A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis
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|ClinicalTrials.gov Identifier: NCT03165435|
Recruitment Status : Not yet recruiting
First Posted : May 24, 2017
Last Update Posted : November 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myasthenia Gravis, Generalized||Biological: CV-MG01 Biological: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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.|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||October 1, 2018|
|Estimated Study Completion Date :||December 31, 2018|
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
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
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.
- 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).
- 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
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
|Contact: Stéphane Huberty, MDfirstname.lastname@example.org|
|University Hospital, Antwerp||Not yet recruiting|
|Edegem, Antwerp, Belgium, 2650|
|Contact: Linda Wagemaekers +3238215760 email@example.com|
|Principal Investigator:||Rudy Mercelis, MD, PhD||UZA|