Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients
Public ClinicalTrials.gov record NCT01925209. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Dose-finding, Pivotal, Phase 2b/3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility and Additional Long Term Safety up to 2 Years in Patients With Sporadic Inclusion Body Myositis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01925209
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 251 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 36 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 26, 2013 (Actual)
- Primary completion
- Jan 6, 2016 (Actual)
- Completion
- Jan 6, 2016 (Actual)
- Last update posted
- Aug 11, 2017
2013 – 2016
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85028 | — |
| Novartis Investigative Site | Orange | California | 92868 | — |
| Novartis Investigative Site | Sacramento | California | 95817 | — |
| Novartis Investigative Site | Miami | Florida | 33101 | — |
| Novartis Investigative Site | Kansas City | Kansas | 66160 | — |
| Novartis Investigative Site | Baltimore | Maryland | 21287 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02114 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02115 | — |
| Novartis Investigative Site | Columbus | Ohio | 43221 | — |
| Novartis Investigative Site | Portland | Oregon | 97239 | — |
| Novartis Investigative Site | Dallas | Texas | 75235 | — |
| Novartis Investigative Site | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01925209, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 11, 2017 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01925209 live on ClinicalTrials.gov.