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

JRCT ID: jRCT2031230019

Registered date:13/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Generalized Myasthenia Gravis
• Date of first enrollment: 13/04/2023
• Target sample size: 200
• Countries of recruitment: US,Japan,Spain,Japan
• Study type: Interventional
• Intervention(s): ALXN1720 or Placebo

Outcome(s)

• Primary Outcome: Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26
• Secondary Outcome: Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kanemoto Koji