Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis
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|ClinicalTrials.gov Identifier: NCT02609022|
Recruitment Status : Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : January 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myasthenia Gravis||Biological: CV-MG01 Biological: Placebo||Phase 1 Phase 2|
Part A of the trial has been designed as a human safety pharmacology and therapeutic exploratory, parallel group, randomised, placebo-controlled, single centre, Investigator and subject-blind study using adaptive dose and sample size approaches.
At the end of part A of the present study, all patients, including those receiving placebo, will be monitored in an open label, long-term safety follow-up part B of the study to assess the treatment effects over time.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A First-in-human and Proof-of-concept Study to Assess the Safety, Tolerability and Immunogenic Response of CV-MG01, Acetylcholine Receptor Mimetic Peptides, as Potential Therapeutic Vaccine, in Patients With Myasthenia Gravis|
|Actual Study Start Date :||March 2016|
|Estimated Primary Completion Date :||September 12, 2019|
|Estimated Study Completion Date :||November 30, 2019|
The therapeutic vaccine 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.
Two dose levels: low and high dose.
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.
- Safety [ Time Frame: End of study part A (38 weeks) ]Safety assessed by laboratory tests, vital signs, electrocardiogram (ECG), adverse events, assessment of local tolerance, physical exams
- Immunogenicity [ Time Frame: End of study part A (38 weeks) ]To assess the immunogenic response after subcutaneous injections of CV-MG01 on the plasma levels of anti-peptide antibodies.
- Biomarker [ Time Frame: End of study part A (38 weeks) ]To assess the effect of CV-MG01 subcutaneous injections on the plasma level of acetylcholine receptor antibodies.
- Clinical efficacy [ Time Frame: End of study part A (38 weeks) ]Clinical efficacy assessed by Quantitative MG testing Procedure extended with MG Composite Scale and MG-ADL (myasthenia gravis activities of daily living)
- Immune response [ Time Frame: End of study part A (38 weeks) ]To explore changes in the humoral and cellular immune responses.
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): NCT02609022
|University Hospital, Antwerp|
|Edegem, Antwerp, Belgium, 2650|
|Principal Investigator:||Rudy Mercelis, MD, PhD||University Hospital, Antwerp|