Actively Recruiting
A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-04-09
75
Participants Needed
12
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged greater than 18 years and male or female
- Clinical diagnosis of generalized myasthenia gravis
- Receiving ravulizumab treatment prior to enrollment
- Receiving oral corticosteroid therapy equivalent to a daily dose 7.5 mg of prednisone or prednisolone for at least 4 continuous weeks before enrollment
- Negative highly sensitive pregnancy test for participants of childbearing potential before starting OCS tapering
- Willingness to sign informed consent
You will not qualify if you...
- Concurrent participation in another interventional clinical trial
- History of chronic hypoadrenalism (Addison's disease)
- Use of oral corticosteroids for other conditions besides generalized myasthenia gravis
- Receipt of a biologic treatment for generalized myasthenia gravis within 5 half-lives before enrollment (e.g., efgartigimod, rozanolixizumab, inebilizumab, rituximab, intravenous immunoglobulin)
- Pregnant, breastfeeding, or intending to conceive during the study
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Research Site
Chicago, Illinois, United States, 60637
Not Yet Recruiting
2
Research Site
Schaumburg, Illinois, United States, 60173
Not Yet Recruiting
3
Research Site
Neptune City, New Jersey, United States, 07753
Not Yet Recruiting
4
Research Site
Raleigh, North Carolina, United States, 27607
Actively Recruiting
5
Research Site
Knoxville, Tennessee, United States, 37920
Not Yet Recruiting
6
Research Site
Bochum, Germany, 44789
Not Yet Recruiting
7
Research Site
Milan, Italy, 20122
Not Yet Recruiting
8
Research Site
Naples, Italy, 80131
Not Yet Recruiting
9
Research Site
Rome, Italy, 00189
Not Yet Recruiting
10
Research Site
Ibaraki, Japan, 305-8576
Not Yet Recruiting
11
Research Site
Kitakyushu-shi, Japan, 807-8555
Not Yet Recruiting
12
Research Site
Kumamoto, Japan, 860-8556
Not Yet Recruiting
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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