A Phase I/II, Single-Center, Randomized, Placebo-Controlled Study Evaluating the Therapeutic Efficacy of Intravenously Injected PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) in Subjects With Severe Inflamed Carotid or Aortic Atherosclerosis Plaques
- Population with target to background ratio of 2.2 of the aorta or carotid artery on
- Current medical history of auto-immune disease/vasculitis, active inflammatory
diseases, Recent (<1 month prior to screening) or ongoing serious infection requiring
IV antibiotic therapy.
- Recent or current treatment with medications that may have a significant effect on
plaque inflammation as measured by plaque TBR, including but not limited to:
- Steroids for at least 6 weeks prior to baseline measurement and during study
(with the exception of inhaled acute use steroids).
- Biological based medicines (anti-TNF (ex. Infliximab), anti-IL-6 therapy (ex.
Tocilizumab) or anti-IL-1 (ex. anakinra)) within 8 weeks before the baseline
visit and during the study
- No other disease modifying antirheumatic drugs (DMRADS) within 6 weeks of
baseline and during study (such as cyclosporine, azatioprine, etc.)
- Known systemic disorders such as hepatic, renal, hematologic, and malignant diseases
or any clinically significant medical condition that could interfere with the conduct
of the study.
- Changes in dose or frequency of doses at least 6 weeks prior to baseline measurement
(unstable dosing) in angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or
angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy,
thiazolidinediones, inhaled steroids, or leukotriene modifying agents, nonsteroidal
anti-inflammatory drugs (NSAIDS), and cyclo-oxygenase-2 inhibitors (COXIBs)
- Standard contra-indications to MRI, 18FDG PET, and CT based on physicians experience
and current practices
- Current medical history of poorly controlled diabetes defined as hemoglobin A1c
- Current medical history of drug or alcohol abuse within 12 months prior to screening.
- History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe
- Inability or unwillingness to comply with the protocol requirements, or deemed by
investigator to be unfit for the study.
- Subject has planned cardiac surgery, PCI or carotid stenting, or major non-cardiac
surgery during the course of the study period or for 14 days after the last
- Use of any investigational drug in the 3 months prior to study drug administration.
- Use of insulin or any oral anti-diabetic (except metformin) in the 30 days prior to
baseline measurements. Those subjects who are taking metformin may be included in the
study if they are on a stable dose for at least 4 weeks and have a HbA1c <7.5%.
- Any contraindications for corticosteroid infusions (for example, but not limited
current infections or vaccinations)