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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.

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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

FieldValue
Enrollment Target 119 participants
Start Date 2021-03-02
Est. Completion 2024-05-28
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.