Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

Study Identifier:
ALXN1720-MG-301
ClinicalTrials.gov Identifier:
NCT05556096
EudraCT Identifier:
2022-000460-21
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Recruitment Complete

Study Details

Medical Condition
  • Generalized Myasthenia Gravis
Study Drug
    Date
    Nov 2022 - May 2025
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 18+ years
    Requirements Information
    Inclusion and Exclusion Criteria
    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
    Sex
    Female & Male
    Age
    18+ years

    Study Details

    Medical Condition
    • Generalized Myasthenia Gravis
    Study Drug
      Date
      Nov 2022 - May 2025
      Phase 1
      Phase 2
      Phase 3
      Phase 4
      N/A
      Patient Requirements
      Sex: Female & Male
      Age: 18+ years years
      Requirements Information
      Inclusion and Exclusion Criteria
      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

      Protocol Summary

      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).

      Trial Locations

      Location
      Status
      Location
      Research Site
      Orange, California, United States, 92868
      Status
      N/A
      Location
      Research Site
      Fort Collins, Colorado, United States, 80528
      Status
      N/A
      Location
      Research Site
      Washington D.C., District of Columbia, United States, 20007
      Status
      N/A
      Location
      Research Site
      Bradenton, Florida, United States, 34209
      Status
      N/A
      Location
      Research Site
      Maitland, Florida, United States, 32751
      Status
      N/A
      Location
      Research Site
      Tampa, Florida, United States, 33612
      Status
      N/A
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