Actively Recruiting
OCTAGON: A Phase 4 Study to Investigate Oral Corticosteroid Tapering in Adults With Generalized Myasthenia Gravis Treated With Ravulizumab
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-04-09
75
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a specific oral corticosteroid (OCS) tapering schedule to reduce steroid use in adults with acetylcholine receptor positive generalized myasthenia gravis (gMG) who are treated with intravenous ravulizumab. This phase 4, multicenter, single-arm study aims to assess both the effectiveness and safety of gradually lowering OCS doses while managing gMG symptoms. Participants will follow a predefined oral corticosteroid tapering schedule during the study period until they complete the tapering process. They will continue receiving ravulizumab as part of their standard medical care, along with prednisone or prednisolone as needed. The treatment period lasts up to approximately 32 weeks, focusing on reducing or discontinuing OCS while monitoring disease status. Throughout the study, researchers will assess how many participants can reduce their daily OCS dose to 5 mg or less, or stop it entirely, without worsening gMG for at least four weeks. They will also track changes in quality of life, daily living activities, and glucocorticoid toxicity. Participants will undergo regular evaluations and safety monitoring during the study, which runs from March 2026 to August 2027.
CONDITIONS
Brief 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 (gMG)
- Receiving ravulizumab treatment prior to enrollment
- Receiving oral corticosteroid therapy equivalent to a daily dose 27 7.5 mg of prednisone/prednisolone for at least 4 continuous weeks before enrollment
- Negative pregnancy test for participants of childbearing potential before starting corticosteroid tapering
- Willing to sign informed consent
You will not qualify if you...
- Participating in another interventional clinical trial
- History of chronic hypoadrenalism (Addison's disease)
- Using oral corticosteroids for conditions other than gMG
- Received certain biologic treatments for gMG within 5 half-lives before enrollment
- Pregnant, breastfeeding, or planning to conceive during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 32 weeks
Participants follow an oral corticosteroid tapering schedule while continuing ravulizumab treatment as part of their standard medical care.
Visits scheduled throughout tapering period to monitor progress
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)
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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