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AzTrials

PsoriasisPhase 4VIP-ANCT03082729

Vascular Inflammation in Psoriasis - Apremilast

A Phase 4 study testing Apremilast in people with Psoriasis and Cardiovascular Diseases, run by University of Pennsylvania at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis, Cardiovascular Diseases
What is being tested?
Apremilast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
7 sitesUnited States
Study dates
24 Apr 2017to 17 Aug 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Buffalo Medical Group, P.C.

    Buffalo, New York, 14221

  • Dermatology and Skin Surgery Center

    Exton, Pennsylvania, 19341

  • Center for Clinical Studies

    Houston, Texas, 77004

  • University of Southern California

    Los Angeles, California, 90033

  • The University of Pennsylvania

    Philadelphia, Pennsylvania, 19140

  • Oregon Medical Research Center

    Portland, Oregon, 97223

  • Derm Associates, P.C.

    Rockville, Maryland, 20850

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Apremilast
Medical subject headings
Psoriasis, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApremilastDrug

    Also called Otezla

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

Study groups in NCT03082729
Study groupRoleWhat they receive
ApremilastOtherApremilast (Otezla), 30mg oral tablet twice per day for 52 weeks. Single arm, open label study.
Receives: Drug: Apremilast

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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).

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

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

    Ferritin is a marker of inflammation.

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

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

    CRP is a marker of inflammation.

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

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

    ICAM-1 is a marker of inflammation.

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

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

    SAA is a marker of inflammation.

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

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

    VCAM-1 is a marker of inflammation.

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

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

    IFN-gamma is a marker of inflammation.

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

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

    IL-1b is a marker of inflammation.

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

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

    IL-10 is a marker of inflammation.

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

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

    IL-17A is a marker of inflammation.

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

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

    IL-6 is a marker of inflammation.

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

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

    IL-8 is a marker of inflammation.

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

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

    IL-9 is a marker of inflammation.

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

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

    MCP-1 is a marker of inflammation.

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

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

    TNF-alpha is a marker of inflammation.

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

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

    IL2RA is a marker of inflammation.

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

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

    GlycA is a marker of inflammation.

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

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

    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).

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

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

    Triglyceride is a marker of lipid function and metabolism.

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

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

    Total Cholesterol is a marker of lipid function and metabolism.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    ApoA1 is a marker of lipid function and metabolism.

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

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

    ApoB is a marker of lipid function and metabolism.

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

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

    TRLTG is a marker of lipid function and metabolism.

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

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

    TRLC is a marker of lipid function and metabolism.

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

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

    TRLP is a marker of lipid function and metabolism.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Insulin is a marker of glucose metabolism.

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

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

    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).

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

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

    Glucose is a marker of metabolism.

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

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

    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.

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

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

    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.

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

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

    Leptin is a marker of adipose dysfunction and general metabolism.

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

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

    Adiponectin is a marker of adipose dysfunction and general metabolism.

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

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

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

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

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

    Citrate is a marker of adipose dysfunction and general metabolism.

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

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

    Valine is a marker of adipose dysfunction and general metabolism.

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

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

    Leucine is a marker of adipose dysfunction and general metabolism.

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

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

    Isoleucine is a marker of adipose dysfunction and general metabolism.

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

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

    Alanine is a marker of adipose dysfunction and general metabolism.

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

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

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

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

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

    Ketone Bodies are markers of adipose dysfunction and general metabolism.

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

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

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

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

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

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

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

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

    Acetone is a marker of adipose dysfunction and general metabolism.

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

Secondary outcomes (76)

  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

    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.

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

  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

    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.

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

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

    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).

    Measured: Baseline, week 16, and week 52.

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

    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.

    Measured: Baseline, week 16, and week 52.

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

    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.

    Measured: Baseline, week 16, and week 52.

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

    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).

    Measured: Baseline, week 16, and week 52.

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

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

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

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

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

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

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

    Ferritin is a marker of inflammation.

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

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

    CRP is a marker of inflammation.

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

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

    ICAM-1 is a marker of inflammation.

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

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

    SAA is a marker of inflammation.

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

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

    VCAM-1 is a marker of inflammation.

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

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

    IFN-gamma is a marker of inflammation.

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

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

    IL-1b is a marker of inflammation.

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

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

    IL-10 is a marker of inflammation.

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

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

    IL-17A is a marker of inflammation.

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

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

    IL-6 is a marker of inflammation.

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

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

    IL-8 is a marker of inflammation.

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

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

    IL-9 is a marker of inflammation.

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

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

    MCP-1 is a marker of inflammation.

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

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

    TNF-alpha is a marker of inflammation.

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

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

    IL2RA is a marker of inflammation.

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

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

    GlycA is a marker of inflammation.

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

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

    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).

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

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

    Triglyceride is a marker of lipid function and metabolism.

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

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

    Total Cholesterol is a marker of lipid function and metabolism.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    ApoA1 is a marker of lipid function and metabolism.

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

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

    ApoB is a marker of lipid function and metabolism.

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

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

    TRLTG is a marker of lipid function and metabolism.

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

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

    TRLC is a marker of lipid function and metabolism.

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

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

    TRLP is a marker of lipid function and metabolism.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Insulin is a marker of glucose metabolism.

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

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

    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).

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

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

    Glucose is a marker of glucose metabolism.

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

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

    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.

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

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

    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.

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

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

    Leptin is a marker of adipose dysfunction and general metabolism.

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

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

    Adiponectin is a marker of adipose dysfunction and general metabolism.

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

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

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

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

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

    Citrate is a marker of adipose dysfunction and general metabolism.

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

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

    Valine is a marker of adipose dysfunction and general metabolism.

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

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

    Leucine is a marker of adipose dysfunction and general metabolism.

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

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

    Isoleucine is a marker of adipose dysfunction and general metabolism.

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

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

    Alanine is a marker of adipose dysfunction and general metabolism.

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

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

    BCAA is a marker of adipose dysfunction and general metabolism.

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

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

    Ketone Bodies are markers of adipose dysfunction and general metabolism.

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

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

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

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

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

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

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

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

    Acetone is a marker of adipose dysfunction and general metabolism.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2017
  2. Study start24 Apr 2017
  3. Primary completion17 Aug 2021
  4. Study completion17 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03082729
Sponsor's protocol ID
826652
Other IDs
97509210
Acronym
VIP-A
Status last verified
Oct 2022
First submitted
22 Feb 2017
Last updated
10 Nov 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gelfand JM, Shin DB, Armstrong AW, Tyring SK, Blauvelt A, Gottlieb S, Lockshin BN, Kalb RE, Fitzsimmons R, Rodante J, Parel P, Manyak GA, Mendelsohn L, Noe MH, Papadopoulos M, Syed MN, Werner TJ, Wan J, Playford MP, Alavi A, Mehta NN. Association of Apremilast With Vascular Inflammation and Cardiometabolic Function in Patients With Psoriasis: The VIP-A Phase 4, Open-label, Nonrandomized Clinical Trial. JAMA Dermatol. 2022 Dec 1;158(12):1394-1403. doi: 10.1001/jamadermatol.2022.3862.

    PubMed 36129688

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Apremilast in people with Psoriasis and Cardiovascular Diseases, run by University of Pennsylvania at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 69 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03082729, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022; AzTrials last refreshed its copy on 31 Oct 2026.

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