A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
NCT07221838 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2026-04-09
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
Interventions
- 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.
Sponsors & Collaborators
-
Alexion Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-04
- Primary Completion
- 2027-08-27
- Completion
- 2027-08-27
- FDA Drug
- Yes
Countries
- United States
- Germany
- Italy
- Japan
Study Locations
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