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Active (not recruiting) Phase 3 NCT05556096

Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

Phase 3 – large-scale trial before approval
Conditions: Generalized Myasthenia Gravis

Sponsor: Alexion Pharmaceuticals, Inc.

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).
Who can participate
Inclusion Criteria: * 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: * History of thymectomy, or any other thymic surgery within 12 months prior to Screening * Untreated thymic malignancy, carcinoma, or thymoma * History of Neisseria meningitidis infection * Pregnancy, breastfeeding, or intention to conceive during the course of the study
Interventions
ALXN1720
COMBINATION_PRODUCT
Placebo
COMBINATION_PRODUCT
Locations 132
Argentina (5)
Research Site
CABA
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Ciudad de Buenos Aires
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Ciudad de Buenos Aires
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Ciudad de Buenos Aires
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Rosario
Austria (2)
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Innsbruck
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Wels
Brazil (7)
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Barretos
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Joinville
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Porto Alegre
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Ribeirão Preto
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Salvador
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São José do Rio Preto
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São Paulo
Canada (3)
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Edmonton , Alberta
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Québec , Quebec
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Toronto , Ontario
China (14)
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Beijing
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Beijing
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Changchun
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Changsha
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Chengdu
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Fuzhou
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Hangzhou
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Hangzhou
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Jinan
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Qingdao
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Shanghai
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Suzhou
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Wuhan
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Xi'an
Denmark (2)
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Aalborg
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Copenhagen
France (6)
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Garches
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Lille
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Marseille
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Nice
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Paris
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Strasbourg
Germany (4)
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Berlin
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Düsseldorf
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München
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Würzburg
Israel (3)
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Hadera
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Haifa
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Petah Tikva
Italy (9)
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Bergamo
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Brescia
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Florence
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Milan
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Naples
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Palermo
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Pisa
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Roma
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Rome
Japan (13)
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Chiba
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Fukushima
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Higashimatsuyama-shi
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Isehara-shi
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Itabashi-ku
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Kawasaki-shi
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Morioka
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Nagasaki
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Nagoya
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Nagoya
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Shinjuku-ku
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Shinjuku-ku
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Suita-shi
Netherlands (1)
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Amsterdam
Poland (6)
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Bydgoszcz
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Katowice
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Krakow
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Krakow
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Lublin
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Poznan
Portugal (2)
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Almada
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Porto
Serbia (2)
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Belgrade
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Niš
South Korea (8)
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Busan
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Daegu
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Gwangju
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Seoul
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Seoul
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Seoul
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Seoul
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Seoul
Spain (9)
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Badalona (Barcelona)
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Córdoba
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L'Hospitalet de Llobregat
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Madrid
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Madrid
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Madrid
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Madrid
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Málaga
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Seville
Switzerland (1)
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Sankt Gallen
Taiwan (4)
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Kaohsiung City
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New Taipei City
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Tainan
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Taipei
Turkey (4)
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Bursa
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Istanbul
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Kocaeli
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Samsun
United Kingdom (4)
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Liverpool
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London
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Oxford
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Sheffield
United States (23)
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Augusta , Georgia
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Bradenton , Florida
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Chapel Hill , North Carolina
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Detroit , Michigan
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East Lansing , Michigan
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Fort Collins , Colorado
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Gainesville , Georgia
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Houston , Texas
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Kansas City , Kansas
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Las Vegas , Nevada
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Lexington , Kentucky
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Maitland , Florida
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Morgantown , West Virginia
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North Charleston , South Carolina
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Orange , California
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Patchogue , New York
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Richmond , Virginia
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Rochester , New York
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Savannah , Georgia
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Springfield , Illinois
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Syracuse , New York
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Tampa , Florida
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Washington D.C. , District of Columbia
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
21.11.2022
Completion date
31.08.2027
Registry ID
NCT05556096
Source
clinicaltrials.gov
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