Recent Updates
Recently added Catalysts

NIC002

Phase 2

Smokers | Monoclonal antibody | Other |Novartis AG|Last Updated: Mar 21, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

NIC002 · 1 trial · 1 indication

Phase 2 1
NCT00736047Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.Smokers
COMPLETED200 Analytics
PHASE2COMPLETED
Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.
Smokers
NCT00736047200
Unlock trial analytics

Study Endpoints

Primary Endpoints

Smoking status
12 weeks
Exhaled carbon monoxide
12 weeks

Secondary Endpoints

Smoking status at various time intervals from target quit date to the end of the study
52 weeks
Safety and tolerability
52 weeks
Immunogenicity (specific anti-nicotine antibodies in serum)
52 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
NIC002BIOLOGICAL -
PlaceboBIOLOGICAL -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

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 b...

Countries:Germany
Unlock Eligibility Criteria

Frequently asked questions about NIC002

What is NIC002 used for?

NIC002 is an investigational monoclonal antibody being studied to help cigarette smokers who are motivated to quit smoking. It was evaluated in a Phase 2 clinical trial for this purpose. The drug is not approved and remains in clinical development.

What does NIC002 target?

NIC002 is a monoclonal antibody designed to target nicotine. By binding to nicotine in the bloodstream, it may prevent nicotine from reaching the brain, potentially reducing the rewarding effects of smoking and aiding in smoking cessation efforts.

Who makes NIC002?

NIC002 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. Novartis conducted a Phase 2 clinical trial to evaluate the drug's efficacy and safety in smokers.

What phase is NIC002 in?

NIC002 is in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug is still investigational and has not received regulatory approval. Further studies would be needed to establish its safety and efficacy.

What clinical trials is NIC002 in?

NIC002 has one completed Phase 2 clinical trial registered as NCT00736047. This study evaluated the efficacy, safety, tolerability, and immunogenicity of a 100 microgram dose of NIC002 in 200 cigarette smokers in Germany who were motivated to quit smoking.

Is NIC002 the same as a nicotine vaccine?

NIC002 is a monoclonal antibody, not a traditional vaccine. However, it is designed to bind to nicotine in the body, similar to how a vaccine-induced antibody would. The clinical trial for NIC002 was described as a vaccine study, but the drug itself is a monoclonal antibody.