Trials / Completed
CompletedNCT04701164
Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ANX005 in Subjects With Guillain-Barré Syndrome
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- Annexon, Inc. · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
This study is intended to evaluate the efficacy and safety of ANX005 administered by intravenous (IV) infusion to participants recently diagnosed with Guillain-Barré Syndrome (GBS). The total duration of study participation is approximately 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ANX005 | Solution for intravenous infusion |
| DRUG | Placebo | Solution for intravenous infusion |
Timeline
- Start date
- 2020-12-17
- Primary completion
- 2024-04-20
- Completion
- 2024-04-20
- First posted
- 2021-01-08
- Last updated
- 2025-05-29
Locations
11 sites across 2 countries: Bangladesh, Philippines
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04701164. Inclusion in this directory is not an endorsement.