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Recruiting NCT07221838

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

Phase IV Interventional Generalized Myasthenia Gravis gMG

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral Corticosteroid Tapering Schedule, Ravulizumab, Prednisone/Prednisolone.
Who it may be relevant to
Registry conditions: Generalized Myasthenia Gravis, gMG. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany, Italy, Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • 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]
  • Percentage Change From Daily OCS Dose (mg/day) at Baseline [Time frame: 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]
  • 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]
  • 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]
  • Aggregate Improvement Score per the GTI-MD in Adult Participants with gMG [Time frame: Baseline up to approximately 32 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Research Site — Chicago
  • Research Site — Schaumburg
  • Research Site — Neptune City
  • Research Site — Raleigh
  • Research Site — Knoxville
Italy · 3 centers
  • Research Site — Milan
  • Research Site — Naples
  • Research Site — Rome
Japan · 3 centers
  • Research Site — Ibaraki
  • Research Site — Kitakyushu-shi
  • Research Site — Kumamoto
Germany · 1 center
  • Research Site — Bochum

Identifiers

NCT: NCT07221838 · D9281R00005 · ALX-MG-502

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗