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NCT02688985 · ClinicalTrials.gov registry record · Phase 3
Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)
A Phase 3 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
NCT02688985 is a Phase 3 study that has completed, run by Genentech. The registered enrollment target is 131 participants.
The verdict
NCT02688985, a Phase 3 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, biomarker study designed to be hypothesis-generating in order to better understand the mechanism of action of ocrelizumab and B-cell biology in RMS or PPMS. The study will be conducted in two cohorts i.e. RMS cohort (4 arm group) and PPMS cohort (one arm group). RMS cohort: Ocrelizumab will be administered as two intravenous (IV) infusions of 300 milligrams (mg) on Days 1 and 15. Subsequent doses will be given as single 600-mg infusions at Weeks 24 and 48. Participants will be randomized in 1:1:1 ratio to receive lumbar puncture (LP) post-treatment at Week 12, 24, or 52 following the first dose of ocrelizumab in three arm groups. A fourth RMS arm with delayed treatment start (Arm 4 \[control group\]) will not be a part of the randomization and will be recruited separately, wherein treatment with ocrelizumab will be delayed for 12 weeks from pre-treatment baseline. PPMS cohort: Ocrelizumab 600 mg will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks. Participants will receive a LP at the start of the study before dosing with ocrelizumab and second LP at Week 52 following the first dose of ocrelizumab. A long-term extension will be conducted for participants that complete the study and continue to receive ocrelizumab. Treatment with ocrelizumab in the entire study will continue for approximately 4.5 years after the first infusion.
Interventions
- PROCEDURE Lumbar Puncture
- DRUG Ocrelizumab
- DRUG Antihistamine
- DRUG Methyloprednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2016-04-29 |
| Est. Completion | 2023-04-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02688985
The ClinicalTrials.gov registry entry for NCT02688985 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Lumbar Puncture is the first listed.
NCT02688985 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02688985 about?
NCT02688985 is a clinical study titled "Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)". This is an open-label, multicenter, biomarker study designed to be hypothesis-generating in order to better understand the mechanism of action of ocrelizumab and B-cell biology in RMS or PPMS. The study will be conducted in two cohorts i.e. RMS cohort (4 arm group) and PPMS cohort (one arm group). R...
What is the current status of trial NCT02688985?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2016-04-29. Estimated completion is 2023-04-11.
What interventions are being tested in trial NCT02688985?
The interventions under investigation include: Lumbar Puncture (PROCEDURE), Ocrelizumab (DRUG), Antihistamine (DRUG), Methyloprednisolone (DRUG).
Who is sponsoring clinical trial NCT02688985?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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