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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by Alexion Pharmaceuticals, Inc.
Sponsor
Alexion Pharmaceuticals, Inc.
Information Provided by (Responsible Party)
Alexion Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
NCT07221838
Other Study ID Numbers:
D9281R00005
First Submitted
October 2, 2025
First Posted
October 27, 2025
Last Update Posted
April 8, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Generalized Myasthenia GravisgMG
Procedure: Oral Corticosteroid Tapering Schedule

Study Design

Study TypeInterventional
Actual Enrollment75 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleOCTAGON: A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis Treated With Ravulizumab
Study Start DateMarch 3, 2026
Actual Primary Completion Date1yr 1mo from now
Actual Study Completion Date1yr 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Oral Corticosteroid Tapering Schedule
During the tapering period, participant will follow an Oral Corticosteroid tapering schedule until OCS tapering is complete
Procedure: 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.

Outcome Measures

Primary Outcome Measures
  1. 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
Secondary Outcome Measures
  1. Proportion of Adult Participants with gMG Who Discontinue OCS (0 mg/day), Sustained ≥ 4 Weeks Without Clinical Deterioration of gMG
  2. Percentage Change From Daily OCS Dose (mg/day) at Baseline
  3. Change from Baseline in the Myasthenia Gravis Quality of Life-15 Revised (MG-QoL-15r) Score in Adult Participants with gMG
  4. Change from Baseline in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in Adult Participants with gMG
  5. Cumulative Worsening Score per the Glucocorticoid Toxicity Index - Metabolic Domains (GTI-MD) in Adult Participants with gMG
  6. Aggregate Improvement Score per the GTI-MD in Adult Participants with gMG

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsAlexion Pharmaceuticals, Inc.
Locations
Research Site | Chicago Illinois, United States, 60637Research Site | Schaumburg Illinois, United States, 60173Research Site | Neptune City New Jersey, United States, 07753Research Site | Raleigh North Carolina, United States, 27607Research Site | Knoxville Tennessee, United States, 37920Research Site | Bochum , Germany, 44789Research Site | Milan , Italy, 20122Research Site | Naples , Italy, 80131Research Site | Rome , Italy, 00189Research Site | Ibaraki , Japan, 305-8576Research Site | Kitakyushu-shi , Japan, 807-8555Research Site | Kumamoto , Japan, 860-8556