Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis
Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis
ClinicalTrials.gov ID: NCT05218096
Sponsor: Alexion
Information provided by: Alexion (Responsible Party)
Last Update Posted: 2023-08-15
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-label Extension (OLE) Period for up to 1.5 years.
OFFICIAL TITLE
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis
INTERVENTION / TREATMENT
Drug: ALXN2050
Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2021-12-30 |
| Primary Completion (Estimated) | 2023-11-30 |
| Study Completion (Estimated) | 2025-12-30 |
| Enrollment (Estimated) | 70 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers | ALXN2050-MG-201 |