A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-27

Study Completion Date

2027-08-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Generalized Myasthenia Gravis gMG

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral Corticosteroid Tapering Schedule

During the tapering period, participant will follow an Oral Corticosteroid tapering schedule until OCS tapering is complete

Group Type EXPERIMENTAL

Oral Corticosteroid Tapering Schedule

Intervention Type PROCEDURE

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

Intervention Type DRUG

Patients being treated with intravenous ravulizumab as part of their standard medical care.

Prednisone/Prednisolone

Intervention Type DRUG

Participants will continue with or be switched to prednisone/prednisolone as per standard medical care.

Interventions

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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.

Intervention Type PROCEDURE

Ravulizumab

Patients being treated with intravenous ravulizumab as part of their standard medical care.

Intervention Type DRUG

Prednisone/Prednisolone

Participants will continue with or be switched to prednisone/prednisolone as per standard medical care.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged greater than 18 years and male or female
* Clinical diagnosis of gMG
* Receiving ravulizumab treatment prior to enrollment
* Receipt of OCS therapy equivalent to a daily dose ≥ 7.5 mg of prednisone/prednisolone for ≥ 4 continuous weeks directly preceding enrollment
* 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.
* Willing to sign informed consent

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No