NCT05681715

A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)

An Open-label, Crossover Study to Evaluate Rozanolixizumab Self-administration by Study Participants With Generalized Myasthenia Gravis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Rozanolixizumab	Rozanolixizumab self-administration via Syringe Driver or Manual Push.

Timeline

• Start date: 2023-04-17
• Primary completion: 2024-04-23
• Completion: 2024-04-23
• First posted: 2023-01-12
• Last updated: 2025-11-06
• Results posted: 2025-05-07

Locations

27 sites across 10 countries: United States, Canada, Georgia, Germany, Italy, Japan, Poland, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study