient Within Treatment Group	Week 52	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.	Annual number of falls per participant	NUMBER
SECONDARY	Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52	Baseline, Week 52	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.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Value	Spread	Units
Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52	BYM338/Bimagrumab 10 mg/kg	8.63	Standard Error 10.934	meters
Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52	BYM338/Bimagrumab 3 mg/kg	9.63	Standard Error 10.770	meters
Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52	BYM338/Bimagrumab 1 mg/kg	-10.27	Standard Error 10.718	meters
Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52	Placebo	-8.96	Standard Error 10.765	meters
Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52	BYM338/Bimagrumab 10 mg/kg	102.8	95% Confidence Interval 101.4 to 104.2	Percentage
Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52	BYM338/Bimagrumab 3 mg/kg	100.4	95% Confidence Interval 99.1 to 101.8	Percentage
Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52	BYM338/Bimagrumab 1 mg/kg	98.3	95% Confidence Interval 97.0 to 99.6	Percentage
Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52	Placebo	97.2	95% Confidence Interval 95.9 to 98.5	Percentage
Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52	BYM338/Bimagrumab 10 mg/kg	-12.44	Standard Error 6.021	newtons
Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52	BYM338/Bimagrumab 3 mg/kg	-20.36	Standard Error 5.843	newtons

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow40

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

Period	Milestone	Group	Participants
Treatment Epoch	STARTED	BYM338/Bimagrumab 10 mg/kg	63
Treatment Epoch	STARTED	BYM338/Bimagrumab 3 mg/kg	63
Treatment Epoch	STARTED	BYM338/Bimagrumab 1 mg/kg	63
Treatment Epoch	STARTED	Placebo	62
Treatment Epoch	Full Analysis Set	BYM338/Bimagrumab 10 mg/kg	63
Treatment Epoch	Full Analysis Set	BYM338/Bimagrumab 3 mg/kg	63
Treatment Epoch	Full Analysis Set	BYM338/Bimagrumab 1 mg/kg	63
Treatment Epoch	Full Analysis Set	Placebo	62
Treatment Epoch	COMPLETED	BYM338/Bimagrumab 10 mg/kg	54
Treatment Epoch	COMPLETED	BYM338/Bimagrumab 3 mg/kg	55

1 to 10 of 40Source ClinicalTrials.gov

See all 40 participant flow

Adverse events564

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	ANAEMIA	Blood and lymphatic system disorders	BYM338/Bimagrumab 10 mg/kg	5	63
other	ANAEMIA	Blood and lymphatic system disorders	BYM338/Bimagrumab 3 mg/kg	3	63
other	ANAEMIA	Blood and lymphatic system disorders	BYM338/Bimagrumab 1 mg/kg	0	63
other	ANAEMIA	Blood and lymphatic system disorders	Placebo	1	62
other	ABDOMINAL PAIN	Gastrointestinal disorders	BYM338/Bimagrumab 10 mg/kg	3	63
other	ABDOMINAL PAIN	Gastrointestinal disorders	BYM338/Bimagrumab 3 mg/kg	4	63
other	ABDOMINAL PAIN	Gastrointestinal disorders	BYM338/Bimagrumab 1 mg/kg	0	63
other	ABDOMINAL PAIN	Gastrointestinal disorders	Placebo	0	62
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	BYM338/Bimagrumab 10 mg/kg	2	63
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	BYM338/Bimagrumab 3 mg/kg	6	63

1 to 10 of 564Source ClinicalTrials.gov

See all 564 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BYM338/Bimagrumab 10 mg/kg
Total, all-cause mortality	BYM338/Bimagrumab 3 mg/kg
Total, all-cause mortality	BYM338/Bimagrumab 1 mg/kg
Total, all-cause mortality	Placebo
Total, other adverse events	BYM338/Bimagrumab 10 mg/kg	63	63
Total, other adverse events	BYM338/Bimagrumab 3 mg/kg	63	63
Total, other adverse events	BYM338/Bimagrumab 1 mg/kg	63	63
Total, other adverse events	Placebo	61	62
Total, serious adverse events	BYM338/Bimagrumab 10 mg/kg	21	63
Total, serious adverse events	BYM338/Bimagrumab 3 mg/kg	11	63

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31397289	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.

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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