Trials / Terminated
TerminatedNCT05218096
Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALXN2050 | Oral tablet. |
| DRUG | Placebo | Oral tablet. |
Timeline
- Start date
- 2022-04-27
- Primary completion
- 2023-11-30
- Completion
- 2024-04-03
- First posted
- 2022-02-01
- Last updated
- 2025-01-09
- Results posted
- 2025-01-09
Locations
46 sites across 8 countries: United States, Canada, Germany, Italy, Serbia, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05218096. Inclusion in this directory is not an endorsement.