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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT04660539 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 119 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
AE=any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with it. AE can therefore be any unfavorable \& unintended sign, symptoms/disease temporally associated with use of a medicinal (investigational) product, whether or not considered related to it. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results
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 |
What the finished NCT04660539 record still lists
NCT04660539 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which satralizumab is the first listed.
NCT04660539 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04660539's enrollment target sits among peer trials
119 1640th of 2000 higher than 360 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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