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NCT05070858 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Generalized Myasthenia Gravis, sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 288
- Enrollment target
- 20
- Study locations
NCT05070858 is a Phase 3 study of Generalized Myasthenia Gravis that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 288 participants, above the 120-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (140% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT05070858, a Phase 3 study of Generalized Myasthenia Gravis, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 288 participants
- Enrollment target
- 20
- Study locations
Study Summary
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)
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Pozelimab
- DRUG Cemdisiran
- DRUG Pozelimab + Cemdisiran
Study Locations (20)
Florida
- SFM Clinical Research, LLC - Boca Raton
- Diverse Clinical Research - Miami
- Aqualane Clinical Research - Naples
- Neurological Services of Orlando - Orlando
- Medsol Clinical Research Center Inc - Port Charlotte
- University of South Florida Morsani Center for Advanced Healthcare - Tampa
Illinois
- NorthShore University Health System - Glenview
- St. Elizabeth's Hospital - O'Fallon
- Northwest Neurology Ltd. - Clinedge - PPDS - Rolling Meadows
California
- University of California Irvine - Irvine
- University of Southern California - Los Angeles
Ohio
- Dayton Center for Neurological Disorders - Centerville
- University of Cincinnati Gardner Neuroscience Institute - Cincinnati
Texas
- National Neuromuscular Research Institute - Austin
- Nerve and Muscle Center of Texas - Houston
Arizona
- HonorHealth Neurology 2018 - Scottsdale
Colorado
- Colorado Springs Neurological Associates - Colorado Springs
Michigan
- Wayne State University School of Medicine - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2028-11-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05070858
The ClinicalTrials.gov registry entry for NCT05070858 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 120-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (140% higher). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05070858 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT05070858 about?
NCT05070858 is a clinical study titled "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". 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 muscl...
What is the current status of trial NCT05070858?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 288 participants. The study started on 2021-12-14. Estimated completion is 2028-11-11.
What conditions does trial NCT05070858 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis.
What interventions are being tested in trial NCT05070858?
The interventions under investigation include: Placebo (OTHER), Pozelimab (DRUG), Cemdisiran (DRUG), Pozelimab + Cemdisiran (DRUG).
Who is sponsoring clinical trial NCT05070858?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05070858 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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