Trials / Completed
CompletedNCT03772587
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Momenta Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281 administered to participants with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing standard of care therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | M281 | M281 administered as IV infusion |
| OTHER | Placebo | Placebo administered as intravenous (IV) infusion |
Timeline
- Start date
- 2019-04-10
- Primary completion
- 2020-06-25
- Completion
- 2020-06-25
- First posted
- 2018-12-11
- Last updated
- 2023-06-27
- Results posted
- 2021-10-27
Locations
61 sites across 8 countries: United States, Belgium, Canada, Germany, Italy, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03772587. Inclusion in this directory is not an endorsement.