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A single arm study to investigate OCS tapering in adult participants with generalized Myasthenia Gravis treated with ravulizumab
EU CTIS ID: 2025-522555-26-00
What this study is testing
To assess the effectiveness of a predefined Oral corticosteroids (OCS) tapering schedule in adult participants with Generalized myasthenia gravis (gMG) treated with ravulizumab and OCS
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged ≥ 18 years at the time of enrollment.
- Clinical diagnosis of gMG.
- Receiving ravulizumab treatment prior to enrollment, in accordance with the locally approved label
- Receipt of OCS therapy equivalent to a daily dose ≥ 7.5 mg of prednisone/prednisolone for ≥ 4 continuous weeks directly preceding enrollment. - Alternative dosing of OCS (such as every other day) is allowed at enrollment, provided the average daily dose per week is equivalent to ≥ 7.5 mg of prednisone/prednisolone and the participant is willing to switch to a daily intake of prednisone/prednisolone at Baseline/Visit 1. - The use of other OCS (e.g., methylprednisolone) is allowed prior to enrolment provided the participant is willing to switch to a daily intake of prednisone/prednisolone at Baseline/Visit 1
- Male or female assigned at birth
- Agrees to follow protocol-specified contraception guidance as outlined in Section 10.5
You likely can't join if
- Concurrent participation in an interventional clinical trial.
- History of chronic hypoadrenalism (ie, Addison’s disease).
- Use of concomitant OCS for comorbid conditions other than gMG.
- Receipt of a biologic for gMG (e.g., efgartigimod, rozanolixizumab, inebilizumab, rituximab, intravenous immunoglobulin) within 5 half-lives of enrollment.
- Pregnant, breastfeeding, or intending to conceive during the course of the study
See the full eligibility criteria
- Aged ≥ 18 years at the time of enrollment.
- Clinical diagnosis of gMG.
- Receiving ravulizumab treatment prior to enrollment, in accordance with the locally approved label
- Receipt of OCS therapy equivalent to a daily dose ≥ 7.5 mg of prednisone/prednisolone for ≥ 4 continuous weeks directly preceding enrollment. - Alternative dosing of OCS (such as every other day) is allowed at enrollment, provided the average daily dose per week is equivalent to ≥ 7.5 mg of prednisone/prednisolone and the participant is willing to switch to a daily intake of prednisone/prednisolone at Baseline/Visit 1. - The use of other OCS (e.g., methylprednisolone) is allowed prior to enrolment provided the participant is willing to switch to a daily intake of prednisone/prednisolone at Baseline/Visit 1
- Male or female assigned at birth
- Agrees to follow protocol-specified contraception guidance as outlined in Section 10.5
- A participant of childbearing potential must have a negative highly sensitive pregnancy test (serum or urine, as required by local regulations) taken at Screening before OCS tapering begins, see Section 8.3.3 Pregnancy Testing. • Additional requirements for pregnancy testing at Visit 3 are located in Section 8.3.3 Pregnancy Testing
- Willing to provide informed consent as described in Section 10.1.3.
- Concurrent participation in an interventional clinical trial.
- History of chronic hypoadrenalism (ie, Addison’s disease).
- Use of concomitant OCS for comorbid conditions other than gMG.
- Receipt of a biologic for gMG (e.g., efgartigimod, rozanolixizumab, inebilizumab, rituximab, intravenous immunoglobulin) within 5 half-lives of enrollment.
- Pregnant, breastfeeding, or intending to conceive during the course of the study
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.