Study Description
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. 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 5:5:1:1 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.
Interventions
DFV890
Placebo
Eligibility Criteria
Inclusion Criteria:
- Male and female participants aged between 18 - 85 years (inclusive) at the start of
screening will be included.
- Subjects must have a body mass index (BMI) within the range of 18 - 45 kg/m2. BMI =
Body weight (kg) / [Height (m)]2
- Documented spontaneous myocardial infarction (MI) (diagnosed according to the
universal MI criteria with or without evidence of ST segment elevation) at least 30
days before the start of screening.
- Participants must have hsCRP levels ≥ 2 mg/L at two timepoints during screening.
Screening values must be separated by a minimum of 8 days. The initial hsCRP value
must be a minimum of 30 days after the qualifying MI or after any percutaneous
coronary intervention (PCI) performed separately from the qualifying MI.
- For participants on statin therapy (HMG-CoA reductase inhibitor), as clinically
indicated, participants must be on a stable regimen (at least 4 weeks before
randomization), with no planned statin dose changes over the course of the trial
treatment period. Unplanned statin dose changes during the trial treatment period
may occur.
Exclusion Criteria:
- Patients receiving concomitant medications that are known to be strong or moderate
inducers of cytochrome CYP2C9 enzyme and/or strong inducers of CYP3A, strong
inhibitors of CYP2C9 and/or strong or moderate inhibitors of CYP3A and the treatment
cannot be discontinued or switched to a different medication within 5 half-lives or
1 week (whichever is longer) prior to Day 1 and for the duration of the study.
- Patients with suspected or proven immunocompromised state at screening
- History of ongoing, chronic, or major recurrent infectious disease, at the
discretion of the investigator, at the start of screening.
- Use of any biologic drugs targeting the immune system within 26 weeks of Day 1
- Multi-vessel Coronary Artery Bypass Graft (CABG) surgery within the past 6 months
prior to the start of screening.
- Symptomatic Class IV heart failure (New York Heart Association) at the start of
screening.
- Planned coronary revascularization (PCI or CABG) or any other major surgical
procedure during the study.
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