Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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.

Study ID: NCT03165435

Conditions

Myasthenia Gravis, Generalized

Interventions

CV-MG01

Placebo

Study Description

Brief 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).

Detailed 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.