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Trial record 1 of 2 for:    curavac
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A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis

This study is currently recruiting participants.
Verified June 2017 by CuraVac
Sponsor:
ClinicalTrials.gov Identifier:
NCT03165435
First Posted: May 24, 2017
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Aepodia
Leiden University Medical Center
University Hospital, Antwerp
Information provided by (Responsible Party):
CuraVac
  Purpose
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).

Condition Intervention Phase
Myasthenia Gravis, Generalized Biological: CV-MG01 Biological: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by CuraVac:

Primary Outcome Measures:
  • Clinical efficacy [ Time Frame: 24 weeks ]
    To assess the efficacy of 3 subcutaneous injections of CV-MG01 compared to placebo, as measured by a decrease from baseline of the QMG total score at 24 weeks after the first injection (equivalent to 12 weeks after last injection).


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

    Evaluation of treatment emergent adverse events (TEAEs) including local injection site reactions (severity assessed with an overall grading scale following the FDA recommendation (FDA, CBER, September 2007)).

    General safety monitoring via physical examinations, vital signs (VS), ECG and standard laboratory tests (clinical chemistry, haematology and urinalysis).


  • Efficacy - Responder rate [ Time Frame: 24 weeks ]
    Proportion of patients with improvement or worsening by ≥ 3 points in the QMG score at week 24 after the first injection in the active group compared to the placebo group


Estimated Enrollment: 66
Anticipated Study Start Date: June 23, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: October 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CV-MG01
The active targeted immunotherapy candidate, CV-MG01 comprises two short synthetic peptides separately conjugated to a carrier protein for the potential treatment of myasthenia gravis
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.
Other Name: Myasterix
Placebo Comparator: Placebo
Aluminium hydroxide adjuvant alone
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165435


Contacts
Contact: Stéphane Huberty, MD 3226860445 info@curavac.com

Locations
Belgium
University Hospital, Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Linda Wagemaekers    +3238215760    myastheniavaccin@uza.be   
Netherlands
Leiden University Medical Center Not yet recruiting
Leiden, Netherlands
Sponsors and Collaborators
CuraVac
Aepodia
Leiden University Medical Center
University Hospital, Antwerp
Investigators
Principal Investigator: Jan Verschuuren, MD, PhD LUMC
  More Information

Additional Information:
Responsible Party: CuraVac
ClinicalTrials.gov Identifier: NCT03165435     History of Changes
Other Study ID Numbers: CV-0003
2017-000323-27 ( EudraCT Number )
First Submitted: May 17, 2017
First Posted: May 24, 2017
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases