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NCT04767698 · ClinicalTrials.gov registry record · Phase 2
Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis
A Phase 2 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT04767698: Clinical Trial Phase 2 study, sponsored by Johns Hopkins University.
NCT04767698 is a Phase 2 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04767698, a Phase 2 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
Multiple sclerosis is the most common inflammatory disease of the central nervous system and a common cause of disability in young adults. Depleting B cells from the circulation with an anti-cluster of differentiation (CD) 20 antibodies has proven to be an effective strategy in reducing relapses and disability in patients with the relapsing-remitting disease. However, continuous and long-term depletion of B-cells can result in reduced immunoglobulin levels, immunosuppression, and an increased tendency for severe infections and perhaps, even malignancy. Blocking B-cell Activating Factor (BAFF) is effective for the treatment of several autoimmune disorders. Belimumab, a BAFF blocking antibody, has been approved by the Food and Drug Administration for the treatment of systemic lupus erythematosus. Belimumab has been shown to have immunomodulatory properties, without resulting in overt immunosuppression. The investigators hypothesize that belimumab, given to patients who received a short course of treatment with B-cell depleting antibody (ocrelizumab), will be safe and equally effective in reducing MS disease activity (as compared to patients receiving continuous treatment with ocrelizumab); while resulting in less immunosuppression, as measured by antibody response to pneumococcal vaccination. Currently, available treatment strategies in relapsing MS sacrifice higher efficacy for long-term safety or vice versa. The proposed strategy in this application combines the long-term safety and high efficacy to treat patients with relapsing-remitting multiple sclerosis (RRMS) and, if eventually proven effective, can be adopted in a large proportion of patients with this chronic disease. This is a randomized, open-labeled trial. Forty eligible participants will be randomized 1:1 to either receiving a form of standard of care, ocrelizumab (300 mg two infusions two weeks apart at baseline and then 600 mg as a single infusion every six months) or belimumab (200 mg subcutaneous (
Interventions
- DRUG Belimumab
- DRUG Short-course Ocrelizumab
- DRUG Continued Ocrelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2022-05-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04767698
The ClinicalTrials.gov registry entry for NCT04767698 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Belimumab is the first listed.
NCT04767698 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04767698 about?
NCT04767698 is a clinical study titled "Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis". Multiple sclerosis is the most common inflammatory disease of the central nervous system and a common cause of disability in young adults. Depleting B cells from the circulation with an anti-cluster of differentiation (CD) 20 antibodies has proven to be an effective strategy in reducing relapses and...
What is the current status of trial NCT04767698?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2021-10-01. Estimated completion is 2022-05-10.
What interventions are being tested in trial NCT04767698?
The interventions under investigation include: Belimumab (DRUG), Short-course Ocrelizumab (DRUG), Continued Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT04767698?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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