Zilucoplan for Myasthenia Gravis
(RAISE-XT Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing zilucoplan, a medication for muscle weakness, in patients with generalized Myasthenia Gravis who were in previous studies. It aims to see if the drug is safe and effective over time by calming the immune system to prevent it from attacking muscles. Zilucoplan is currently being tested for its potential to improve disease control in generalized myasthenia gravis.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It only mentions that you must have completed a previous zilucoplan study to participate.
What data supports the effectiveness of the drug Zilucoplan for treating myasthenia gravis?
Zilucoplan has been approved in Japan, the USA, and the EU for treating generalized myasthenia gravis in adults who are positive for anti-acetylcholine receptor antibodies and do not respond well to other treatments. A study showed that Zilucoplan is effective and well-tolerated in these patients, providing a new option for those with this challenging condition.12345
What safety data exists for Zilucoplan in humans?
Zilucoplan has been studied for safety in patients with generalized myasthenia gravis, showing it is generally well tolerated when self-administered under the skin. It has been approved in Japan, the USA, and the EU, indicating regulatory bodies have found its safety profile acceptable for use in adults with this condition.12678
How is the drug Zilucoplan different from other treatments for myasthenia gravis?
Zilucoplan is unique because it is a self-administered injection that specifically targets and inhibits complement component 5 (C5), a part of the immune system involved in the disease process, offering a new option for patients who do not respond well to traditional treatments like steroids or other immunosuppressants.1291011
Research Team
UCB Cares
Principal Investigator
001 844 599 2273
Eligibility Criteria
This trial is for individuals with generalized Myasthenia Gravis (gMG) who have already completed a qualifying study involving zilucoplan. They should not be part of any other clinical trials testing new treatments, although observational studies are okay.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive zilucoplan and are monitored for efficacy, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive zilucoplan to evaluate long-term efficacy, safety, and tolerability
Treatment Details
Interventions
- Zilucoplan
Zilucoplan is already approved in United States, European Union for the following indications:
- Generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive
- Generalized myasthenia gravis in adults whose immune system produces antibodies against the acetylcholine receptor
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
Ra Pharmaceuticals
Lead Sponsor
Ra Pharmaceuticals, Inc.
Lead Sponsor