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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031230019
Enrollment
200
Registered
2023-04-13
Start date
2023-04-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Myasthenia Gravis

Interventions

ALXN1720 or Placebo

Sponsors

Terada Michinori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26

Secondary

MeasureTime frame
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26

Countries

Japan, Spain, US

Contacts

Public ContactMichinori Terada

Alexion Pharma GK

JPDept-DevOps-PMCO@alexion.com+81-3-3457-9559

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026