Adults 40 to 75, any sex, with Sporadic Inclusion Body Myositis (sIBM). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events as a Measure of Safety and TolerabilityPrimary· 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
Death
Group
Value
95% CI
BYM338
0
Serious adverse events (SAE)
Group
Value
95% CI
BYM338
2
Adverse Events (AE)
Group
Value
95% CI
BYM338
10
Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA)Secondary· 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.
Day 1
Group
Value
95% CI
BYM338
0
± 0
Day 57
Group
Value
95% CI
BYM338
4.292
± 2.7480
Day 113
Group
Value
95% CI
BYM338
5.552
± 3.6066
Day 169
Group
Value
95% CI
BYM338
7.463
± 4.5687
Day 365
Group
Value
95% CI
BYM338
6.919
± 2.9669
Day 533
Group
Value
95% CI
BYM338
6.885
± 3.7894
Day 729
Group
Value
95% CI
BYM338
0.727
± NA
Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. DosingSecondary· 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
Day 29 (n=10)
Group
Value
95% CI
BYM338
13.4
± 5.01
Day 85 (n=10)
Group
Value
95% CI
BYM338
24.1
± 13.1
Day 169 (n=10)
Group
Value
95% CI
BYM338
26.3
± 15.9
Day 253 (n=9)
Group
Value
95% CI
BYM338
28.8
± 12.1
Day 337 (n=10)
Group
Value
95% CI
BYM338
24.4
± 14.6
Day 421 (n=9)
Group
Value
95% CI
BYM338
24.5
± 11.5
Day 505 (n=8)
Group
Value
95% CI
BYM338
28.3
± 10.6
Day 589 (n=6)
Group
Value
95% CI
BYM338
39.8
± 30.2
Changes From Baseline in Muscle Strength.Secondary· 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
Quadriceps score left side Day 1
Group
Value
95% CI
BYM338
0
± 0
left side Day 113
Group
Value
95% CI
BYM338
-5.80
± 28.160
left side Day 169
Group
Value
95% CI
BYM338
-5.95
± 26.587
left side Day 365
Group
Value
95% CI
BYM338
-9.51
± 28.149
left side Day 533
Group
Value
95% CI
BYM338
-25.77
± 21.321
left side Day 729
Group
Value
95% CI
BYM338
178.26
± NA
Quadriceps score Right side Day 1
Group
Value
95% CI
BYM338
0
± 0
Right side Day 113
Group
Value
95% CI
BYM338
-4.83
± 29.904
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)Secondary· Baseline,Day 1, 113, 169, 365, 533, 729
The effect of BYM338 on additional muscle function measures (hand-grip and pinch-grip dynamometry).
Left hand-grip day 1
Group
Value
95% CI
BYM338
0
± 0
Left hand-grip day 113
Group
Value
95% CI
BYM338
25.58
± 37.544
Left hand-grip day 169
Group
Value
95% CI
BYM338
21.36
± 43.815
Left hand-grip day 365
Group
Value
95% CI
BYM338
-1.42
± 47.973
Left hand-grip day 533
Group
Value
95% CI
BYM338
2.78
± 16.934
Left hand-grip day 729
Group
Value
95% CI
BYM338
8.95
± 24.034
Right hand-grip day 1
Group
Value
95% CI
BYM338
0
± 0
Right hand-grip day 113
Group
Value
95% CI
BYM338
99.59
± 184.472
Changes From Baseline in Muscle Function 6 Minute Walking DistanceSecondary· 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.
Day 1
Group
Value
95% CI
BYM338
0
± 0
Day 113
Group
Value
95% CI
BYM338
-1.56
± 13.685
Day 169
Group
Value
95% CI
BYM338
-7.41
± 12.463
Day 365
Group
Value
95% CI
BYM338
-8.97
± 15.763
Day 533
Group
Value
95% CI
BYM338
-16.99
± 22.382
Day 729
Group
Value
95% CI
BYM338
-17.86
± NA
Change From Baseline of Thigh Muscle Volume (TMV) by MRI ScanSecondary· 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
Day 1
Group
Value
95% CI
BYM338
0
± 0
Day 57
Group
Value
95% CI
BYM338
4.14
± 4.250
Day 113
Group
Value
95% CI
BYM338
4.51
± 6.300
Pharmacokinetics (PK) Parameter of CmaxSecondary· 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.
Group
Value
95% CI
BYM338
278
± 62.6
Time to Reach the Maximum Concentration After Drug Administration (Tmax)Secondary· Day 1
The time to reach the maximum concentration after drug administration
Group
Value
95% CI
BYM338
0.744
0.648 – 4.73
Adverse events — posted to ClinicalTrials.gov
Time frame: period up to 104 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
BYM338 10mg/kg i.v.
Serious: 2/10 (20%)
Deaths: —
Serious adverse events (9 terms)
Reaction
System
BYM338 10mg/kg i.v.
Anaemia
Blood and lymphatic system disorders
—
Myocardial infarction
Cardiac disorders
—
Tachyarrhythmia
Cardiac disorders
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
Haemorrhoidal haemorrhage
Gastrointestinal disorders
—
Dehydration
Metabolism and nutrition disorders
—
Iron deficiency
Metabolism and nutrition disorders
—
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study is an open-label, long-term study for those patients who participated in the prior proof-of-concept protocol, in which the preliminary efficacy for BYM338 in patients with sIBM was demonstrated after a single 30 mg/kg i.v. dose of BYM338. This study is designed to confirm the efficacy, safety and tolerability of BYM338 in sIBM with long-term dosing. However due to lack of efficacy in patients with sIBM, the study was terminated early.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 30 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02250443.