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Completed

NCT Number: NCT03082729

Vascular Inflammation in Psoriasis - Apremilast

The purpose of the VIP-A study is to determine the effect of apremilast on aortic vascular inflammation, cardiometabolic biomarkers and body composition in patients with moderate-severe psoriasis.

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Key information

Conditions

Psoriasis Cardiovascular Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Southern California, Los Angeles, California, United States

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About this study

The primary objectives of this study are to determine the effect of apremilast on aortic vascular inflammation, cardiometabolic biomarkers and body composition in patients with moderate-severe psoriasis. Fluorodeoxyglucose (FDG) - positron emission tomography (PET)/computed tomography (CT) will be used to assess vascular inflammation, with multi-volumetric product, tissue-to-background ratio and total atherosclerotic burden, and body composition via volumetric quantification. This is a year-long, single arm, open label study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females 18 years of age and older.
  • Clinical diagnosis of psoriasis for at least 6 months as determined by medical history interview and confirmation of diagnosis through physical examination by Investigator.
  • Stable plaque psoriasis for at least 2 months before screening and at baseline (Week 0) as determined by medical history interview.
  • Moderate to severe psoriasis defined by ≥ 10 percent Body Surface Area (BSA) involvement at the baseline (Week 0) visit.
  • Psoriasis Area and Severity Index (PASI) score of ≥ 12 at the Baseline (Week 0) visit.
  • Participant is a candidate for systemic therapy and has active psoriasis despite prior treatment with topical agents.
  • Women are eligible to participate in the study if they meet one of the following criteria:
  • Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and baseline. Women of childbearing potential must undergo periodic pregnancy testing during the study and agree to use at least one of the following methods of contraception throughout the study duration and for at least 28 days after taking the last dose of investigational product:
  • Oral contraceptives
  • Transdermal contraceptives
  • Injectable or implantable methods
  • Intrauterine devices
  • Vaginal ring
  • Vasectomized partner
  • Barrier methods (Male or female condom (latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.);
  • Women who are postmenopausal (for at least one year), sterile, or hysterectomized;
  • Women who have undergone tubal ligation will be required to undergo periodic pregnancy testing during the duration of the study
  • Sexual abstinence, defined as total abstinence from sexual intercourse, is considered an adequate form of contraception. (Agreement to comply with sexual abstinence must be recorded in the source document).
  • Participants using oral or parenteral forms of contraceptives must have been using these methods for at least 90 days prior to baseline visit.
  • Men (including those who have had a vasectomy), who engage in activity in which conception is possible, are eligible to participate if they:
  • Use barrier contraception (male latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product.
  • Participant is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile and physical examination performed at screening.

Exclusion criteria

  • Prior treatment with apremilast.
  • Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
  • Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
  • Cannot avoid topical prescription medications for psoriasis for at least 14 days prior to the baseline visit (week 0) and during the study, with the exception of hydrocortisone 2.5% for the face and intertriginous areas.
  • Cannot avoid ultraviolet B (UVB) phototherapy or Excimer laser for at least 14 days prior to the Baseline (Week 0) visit and during the study.
  • Cannot avoid psoralen-ultraviolet A (UVA) phototherapy for at least 30 days prior to the Baseline (Week 0) visit and during the study.
  • Use of systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis, during the study:
  • Systemic therapies must be discontinued at least 30 days prior to the Baseline (Week 0) visit except for biologics.
  • All biologics, except interleukin (IL)-12/IL-23 antagonists, must be discontinued for at least 90 days prior to Baseline (Week 0).
  • Any IL-12/IL-23 antagonist (e.g., ustekinumab, briakinumab) must be discontinued for at least 180 days prior to Baseline (Week 0).
  • Investigational agents must be discontinued at least 30 days or 5 half-lives (whichever is longer) prior to the Baseline (Week 0) visit.
  • Participant is ≥ 300lbs
  • Participant is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
  • Participant is taking a medication that interferes with metabolism of apremilast, including but not limited to rifampin, phenobarbital, carbamazepine, phenytoin
  • Poorly controlled medical condition, such as unstable ischemic heart disease, cerebrovascular accident or myocardial infarction within the prior 6 months, psychiatric disease requiring frequent hospitalization, and any other condition, which, in the opinion of the Investigator, would put the participant at risk by participation in the study.
  • Prior history of suicide attempt at any time in the participant's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
  • Uncontrolled hypertension, with measured systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg
  • Participant has infection or risk factors for severe infections, for example
  • Positive serology or known history of HIV, hepatitis B or C, or other severe, recurrent, or persistent infections;
  • Excessive immunosuppression or other factors associated with it, including human immunodeficiency virus infection;
  • Active tuberculosis (TB) disease;
  • Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the 30 days prior to baseline;
  • Infection requiring treatment with oral or parenteral (other than IV) antibiotics within 14 days prior to baseline;
  • Participant has received vaccination with a live viral agent within 30 days prior to screening or will require a live vaccination during study participation including up to 30 days after the last dose of study drug.
  • Participant has history of hematological or solid malignancy other than successfully treated basal cell carcinoma, non-metastatic cutaneous squamous cell carcinoma or cervical intraepithelial neoplasia or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
  • Female participant who is pregnant or breast-feeding or considering becoming pregnant during the study.
  • Screening clinical laboratory analyses showing any of the following abnormal results:
  • White blood cell (WBC) count <3.0 x 109/L. (Subject can be included if WBC count is <3.0 x 109/L and absolute neutrophil count (ANC) is >1000 cells / mm3.)
  • WBC count > 15 x 109/L;
  • Hemoglobin (Hgb) < 9.0 x 109/L;
  • Platelet count < 100 x 109/L;
  • Serum creatinine >1.5 mg/dL ;
  • Serum aspartate transaminase or alanine transaminase >2.0 upper limits of normal
  • Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
  • History of substance abuse within 365 days of screening visit.
  • Alcohol use of more than 14 drinks per week within 14 days of the baseline visit
  • If subject is on cholesterol-lowering medication (e.g. statin), dose and form of medication must be stable for 90 days prior to week 0 and remain stable throughout the duration of the study.

Treatment and study plan

Apremilast

Drug

Apremilast (brand name Otezla) is a medication for the treatment of certain types of psoriasis and psoriatic arthritis.

Other names: Otezla

Primary outcomes

  1. Change in Total Vascular Inflammation of the Aorta as Measured by FDG-PET/CT Between Baseline and Week 16.

    Time frame: After the completion of week 16 visit by all study participants.

    The primary analysis will consist of comparisons of total vascular inflammation of the aorta between week 16 and baseline using [18F]-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) / Computed Tomography (CT) (FDG-PET/CT). Tissue-to-background ratio (TBR) of the standardized uptake value (SUV) is used to assess the level of inflammation of the aorta relative to the venous blood pool (background reference).

  2. Changes in Cardiometabolic Markers Between Baseline and Week 16: Ferritin

    Time frame: After the completion of week 16 visit by all study participants.

    Ferritin is a marker of inflammation.

  3. Changes in Cardiometabolic Markers Between Baseline and Week 16: C Reactive Protein (CRP)

    Time frame: After the completion of week 16 visit by all study participants.

    CRP is a marker of inflammation.

  4. Changes in Cardiometabolic Markers Between Baseline and Week 16: Intercellular Adhesion Molecule (ICAM)-1

    Time frame: After the completion of week 16 visit by all study participants.

    ICAM-1 is a marker of inflammation.

  5. Changes in Cardiometabolic Markers Between Baseline and Week 16: Serum Amyloid-A (SAA)

    Time frame: After the completion of week 16 visit by all study participants.

    SAA is a marker of inflammation.

  6. Changes in Cardiometabolic Markers Between Baseline and Week 16: Vascular Cell Adhesion Molecule (VCAM)-1

    Time frame: After the completion of week 16 visit by all study participants.

    VCAM-1 is a marker of inflammation.

  7. Changes in Cardiometabolic Markers Between Baseline and Week 16: Interferon (IFN)-Gamma

    Time frame: After the completion of week 16 visit by all study participants.

    IFN-gamma is a marker of inflammation.

  8. Changes in Cardiometabolic Markers Between Baseline and Week 16: Interleukin (IL)-1b

    Time frame: After the completion of week 16 visit by all study participants.

    IL-1b is a marker of inflammation.

  9. Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-10

    Time frame: After the completion of week 16 visit by all study participants.

    IL-10 is a marker of inflammation.

  10. Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-17A

    Time frame: After the completion of week 16 visit by all study participants.

    IL-17A is a marker of inflammation.

  11. Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-6

    Time frame: After the completion of week 16 visit by all study participants.

    IL-6 is a marker of inflammation.

  12. Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-8

    Time frame: After the completion of week 16 visit by all study participants.

    IL-8 is a marker of inflammation.

  13. Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-9

    Time frame: After the completion of week 16 visit by all study participants.

    IL-9 is a marker of inflammation.

  14. Changes in Cardiometabolic Markers Between Baseline and Week 16: Monocyte Chemoattractant Protein (MCP)-1

    Time frame: After the completion of week 16 visit by all study participants.

    MCP-1 is a marker of inflammation.

  15. Changes in Cardiometabolic Markers Between Baseline and Week 16: Tumor Necrosis Factor (TNF)-Alpha

    Time frame: After the completion of week 16 visit by all study participants.

    TNF-alpha is a marker of inflammation.

  16. Changes in Cardiometabolic Markers Between Baseline and Week 16: IL2RA

    Time frame: After the completion of week 16 visit by all study participants.

    IL2RA is a marker of inflammation.

  17. Changes in Cardiometabolic Markers Between Baseline and Week 16: GlycA

    Time frame: After the completion of week 16 visit by all study participants.

    GlycA is a marker of inflammation.

  18. Changes in Cardiometabolic Markers Between Baseline and Week 16: Cholesterol Efflux Capacity

    Time frame: After the completion of week 16 visit by all study participants.

    Cholesterol Efflux Capacity is a marker of lipid function and metabolism.

    The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)]. Cholesterol efflux capacity is inversely correlated with incidence of cardiovascular events (i.e. higher cholesterol efflux capacity is better for patients).

  19. Changes in Cardiometabolic Markers Between Baseline and Week 16: Triglyceride

    Time frame: After the completion of week 16 visit by all study participants.

    Triglyceride is a marker of lipid function and metabolism.

  20. Changes in Cardiometabolic Markers Between Baseline and Week 16: Total Cholesterol

    Time frame: After the completion of week 16 visit by all study participants.

    Total Cholesterol is a marker of lipid function and metabolism.

  21. Changes in Cardiometabolic Markers Between Baseline and Week 16: High-density Lipoprotein (HDL) - Cholesterol (C)

    Time frame: After the completion of week 16 visit by all study participants.

    HDL-C is a marker of lipid function and metabolism.

  22. Changes in Cardiometabolic Markers Between Baseline and Week 16: HDL-Particle Number (P)

    Time frame: After the completion of week 16 visit by all study participants.

    HDL-P is a marker of lipid function and metabolism.

  23. Changes in Cardiometabolic Markers Between Baseline and Week 16: HDL-Particle Size (Z)

    Time frame: After the completion of week 16 visit by all study participants.

    HDL-Z is a marker of lipid function and metabolism.

  24. Changes in Cardiometabolic Markers Between Baseline and Week 16: Small (S)-HDL-P

    Time frame: After the completion of week 16 visit by all study participants.

    S-HDL-P is a marker of lipid function and metabolism.

  25. Changes in Cardiometabolic Markers Between Baseline and Week 16: Medium (M)-HDL-P

    Time frame: After the completion of week 16 visit by all study participants.

    M-HDL-P is a marker of lipid function and metabolism.

  26. Changes in Cardiometabolic Markers Between Baseline and Week 16: Large and Medium (LM)-HDL-P

    Time frame: After the completion of week 16 visit by all study participants.

    LM-HDL-P is a marker of lipid function and metabolism.

  27. Changes in Cardiometabolic Markers Between Baseline and Week 16: Large (L)-HDL-P

    Time frame: After the completion of week 16 visit by all study participants.

    L-HDL-P is a marker of lipid function and metabolism.

  28. Changes in Cardiometabolic Markers Between Baseline and Week 16: Low-density Lipoprotein (LDL)-C

    Time frame: After the completion of week 16 visit by all study participants.

    LDL-C is a marker of lipid function and metabolism.

  29. Changes in Cardiometabolic Markers Between Baseline and Week 16: LDL-P

    Time frame: After the completion of week 16 visit by all study participants.

    LDL-P is a marker of lipid function and metabolism.

  30. Changes in Cardiometabolic Markers Between Baseline and Week 16: LDL-Z

    Time frame: After the completion of week 16 visit by all study participants.

    LDL-Z is a marker of lipid function and metabolism.

  31. Changes in Cardiometabolic Markers Between Baseline and Week 16: S-LDL-P

    Time frame: After the completion of week 16 visit by all study participants.

    S-LDL-P is a marker of lipid function and metabolism.

  32. Changes in Cardiometabolic Markers Between Baseline and Week 16: L-LDL-P

    Time frame: After the completion of week 16 visit by all study participants.

    L-LDL-P is a marker of lipid function and metabolism.

  33. Changes in Cardiometabolic Markers Between Baseline and Week 16: Very Large (VL)-LDL-P

    Time frame: After the completion of week 16 visit by all study participants.

    VL-LDL-P is a marker of lipid function and metabolism.

  34. Changes in Cardiometabolic Markers Between Baseline and Week 16: Very Low-density Lipoprotein (VLDL)-P

    Time frame: After the completion of week 16 visit by all study participants.

    VLDL-P is a marker of lipid function and metabolism.

  35. Changes in Cardiometabolic Markers Between Baseline and Week 16: VLDL-Z

    Time frame: After the completion of week 16 visit by all study participants.

    VLDL-Z is a marker of lipid function and metabolism.

  36. Changes in Cardiometabolic Markers Between Baseline and Week 16: VLDL-Triglycerides (TG)

    Time frame: After the completion of week 16 visit by all study participants.

    VLDL-TG is a marker of lipid function and metabolism.

  37. Changes in Cardiometabolic Markers Between Baseline and Week 16: S-VLDL-P

    Time frame: After the completion of week 16 visit by all study participants.

    S-VLDL-P is a marker of lipid function and metabolism.

  38. Changes in Cardiometabolic Markers Between Baseline and Week 16: M-VLDL-P

    Time frame: After the completion of week 16 visit by all study participants.

    M-VLDL-P is a marker of lipid function and metabolism.

  39. Changes in Cardiometabolic Markers Between Baseline and Week 16: LM-VLDL-P

    Time frame: After the completion of week 16 visit by all study participants.

    LM-VLDL-P is a marker of lipid function and metabolism.

  40. Changes in Cardiometabolic Markers Between Baseline and Week 16: L-VLDL-P

    Time frame: After the completion of week 16 visit by all study participants.

    L-VLDL-P is a marker of lipid function and metabolism.

  41. Changes in Cardiometabolic Markers Between Baseline and Week 16: Intermediate-density Lipoprotein (IDL)-P

    Time frame: After the completion of week 16 visit by all study participants.

    IDL-P is a marker of lipid function and metabolism.

  42. Changes in Cardiometabolic Markers Between Baseline and Week 16: Apolipoprotein A1 (ApoA1)

    Time frame: After the completion of week 16 visit by all study participants.

    ApoA1 is a marker of lipid function and metabolism.

  43. Changes in Cardiometabolic Markers Between Baseline and Week 16: Apolipoprotein B (ApoB)

    Time frame: After the completion of week 16 visit by all study participants.

    ApoB is a marker of lipid function and metabolism.

  44. Changes in Cardiometabolic Markers Between Baseline and Week 16: TRLTG

    Time frame: After the completion of week 16 visit by all study participants.

    TRLTG is a marker of lipid function and metabolism.

  45. Changes in Cardiometabolic Markers Between Baseline and Week 16: (Triglyceride-Rich Lipoprotein Cholesterol) TRLC

    Time frame: After the completion of week 16 visit by all study participants.

    TRLC is a marker of lipid function and metabolism.

  46. Changes in Cardiometabolic Markers Between Baseline and Week 16: (Triglyceride-Rich Lipoprotein) TRLP

    Time frame: After the completion of week 16 visit by all study participants.

    TRLP is a marker of lipid function and metabolism.

  47. Changes in Cardiometabolic Markers Between Baseline and Week 16: VS-TRLP

    Time frame: After the completion of week 16 visit by all study participants.

    VS-TRLP is a marker of lipid function and metabolism.

  48. Changes in Cardiometabolic Markers Between Baseline and Week 16: S-TRLP

    Time frame: After the completion of week 16 visit by all study participants.

    S-TRLP is a marker of lipid function and metabolism.

  49. Changes in Cardiometabolic Markers Between Baseline and Week 16: M-TRLP

    Time frame: After the completion of week 16 visit by all study participants.

    M-TRLP is a marker of lipid function and metabolism.

  50. Changes in Cardiometabolic Markers Between Baseline and Week 16: L-TRLP

    Time frame: After the completion of week 16 visit by all study participants.

    L-TRLP is a marker of lipid function and metabolism.

  51. Changes in Cardiometabolic Markers Between Baseline and Week 16: VL-TRLP

    Time frame: After the completion of week 16 visit by all study participants.

    VL-TRLP is a marker of lipid function and metabolism.

  52. Changes in Cardiometabolic Markers Between Baseline and Week 16: Insulin

    Time frame: After the completion of week 16 visit by all study participants.

    Insulin is a marker of glucose metabolism.

  53. Changes in Cardiometabolic Markers Between Baseline and Week 16: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: After the completion of week 16 visit by all study participants.

    HOMA-IR is a marker of glucose metabolism. HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose [mg/dl] * fasting insulin [mU/ml]/405).

  54. Changes in Cardiometabolic Markers Between Baseline and Week 16: Glucose

    Time frame: After the completion of week 16 visit by all study participants.

    Glucose is a marker of metabolism.

  55. Changes in Cardiometabolic Markers Between Baseline and Week 16: Diabetes Risk Index (DRI)

    Time frame: After the completion of week 16 visit by all study participants.

    DRI is a marker of glucose metabolism. DRI is a nuclear magnetic resonance spectroscopy (NMR)-derived multimarker score (values 1-100) that predicts a patient's risk of developing type 2 diabetes mellitus (T2D) independent of glycemic status. DRI derives its performance from the weighted addition of the Lipoprotein Insulin Resistance Index (LP-IR) scores with simultaneously-measured levels of branched-chain amino acids (BCAA). Higher scores indicate greater risk.

  56. Changes in Cardiometabolic Markers Between Baseline and Week 16: Lipoprotein Insulin Resistance Index (LP-IR)

    Time frame: After the completion of week 16 visit by all study participants.

    LP-IR is a marker of glucose metabolism. LP-IR is a marker of insulin resistance, and as such the LP-IR score predicts a patient's likelihood of future development of type 2 diabetes. LP-IR is a multimarker index (values 0-100) based on the concentrations of particular lipoprotein subclasses. Greater score indicates higher likelihood of developing diabetes.

  57. Changes in Cardiometabolic Markers Between Baseline and Week 16: Leptin

    Time frame: After the completion of week 16 visit by all study participants.

    Leptin is a marker of adipose dysfunction and general metabolism.

  58. Changes in Cardiometabolic Markers Between Baseline and Week 16: Adiponectin

    Time frame: After the completion of week 16 visit by all study participants.

    Adiponectin is a marker of adipose dysfunction and general metabolism.

  59. Changes in Cardiometabolic Markers Between Baseline and Week 16: Fetuin A

    Time frame: After the completion of week 16 visit by all study participants.

    Fetuin A is a marker of adipose dysfunction and general metabolism.

  60. Changes in Cardiometabolic Markers Between Baseline and Week 16: Citrate

    Time frame: After the completion of week 16 visit by all study participants.

    Citrate is a marker of adipose dysfunction and general metabolism.

  61. Changes in Cardiometabolic Markers Between Baseline and Week 16: Valine

    Time frame: After the completion of week 16 visit by all study participants.

    Valine is a marker of adipose dysfunction and general metabolism.

  62. Changes in Cardiometabolic Markers Between Baseline and Week 16: Leucine

    Time frame: After the completion of week 16 visit by all study participants.

    Leucine is a marker of adipose dysfunction and general metabolism.

  63. Changes in Cardiometabolic Markers Between Baseline and Week 16: Isoleucine

    Time frame: After the completion of week 16 visit by all study participants.

    Isoleucine is a marker of adipose dysfunction and general metabolism.

  64. Changes in Cardiometabolic Markers Between Baseline and Week 16: Alanine

    Time frame: After the completion of week 16 visit by all study participants.

    Alanine is a marker of adipose dysfunction and general metabolism.

  65. Changes in Cardiometabolic Markers Between Baseline and Week 16: BCAA

    Time frame: After the completion of week 16 visit by all study participants.

    Branched-chain amino acids (BCAA) is a marker of adipose dysfunction and general metabolism.

  66. Changes in Cardiometabolic Markers Between Baseline and Week 16: Ketone Bodies

    Time frame: After the completion of week 16 visit by all study participants.

    Ketone Bodies are markers of adipose dysfunction and general metabolism.

  67. Changes in Cardiometabolic Markers Between Baseline and Week 16: Beta Hydroxybutyrate

    Time frame: After the completion of week 16 visit by all study participants.

    Beta Hydroxybutyrate is a marker of adipose dysfunction and general metabolism.

  68. Changes in Cardiometabolic Markers Between Baseline and Week 16: Acetoacetic Acid

    Time frame: After the completion of week 16 visit by all study participants.

    Acetoacetic Acid is a marker of adipose dysfunction and general metabolism.

  69. Changes in Cardiometabolic Markers Between Baseline and Week 16: Acetone

    Time frame: After the completion of week 16 visit by all study participants.

    Acetone is a marker of adipose dysfunction and general metabolism.

Secondary outcomes

  1. Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Visceral Adipose Tissue

    Time frame: After the completion of week 52 visit by all study participants.

    Secondary analysis will consist of comparisons of change in body composition between weeks 52, 16, and baseline. Visceral adipose tissue quantification using a single CT slice at the level of the umbilicus using computer-assisted tissue segmentation (Pescatori LC et al. Quantification of visceral adipose tissue by computed tomography and magnetic resonance imaging: reproducibility and accuracy. Radiol Bras. 2019 15(1):1-6.).

    The values represent the cross-sectional area of the tissue segmented on the CT slice (cm^2); higher values indicate greater amount of visceral adipose tissue.

  2. Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Subcutaneous Adipose Tissue

    Time frame: After the completion of week 52 visit by all study participants.

    Secondary analysis will consist of comparisons of change in body composition between weeks 52, 16, and baseline. Subcutaneous adipose tissue quantification using a single CT slice at the level of the umbilicus using computer-assisted tissue segmentation (Pescatori LC et al. Quantification of visceral adipose tissue by computed tomography and magnetic resonance imaging: reproducibility and accuracy. Radiol Bras. 2019 15(1):1-6.).

    The values represent the cross-sectional area of the tissue segmented on the CT slice (cm^2); higher values indicate greater amount of subcutaneous adipose tissue.

  3. Changes in Physician Reported Outcomes: Psoriasis Area and Severity Index (PASI)

    Time frame: Baseline, week 16, and week 52.

    Secondary analysis will consist of comparisons of change in PASI scores. PASI is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).

  4. Changes in Physician Reported Outcomes: Physician Global Assessment (PGA)

    Time frame: Baseline, week 16, and week 52.

    Secondary analysis will consist of comparisons of change in PGA scores. Physician Global Assessment (PGA) is calculated by averaging three subcomponent scores (induration, erythema, and scaling) that are graded from 0 (no involvement) to 5 (maximum involvement) that are averaged over all psoriatic lesions. Higher scores indicate greater disease burden.

  5. Changes in Patient Reported Outcomes: Dermatology Life Quality Index (DLQI)

    Time frame: Baseline, week 16, and week 52.

    Secondary analysis will consist of comparisons of change in DLQI scores. DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. The score ranges from 0 to 30; 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect.

  6. Changes in Patient Reported Outcomes: Pruritis by Visual Analog Scales (VAS)

    Time frame: Baseline, week 16, and week 52.

    Secondary analysis will consist of comparisons of change in Pruritus VAS scores.

    A visual analogue scale for pruritus (itch), ranging from 0 (no itch) to 100 (worst imaginable itch).

  7. Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline.

    Time frame: After the completion of week 52 visit by all study participants.

    Secondary analysis will consist of comparisons of vascular inflammation of the five aortic segments using TBR between week 52, 16, and baseline.

  8. Change in Total Vascular Inflammation of the Aorta as Measured by FDG-PET/CT Between Week 52 and Earlier Time Points.

    Time frame: After the completion of week 52 visit by all study participants.

    Secondary analysis will consist of comparisons of total vascular inflammation of the aorta using TBR between week 52, 16, and baseline.

  9. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ferritin

    Time frame: After the completion of week 52 visit by all study participants.

    Ferritin is a marker of inflammation.

  10. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): CRP

    Time frame: After the completion of week 52 visit by all study participants.

    CRP is a marker of inflammation.

  11. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ICAM-1

    Time frame: After the completion of week 52 visit by all study participants.

    ICAM-1 is a marker of inflammation.

  12. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): SAA

    Time frame: After the completion of week 52 visit by all study participants.

    SAA is a marker of inflammation.

  13. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VCAM-1

    Time frame: After the completion of week 52 visit by all study participants.

    VCAM-1 is a marker of inflammation.

  14. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IFN-gamma

    Time frame: After the completion of week 52 visit by all study participants.

    IFN-gamma is a marker of inflammation.

  15. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-1b

    Time frame: After the completion of week 52 visit by all study participants.

    IL-1b is a marker of inflammation.

  16. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-10

    Time frame: After the completion of week 52 visit by all study participants.

    IL-10 is a marker of inflammation.

  17. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-17A

    Time frame: After the completion of week 52 visit by all study participants.

    IL-17A is a marker of inflammation.

  18. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-6

    Time frame: After the completion of week 52 visit by all study participants.

    IL-6 is a marker of inflammation.

  19. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-8

    Time frame: After the completion of week 52 visit by all study participants.

    IL-8 is a marker of inflammation.

  20. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-9

    Time frame: After the completion of week 52 visit by all study participants.

    IL-9 is a marker of inflammation.

  21. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): MCP-1

    Time frame: After the completion of week 52 visit by all study participants.

    MCP-1 is a marker of inflammation.

  22. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TNF-alpha

    Time frame: After the completion of week 52 visit by all study participants.

    TNF-alpha is a marker of inflammation.

  23. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL2RA

    Time frame: After the completion of week 52 visit by all study participants.

    IL2RA is a marker of inflammation.

  24. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): GlycA

    Time frame: After the completion of week 52 visit by all study participants.

    GlycA is a marker of inflammation.

  25. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Cholesterol Efflux Capacity

    Time frame: After the completion of week 52 visit by all study participants.

    Cholesterol Efflux Capacity is a marker of lipid function and metabolism. The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)]. Cholesterol efflux capacity is inversely correlated with incidence of cardiovascular events (i.e. higher cholesterol efflux capacity is better for patients).

  26. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Triglyceride

    Time frame: After the completion of week 52 visit by all study participants.

    Triglyceride is a marker of lipid function and metabolism.

  27. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Total Cholesterol

    Time frame: After the completion of week 52 visit by all study participants.

    Total Cholesterol is a marker of lipid function and metabolism.

  28. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-C

    Time frame: After the completion of week 52 visit by all study participants.

    HDL-C is a marker of lipid function and metabolism.

  29. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    HDL-P is a marker of lipid function and metabolism.

  30. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-Z

    Time frame: After the completion of week 52 visit by all study participants.

    HDL-Z is a marker of lipid function and metabolism.

  31. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-HDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    S-HDL-P is a marker of lipid function and metabolism.

  32. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-HDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    M-HDL-P is a marker of lipid function and metabolism.

  33. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LM-HDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    LM-HDL-P is a marker of lipid function and metabolism.

  34. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-HDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    L-HDL-P is a marker of lipid function and metabolism.

  35. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-C

    Time frame: After the completion of week 52 visit by all study participants.

    LDL-C is a marker of lipid function and metabolism.

  36. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    LDL-P is a marker of lipid function and metabolism.

  37. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-Z

    Time frame: After the completion of week 52 visit by all study participants.

    LDL-Z is a marker of lipid function and metabolism.

  38. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-LDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    S-LDL-P is a marker of lipid function and metabolism.

  39. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-LDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    L-LDL-P is a marker of lipid function and metabolism.

  40. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VL-LDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    VL-LDL-P is a marker of lipid function and metabolism.

  41. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    VLDL-P is a marker of lipid function and metabolism.

  42. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-Z

    Time frame: After the completion of week 52 visit by all study participants.

    VLDL-Z is a marker of lipid function and metabolism.

  43. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-TG

    Time frame: After the completion of week 52 visit by all study participants.

    VLDL-TG is a marker of lipid function and metabolism.

  44. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-VLDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    S-VLDL-P is a marker of lipid function and metabolism.

  45. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-VLDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    M-VLDL-P is a marker of lipid function and metabolism.

  46. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LM-VLDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    LM-VLDL-P is a marker of lipid function and metabolism.

  47. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-VLDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    L-VLDL-P is a marker of lipid function and metabolism.

  48. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IDL-P

    Time frame: After the completion of week 52 visit by all study participants.

    IDL-P is a marker of lipid function and metabolism.

  49. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoA1

    Time frame: After the completion of week 52 visit by all study participants.

    ApoA1 is a marker of lipid function and metabolism.

  50. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoB

    Time frame: After the completion of week 52 visit by all study participants.

    ApoB is a marker of lipid function and metabolism.

  51. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLTG

    Time frame: After the completion of week 52 visit by all study participants.

    TRLTG is a marker of lipid function and metabolism.

  52. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLC

    Time frame: After the completion of week 52 visit by all study participants.

    TRLC is a marker of lipid function and metabolism.

  53. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLP

    Time frame: After the completion of week 52 visit by all study participants.

    TRLP is a marker of lipid function and metabolism.

  54. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VS-TRLP

    Time frame: After the completion of week 52 visit by all study participants.

    VS-TRLP is a marker of lipid function and metabolism.

  55. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-TRLP

    Time frame: After the completion of week 52 visit by all study participants.

    S-TRLP is a marker of lipid function and metabolism.

  56. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-TRLP

    Time frame: After the completion of week 52 visit by all study participants.

    M-TRLP is a marker of lipid function and metabolism.

  57. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-TRLP

    Time frame: After the completion of week 52 visit by all study participants.

    L-TRLP is a marker of lipid function and metabolism.

  58. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VL-TRLP

    Time frame: After the completion of week 52 visit by all study participants.

    VL-TRLP is a marker of lipid function and metabolism.

  59. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Insulin

    Time frame: After the completion of week 52 visit by all study participants.

    Insulin is a marker of glucose metabolism.

  60. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HOMA-IR

    Time frame: After the completion of week 52 visit by all study participants.

    HOMA-IR is a marker of glucose metabolism. HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose [mg/dl] * fasting insulin [mU/ml]/405).

  61. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Glucose

    Time frame: After the completion of week 52 visit by all study participants.

    Glucose is a marker of glucose metabolism.

  62. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): DRI

    Time frame: After the completion of week 52 visit by all study participants.

    DRI is a marker of glucose metabolism. DRI is a nuclear magnetic resonance spectroscopy (NMR)-derived multimarker score (values 1-100) that predicts a patient's risk of developing type 2 diabetes mellitus (T2D) independent of glycemic status. DRI derives its performance from the weighted addition of the Lipoprotein Insulin Resistance Index (LP-IR) scores with simultaneously-measured levels of branched-chain amino acids (BCAA). Higher scores indicate greater risk.

  63. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LP-IR

    Time frame: After the completion of week 52 visit by all study participants.

    LP-IR is a marker of glucose metabolism. LP-IR is a marker of insulin resistance, and as such the LP-IR score predicts a patient's likelihood of future development of type 2 diabetes. LP-IR is a multimarker index (values 0-100) based on the concentrations of particular lipoprotein subclasses. Greater score indicates higher likelihood of developing diabetes.

  64. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leptin

    Time frame: After the completion of week 52 visit by all study participants.

    Leptin is a marker of adipose dysfunction and general metabolism.

  65. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Adiponectin

    Time frame: After the completion of week 52 visit by all study participants.

    Adiponectin is a marker of adipose dysfunction and general metabolism.

  66. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Fetuin A

    Time frame: After the completion of week 52 visit by all study participants.

    Fetuin A is a marker of adipose dysfunction and general metabolism.

  67. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Citrate

    Time frame: After the completion of week 52 visit by all study participants.

    Citrate is a marker of adipose dysfunction and general metabolism.

  68. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Valine

    Time frame: After the completion of week 52 visit by all study participants.

    Valine is a marker of adipose dysfunction and general metabolism.

  69. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leucine

    Time frame: After the completion of week 52 visit by all study participants.

    Leucine is a marker of adipose dysfunction and general metabolism.

  70. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Isoleucine

    Time frame: After the completion of week 52 visit by all study participants.

    Isoleucine is a marker of adipose dysfunction and general metabolism.

  71. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Alanine

    Time frame: After the completion of week 52 visit by all study participants.

    Alanine is a marker of adipose dysfunction and general metabolism.

  72. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): BCAA

    Time frame: After the completion of week 52 visit by all study participants.

    BCAA is a marker of adipose dysfunction and general metabolism.

  73. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ketone Bodies

    Time frame: After the completion of week 52 visit by all study participants.

    Ketone Bodies are markers of adipose dysfunction and general metabolism.

  74. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Beta Hydroxybutyrate

    Time frame: After the completion of week 52 visit by all study participants.

    Beta Hydroxybutyrate is a marker of adipose dysfunction and general metabolism.

  75. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetoacetic Acid

    Time frame: After the completion of week 52 visit by all study participants.

    Acetoacetic Acid is a marker of adipose dysfunction and general metabolism.

  76. Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetone

    Time frame: After the completion of week 52 visit by all study participants.

    Acetone is a marker of adipose dysfunction and general metabolism.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Celgene Corporation
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

A Phase IV, Open Label Study of the Effects of Apremilast on Vascular Inflammation and Cardiometabolic Function in Psoriasis

Acronym: VIP-A

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2017
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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