Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
NCT ID: NCT05556096
Last Updated: 2026-01-23
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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ACTIVE_NOT_RECRUITING
PHASE3
261 participants
INTERVENTIONAL
2022-11-21
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ALXN1720
Participants will receive a weight-based initial (loading) dose of ALXN1720 on Day 1, followed by weight-based maintenance treatment with ALXN1720 on Day 8 and once every week (Q1W) thereafter for a total of 26 weeks. Following this randomized controlled treatment (RCT) period, all participants will receive ALXN1720 in an open-label extension (OLE) period of 105 weeks.
ALXN1720
Combination product consisting of syringe prefilled with ALXN1720.
Placebo
Participants will receive placebo during the 26-week RCT period, after which they will enter the OLE period of the study and receive ALXN1720.
Placebo
Combination product consisting of syringe prefilled with placebo.
Interventions
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ALXN1720
Combination product consisting of syringe prefilled with ALXN1720.
Placebo
Combination product consisting of syringe prefilled with placebo.
Eligibility Criteria
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Inclusion Criteria
* 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
18 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
Beijing, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Chengdu, , China
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Fuzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Jinan, , China
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Qingdao, , China
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Shanghai, , China
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Suzhou, , China
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Wuhan, , China
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Xi'an, , China
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Aalborg, , Denmark
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Copenhagen, , Denmark
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Garches, , France
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Lille, , France
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Marseille, , France
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Nice, , France
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Paris, , France
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Strasbourg, , France
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Berlin, , Germany
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Düsseldorf, , Germany
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München, , Germany
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Würzburg, , Germany
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Hadera, , Israel
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Haifa, , Israel
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Petah Tikva, , Israel
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Bergamo, , Italy
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Brescia, , Italy
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Florence, , Italy
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Milan, , Italy
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Napoli, , Italy
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Palermo, , Italy
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Pisa, , Italy
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Roma, , Italy
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Rome, , Italy
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Chiba, , Japan
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Fukushima, , Japan
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Higashimatsuyama-shi, , Japan
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Isehara-shi, , Japan
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Itabashi-ku, , Japan
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Kawasaki-shi, , Japan
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Morioka, , Japan
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Nagasaki, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Shinjuku-ku, , Japan
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Shinjuku-ku, , Japan
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Suita-shi, , Japan
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Amsterdam, , Netherlands
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Bydgoszcz, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Almada, , Portugal
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Porto, , Portugal
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Belgrade, , Serbia
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Niš, , Serbia
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Busan, , South Korea
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Daegu, , South Korea
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Gwangju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Badalona (Barcelona), , Spain
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Córdoba, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Seville, , Spain
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Sankt Gallen, , Switzerland
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Bursa, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Liverpool, , United Kingdom
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London, , United Kingdom
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Oxford, , United Kingdom
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Sheffield, , United Kingdom
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Orange, California, United States
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Fort Collins, Colorado, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Maitland, Florida, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
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Gainesville, Georgia, United States
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Savannah, Georgia, United States
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Springfield, Illinois, United States
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Kansas City, Kansas, United States
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Lexington, Kentucky, United States
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Detroit, Michigan, United States
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East Lansing, Michigan, United States
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Las Vegas, Nevada, United States
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Patchogue, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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Chapel Hill, North Carolina, United States
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North Charleston, South Carolina, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
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Morgantown, West Virginia, United States
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CABA, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Rosario, , Argentina
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Innsbruck, , Austria
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Wels, , Austria
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Barretos, , Brazil
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Joinville, , Brazil
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Porto Alegre, , Brazil
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Ribeirão Preto, , Brazil
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Salvador, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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Edmonton, Alberta, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
Countries
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Other Identifiers
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2022-000460-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALXN1720-MG-301
Identifier Type: -
Identifier Source: org_study_id
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