A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis
NCT ID: NCT06392386
Last Updated: 2025-12-05
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
PHASE2/PHASE3
12 participants
INTERVENTIONAL
2024-06-28
2026-09-30
Brief Summary
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The participants will be in the study for up to 14 weeks.
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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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Efgartigimod PH20 SC
Participants aged 12 to \<18 years receiving efgartigimod PH20 SC treatment
Efgartigimod PH20 SC
Subcutaneous injections
Interventions
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Efgartigimod PH20 SC
Subcutaneous injections
Eligibility Criteria
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Inclusion Criteria
* The participant is aged 2 to \<18 years at the time of informed consent/assent
* The participant has been diagnosed with generalised Myasthenia Gravis that is supported by a physical examination and confirmed seropositivity for anti-acetylcholine receptor antibodies
* The participant has had an unsatisfactory response to immunosuppressants, corticosteroids, or acetylcholinesterase inhibitors but is on stable concomitant MG therapy. If receiving corticosteroids and/or immunosuppressants, must be on a stable dose for ≥1 month before screening
* The participant agrees to use birth control consistent with local regulations and people of child-bearing potential must have a negative blood pregnancy test at screening and a negative urine pregnancy test before receiving the study drug
Exclusion Criteria
* Has worsening muscle weakness secondary to a concurrent infection or as a result of a medication
* Has a documented lack of clinical response to plasma exchange (PLEX)
* Received a live or live-attenuated vaccine within \<4 weeks before screening
* Received a thymectomy within 3 months before screening or is planning to get a thymectomy during their participation in the study
* Has a known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of generalised Myasthenia Gravis or puts the participant at undue risk
* History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer
* Clinically significant active infection that is not sufficiently resolved in the investigator's opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV
* Has a positive PCR test for SARS-CoV-2 at screening
* Has/had a clinically significant disease, had recent major surgery (within 3 months of screening) or intends to have major surgery during the study, or has/had any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
* Has received a different study drug in another clinical study within \<12 before screening
* Is currently participating in another interventional clinical study
* Has previously participated in an efgartigimod clinical study and received at least one dose of study drug
* Has a known hypersensitivity to study drug or any of its excipients
* Has a history of or current episode of alcohol, drug, or medication abuse as assessed by the investigator
* Use of some medications before screening (more information is found in the protocol)
2 Years
17 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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Carolinas HealthCare System Neurosciences Institute - Neurology
Charlotte, North Carolina, United States
Neurology Rare Disease Center
Denton, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
UZ Gent
Ghent, , Belgium
Childrens Hospital of Eastern Ontario
Ottawa, , Canada
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Ostrava
Ostrava, , Czechia
AP-HM- Hôpital de La Timone
Marseille, , France
Universitätsklinikum Essen
Essen, , Germany
Hadassah Medical Center- Ein Kerem
Jerusalem, , Israel
Schneider Children's Medical Center of Israel
Petah Tikvah, , Israel
Tel Aviv Sourasky Medical Center Ichilov
Tel Aviv, , Israel
Istituto G Gaslini Ospedale Pediatrico IRCCS
Genova, , Italy
Leiden University Medical Center
Leiden, , Netherlands
Uniwersyteckie Centrum Kliniczne w Gdansku
Gdansk, , Poland
Neurologia Śląska Centrum Medyczne
Katowice, , Poland
Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM
Warsaw, , Poland
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Hôpital Nestlé
Lausanne, , Switzerland
Oxford Children's Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-506159-12-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARGX-113-2207
Identifier Type: -
Identifier Source: org_study_id
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