The Evaluation of Belimumab in Myasthenia Gravis (MG)
Public ClinicalTrials.gov record NCT01480596. 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, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects With Generalized Myasthenia Gravis (MG)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Study BEL115123 is a randomized, placebo-controlled, double-blind, multinational study of belimumab (10 mg/kg) to investigate the efficacy and safety of belimumab in subjects with MG. The study will enroll male and female outpatients (\> or equal to 18 years of age) with a diagnosis of MG who are 1) acetylcholine receptor (AChR) antibody positive or muscle specific kinase (MuSK) antibody positive, 2) on current standard of care therapy, and 3) continue to exhibit signs of MG. The study will include 3 phases: a 4 week screening period, a 24 week treatment period, and a 12 week follow-up period. IP will be administered intravenously on Days 0, 14, 28 and then every 28 days through and including Week 20. At Week 24, primary outcomes will be obtained. Follow up evaluations will be conducted at Weeks 28, 32 and 36 for all subjects. The primary objective of this study is to assess the efficacy of belimumab as evaluated by the change in the quantitative myasthenia gravis (QMG) score.
Study identification
- NCT ID
- NCT01480596
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Apr 2013 (Type not available)
- Primary completion
- Aug 2015 (Actual)
- Completion
- Oct 2015 (Actual)
- Last update posted
- Feb 9, 2017
2013 – 2015
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85018 | — |
| GSK Investigational Site | Los Angeles | California | 90033 | — |
| GSK Investigational Site | Orange | California | 92868 | — |
| GSK Investigational Site | Colorado Springs | Colorado | 80907 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20037 | — |
| GSK Investigational Site | Miami | Florida | 33136 | — |
| GSK Investigational Site | Tampa | Florida | 33612 | — |
| GSK Investigational Site | Kansas City | Kansas | 66160 | — |
| GSK Investigational Site | Chapel Hill | North Carolina | — | — |
| GSK Investigational Site | Columbus | Ohio | 43210 | — |
| GSK Investigational Site | Hershey | Pennsylvania | 17033-0859 | — |
| GSK Investigational Site | Charleston | South Carolina | 29425 | — |
| GSK Investigational Site | Houston | Texas | 77030 | — |
| GSK Investigational Site | Burlington | Vermont | 05405 | — |
| GSK Investigational Site | Charlottesville | Virginia | 22908 | — |
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 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01480596, 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 Feb 9, 2017 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01480596 live on ClinicalTrials.gov.