Trials / Active Not Recruiting
Active Not RecruitingNCT06038526
Evaluation of Canakinumab in High-Risk Former-Smokers
Molecular Studies of Canakinumab in High-Risk Former-Smokers (CANIFS)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Peter Shields · Academic / Other
- Sex
- All
- Age
- 55 Years – 73 Years
- Healthy volunteers
- Accepted
Summary
This phase II trial tests the impact of canakinumab on biologic samples (buccal, nasal, and blood) from former smokers with increased risk of cancer. Canakinumab blocks the activity of a protein called interleukin-1 beta (IL-1b), an agent of the inflammatory system and is used for the treatment of different non-cancer diseases (like auto-inflammatory diseases). Giving canakinumab may block the inflammatory system and could have positive effects to reduce cancer growth.
Detailed description
PRIMARY OBJECTIVE: I. To compare baseline bronchoscopy biospecimens with samples approximately 70 days after administration of canakinumab (2 doses, approximately 14 days apart) in healthy former smokers. SECONDARY OBJECTIVE: I. Determine the impact of IL-1beta inhibition on downstream inflammatory pathways. OUTLINE: Patients undergo bronchoscopy over 30-60 minutes on day 7 and receive canakinumab subcutaneously (SC) 60 minutes and 2 weeks after the initial bronchoscopy. Patients undergo an additional bronchoscopy on day 77. Patients undergo buccal, nasal, and blood sample collection and carbon monoxide (CO testing on study).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biospecimen Collection | Undergo buccal, nasal, and blood sample collection |
| PROCEDURE | Bronchoscopy | Undergo bronchoscopy |
| BIOLOGICAL | Canakinumab | Given SC |
| PROCEDURE | Carbon Monoxide Measurement | Undergo CO testing |
| OTHER | Survey Administration | Ancillary studies |
Timeline
- Start date
- 2024-03-11
- Primary completion
- 2026-04-30
- Completion
- 2026-07-31
- First posted
- 2023-09-14
- Last updated
- 2026-02-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06038526. Inclusion in this directory is not an endorsement.