A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Generalized Myasthenia Gravis
In brief
This study is researching the experimental drugs called pozelimab and cemdisiran, and cemdisiran monotherapy. The study is focused on patients with generalized Myasthenia Gravis (gMG). Myasthenia gravis is a disease that causes weakness and fatigue in muscles in the body because the nerves and muscles are not communicating properly. The aim of the study is to see how effective pozelimab and cemdisiran are when used in combination and when pozelimab and cemdisiran are used alone for patients with gMG. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How the study drugs work inside the body * How much of the study drugs are in the blood at different times * Whether the body makes antibodies against pozelimab and cemdisiran (which could make the drugs less effective or could lead to side effects)
Key facts
- Study ID
- NCT05070858
- Run by
- Regeneron Pharmaceuticals
- People needed
- 288
- Starts
- 2021-12-14
- Expected to finish
- 2028-11-11
- Last updated by the study team
- 2026-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California Irvine — Irvine, California, United States
- University of Southern California — Los Angeles, California, United States
- Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
- SFM Clinical Research, LLC — Boca Raton, Florida, United States
- Diverse Clinical Research — Miami, Florida, United States
- Aqualane Clinical Research — Naples, Florida, United States
- Neurological Services of Orlando — Orlando, Florida, United States
- Medsol Clinical Research Center Inc — Port Charlotte, Florida, United States
- University of South Florida Morsani Center for Advanced Healthcare — Tampa, Florida, United States
- NorthShore University Health System — Glenview, Illinois, United States
- St. Elizabeth's Hospital — O'Fallon, Illinois, United States
- Northwest Neurology Ltd. - Clinedge - PPDS — Rolling Meadows, Illinois, United States
- Wayne State University School of Medicine — Detroit, Michigan, United States
- Dayton Center for Neurological Disorders — Centerville, Ohio, United States
- University of Cincinnati Gardner Neuroscience Institute — Cincinnati, Ohio, United States
- Penn Medicine University City — Philadelphia, Pennsylvania, United States
- National Neuromuscular Research Institute — Austin, Texas, United States
- Nerve and Muscle Center of Texas — Houston, Texas, United States
- Universitair Ziekenhuis Antwerpen — Edegem, Antwerp, Belgium
- AZ Sint-Lucas — Ghent, Oost-Vlaanderen, Belgium
- IMV Pesquisa Neurologica — Porto Alegre, Rio Grande do Sul, Brazil
- Jordy Sinapse Medicina LTDA — Itapevi, São Paulo, Brazil
- Faculdade de Medicina Do ABC — Santo André, São Paulo, Brazil
- Pseg Centro de Pesquisa Clinica S.A — São Paulo, Brazil
- HonorHealth Neurology 2018 — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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