A study to evaluate the efficacy of CV-MG01 (Myasterix), a therapy for Myasthenia gravis

Phase 1

• Conditions: Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack.; MedDRA version: 19.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-000323-27-NL
• Lead Sponsor: CuraVac Europe SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-18
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

[1] Male or female Patient, with generalised myasthenia gravis (Grades 2, 3 and 4a) as per myasthenia gravis foundation of America (MGFA)
classification system.
[2] Quantitative Myasthenia Gravis (QMG) score of 10 or greater at screening and baseline.
[3] Age of minimum 18, at the time of the consent form signature.
[4] Patient with documented positive antibodies to AChR in one of the available validated laboratory test.
[5] 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.
[6] 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..
[7] Venous access sufficient to allow blood sampling as per the protocol.
[8] Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
[9] Have given written informed consent approved by the relevant Ethics Committee (EC) governing the site.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

[10] MG patients of Grade 5 based on myasthenia gravis foundation of America (MGFA) classification.
[11] Patients with history or presence of a primary or recurrent malignant disease including the presence or history of a thymoma.
[12] Thymectomy planned during Part A of the study period or performed within 1 year prior to the first dose of study.
[13] 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.
[14] 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.
[15] History or evidence of rituximab treatment within 6 months prior to first dose of study.
[16] 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.
[17] At high risk for aspiration.
[18] Pulmonary: forced vital capacity reduced to less than 70% of predicted capacity.
[19] History of severe allergic disease or reactions likely to be exacerbated by any component of the vaccine.
[20] History or evidence of Lambert-Eaton myasthenic syndrome, druginduced myasthenia gravis, hereditary forms of myasthenic syndrome.
[21] History of relevant chronic degenerative, psychiatric, or neurological disorder other than MG.
[22] Severe hepatic, renal or cardiac insufficiency or uncontrolled hypertension
[23] Major congenital defects or serious chronic illness other than MG.
[24] Positive pregnancy test or desire to become pregnant during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified