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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT07221838
Phase
PHASE4
Status
Recruiting
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Conditions

  • Generalized Myasthenia Gravis
  • gMG

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 4, 2026
Status verified
Mar 2026
Primary completion
Aug 27, 2027
Completion
Aug 27, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Corticosteroid Tapering Schedule
    During the tapering period, participant will follow an Oral Corticosteroid tapering schedule until OCS tapering is complete

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 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteChicagoIllinois60637-
Research SiteSchaumburgIllinois60173-
Research SiteNeptune CityNew Jersey07753-
Research SiteRaleighNorth Carolina27607-
Research SiteKnoxvilleTennessee37920-

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Research Site· Chicago, ILResearch Site· Schaumburg, ILResearch Site· Neptune City, NJResearch Site· Raleigh, NCResearch Site· Knoxville, TN

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