NCT07221838

A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab

OCTAGON: A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis Treated With Ravulizumab

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter single arm study designed to evaluate the effectiveness and safety of a predefined oral corticosteroids (OCS) tapering schedule to reduce OCS use in adult participants with acetylcholine receptor positive (AChR+) generalized myasthenia gravis (gMG) being treated with intravenous ravulizumab.

Conditions

• Generalized Myasthenia Gravis
• gMG

Interventions

Type	Name	Description
PROCEDURE	Oral Corticosteroid Tapering Schedule	During the tapering period, participant will follow an Oral Corticosteroid tapering schedule as applicable to the participant. The oral corticosteroid (prednisone/prednisolone) is provided as per standard medical care.
DRUG	Ravulizumab	Patients being treated with intravenous ravulizumab as part of their standard medical care.
DRUG	Prednisone/Prednisolone	Participants will continue with or be switched to prednisone/prednisolone as per standard medical care.

Timeline

• Start date: 2026-03-04
• Primary completion: 2027-08-27
• Completion: 2027-08-27
• First posted: 2025-10-28
• Last updated: 2026-04-09

Locations

12 sites across 4 countries: United States, Germany, Italy, Japan

Regulatory

• FDA-regulated drug study