Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07221838

A Study to Investigate OCS Tapering in Adult Participants 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Generalized Myasthenia Gravis Adrenal Gland Diseases Adrenal Insufficiency Autoimmune Diseases Autoimmune Diseases of the Nervous System Endocrine System Diseases Immune System Diseases Myasthenia Gravis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System gMG

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Bochum, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Corticosteroid Tapering Schedule

Procedure

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

Drug

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

prednisone/prednisolone

Drug

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

Primary outcomes

  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

    Time frame: Up to approximately 32 weeks

Secondary outcomes

  1. 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

  2. Percentage Change From Daily OCS Dose (mg/day) at Baseline

    Time frame: Baseline, Up to approximately 32 weeks

  3. 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

  4. 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

  5. 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

  6. Aggregate Improvement Score per the GTI-MD in Adult Participants with gMG

    Time frame: Baseline up to approximately 32 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

[email protected]

1-855-752-2356

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: OCTAGON

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 28, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.