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NCT01480596 · ClinicalTrials.gov registry record · Phase 2
The Evaluation of Belimumab in Myasthenia Gravis (MG)
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01480596 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 40 participants.
The verdict
NCT01480596, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER Placebo
- BIOLOGICAL Belimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01480596
The ClinicalTrials.gov registry entry for NCT01480596 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01480596 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01480596 about?
NCT01480596 is a clinical study titled "The Evaluation of Belimumab in Myasthenia Gravis (MG)". 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)...
What is the current status of trial NCT01480596?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2013-04. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01480596?
The interventions under investigation include: Placebo (OTHER), Belimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01480596?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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