Study on Canakinumab for High-Risk Former Smokers

Sponsor: Peter Shields

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06038526

Provider View

This clinical trial is exploring the effects of canakinumab, a medication that blocks inflammation, on former smokers who are at a higher risk of developing cancer. The study aims to see if canakinumab can reduce cancer growth by blocking inflammation.

Patient Parameters

Program Overview

This study is testing the effects of canakinumab, a drug that blocks a protein involved in inflammation, in former smokers who have a higher risk of cancer. Canakinumab is already used to treat other inflammatory diseases. Researchers want to see if it can also help reduce cancer growth by blocking inflammation. Participants will provide samples from their mouth, nose, and blood to help measure the drug's impact.

Description

The main goal of this study is to compare samples taken from the lungs of healthy former smokers before and after they receive canakinumab. Participants will undergo a procedure called bronchoscopy to collect these samples. They will receive two doses of canakinumab, given under the skin, about two weeks apart. The study will also look at how blocking the protein IL-1beta affects other inflammation-related processes in the body. Participants will have additional tests, including collecting samples from the mouth, nose, and blood, and measuring carbon monoxide levels.

Eligibility Criteria

Inclusion Criteria

  • Aged between 55 and 73 years old.
  • Women must be post-menopausal or have a negative pregnancy test and use effective birth control during the study and for 6 weeks after.
  • Must be a former smoker who hasn't smoked in at least 5 years.
  • Have a history of smoking at least 30 pack-years.
  • No significant or unstable medical conditions.
  • Have a high level of C-reactive protein (hsCRP) in the blood, indicating increased risk.
  • Negative COVID-19 test, with no symptoms for at least 3 months if previously positive.
  • Able to read and understand study documents and give consent.

Exclusion Criteria

  • Smoked tobacco or cannabis in the last 5 years.
  • Used e-cigarettes or vaped in the last 5 years.
  • High carbon monoxide levels in the breath.
  • History of or recent exposure to tuberculosis.
  • Body mass index (BMI) over 45.
  • Regular use of aspirin or NSAIDs.
  • Serious medical conditions like cancer or immune disorders.
  • Chronic lung diseases like asthma or bronchitis.
  • Recent lung infections or procedures.
  • Recent use of certain medications like antibiotics or steroids.
  • Use of immunosuppressants or certain other medications.
  • Recent live vaccines.
  • Allergies to study medications.
  • Recent alcohol or drug abuse.
  • Unable to read or understand study documents.

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