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Monoclonal Antibodies

Gefurulimab for Myasthenia Gravis

Phase 3
Recruiting
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 6 to < 18 years of age at the time of signing the informed consent/assent
Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV
Must not have
Untreated thymic malignancy, carcinoma, or thymoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to study how gefurulimab works in children with a specific type of muscle disease called gMG.

Who is the study for?
This trial is for pediatric patients aged 6 to less than 18 with generalized muscle weakness due to AChR+ Myasthenia Gravis. They must have tested positive for specific autoantibodies and be vaccinated against certain meningococcal infections, or take antibiotics if recently vaccinated. Those with untreated thymic conditions, recent thymic surgery, a history of certain infections, or who are pregnant cannot participate.
What is being tested?
The study aims to evaluate the effects and body's handling (pharmacokinetics/pharmacodynamics) of Gefurulimab in children with AChR+ generalized Myasthenia Gravis over the course of the study.
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions similar to other immunotherapies such as infusion-related responses, increased risk of infections due to immune system suppression, allergic reactions, and possibly others based on how Gefurulimab affects the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 and 17 years old.
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I have been diagnosed with Myasthenia Gravis and experience moderate to severe muscle weakness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an untreated cancer of the thymus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: GefurulimabExperimental Treatment1 Intervention
On Day 1, participants will receive a weight based loading dose followed by a weekly maintenance dose for up to 122 weeks.

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
263 Previous Clinical Trials
140,579 Total Patients Enrolled
11 Trials studying Myasthenia Gravis
1,354 Patients Enrolled for Myasthenia Gravis
~8 spots leftby Jul 2027
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