Vascular Inflammation in Psoriasis - Extension Study (VIP-E)

University of Pennsylvania

Status and phase: Completed; Phase 4

Conditions: Psoriasis; Cardiovascular Disease

Treatments: Drug: Adalimumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01866592

817552

Details and patient eligibility

About

VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over subjects of the VIP study (# 814278) to active drug (adalimumab) to determine if there is sustained improvement in vascular inflammation, lipid metabolism, and inflammatory markers. VIP-E extends VIP study procedures for 40-52 weeks including questionnaires, physical exams, blood and urine samples, lab tests, one additional FDG-PET/CT scan, and adalimumab injections following FDA-approved psoriasis treatment regimen.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females 18 years of age and older.

2. Subject completed the VIP Study

3. Subject willing and able to avoid prolonged exposure of skin affected by psoriasis to natural or sunlight or tanning beds during the course of the study

4. Subject is willing and able to avoid topical or systemic prescription treatments for psoriasis besides adalimumab during the course of the study

5. Women are eligible to participate in the study if they meet one of the following criteria:

   1. Women of childbearing potential must undergo pregnancy testing during the baseline visit and agree to use one of the following methods of contraception throughout the 13-month study:

      • Oral contraceptives;
      • Transdermal contraceptives
      • Injectable or implantable methods
      • Intrauterine devices
      • Barrier methods (for example but not limited to a diaphragm with spermicide, condom with spermicide); or
      • Vasectomized partner
      • Subjects using oral or parental forms of contraceptives must have been using those methods of birth control for at least three months prior to the baseline visit.

   2. Women who have undergone tubal ligation

   3. Women who are postmenopausal (for at least one year), sterile, or hysterectomized are eligible to participate

   4. Women who agree to be sexually abstinent, defined as total abstinence from sexual intercourse, as a form of contraception are eligible to participate in the study.

6. Subject 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.

7. Able and willing to give written informed consent and to comply with requirements of this study protocol.

Exclusion criteria

1. Previous adverse event following exposure to a TNF-alpha antagonist that led to discontinuation of the TNF inhibitor and contraindicates future treatment.

2. Previous lack of response to a TNF-alpha antagonist led to discontinuation.

3. Diagnosis of erythrodermic psoriasis, generalized pustular psoriasis, or medication-induced or medication-exacerbated psoriasis.

4. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.

5. Subject is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.

6. Poorly controlled medical condition, such as unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents, psychiatric disease requiring frequent hospitalization, and any other condition, which, in the opinion of the Investigator, would put the subject at risk by participation in the study.

7. History of diabetes mellitus, type 1 or type 2 (patients with type 2 diabetes may be enrolled if the duration of diabetes is <10 years and HbA1c is <7.0%)

8. Uncontrolled hypertension, with measured systolic blood pressure >180 mmHg or diastolic blood pressure >90 mmHg

9. History of demyelinating diseases or lupus.

10. Subject has infection or risk factors for severe infections, for example:

    • 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;
    • Evidence of latent TB infection demonstrated by Purified Protein Derivative (PPD) ≥ 5 mm of induration or positive Quantiferon-GOLD results as determined within 6 months of the baseline visit for VIP-E; except if prophylactic treatment for TB, as recommended by local guidelines, is initiated prior to administration of study drug or if there is documentation that the subject has received prophylactic treatment for TB previously.
    • Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the month prior to Baseline;
    • Infection requiring treatment with oral or parenteral antibiotics within 14 days prior to Baseline;
    • Subject will require a live vaccination during study participation including up to 30 days after the last dose of study drug.

11. Subject has history of hematological or solid malignancy within the past five years other than successfully treated basal cell carcinoma, non-metastatic cutaneous squamous cell carcinoma or cervical carcinoma in situ.

12. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.

13. Clinic laboratory analyses showing any of the following abnormal results:

    • Hemoglobin (Hgb) < 10 g/dL in females or <12 g/dL in males;

    • White blood cell (WBC) count <2.5 x 109/L

      • Subject can be included if WBC count is <2.5 x x 109/L and absolute neutrophil count (ANC) is >1000 cells / mm3.

    • WBC count > 15 x 109/L;

    • Platelet count < 100 x 109/L;

    • Serum aspartate transaminase (AST) or alanine transaminase (ALT) >2.5 upper limits of normal (ULN);

    • Serum total bilirubin ≥2 mg/dL (≥26 µmol/L)

14. Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.

15. If subject is on cholesterol-lowering medication (e.g. statin), dose and form of medication must be stable for 90 days prior to baseline and remain stable throughout the duration of the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

Single-Arm, open-label extension trial

Other group

Description:

Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.

Treatment:

Drug: Adalimumab