Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis

• Status: Recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of ALXN2050 (120 milligrams [mg], 180 mg) in participants with generalized myasthenia gravis (gMG).

Safety will be monitored throughout the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexion Pharmaceuticals

Criteria

Key Inclusion Criteria:

• Diagnosed with MG at least 3 months (90 days) prior to the date of the Screening Visit.

• Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at the Screening Visit.

• MG-ADL total score must be ≥ 5 (with at least 50% of the score attributed to non-ocular elements) at the Screening Visit and at randomization (Day 1).

• Participants receiving treatment with protocol-specified immunosuppressive therapies, corticosteroids, or acetylcholinesterase inhibitors must have been receiving treatment and on a stable dose prior to the date of the Screening Visit, with no changes to the regimen expected during screening, the PEP, and/or the ETP.

Key Exclusion Criteria:

• Estimated glomerular filtration rate ≤ 30 milliliters/minute/1.73 squared meters during Screening calculated by Chronic Kidney Disease Epidemiology Collaboration.

• History of thymectomy, thymomectomy, or any other thymic surgery within 12 months prior to the Screening Visit.

• Any untreated thymic malignancy, carcinoma, or thymoma. Participants with a history of treated thymic malignancy or carcinoma are eligible for enrollment if they meet pre-specified conditions outlined in the protocol.

• Clinical features consistent with Clinical Deterioration at the time of the Screening Visit or at any time during the Screening Period prior to randomization (Day 1).

• Use of the following within the time periods specified below:

1. Intravenous immunoglobulin G or subcutaneous immunoglobulin within the 4 weeks (28 days) prior to the Screening Visit.

2. Use of tacrolimus or cyclosporine within the 4 weeks (28 days) prior to the Screening Visit.