A randomized, double-blind, multicenter, 24-week study of subcutaneous secukinumab to assess anti-interleukin-17A treatment in plaque psoriasis patients with coexisting non-alcoholic fatty liver disease (pINPOINt) - pINPOINt

ovartis Pharma GmbH0 个研究点目标入组 90 人开始时间: 2019年10月24日最近更新: 2021年8月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 90

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study, and must provide written, signed and dated informed consent before any study assessment is performed.
•2. Men and women = 18 years of age at the time of consent.
•3. Moderate to severe plaque-type psoriasis diagnosed for at least 6 months prior to Screening with a PASI of >10 at baseline.
•4. Candidate for systemic therapy, defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by:
•topical treatment and/or,
•Phototherapy and/or,
•Previous systemic therapy.
•5. Diagnosis of NAFLD by either ultrasound at Screening or liver histology within 6 months before Baseline.
•6. Obesity with BMI > 25 kg/m2 at Screening.
•7. Elevation of ALT 1.2 to 3.0 × ULN.
•8. Liver fat = 8% at Screening as determined by the reading of the central MRI vendor of locally produced images. Note: the MRI assessment should only be performed after eligibility has been confirmed for all other Screening assessments.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

排除标准

•1. Forms of psoriasis other than chronic plaque-type psoriasis at Screening.
•2. Drug-induced psoriasis at Screening and baseline.
•3. Ongoing use of prohibited treatments. Respective washout periods detailed in this section have to be adhered to.
•4. History of hypersensitivity to any of the study drug constituents.
•5. Pregnant or nursing (lactating) women.
•6. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the study or longer if required by locally approved prescribing information.
•7. Previous treatment with biological drug targeting IL-17 or the IL-17 receptor.
•8. Past medical history record of infection with HIV, hepatitis B or hepatitis C prior to screening.
•9. Active systemic infections during the last two weeks (exception: common cold) prior to randomization or any infection that reoccurs on a regular basis.
•10. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold Plus (QFT) test at screening. Subjects with a positive or indeterminate QFT test may participate in the study if full tuberculosis work up (according to local practice/guidelines) was completed within 12 weeks prior to randomization and establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment according to local guidelines must have been completed prior to screening. During treatment of latent tuberculosis, ALT had to remain below 2x compared to pre-treatment ALT value.
•11. Significant medical problems, including but not limited to:
•Congestive heart failure [New York Heart Association status of class III or IV].
•Severely reduced kidney function (eGFR = 29 mL/min/1.73 m2).
•12. Unstable weight (± 5%) over the last 6 months prior to Screening.
•13. Type I diabetes, or uncontrolled Type II diabetes defined as HbAlc = 10% at Screening.
•14. Total white blood cell (WBC) count < 2500/µL, or neutrophils < 1500/µL or hemoglobin < 8.5 g/dL at Screening.
•15. Evidence of hepatic decompensation or severe liver impairment or cirrhosis, as defined by the presence of any of the following abnormalities:
•Serum albumin < 3.2 mg/dL
•INR > 1.3
•Total bilirubin > 1.3 mg/dL
•AST > 5 × ULN
•Alkaline phosphatase > 300 IU/L
•Platelets outside of normal reference range (± 5%)
•History of esophageal varices, ascites, or hepatic encephalopathy
•Splenomegaly
•16. History of liver transplantation or planned liver transplant.
•17. History of biliary diversion.
•18. Presence or history of other liver disease (including but not limited to autoimmune hepatitis, hereditary hemochromatosis, alpha 1-antitrypsin deficiency, Wilson’s disease, drug-induced liver disease).
•19. Current, or history of, significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females or more than 30 g/day in males, on average) or a score on the modified AUDIT questionnaire = 8.
•20. History of bariatric surgery or intention to have bariatric surgery during study conduct.
•Other protocol-defined exclusion criteria may apply.

研究者

发起方

ovartis Pharma GmbH

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