A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis

  • STATUS
    Not Recruiting
Updated on 12 January 2021

Summary

This is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to evaluate the safety and efficacy of ravulizumab for the treatment of patients with gMG. Approximately 160 eligible patients will be stratified by region (North America, Europe, Asia-Pacific, and Japan) and randomized 1:1 to 1 of 2 treatment groups: (1) ravulizumab infusion or (2) placebo infusion. There will be 3 periods in this study: Screening Period, Randomized-Controlled Period, and an Open-Label Extension (OLE) Period.

 

Description

Eight weeks after the final dose of study drug is administered, all enrolled patients will return for an End of Study (EOS) Visit (Visit 30) at Week 132 (± 2 days), during which final study assessments will be conducted. If a patient withdraws from the study or completes the study early because ravulizumab has become registered or approved (in accordance with country-specific regulations) prior to Visit 29, the patient will be encouraged to return for an Early Termination Visit, 8 weeks (± 2 days) after the last dose of study drug was administered, during which final planned safety assessments will be conducted. Attempts should be made to follow all patients for safety for 8 weeks following the patient’s last dose of study drug.

Patients being treated with an immunosuppressive therapy (IST) at the time of the Screening Visit may continue to receive ISTs throughout the Randomized-Controlled and OLE Periods. However, the dosage of IST must not be changed and no new ISTs may be added during the Randomized-Controlled Period of the study, unless deemed by the Investigator to be medically necessary.

Throughout the study, rescue therapy (eg, high-dose corticosteroids, plasmapheresis/plasma exchange, or intravenous immunoglobulin) will be allowed if a patient experiences Clinical Deterioration, as defined by the study protocol. The rescue therapy used for a particular patient will be at the discretion of the Investigator.

The primary endpoint for this study will be measured at Week 26. Endpoints will be measured and analyzed irrespective of rescue therapy. For those patients who complete the study, as defined in the protocol, the EOS Visit is defined as patient’s last visit in the (up to) 2-year OLE Period. Including the 8-week safety follow-up, which begins after the patient’s last dose of study drug is administered, the overall study-duration for an individual patient is estimated to take up to 132 weeks (from enrollment through the end of the Safety Follow-up).

 

Details
Condition Myasthenia Gravis generalised, Generalized Myasthenia Gravis
Clinical Study IdentifierTX217967
Last Modified on12 January 2021

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