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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2026-02-12

No results posted yet for this 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

Interventions

DRUG

Pozelimab + Cemdisiran

Subcutaneous administration as described in the protocol

DRUG

Cemdisiran

SC administration as described in the protocol

OTHER

Placebo

SC administration as described in the protocol

DRUG

Pozelimab

SC administration as described in the protocol

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-14
Primary Completion
2025-07-08
Completion
2028-11-11
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • France
  • Georgia
  • Germany
  • India
  • Italy
  • Japan
  • Poland
  • Serbia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05070858 on ClinicalTrials.gov