Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the USA / NCT07221838
Recruiting Phase 4

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 ScheduleRavulizumab →Prednisone/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
No
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)

FacilityCityRegionStatus
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

Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism Active, not recruiting
Long-term Safety of Danicopan: IPIG Registry-based Cohort Study Active, not recruiting
A Prospective Sub-Study of the Global Hypophosphatasia Registry Recruiting
Registry of Patients With Hypophosphatasia Enrolling by invitation
Lysosomal Acid Lipase (LAL) Deficiency Registry Recruiting

Other trials for the same condition

Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis Active, not recruiting
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis Recruiting
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis Recruiting
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis Enrolling by invitation
Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis Active, not 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