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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03165435
• Date of registration: 17/05/2017
• Prospective Registration: Yes
• Primary sponsor: CuraVac
• Public title: A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis
• Scientific 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.
• Date of first enrolment: July 2018
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03165435
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Belgium, Netherlands

Contacts

• Name: Rudy Mercelis, MD, PhD
• Affiliation: UZA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female Patient, with generalised myasthenia gravis (Grades 2, 3 and 4a) as per
myasthenia gravis foundation of America (MGFA) classification system.

- Quantitative Myasthenia Gravis (QMG) score of 10 or greater at screening and baseline.

- Age of minimum 18, at the time of the consent form signature.

- Patient with documented positive antibodies to AChR in one of the available validated
laboratory test.

- Patient may use corticosteroid treatment initiated for at least 3 months before
screening, equivalent to a daily dose of 30mg prednisone as maximum, and stable (+/-
5mg change) at least 1 month before the screening and up to the first injection.

- Patient may use one or two immunosuppressive drugs (initiated for a least 6 months)
with or without concomitant use of corticosteroid, providing that the dosage has been
stable/unchanged for 3 months before the screening and up to the first injection.

- Venous access sufficient to allow blood sampling as per the protocol.

- Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures.

- Have given written informed consent approved by the relevant Ethics Committee (EC)
governing the site.

Exclusion Criteria:

- MG patients of Grade 5 based on myasthenia gravis foundation of America (MGFA)
classification.

- Patients with history or presence of a primary or recurrent malignant disease
including the presence or history of a thymoma.

- Thymectomy planned during Part A of the study period or performed within 1 year prior
to the first dose of study.

- Any confirmed or suspected immunosuppressive or immunodeficient condition not related
to the treatment of MG, including human immunodeficiency virus (HIV) infection, or a
family history of congenital or hereditary immunodeficiency.

- History or evidence of administration of immunoglobulins and/or any blood products
within 3 months prior to the first dose of study drug, or a planned administration of
immunoglobulins during the first 3 months of the study.

- History or evidence of rituximab treatment within 6 months prior to first dose of
study.

- History or evidence of plasmapheresis within 3 months prior to the first dose of
study, or a planned plasmapheresis during the first 3 months of the study.

- At high risk for aspiration.

- Pulmonary: forced vital capacity reduced to less than 70% of predicted capacity.

- History of severe allergic disease or reactions likely to be exacerbated by any
component of the vaccine.

- History or evidence of Lambert-Eaton myasthenic syndrome, drug-induced myasthenia
gravis, hereditary forms of myasthenic syndrome.

- History of relevant chronic degenerative, psychiatric, or neurological disorder other
than MG.

- Severe hepatic, renal or cardiac insufficiency or uncontrolled hypertension

- Major congenital defects or serious chronic illness other than MG.

- Positive pregnancy test or desire to become pregnant during the study.

- Female patients of child-bearing potential that do not use a reliable and highly
effective method of contraception (see Section 7.2 Contraception) at least one month
before first injection, during the study and until the end of Part A.

- Any significant out-of-range Clinical Laboratory results considered as clinically
significant and that prevent Subject's participation into the study according to
Investigator's judgment.

- Previous completion or withdrawal from this study or study CV-0002.

- Sponsor employees or Investigator site personnel directly affiliated with this study,
and their immediate families. Immediate family is defined as a spouse, parent, child
or sibling, whether biological or legally adopted.

- Any medical condition or concomitant medication that, in the opinion of the
Investigator, might interfere with the subject's participation in the study, poses any
added risk for the subject, or confounds the assessment of the subjects.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myasthenia Gravis, Generalized

Intervention(s)

Biological: CV-MG01

Biological: Placebo

Primary Outcome(s)

Clinical efficacy [Time Frame: 24 weeks]

Secondary Outcome(s)

Efficacy - Responder rate [Time Frame: 24 weeks]

Safety (ohysical examens and laboratory tests) and local tolerance (FDA grading scale) [Time Frame: 24 weeks]

Secondary ID(s)

CV-0003

2017-000323-27

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital, Antwerp

Aepodia