Clinical Trial Alert: Phase 3 Study of Rozanolixizumab in Individuals With Generalized Myasthenia Gravis
By MDA Staff | Tuesday, February 23, 2021
Researchers at UCB BioSciences are seeking individuals living with generalized myasthenia gravis (gMG) to participate in a phase 3 study. The objective of the study is to confirm the clinical efficacy and to assess safety and tolerability of rozanolixizumab. The therapy may help reduce the typical signs and symptoms of gMG, which are caused by autoantibodies that disrupt the signaling between nerves and muscles in people living with gMG.
Not all participants will receive rozanolixizumab during this study; participants will be randomized to receive rozanolixizumab or an inactive placebo control, and neither the participants nor the study team will know who is receiving the drug or placebo (double-blinded study). At the end of the study, subjects will be given the option of enrolling in an open-label extension study.
This 18-week study will consist of a total of 14 visits. The study will start with the screening on visit one. Participants will then receive six weekly subcutaneous (under-the-skin) infusions of the study drug over a five-week period, as well as routine tests and monitoring up to week six. Observational visits will continue every other week until the completion of the study.
To be eligible, individuals must meet the following criteria:
- Older than age 18
- Documented diagnosis of gMG
- Confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) at screening (visit 1)
- Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of at least 3 (with >3 points from non-ocular symptoms) and a quantitative myasthenia gravis (QMG) score of at least 11
- Considered for additional treatment such as intravenous immunoglobulin G (IVIg) or plasma exchange (PEX) by the investigator
Individuals may not be eligible to participate if they are previously or currently affected by another illness that might interfere with the ability to undergo safe testing.
Please visit https://clinicaltrials.gov/ct2/show/NCT03971422 or www.mycaringstudy.com for the full listing of exclusion criteria.
Travel support may be available.
To learn more or to inquire about participation, email UCBCares@ucb.com or call (844) 599-2273.
TAGS: Clinical Trial Alert, Clinical Trials, Drug Development, Research
TYPE: Blog Post
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