DV0013 UCB auto-injector
Research type
Research Study
Full title
A multicenter, open-label, outpatient study to evaluate the safe and effective use of a zilucoplan auto-injector combination product for subcutaneous self-administration by study participants with generalized myasthenia gravis
IRAS ID
1009938
Contact name
Iska Krautz
Contact email
Sponsor organisation
UCB Biopharma SRL
Clinicaltrials.gov Identifier
Research summary
A company called UCB has planned this study. UCB makes new treatments, and they are working with the study doctor to do this study. UCB is also known as the “sponsor” of this study, which means that they are managing and paying for the study. As the study sponsor, UCB is responsible for how the study is done.\nThe study is planned to have a total of 25 participants. It is planned to take place in about 20 research sites in Europe and the US.\nResearchers want to learn more about the zilucoplan auto-injector. An auto injector has a syringe with medicine placed inside of a device which will deliver an injection. Unlike a pre-filled syringe, it does not have a plunger that must be pushed down to deliver the injection.\nThe zilucoplan auto-injector is designed for patients to self-administer the drug zilucoplan. The device will have a zilucoplan pre-filled syringe inside an auto injector. The zilucoplan pre-filled syringe is an approved treatment for myasthenia gravis that patients are currently using.\nMyasthenia gravis is a serious condition that has many symptoms, like muscle weakness and fatigue. Some patients can manage their symptoms with oral or intravenous medications, but some patients need other options. The zilucoplan auto-injector may be easier for some patients to use than other options that are currently available.\nFor patients who decide to participate, we expect that study participation will last about 21 days.\nOverall, this study should take about 5 months in total to complete for all participants (depending on how quickly participants join the study). Study participants will only be asked to visit the research site 2 times in person or participate in remote visits by telephone.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0102
Date of REC Opinion
28 Jun 2024
REC opinion
Further Information Favourable Opinion