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ACTIVE NOT RECRUITING 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

NCT05070858 · View on ClinicalTrials.gov ↗

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)

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

FieldValue
Enrollment Target 288 participants
Start Date 2021-12-14
Est. Completion 2028-11-11
Phase Phase 3

Sponsor

Regeneron Pharmaceuticals

290 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05070858 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, Illinois, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05070858?

The interventions under investigation include: Placebo (OTHER), Pozelimab (DRUG), Cemdisiran (DRUG), Pozelimab + Cemdisiran (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05070858?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial