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NCT01457924 · ClinicalTrials.gov registry record · Phase 2
Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 232
- Enrollment target
NCT01457924 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 232 participants.
The verdict
NCT01457924, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 232 participants
- Enrollment target
Study Summary
Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid immunoblast stage only. A recent trial with an anti-CD20 mAb (rituximab) demonstrated that targeting B-cells reduces the number of gadolinium-enhancing (GdE) T1 lesions and the relapse rate in relapsing-remitting multiple sclerosis (RRMS). Ofatumumab has been shown to be both well tolerated and efficacious in several indications, including a small, placebo-controlled trial in RRMS using an intravenous (IV) formulation. This double-blind, placebo-controlled, parallel-group study will investigate the safety and efficacy of a subcutaneous formulation of ofatumumab in the treatment of subjects with RRMS. The primary objective of the study is to investigate the efficacy as assessed by magnetic resonance imaging. Other objectives will include evaluation of tolerability/safety, dose-response relationship, pharmacokinetics, pharmacodynamics, exposure-response, as well as other clinical endpoints.
Interventions
- DRUG Placebo
- DRUG Ofatumumab 3mg
- DRUG Ofatumumab 30mg
- DRUG Ofatumumab 60mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2011-11-01 |
| Est. Completion | 2015-06-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01457924
The ClinicalTrials.gov registry entry for NCT01457924 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 232 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 4 interventions - of which Placebo is the first listed.
NCT01457924 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01457924 about?
NCT01457924 is a clinical study titled "Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis". Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid immunoblast stage only. A recent trial w...
What is the current status of trial NCT01457924?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 232 participants. The study started on 2011-11-01. Estimated completion is 2015-06-10.
What interventions are being tested in trial NCT01457924?
The interventions under investigation include: Placebo (DRUG), Ofatumumab 3mg (DRUG), Ofatumumab 30mg (DRUG), Ofatumumab 60mg (DRUG).
Who is sponsoring clinical trial NCT01457924?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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