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A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vascular Inflammation in Participants With Atherosclerosis at Risk for Major Adverse Cardiac Events

ConditionAtherosclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

The main purpose of the study is to evaluate the efficacy of selnoflast compared with placebo in participants with atherosclerosis, at high-risk for major adverse cardiovascular event (MACE), who are currently on standard-of-care (SOC) therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed evidence of atherosclerosis

Left or right carotid TBR ≥ 1.8 or aorta TBR ≥ 2.0 on centrally-assessed 18F-fluorodeoxyglucose-Positron Emission Tomography (18F-FDG-PET) scan

Stable treatment of atherosclerosis through the use of SOC medications or revascularization

QT interval corrected through use of Fridericia's formula (QTcF) of ≤ 450 milliseconds (ms) in men and ≤ 470 ms in women by a single 12-lead electrocardiogram (ECG) recording

Disqualifiers

Individuals with Class III and IV heart failure

Uncontrolled cardiac arrhythmia

Uncontrolled hypertension

Suspected or known immunocompromised state

Trial design

Design model

Parallel

Treatments tested in this trial

  • Selnoflast

    Drug

    Selnoflast will be administered as per the schedule specified in the respective arm.

  • Placebo

    Drug

    Placebo will be administered as per the schedule specified in the respective arm.

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: SelnoflastExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in mdsTBR (Most-diseased Segment TBR [Target-to-background Ratio]) of Index Vessel From Baseline to Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 milligrams per liter [mg/L])

hsCRP=high-sensitivity C-reactive protein.

Time frame
Baseline up to Week 12

Secondary outcomes

1

Change From Baseline in mdsTBR of Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2mg/L)

Time frame
Baseline and Week 12
2

Change From Baseline in mdsTBR of Carotids at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2 mg/L)

Time frame
Baseline and Week 12
3

Change From Baseline in mdsTBR of Carotids at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L)

Time frame
Baseline and Week 12
4

Change From Baseline in Active Segments TBR and the Whole Vessel TBR of the Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2 mg/L)

Time frame
Baseline and Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov
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