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NCT04660539 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
NCT04660539 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 119 participants.
The verdict
NCT04660539, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
Study Summary
This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 and BN40900. Participants will receive satralizumab as monotherapy or in combination with one of the following background immunosuppressive treatments: azathioprine (AZA), mycophenolate mofetil (MMF), or oral corticosteroids.
Interventions
- DRUG satralizumab
- DRUG azathioprine (AZA)
- DRUG mycophenolate mofetil (MMF)
- DRUG oral corticosteroids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2024-05-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04660539
The ClinicalTrials.gov registry entry for NCT04660539 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which satralizumab is the first listed.
NCT04660539 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04660539 about?
NCT04660539 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)". This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 and BN40900. Participants will receive satralizumab as...
What is the current status of trial NCT04660539?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2021-03-02. Estimated completion is 2024-05-28.
What interventions are being tested in trial NCT04660539?
The interventions under investigation include: satralizumab (DRUG), azathioprine (AZA) (DRUG), mycophenolate mofetil (MMF) (DRUG), oral corticosteroids (DRUG).
Who is sponsoring clinical trial NCT04660539?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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