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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03165435
Other study ID # CV-0003
Secondary ID 2017-000323-27
Status Withdrawn
Phase Phase 2/Phase 3
First received
Last updated
Start date July 2018
Est. completion date December 31, 2019

Study information

Verified date May 2018
Source CuraVac
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


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Study Design


Intervention

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.
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.

Locations

Country Name City State
Belgium University Hospital, Antwerp Edegem Antwerp

Sponsors (3)

Lead Sponsor Collaborator
CuraVac Aepodia, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical efficacy 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). 24 weeks
Secondary Safety (ohysical examens and laboratory tests) and local tolerance (FDA grading scale) 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).
24 weeks
Secondary Efficacy - Responder rate 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 24 weeks
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