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RecruitingInterventionalPhase 4

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

NCT ID: NCT07221838Sponsor: Alexion Pharmaceuticals, Inc.Last updated: 2026-04-09

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.

Arms & interventions

  • ProcedureOral 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.

  • DrugRavulizumab

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

  • DrugPrednisone/Prednisolone

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

Outcome measures

Primary

  • 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

  • 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

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (5)

Research Site

Chicago, Illinois, 60637

Not Yet Recruiting

Research Site

Schaumburg, Illinois, 60173

Not Yet Recruiting

Research Site

Neptune City, New Jersey, 07753

Not Yet Recruiting

Research Site

Raleigh, North Carolina, 27607

Recruiting

Research Site

Knoxville, Tennessee, 37920

Not Yet Recruiting
A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab | Cancerify