Recruiting

C5 Inhibition

Sponsor:

Alexion Pharmaceuticals, Inc.

Code:

NCT04202341

Conditions

Generalized Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Long-term, multicenter, multinational, observational, registry of patients with gMG that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT) such as eculizumab (Soliris®) and ravulizumab (Ultomiris®).

Conditions

Generalized Myasthenia Gravis

Study ID

NCT04202341

Start date

Dec 2, 2019

Status verified date

Feb, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participants with a diagnosis of gMG who are treated with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment.
2. Capable of giving signed informed consent, which includes compliance with the protocol requirements and restrictions.
3. Participants must have myasthenia gravis historical data, such as MG-ADL and MGFA class, available to be enrolled in the Registry.

Exclusion Criteria:

1\. Participants currently enrolled in an Alexion-sponsored interventional clinical study for treatment of gMG cannot be enrolled in the Alexion gMG Registry while enrolled/participating in the clinical study for gMG therapy.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score [ Time Frame: Approximately 5 years from enrollment ]

Central Contacts and Locations

Central contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356clinicaltrials@alexion.com

Locations

Clinical Trial Site

Recruiting

Birmingham, Alabama, United States, 35294

Clinical Trial Site

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Scottsdale, Arizona, United States, 85251

Clinical Trial Site

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Fresno, California, United States, 93710

Clinical Trial Site

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Orange, California, United States, 92868

Clinical Trial Site

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Rancho Mirage, California, United States, 92270

Clinical Trial Site

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Sylmar, California, United States, 91342

Clinical Trial Site

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Colorado Springs, Colorado, United States, 80907

Clinical Trial Site

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Fort Collins, Colorado, United States, 80528

Clinical Trial Site

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New Haven, Connecticut, United States, 06520

Clinical Trial Site

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Washington D.C., District of Columbia, United States, 10010

Clinical Trial Site

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Clearwater, Florida, United States, 33761

Clincal Trial Site

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Gainesville, Florida, United States, 32608

Clinical Trial Site

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Jacksonville, Florida, United States, 32209

Clinical Trial Site

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Tampa, Florida, United States, 33612

Clinical Trial Site

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Augusta, Georgia, United States, 30912

Clinical Trial Site

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Iowa City, Iowa, United States, 52242

Clinical Trial Site

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Lexington, Kentucky, United States, 40503

Clinical Trial Site

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Boston, Massachusetts, United States, 02215

Clinical Trial Site

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Lansing, Michigan, United States, 48824

Clinical Trial Site

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Columbia, Missouri, United States, 65212

Clinical Trial Site

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New Hyde Park, New York, United States, 11042

Clinical Trial Site

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Chapel Hill, North Carolina, United States, 27599

Clinical Trial Site

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Charlotte, North Carolina, United States, 28207

Clinical Trial Site

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Durham, North Carolina, United States, 27705

Clinical Trial Site

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Dayton, Ohio, United States, 45459

Clinical Trial Site

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Philadelphia, Pennsylvania, United States, 19104

Clinical Trial Site

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Chattanooga, Tennessee, United States, 37403

Clinical Trial Site

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Knoxville, Tennessee, United States, 37920

Clinical Trial Site

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Dallas, Texas, United States, 75206

Clinical Trial Site

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Houston, Texas, United States, 77030

Clinical Trial Site

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Burlington, Vermont, United States, 05401

Clinical Trial Site

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Milwaukee, Wisconsin, United States, 53215

Clinical Trial Site

Recruiting

Brampton, Ontario, Canada, L6R 3J7

Clinical Trial Site

Recruiting

London, Ontario, Canada, N6A 5A5

Clinical Trial Site

Recruiting

Montreal, Quebec, Canada, H2X 3E4

More Information

Sponsor

Alexion Pharmaceuticals, Inc.

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • gMG
  • Soliris
  • Ultomiris
  • Alexion C5 Inhibition Therapy
  • Alexion C5IT
  • Patient Registry
  • Generalized Myasthenia Gravis
  • Alexion Registry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc. on 2026-02-18.