Trials / Completed
CompletedNCT05225675
A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults with Multifocal Motor Neuropathy
A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults with Multifocal Motor Neuropathy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- argenx · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2, randomized, double-blinded, placebo-controlled, parallel-group, multicenter trial to evaluate the safety and efficacy of 2 dose regimens of ARGX-117 versus placebo, in participants with MMN previously stabilized with IVIg (intravenous immunoglobulin).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ARGX-117 | Intravenous administration of ARGX-117 |
| OTHER | Placebo | Intravenous administration of placebo |
Timeline
- Start date
- 2022-03-31
- Primary completion
- 2024-06-04
- Completion
- 2024-06-04
- First posted
- 2022-02-04
- Last updated
- 2024-10-18
Locations
40 sites across 11 countries: United States, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05225675. Inclusion in this directory is not an endorsement.