Status:
TERMINATED
Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Generalized Myasthenia Gravis
Myasthenia Gravis
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
Brief 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.
Detailed Description
The study consists of a blinded 8-week Primary Evaluation Period (PEP) and a blinded 26-week Extended Treatment Period (ETP). After completion of 34 weeks of treatment, participants will enter an Open...
Eligibility Criteria
Inclusion
- Diagnosed with MG at least 3 months (90 days) prior to the date of the Screening Visit. Confirmation of MG must be made via the following:
- Positive serologic test for anti AChR antibodies at the Screening Visit, and
- Abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation, or
- Positive response to an AChEI test (eg, edrophonium chloride test), or
- Improvement of signs or symptoms related to MG during treatment with an oral AChEI, as determined by the treating physician
- 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.
Exclusion
- 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:
- Intravenous immunoglobulin G or subcutaneous immunoglobulin within the 4 weeks (28 days) prior to the Screening Visit.
- Use of tacrolimus or cyclosporine within the 4 weeks (28 days) prior to the Screening Visit.
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05218096
Start Date
April 27 2022
End Date
April 3 2024
Last Update
January 9 2025
Active Locations (46)
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1
Research Site
Phoenix, Arizona, United States, 85028
2
Research Site
Aurora, Colorado, United States, 80045
3
Research Site
Boca Raton, Florida, United States, 33487
4
Research Site
Port Charlotte, Florida, United States, 33952