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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: Active Phase 3 study of Generalized Myasthenia Gravis, sponsored by Regeneron Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
The total MG-ADL score ranges from 0 to 24 points, with higher scores indicating greater functional impairment and disability
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 |
What the registry record for NCT05070858 still lists
NCT05070858 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, above the 120-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (140% higher).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Generalized Myasthenia Gravis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05070858's enrollment target sits among peer trials
288 2nd of 26 the highest of 26 other Generalized Myasthenia Gravis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Generalized Myasthenia Gravis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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