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

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.

Timeline

Start

2023-04-17

Primary completion

2024-04-23

Completion

2024-04-23

Outcome

Met primary endpoint

paper The primary endpoint was successful rozanolixizumab self-administration PMID 41074934 ↗

paper The self-administration success rate was 100% with both methods. PMID 41074934 ↗

Publications

• Results Bril V, Antozzi C, Berkowicz T, Druzdz A, Gandhi Mehta RK, Mahuwala ZK, Zschuntzsch J, Boehnlein M, Kerbusch V, Lavrov A, Morris M, Singh P, Leite MI. Self-administration of rozanolixizumab via manual push and infusion pump methods in patients with generalised myasthenia gravis: a randomised, phase 3, open-label, crossover study. J Neurol. 2025 Oct 11;272(10):686. doi: 10.1007/s00415-025-13420-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rozanolixizumab	Monoclonal antibody	—	Subcutaneous

Indications