Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

Novartis

Status and phase: Completed; Phase 2

Conditions: Smokers

Treatments: Biological: Placebo; Biological: NIC002

Study type: Interventional

Funder types: Industry

Identifiers

NCT00736047

CNIC002A2201

Details and patient eligibility

About

This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy male and female smoking subjects age 18 to 65 years of age
• Subjects must be smoking 10 or more cigarettes per day during the past 12 months
• The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
• The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.

Exclusion criteria

• Attempted to quit smoking in the three (3) months.
• Prior use of smoking cessation aid.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Biological: NIC002

2

Placebo Comparator group

Treatment:

Biological: Placebo