Generalized Myasthenia GravisPhase 4OCTAGONNCT07221838
A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
A Phase 4 study testing Oral Corticosteroid Tapering Schedule, Ravulizumab and Prednisone/Prednisolone in people with Generalized Myasthenia Gravis and gMG, run by Alexion Pharmaceuticals, Inc. at 12 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Myasthenia Gravis, gMG
- What is being tested?
- Oral Corticosteroid Tapering Schedule, Ravulizumab and Prednisone/Prednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 4 Mar 2026to 27 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 4 countries
United States5 sites, 5 recruiting
- Not yet recruiting
Research Site
Chicago, Illinois, 60637
- Not yet recruiting
Research Site
Knoxville, Tennessee, 37920
- Not yet recruiting
Research Site
Neptune City, New Jersey, 07753
- Recruiting
Research Site
Raleigh, North Carolina, 27607
- Not yet recruiting
Research Site
Schaumburg, Illinois, 60173
Italy3 sites, 3 recruiting
- Not yet recruiting
Research Site
Milan, 20122
- Not yet recruiting
Research Site
Naples, 80131
- Not yet recruiting
Research Site
Rome, 00189
Japan3 sites, 3 recruiting
- Not yet recruiting
Research Site
Ibaraki, 305-8576
- Not yet recruiting
Research Site
Kitakyushu-shi, 807-8555
- Not yet recruiting
Research Site
Kumamoto, 860-8556
About this study
Official title: 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.
- Conditions
- Generalized Myasthenia Gravis, gMG
- Being tested
- Oral Corticosteroid Tapering Schedule, Ravulizumab, Prednisone/Prednisolone
- Keywords
- Generalized myasthenia gravis, gMG, Glucocorticoid toxicity, Complement C5 inhibitor, Prednisone reduction, Cortisol monitoring, ravulizumab, corticosteroids, adrenal insufficiency, steroid sparing
- Medical subject headings
- Myasthenia Gravis, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Corticosteroid Tapering ScheduleProcedure or surgery
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.
RavulizumabDrug
Patients being treated with intravenous ravulizumab as part of their standard medical care.
Prednisone/PrednisoloneDrug
Participants will continue with or be switched to prednisone/prednisolone as per standard medical care.
| Study group | Role | What they receive |
|---|---|---|
| Oral Corticosteroid Tapering Schedule | Experimental | During the tapering period, participant will follow an Oral Corticosteroid tapering schedule until OCS tapering is complete Receives: Procedure: Oral Corticosteroid Tapering Schedule; Drug: Ravulizumab; Drug: Prednisone/Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to approximately 32 weeks
Secondary outcomes (6)
Proportion of Adult Participants with gMG Who Discontinue OCS (0 mg/day), Sustained ≥ 4 Weeks Without Clinical Deterioration of gMG
Measured: Up to approximately 32 weeks
Percentage Change From Daily OCS Dose (mg/day) at Baseline
Measured: 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
Measured: 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
Measured: Baseline, Up to approximately 32 weeks
Cumulative Worsening Score per the Glucocorticoid Toxicity Index - Metabolic Domains (GTI-MD) in Adult Participants with gMG
Measured: Baseline up to approximately 32 weeks
Aggregate Improvement Score per the GTI-MD in Adult Participants with gMG
Measured: Baseline up to approximately 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start4 Mar 2026
- Primary completion27 Aug 2027 (estimated)
- Study completion27 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221838
- Sponsor's protocol ID
- D9281R00005
- Other IDs
- ALX-MG-502
- Acronym
- OCTAGON
- Status last verified
- Mar 2026
- First submitted
- 3 Oct 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCTAGON: A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis Treated With Ravulizumab
- ClinicalTrials.gov ID
- NCT07221838
- Acronym / sponsor ID
- OCTAGON / D9281R00005
- Conditions
- Generalized Myasthenia Gravis, gMG
- Keywords
- Generalized myasthenia gravis, gMG, Glucocorticoid toxicity, Complement C5 inhibitor, Prednisone reduction, Cortisol monitoring, ravulizumab, corticosteroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 27 Aug 2027 (estimated)
- Study completion
- 27 Aug 2027 (estimated)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Corticosteroid Tapering Schedule | Experimental | Procedure: Oral Corticosteroid Tapering Schedule, Drug: Ravulizumab, Drug: Prednisone/PrednisoloneDuring the tapering period, participant will follow an Oral Corticosteroid tapering schedule until OCS tapering is complete |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Corticosteroid Tapering ScheduleDuring 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. | Procedure or surgery | Oral Corticosteroid Tapering Schedule |
| RavulizumabPatients being treated with intravenous ravulizumab as part of their standard medical care. | Drug | Oral Corticosteroid Tapering Schedule |
| Prednisone/PrednisoloneParticipants will continue with or be switched to prednisone/prednisolone as per standard medical care. | Drug | Oral Corticosteroid Tapering Schedule |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Corticosteroid Tapering Schedule, Ravulizumab and Prednisone/Prednisolone in people with Generalized Myasthenia Gravis and gMG, run by Alexion Pharmaceuticals, Inc. at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Italy, Japan, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexion Pharmaceuticals, Inc. (Sponsor) (1-855-752-2356, clinicaltrials@alexion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.