Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia Gravis

Study Identifier:
ALXN1830-MG-201
ClinicalTrials.gov Identifier:
NCT04982289
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other

Study Details

Medical Condition
  • Generalized Myasthenia Gravis
Study Drug
  • Drug: ALXN1830
Date
Jan 2022 - Jan 2023
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 myasthenia gravis.
  • Positive serologic test for anti-acetylcholine receptor antibodies.
  • Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at Screening.
  • MG-ADL profile must be ≥ 5.
  • Participants receiving stable treatment with azathioprine; other immunosuppressive therapies.
  • Total IgG level at Screening ≥ 600 milligrams/deciliter.
Exclusion Criteria
  • History of thymectomy, thymomectomy, or any other thymic surgery within 12 months prior to Screening.
  • Any untreated thymic malignancy, carcinoma, or thymoma.
  • Intravenous immunoglobulin within the 6 weeks, and/or use of plasmapheresis/plasma exchange prior to randomization (Day 1).
  • Use of rituximab within the 3 months (90 days) prior to Screening.
  • Participants who have received previous treatment with any biological agent or other anti-neonatal fragment crystallizable receptor therapy within 5 half-lives or 90 days after last dose (whichever is longer).
  • Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Generalized Myasthenia Gravis
Study Drug
  • Drug: ALXN1830
Date
Jan 2022 - Jan 2023
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 myasthenia gravis.
  • Positive serologic test for anti-acetylcholine receptor antibodies.
  • Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at Screening.
  • MG-ADL profile must be ≥ 5.
  • Participants receiving stable treatment with azathioprine; other immunosuppressive therapies.
  • Total IgG level at Screening ≥ 600 milligrams/deciliter.
Exclusion Criteria
  • History of thymectomy, thymomectomy, or any other thymic surgery within 12 months prior to Screening.
  • Any untreated thymic malignancy, carcinoma, or thymoma.
  • Intravenous immunoglobulin within the 6 weeks, and/or use of plasmapheresis/plasma exchange prior to randomization (Day 1).
  • Use of rituximab within the 3 months (90 days) prior to Screening.
  • Participants who have received previous treatment with any biological agent or other anti-neonatal fragment crystallizable receptor therapy within 5 half-lives or 90 days after last dose (whichever is longer).
  • Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.

Protocol Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics (PD), immunogenicity, and efficacy of subcutaneous (SC) ALXN1830 in adults with generalized myasthenia gravis (gMG).

Trial Locations

Location
Status
Location
Clinical Study Site
Phoenix, Arizona, United States, 85028
Status
N/A