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A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
Sponsor: Alexion Pharmaceuticals, Inc.
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.
Official title: OCTAGON: A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis Treated With Ravulizumab
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2026-03-04
Completion Date
2027-08-27
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
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.
Ravulizumab
Patients being treated with intravenous ravulizumab as part of their standard medical care.
Prednisone/Prednisolone
Participants will continue with or be switched to prednisone/prednisolone as per standard medical care.
Locations (12)
Research Site
Chicago, Illinois, United States
Research Site
Schaumburg, Illinois, United States
Research Site
Neptune City, New Jersey, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Bochum, Germany
Research Site
Milan, Italy
Research Site
Naples, Italy
Research Site
Rome, Italy
Research Site
Ibaraki, Japan
Research Site
Kitakyushu-shi, Japan
Research Site
Kumamoto, Japan