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A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis

Myasthenia Gravis, Generalized Clinical Trial

Official title:
A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Active Targeted Immunotherapy CV-MG01 in Patients With Moderate to Severe Myasthenia Gravis.

Clinical Trial Summary

Study CV-0003 will be the second clinical trial administering CV-MG01 in humans. This will be a phase 2/3 proof-of-efficacy therapeutic confirmatory study following the proof-of-concept exploratory phase 1 study (CV-0002).

Clinical Trial Description

The review of the clinical data accumulated so far in Study CV-0002 indicated that the safety and tolerability profile of CV-MG01 is considered very good, with positive immunogenicity results after the high dose regimen of CV-MG01. The preliminary results also show an indication of efficacy of CV-MG01, as based on the different scales and questionnaires results, all specific to MG disease. Therefore, it is proposed to investigate, in an appropriately designed, randomised, double-blind and powered study, the clinical efficacy of CV-MG01 in a larger cohort of MG patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03165435
Study type Interventional
Source CuraVac
Contact
Status Withdrawn
Phase Phase 2/Phase 3
Start date July 2018
Completion date December 31, 2019
View Details
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