A Ph3, open-label, crossover self-admin study of rozanolixizumab in gMG
Research type
Research Study
Full title
An open-label, crossover study to evaluate rozanolixizumab self-administration by study participants with generalized Myasthenia Gravis
IRAS ID
1006691
Contact name
Agnes Crespy Maloney
Contact email
Sponsor organisation
UCB Biopharma SRL
Eudract number
2022-003870-21
Research summary
Myasthenia gravis (MG) is a serious, sometimes life threatening, debilitating autoimmune disorder associated with numerous symptoms including muscular weakness and fatigue. In autoimmune disorders a patient’s immune system attacks their own body. In the case of MG, the immune system targets and destroys body proteins responsible for communication between nerves and muscles. This then results in muscle weakness.
Several commonly prescribed treatments act, at least in part, by reducing the quantity of circulating immune system proteins. While the standard of care for MG involves the use of a variety of therapeutic agents there remains a need for a safe and effective treatment which is convenient and does not have significant side effects.
Rozanolixizumab (the “study drug”) helps break down circulating immune system proteins, including those which attack the body in MG, lowering their levels in the blood.
The purpose of this open label study is to understand the ability of participants to successfully self-administer the study drug after receiving training to self-administer it using the syringe driver and manual push methods.
The additional purposes of this open-label study are:
1. To understand how safe the study drug is and how well participants are able to tolerate it;
2. To evaluate symptom changes in study participants with gMG.This study will involve about 30 study participants across approximately multiple centres throughout North America, Europe, and Japan. The Sponsor of this study is UCB Biopharma SRL.
REC name
Wales REC 2
REC reference
23/WA/0074
Date of REC Opinion
23 Aug 2023
REC opinion
Further Information Favourable Opinion