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

NCT03165435 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2018-05-30

No results posted yet for this study

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).

Conditions

  • Myasthenia Gravis, Generalized

Interventions

BIOLOGICAL

CV-MG01

3 consecutive subcutaneous injections of CV-MG01. The three injections are planned for each patient on Days 1, 29 (+/- 3 days) and 85 (+/- 7 days), respectively.

BIOLOGICAL

Placebo

3 consecutive subcutaneous injections of placebo. The three injections are planned for each patient on Days 1, 29 (+/- 3 days) and 85 (+/- 7 days), respectively.

Sponsors & Collaborators

  • Aepodia

    collaborator INDUSTRY

  • University Hospital, Antwerp

    collaborator OTHER

  • CuraVac

    lead INDUSTRY

Principal Investigators

  • Rudy Mercelis, MD, PhD · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2019-10-01
Completion
2019-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

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 NCT03165435 on ClinicalTrials.gov