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

April 6, 2026 updated by: Alexion Pharmaceuticals, Inc.

OCTAGON: A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis Treated With Ravulizumab

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bochum, Germany, 44789
        • Not yet recruiting
        • Research Site
  • Italy
      • Milan, Italy, 20122
        • Not yet recruiting
        • Research Site
      • Naples, Italy, 80131
        • Not yet recruiting
        • Research Site
      • Rome, Italy, 00189
        • Not yet recruiting
        • Research Site
  • Japan
      • Ibaraki, Japan, 305-8576
        • Not yet recruiting
        • Research Site
      • Kitakyushu-shi, Japan, 807-8555
        • Not yet recruiting
        • Research Site
      • Kumamoto, Japan, 860-8556
        • Not yet recruiting
        • Research Site
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • Research Site
      • Schaumburg, Illinois, United States, 60173
        • Not yet recruiting
        • Research Site
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • Not yet recruiting
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Not yet recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ravulizumab
Patients being treated with intravenous ravulizumab as part of their standard medical care.
Drug: Prednisone/Prednisolone
Participants will continue with or be switched to prednisone/prednisolone as per standard medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Up to approximately 32 weeks
Up to approximately 32 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Adult Participants with gMG Who Discontinue OCS (0 mg/day), Sustained ≥ 4 Weeks Without Clinical Deterioration of gMG
Time Frame: Up to approximately 32 weeks
Up to approximately 32 weeks
Percentage Change From Daily OCS Dose (mg/day) at Baseline
Time Frame: Baseline, Up to approximately 32 weeks
Baseline, Up to approximately 32 weeks
Change from Baseline in the Myasthenia Gravis Quality of Life-15 Revised (MG-QoL-15r) Score in Adult Participants with gMG
Time Frame: Baseline, Up to approximately 32 weeks
Baseline, Up to approximately 32 weeks
Change from Baseline in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in Adult Participants with gMG
Time Frame: Baseline, Up to approximately 32 weeks
Baseline, Up to approximately 32 weeks
Cumulative Worsening Score per the Glucocorticoid Toxicity Index - Metabolic Domains (GTI-MD) in Adult Participants with gMG
Time Frame: Baseline up to approximately 32 weeks
Baseline up to approximately 32 weeks
Aggregate Improvement Score per the GTI-MD in Adult Participants with gMG
Time Frame: Baseline up to approximately 32 weeks
Baseline up to approximately 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2026

Primary Completion (Estimated)

August 27, 2027

Study Completion (Estimated)

August 27, 2027

Study Registration Dates

First Submitted

October 3, 2025

First Submitted That Met QC Criteria

October 24, 2025

First Posted (Actual)

October 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9281R00005
  • ALX-MG-502 (Other Identifier: Alexion)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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