E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The intended indication for the drug under investigation is smoking relapse prevention. Tobacco smoking has been identified as the single largest preventable cause of morbidity and premature death in the developed world. The prevalence of smoking range from about 20 to 50 per cent in the developed countries and from a global perspective, tobacco smoking continues to increase. The study will be performed in smokers. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056478 |
E.1.2 | Term | Nicotine addiction |
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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 main objective of the study is to evaluate the efficacy of Niccine compared to placebo, on relapse prevention at twelve months after the first vaccination with the study drug. The objective will be explored following six intramuscular injections of the study drug in subjects who have recently quit smoking with the smoking cessation aid Varenicline. |
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E.2.2 | Secondary objectives of the trial |
Safety Relapse prevention at six, nine and twelve months Point prevalence Nicotine withdrawal Exhaled carbon monoxide Immunogenicity of Niccine Time to first relapse Smoking habits (including compensatory smoking) Continouse abstinence Craving
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Cigarette smokers, smoking on average at least 10 cigarettes per day, has fewer than three months of abstinence in the past year and is motivated to quit. 2. Men or women, 25 to 50 years of age (inclusive). 3. Women of childbearing capacity must use a reliable contraceptive method, e.g. the double barrier method, an intra-uterine device or oral contraceptive. 4. Positive for exhaled carbon monoxide (CO), >5 ppm. 5. Healthy and with normal findings in the pre-study physical examination (as judged by the Investigator) 6. Has signed the Informed Consent Form
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E.4 | Principal exclusion criteria |
1. Pregnant and lactating female 2. Previous treatment with any nicotine vaccine 3. Vaccination with any other vaccine product from four weeks before first dose or planned vaccination until four weeks after the last vaccination with the investigational product. 4. Vaccination with any other medicinal product containing TT within two years prior to enrolment. 5. Concurrent use of any drug that may have a negative effect on the immune system (as judged by the investigator) 6. Use of antidepressant or antipsychotic drugs within six months prior to enrolment in the study 7. Concurrent use of any other nicotine containing product than cigarettes 8. Current diagnosis or a history of repeated depressive episodes or of anxiety disorders or psychosis. 9. Clinical diagnosis of moderate to severe asthma or COPD or emphysema. 10. Unstable heart disease (as judged by the Investigator). 11. Use of any smoking cessation drugs within six months of enrolment in the study. 12. Known hyper reactivity to previous vaccinations with TT. 13. Known or suspected allergy or hypersensitivity to any of the components in the investigational or reference products. 14. Suspected abuse or misuse of alcohol or any of the drugs tested for during screening. 15. Diseases with immunological etiology, e.g. autoimmune disorders. 16. History of cancer. 17. Positive serology for HIV and/or Hepatitis B and/or Hepatitis C. 18. Participation in another clinical study within three months prior to enrolment or during the present study. 19. If the Investigator, for any other reason, assesses that the Subject should not be included (e.g. planned travel, expected low compliance, expected withdrawal).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is to evaluate Niccines effect on preventing smoking relapses in Subjects that have recently quit smoking. Relapses will be assessed by smoking questionnaires. |
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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 | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 14 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 14 |