Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06031844
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-09-04
Brief Title:
A Study to Investigate the Efficacy Safety and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Placebo-controlled Parallel-group Investigator- and Participant-blinded Phase 2a Study to Investigate the Efficacy Safety and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 2a clinical trial will evaluate the effectiveness safety and tolerability of increasing dose strengths of an oral daily medication DFV890 administered for 12 weeks to reduce key markers of inflammation related to CVD risk such as IL-6 and IL-18 in approximately 24 people with known heart disease and an elevated marker of inflammation hsCRP
Detailed Description:
This is a multi-center randomized placebo-controlled participant- and investigator-blinded study to evaluate the efficacy safety and tolerability of intra-individual dose escalation of DFV890 for inflammatory marker reduction in participants with coronary heart disease and elevated hsCRP The study consists of a screening period of up to 60 days a treatment period of approximately 12 weeks an end of treatment EOT visit on Day 85 which is one day after the last dose on Day 84 a follow-up period of approximately 1 week and a standard safety-follow-up call approximately 30 days following the last dose The overall study duration is approximately 24 weeks and approximately 24 participants will be enrolled into the trial
Participants meeting all eligibility criteria will be randomized in a 5511 ratio to one of four treatment sequences three DFV890 treatment sequences or a placebo-only sequence The dose of DFV890 will be uptitrated according to the specific treatment sequence that the participant is assigned to approximately every three weeks at the scheduled visits on Days 22 43 and 64
Participants meeting all eligibility criteria will be randomized in a 5511 ratio to one of four treatment sequences three DFV890 treatment sequences or a placebo-only sequence The dose of DFV890 will be uptitrated according to the specific treatment sequence that the participant is assigned to approximately every three weeks at the scheduled visits on Days 22 43 and 64
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None