Self-Administered Rozanolixizumab for Myasthenia Gravis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called rozanolixizumab for individuals with generalized Myasthenia Gravis (gMG), a condition that causes muscle weakness. The main goal is to determine if participants can successfully self-administer the medication at home using two methods: a syringe driver and a manual push. Participants will receive weekly doses for 18 weeks. This trial suits those with gMG who feel comfortable managing their medication at home. As a Phase 3 trial, it represents the final step before potential FDA approval, offering participants a chance to contribute to the advancement of a promising treatment.
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.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that rozanolixizumab is generally safe for people with generalized myasthenia gravis (gMG). In studies, patients received weekly treatments for up to a year, and most tolerated it well without major issues. The most common minor side effects included headaches and injection site reactions. Importantly, the FDA has already approved rozanolixizumab for treating gMG, indicating a strong safety record for this condition.12345
Why do researchers think this study treatment might be promising for Myasthenia Gravis?
Rozanolixizumab is unique because it offers a new approach for treating myasthenia gravis by targeting the neonatal Fc receptor (FcRn), which plays a role in the degradation of antibodies. Unlike traditional treatments like cholinesterase inhibitors, corticosteroids, or immunosuppressants, rozanolixizumab specifically aims to reduce the levels of harmful antibodies without broadly suppressing the immune system. Researchers are excited about this treatment because its targeted action could lead to fewer side effects and a more efficient alleviation of symptoms. Additionally, the option for self-administration using syringe drivers or manual push methods could greatly enhance convenience and quality of life for patients.
What evidence suggests that rozanolixizumab might be an effective treatment for Myasthenia Gravis?
In earlier studies, rozanolixizumab showed promising results for treating generalized Myasthenia Gravis (gMG). Research indicates that patients experienced noticeable improvements in their symptoms with this treatment. Clinical trials demonstrate that it works quickly, providing significant symptom relief for many patients. Additionally, its long-term safety and tolerability have been well-documented, suggesting it is a reliable option for ongoing use. Overall, strong clinical evidence supports rozanolixizumab as a hopeful treatment for those with gMG.
In this trial, participants will receive rozanolixizumab through two different administration sequences: one group will use a syringe driver followed by manual push, while the other group will use manual push followed by a syringe driver.45678Who 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:
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
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