Trials / Completed
CompletedNCT03971422
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- UCB Biopharma SRL · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rozanolixizumab | Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2. |
| OTHER | Placebo | Subjects will receive placebo at pre-specified time points. |
Timeline
- Start date
- 2019-06-03
- Primary completion
- 2021-08-31
- Completion
- 2021-10-26
- First posted
- 2019-06-03
- Last updated
- 2025-12-24
- Results posted
- 2023-08-21
Locations
112 sites across 17 countries: United States, Belgium, Canada, Czechia, Denmark, France, Georgia, Germany, Hungary, Italy, Japan, Poland, Russia, Serbia, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03971422. Inclusion in this directory is not an endorsement.