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

NCT07221838 · tracked via the Priya Life Science USA tracker

Sponsor

Alexion Pharmaceuticals, Inc.

Phase

Phase 4

Started

2026-03-04

Last updated

2026-04-09

Condition(s) studied

Generalized Myasthenia GravisgMG

Investigational drug(s) / intervention(s)

Oral Corticosteroid Tapering ScheduleRavulizumabPrednisone/Prednisolone

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.

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

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Proportion of Adult Participants With gMG Who Either: Discontinue Oral Corticosteroids (OCS) or Reduce Their Daily OCS Dosage ≤ 5 mg/day and Maintain this Status for ≥ 4 Weeks Without Clinical Deterioration of gMG — Up to approximately 32 weeks

Trial sites (12)

Facility	City	Region	Status
Research Site	Chicago	Illinois	Not Yet Recruiting
Research Site	Schaumburg	Illinois	Not Yet Recruiting
Research Site	Neptune City	New Jersey	Not Yet Recruiting
Research Site	Raleigh	North Carolina	Recruiting
Research Site	Knoxville	Tennessee	Not Yet Recruiting
Research Site	Bochum	Germany	Not Yet Recruiting
Research Site	Milan	Italy	Not Yet Recruiting
Research Site	Naples	Italy	Not Yet Recruiting
Research Site	Rome	Italy	Not Yet Recruiting
Research Site	Ibaraki	Japan	Not Yet Recruiting
Research Site	Kitakyushu-shi	Japan	Not Yet Recruiting
Research Site	Kumamoto	Japan	Not Yet Recruiting

On this site

📄 Ultomiris (ravulizumab) drug profile →

More Alexion Pharmaceuticals, Inc. trials in the USA

A Study About the Natural History in Adults With BAG3 Dilated Cardiomyopathy (a Type of Heart Disease) (BAG3 DCM) Active, not recruiting

An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of ALXN2220 in Adults With Transthyretin Amyloid Cardiomyopathy Starting soon

Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis Active, not recruiting

Registry of Patients With Hypophosphatasia Enrolling by invitation

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES) Active, not recruiting

Other trials for the same condition

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis Recruiting

Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis Active, not recruiting

ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis Recruiting

PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis Recruiting

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07221838 on ClinicalTrials.gov ↗ ← All trials in the USA