Phase 2 N=323 Randomized Quadruple-blind Treatment

Integrated Biomarker And Imaging Study - 2

Atherosclerosis

Bottom Line

View on ClinicalTrials.gov: NCT00268996 ↗

Enrolled (actual)

323

Serious AEs

28.2%

Results posted

Feb 2018

Primary outcome: Primary: Mean Circulating High Sensitivity C- Reactive Protein (Hs-CRP) Levels at Week 52. — 1.034; 0.913 mg per litre (mg/L) — p=0.348

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SB-480848 (Drug); SB-480848 matching placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Aug 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Circulating High Sensitivity C- Reactive Protein (Hs-CRP) Levels at Week 52.	1.034; 0.913	0.348
PRIMARY Change From Baseline in the Density of Rotterdam Classification (ROC) Grade III/IV Strain Spots/10 Millimeter (mm) Within the Region of Interest (ROI) on IVUS Grey Scale Based Palpography at the End of Week 52.	0.003; -0.079	0.220
SECONDARY Circulating Hs-CRP at the End of Week 26.	0.924; 0.960	0.751
SECONDARY Mean Lipoprotein Phospholipase A2 (Lp-PLA2) Activity at the End of Week 26 and Week 52	151.412; 59.449; 152.061; 61.850	<0.001 sig
SECONDARY Change From Baseline in Plaque Volume as IVUS-Grey Scale Assessments at Week 52	-5.126; -4.873	0.945
SECONDARY Change From Baseline in Percent Obstruction Volume as IVUS-Grey Scale Assessments at Week 52	0.007; -0.054	0.898
SECONDARY Change From Baseline in Necrotic Core Volume as Intravenous Ultrasound-Virtual Histology (IVUS-VH) Assessments at Week 52	4.633; -0.531	0.012 sig
SECONDARY Change From Baseline in Necrotic Core as a Percent of IVUS-VH Plaque at the End of Week 52.	2.502; 0.535	0.047 sig
SECONDARY Mean Interlukin 6 (IL-6) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52	1.851; 1.979; 2.019; 2.267	0.487
SECONDARY Mean Intercellular Adhesion Molecule-1 (ICAM-1) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52	269.444; 266.447; 277.947; 268.950	0.687
SECONDARY Mean Myeloperoxidase (MPO) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52	324.534; 378.811; 370.999; 405.339	0.022 sig
SECONDARY Mean sCD40L Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52	178.738; 206.351; 183.449; 254.200	0.196
SECONDARY Mean Matrix Metaloproteinases-9 (MMP-9) Levels as Circulating Biomarkers Associated With Plaque Instability at Week 26 and Week 52.	481.581; 471.477; 488.998; 498.709	0.790
SECONDARY Mean Levels of Oxidised Phospholipids/ Apolipoprotein B100 (oxPL/apoB) Ratio as Target Circulating Biomarkers at the End of Week 26 and Week 52.	3114.718; 3106.872; 2711.118; 2478.376	0.980
SECONDARY Mean Levels of Oxidized Non-esterified Fatty Acids (Ox-NEFA) as Target Circulating Biomarkers at the End of Week 26 and Week 52	—	—
SECONDARY Change From Baseline in Vessel Volume and Lumen Volume as IVUS-Grey Scale Assessments at Week 52.	-11.211; -9.453; -6.693; -4.066	0.811
SECONDARY Change From Baseline in Mean Plaque Area, Mean Vessel Area, and Mean Lumen Area as IVUS-Grey Scale Assessments at Week 52.	-0.112; -0.124; -0.242; -0.194; -0.130; -0.069	0.873
SECONDARY Change From Baseline in Fibrous Tissue Volume and Fibro-fatty Volume as IVUS-VH Assessments at Week 52	-6.985; -7.569; -3.342; -1.415	0.854
SECONDARY Change From Baseline in Fibrous Tissue and Fibro-fatty as a Percent of IVUS-VH Plaque as IVUS-VH Assessments at Week 52	-4.007; -2.007; -0.782; -0.043	0.021 sig

Summary

IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers, safety and tolerability.

Eligibility Criteria

Inclusion criteria

Successful PCI (Percutaneous Coronary Intervention) or uncomplicated diagnostic catheterization
Suitable non-intervened coronary artery with IVUS
Antiplatelet therapy

Exclusion criteria

Clinical instability
Previous CABG (Coronary Artery By-pass Graft) surgery
Planned major surgery
Recent stroke
Abnormal QTc
Renal or hepatic impairment
Uncontrolled hypertension
Use of corticosteroids
Class III or IV heart failure
Asthma

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00268996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.