An international Phase 3 clinical trial assessing the efficacy, safety, and tolerability of rozanolixizumab as a treatment for generalized myasthenia gravis (MG) is currently recruiting participants at 114 study locations.
To qualify for the study (NCT03971422), participants must be over age 18, diagnosed with generalized MG, have a minimum Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of 3 and a minimum quantitative myasthenia gravis (QMG) score of 11, and have a positive record of autoantibodies against acetylcholine receptor or muscle-specific kinase — the two most common self-directed antibodies in people with MG.
To learn more about eligibility for the trial, called MycarinGstudy, and to take the pre-screener, go here.
Notably, MG-ADL is an eight-question survey of symptom severity, with total scores ranging from 0 to 24. In turn, QMG is a physician-reported scale often used in clinical studies. Higher scores represent greater impairments in both tools.
In the double-blind, 18-week study, participants will be randomly assigned to receive either rozanolixizumab (one of two doses) or a placebo. After an initial screening, the patients will receive six weekly doses of rozanolixizumab or the placebo, administered by subcutaneous (under-the-skin) injection for five weeks. This will be followed by observational visits every other week through the end of the study period.
All participants will then have the opportunity to enroll in an optional open-label extension study, in which each patient will receive rozanolixizumab.
The primary outcome or goal of the trial is a change in MG-ADL score from baseline (start of the study) to day 43, occurring at visit 10.
An estimated 240 participants will be recruited at locations in the U.S., Belgium, Canada, Czech Republic, Denmark, France, Georgia, Germany, Hungary, Italy, Japan, Poland, Russia, Spain, Taiwan, and the U.K. To find a study location near you, visit the trial site or go to the trial page.
In people with MG, an autoimmune disease, the neonatal Fc receptor (FcRn) protein binds to autoantibodies, preventing their degradation and increasing their concentration in circulation in the body. Rozanolixizumab (UCB7665) is a monoclonal antibody that acts by selectively binding FcRn, leading to reduced levels of circulating autoantibodies.
A Phase 1 trial (NCT02220153) completed in 2015 found subcutaneous rozanolixizumab to be safer than intravenous (into-the-vein) dosing in healthy adults. Results from the MG0002 Phase 2 trial (NCT03052751), which ended in 2018, indicate that the therapy reduces the concentration of antibodies circulating in the blood and provides clinical benefits across several disease-related assessments.
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