Self-Administered Rozanolixizumab for Myasthenia Gravis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to see if patients with generalized Myasthenia Gravis can successfully learn to inject themselves with rozanolixizumab, a medication that helps reduce muscle weakness by targeting harmful antibodies. Rozanolixizumab is being tested to see how well it works and how safe it is for treating generalized myasthenia gravis.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What is known about the safety of Rozanolixizumab for human use?
How is the drug Rozanolixizumab unique for treating myasthenia gravis?
Rozanolixizumab is unique because it is the first drug approved in the USA for treating generalized myasthenia gravis in adults who are positive for either anti-acetylcholine receptor or anti-muscle-specific kinase antibodies, and it works by blocking the neonatal Fc receptor, which is a novel approach compared to other treatments.12346
What data supports the effectiveness of the drug Rozanolixizumab for treating myasthenia gravis?
Rozanolixizumab has been approved in the USA for treating generalized myasthenia gravis in adults who are positive for specific antibodies, based on its ability to block a receptor involved in the disease. Clinical trials have shown it to be effective and safe for this condition, offering a new option for patients who may not respond well to traditional treatments.12378
Who Is on the Research Team?
UCB Cares
Principal Investigator
001 844 599 2273
Are You a Good Fit for This Trial?
This trial is for individuals with generalized Myasthenia Gravis (gMG) who are capable of self-administering medication and weigh at least 35 kg. Participants must be willing to use a syringe driver or manual push method after training. Those with severe muscle weakness, hypersensitivity to similar drugs, active infections, recent live vaccinations, or certain medical histories cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Training
Participants are trained in the self-administration technique using the syringe driver and manual push methods
Self-administration Period 1
Participants self-administer rozanolixizumab using the syringe driver method
Self-administration Period 2
Participants self-administer rozanolixizumab using the manual push method
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rozanolixizumab
Rozanolixizumab is already approved in United States, European Union, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
UCB Biopharma SRL
Lead Sponsor
Jean-Christophe Tellier
UCB Biopharma SRL
Chief Executive Officer since 2015
MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD
Dr. Iris Loew-Friedrich
UCB Biopharma SRL
Chief Medical Officer since 2014
MD from University of Leuven, PhD in Medical Sciences from University of Leuven