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

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ClinicalTrials.gov Identifier: NCT03165435
Recruitment Status : Withdrawn (Not enough participating centres to complete recruitment in a timely manner.)
First Posted : May 24, 2017
Last Update Posted : May 30, 2018
Sponsor:
Collaborators:
Aepodia
University Hospital, Antwerp
Information provided by (Responsible Party):
CuraVac

Tracking Information
First Submitted Date  ICMJE May 17, 2017
First Posted Date  ICMJE May 24, 2017
Last Update Posted Date May 30, 2018
Estimated Study Start Date  ICMJE July 2018
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03165435 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
  • Safety (ohysical examens and laboratory tests) and local tolerance (FDA grading scale) [ Time Frame: 30 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: 30 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis
Official Title  ICMJE 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.
Brief 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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Myasthenia Gravis, Generalized
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Biological: CV-MG01
  • Placebo Comparator: Placebo
    Aluminium hydroxide adjuvant alone
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 28, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2017)
66
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT03165435
Other Study ID Numbers  ICMJE CV-0003
2017-000323-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CuraVac
Study Sponsor  ICMJE CuraVac
Collaborators  ICMJE
  • Aepodia
  • University Hospital, Antwerp
Investigators  ICMJE
Principal Investigator: Rudy Mercelis, MD, PhD UZA
PRS Account CuraVac
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP