NCT04650854

A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Rozanolixizumab	Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.

Timeline

• Start date: 2021-02-03
• Primary completion: 2024-01-25
• Completion: 2024-01-25
• First posted: 2020-12-03
• Last updated: 2025-04-18
• Results posted: 2025-04-18

Locations

69 sites across 14 countries: United States, Canada, Czechia, Denmark, France, Georgia, Germany, Italy, Japan, Poland, Russia, Serbia, Spain, Taiwan

Regulatory

• FDA-regulated drug study