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Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis

NCT02609022 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-01-28

No results posted yet for this study

Summary

Study CV-0002 is the first clinical trial administering CV-MG01 in humans. This clinical trial is a safety and proof-of-concept study (proof of mechanism of action) intended to assess the safety, tolerability and immunogenic response following 3 subcutaneous injections of CV-MG01 as a potential therapeutic vaccine / active immunotherapy in myasthenia gravis (MG) patients.

Conditions

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. Two dose levels: low and high dose.

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

  • Leiden University Medical Center

    collaborator OTHER

  • CuraVac

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

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 NCT02609022 on ClinicalTrials.gov