An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD
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|ClinicalTrials.gov Identifier: NCT04201262|
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : August 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder||Biological: Ravulizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||External Placebo-Controlled, Open-Label Design|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)|
|Actual Study Start Date :||December 13, 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||July 2024|
During the Primary Treatment Period, all participants will receive open-label ravulizumab via intravenous (IV) infusion starting on Day 1. The Primary Treatment Period will continue until the last enrolled participant completes Week 26 in the study (expected to be approximately 2 years after the first participant is enrolled).
After completion of the Primary Treatment Period, all participants will have the opportunity to continue receiving ravulizumab in the Long-Term Extension Period of the study. For each participant, the Long-Term Extension Period continues for up to 2 years, or until ravulizumab is approved and/or available (in accordance with country-specific regulations), whichever occurs first.
Participants will receive a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until end of the Long-Term Extension Period.
- Time To First Adjudicated On-Trial Relapse [ Time Frame: Baseline, up to 2 years (end of the Primary Treatment Period) ]
- Incidence Of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events, And TEAEs Leading To Study Drug Discontinuation [ Time Frame: Baseline, up to 2 years (end of the Primary Treatment Period) ]
- Adjudicated On-Trial Annualized Relapse Rate [ Time Frame: Baseline, up to 2 years (end of the Primary Treatment Period) ]
- Clinically Important Worsening In Expanded Disability Status Scale [ Time Frame: Baseline, up to 2 years (end of the Primary Treatment Period) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04201262
|Contact: Alexion Pharmaceuticals Inc.||email@example.com|