| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| elevated hsCRP and other biomarkers for inflammation |
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| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
The aim of this study is to assess and characterize the efficacy, safety and tolerability of VB-201. The effect of VB-201 compared to placebo(a ‘dummy treatment’ that looks like the VB-201 tablet but has no effect) will be observed while being administered at multiple doses ranging from 5mg to 240mg, for a duration of 4 weeks. The study will enroll 320 subjects with elevated high sensitivity C-Reactive Protein (hsCRP), a blood level that indicates you may have inflammation in your body.
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| E.2.2 | Secondary objectives of the trial |
The secondary objective is to examine the effect of a 4 week treatment with different doses (5mg to 240mg) of VB-201 as compared with placebo (a ‘dummy treatment’) on inflammatory related biomarkers and RNA expression of inflammation related genes.
The objective of the pharmacokinetic (PK)sub study is to assess the pharmacokinetics of VB-201 at the higher doses (120mg and 240mg). |
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| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
| There is a PK sub-study which is described in full in the main study protocol. |
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| E.3 | Principal inclusion criteria |
1)Fully understand all elements of and have signed and dated the written Independent Ethics Committee (IEC) approved informed consent before initiation of protocol-specified procedures;
2)Male or female patients, ≥18 to ≤75 years of age;
3)Subjects who have a screening hsCRP level between 2 mg/L - 10 mg/L on 2 separate tests (3-7 days apart);
4)Subjects must be on a stable high dose of statin for at least 3 months prior to screening including either atorvastatin ≥20 mg /day or rosuvastatin ≥10 mg /day or simvastatin ≥40mg/day;
5)For a female subject; either:
- subject is of non-childbearing potential, defined as: menopause with amenorrhea >2 years, hysterectomy, or bilateral oopherectomy
or
- agrees to continue to use adequate contraception (implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence or vasectomised partner) throughout the study and for at least one month following termination and have a negative pregnancy test at screening and before the first dose of study drug;
Males must use at least one method of contraception (e.g.,
condom) throughout the study;
6)In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.
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| E.4 | Principal exclusion criteria |
1)Subjects receiving systemic corticosteroid or biologic anti-inflammatory therapy;
2)Received any investigational drug within 30 days of screening;
3)The subject has a known allergy or sensitivity to the study treatment(s) or to any of the excipients contained in the study drug formulation (see list of ingredients in the Investigator’s Brochure);
4)Any other acute or chronic medical condition that, in the opinion of the investigator, increases the risk to the subject or the likelihood that the subject will be unable to complete the study;
5)Diagnosis of an inflammatory condition known to affect CRP such as Rheumatoid arthritis, Multiple sclerosis, Inflammatory Bowl disease, Psoriasis etc.
6)Subjects with any laboratory test at screening that common medical practice would deem as significantly abnormal. The following will be deemed as significantly abnormal:
• alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase ³1.5 times the upper limit of normal (ULN) or
• cytopenia (to include any of the following: WBC <3.5´103/μL; Hgb <10 g/dL; platelets <120´103/μL; neutrophils absolute <1.5´103/μL; lymphocytes absolute <0.8´103/μL) or
• Creatinine ³1.25 times the upper limit of normal (ULN);
If, in the investigator’s opinion, there is no reason for the test result(s) to be abnormal, the abnormal test(s) may be repeated once during the screening period;
7)Presence of, or history of cancer, with the exception of completely excised, non-metastatic squamous cell or basal cell carcinomas of the skin;
8)Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of Day 0, or a history or presence of recurrent or chronic infection (e.g. viral infections, [including hepatitis B or C, HIV], bacterial infections, systemic fungal infections, or syphilis);
9)Subjects with a history of coronary events within the last 6 months;
10)Subjects presenting with HbA1c > 8.5 % within 3 months of screening;
11)History of substance abuse, including alcohol abuse, within the past year;
12)Has a history of or has a current, clinically significant major psychiatric disorder (e.g., major depressive disorder, psychosis, schizophrenia) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV TR) [Exception; Subjects with depression that has been adequately controlled for at least 6 months may enroll in the study].
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Change from baseline of hsCRP levels.
The change will be calculated as the difference between the average of 2 hsCRP sample determinations at screening (3-7 days apart) and the average of the 2 hsCRP determinations at week 4 (on day 25 and day 28). For PART B only, the change in hsCRP level will also be assessed at week 2 and week 8. |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| The study is considered completed with the last visit of the last subject participating in the study. |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 1 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 1 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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