PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
NCT ID: NCT06607627
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
12 participants
INTERVENTIONAL
2024-11-13
2029-01-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gefurulimab
On Day 1, participants will receive a weight based loading dose followed by a weekly maintenance dose for up to 122 weeks.
Gefurulimab
Combination product consisting of syringe prefilled with gefurulimab will be administered weekly via subcutaneous (SC) injection.
Interventions
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Gefurulimab
Combination product consisting of syringe prefilled with gefurulimab will be administered weekly via subcutaneous (SC) injection.
Eligibility Criteria
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Inclusion Criteria
* Participant must be 12 to \< 18 years of age at the time of signing the informed consent/assent.
* All participants must be vaccinated against meningococcal infection from serogroups A, B, C, W, and Y within 3 years and at least 2 weeks prior to the first dose of study intervention administration.
* Participant must be 6 to \< 18 years of age at the time of signing the informed consent/assent.
* All participants must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) within 3 years prior to study intervention on Day 1. If vaccination occurs \< 2 weeks prior to Day 1, the participants will receive prophylactic antibiotics for at least 2 weeks after initial meningococcal vaccination for serogroups A,C,W,Y (and B, where available)
* Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV
* Positive serological test for autoantibodies against AChR
Exclusion Criteria
* Untreated thymic malignancy, carcinoma, or thymoma
* History of Neisseria meningitidis infection
* Pregnancy, breastfeeding, or intention to conceive during the course of the study
6 Years
17 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
Washington D.C., District of Columbia, United States
Research Site
Norfolk, Virginia, United States
Research Site
Joinville, , Brazil
Research Site
Salvador, , Brazil
Research Site
São José do Rio Preto, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Saitama-shi, , Japan
Research Site
Bydgoszcz, , Poland
Research Site
Lodz, , Poland
Research Site
Warsaw, , Poland
Research Site
New Taipei City, , Taiwan
Research Site
Taipei, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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2024-515157-17-00
Identifier Type: OTHER
Identifier Source: secondary_id
ALXN1720-MG-302
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1327-6615
Identifier Type: OTHER
Identifier Source: secondary_id
D6780C00004
Identifier Type: -
Identifier Source: org_study_id
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