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Ocrelizumab SC in MS Patients Switching From Approved Anti-CD20 Therapy
NCT07609719Phase 4
Key facts
- Status
- Recruiting
- Start
- Sep 2026
- Primary completion
- Feb 2029
- Countries
- 2
- Sponsor
- Genentech
- Drugs
- ocrelizumab
- Conditions
- multiple sclerosis (MS)
01
Overview
Phase 4, open-label, single-arm trial of ocrelizumab in multiple sclerosis (MS), sponsored by Genentech. Primary endpoint: Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gadolinium-enhanced (Gd+) Lesions at 24 weeks. Started Sep 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
OCR SC
Participants will receive OCR SC, 920 mg at Day 1 and at Week 24.
03
Who it enrols
Patients with RMS or PPMS (EDSS 0-6.5) who are discontinuing a prior approved anti-CD20 therapy (ofatumumab SC, ublituximab IV, or ocrelizumab IV) for reasons other than suboptimal response or severe adverse events.
04
Endpoints
Primary
Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gadolinium-enhanced (Gd+) Lesions
Secondary
Percentage of Participants With no New or Enlarging T2 Lesions
Number of Participants With Adverse Events
Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gadolinium-enhanced (Gd+) Lesions
Change From Baseline in Cluster of Differentiation 19 (CD19+) B-cell Counts
Treatment Satisfaction Score With Prior aCD20 Therapy
Treatment Administration Satisfaction Score After Dose of OCR SC
Treatment Satisfaction Score With OCR SC
Change From Baseline in Multiple Sclerosis Impact Scale Scores
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