NCT03478280Unknown4 期
Effect of Brodalumab Compared to Placebo on Vascular Inflammation in Moderate-to-severe Psoriasis
Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年9月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The aortic wall inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.
研究概览
简要总结
A randomised, double-blind, placebo-controlled, trial to evaluate the efficacy of brodalumab monotherapy on vascular and systemic inflammation by 18F-FDG-PET/CT in subjects with moderate-to-severe plaque-type psoriasis who are candidates for systemic therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from the subject prior to performing any protocol-related procedures.
- •Age 40 and above.
- •Diagnosis of chronic plaque psoriasis confirmed by a dermatologist
排除标准
- •Non-Danish speaking
- •Known or suspected allergy or reaction to any component of the IMP formulation.
- •History of inflammatory bowel disease, arthritis (not including psoriatic arthritis), systemic lupus erythematosus, and active inflammatory skin diseases.
- •A history of malignancies within the past five years (excluding localized non-melanoma skin cancer).
- •Topical corticosteroid treatment (class III or stronger) and/or ultraviolet type B phototherapy within 2 weeks prior to randomization
- •Treatment with psoralen plus ultraviolet type A photochemotherapy, methotrexate, cyclosporine, acitretin, or fumaric acid esters within 4 weeks prior to randomization.
- •Treatment with adalimumab, etanercept, infliximab, cosentyx, or ixekizumab within 12 weeks, ustekinumab within 24 weeks, or other immunosuppressive or anti-inflammatory agents within 5 half-lives of the active substance prior to the FDG-PET/CT, respectively.
- •Scheduled surgery during the trial period (expect minor minimally invasive procedures).
- •Systemic infection or fever within 7 days prior to FDG-PET/CT.
- •Severe obesity (> 150 kg due to a PET/CT scanner limitation).
- •Presence of uncontrolled diabetes mellitus (HbA1c > 75 mmol/mol and/or blood sugar > 11.1 mmol/l and/or clinical judgment).
- •History of coagulation defects (clinical judgment).
- •Active or latent tuberculosis requiring treatment.
- •Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb may be randomised provided they are hepatitis B vaccinated and have negative HBsAg and HBcAb.
- •History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal report.
- •No history of varicella zoster infection and negative varicella antibody test (until varicella vaccination is completed).
- •History of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the investigator.
- •History of intravenous drug use.
- •History of attempted suicide or is at significant risk of suicide.
- •Major surgery within the past 3 months.
- •Pregnancy or lactation (Women of childbearing potential must use a highly effective* form of birth control (confirmed by the investigator) throughout the trial and until 12 weeks after discontinuation of treatment with brodalumab.
- •Claustrophobia.
- •Reduced renal function (serum creatinine > 200 μmol/L or cr-EDTA clearance < 30 ml/min)
- •Any disorder, including but not limited to, cardiovascular, lung, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, psychiatric, or major physical impairment that is not stable, in the opinion of the investigator, and could:
- •Affect the safety of the subject throughout the trial.
- •Influence the findings of the trial or their interpretations.
- •Impede the subject's ability to complete the entire duration of trial.
- •A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as bilateral tubal occlusion, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), sexual abstinence (when this is in line with the preferred and usual life style of the subject), vasectomised partner (given that the subject is monogamous). The subjects must have used the contraceptive method continuously for at least 1 month prior to the pregnancy test. A female is defined as not being of child bearing potential if she is postmenopausal (at least 12 months with no menses without an alternative medical cause prior to screening), or surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy).
研究组 & 干预措施
Brodalumab
Active Comparator
Subjects will receive 210 mg of Kyntheum administered by subcutaneous injection at Weeks 0, 1 and 2 followed by 210 mg every other week (EOW) thereafter.
干预措施: Brodalumab (Drug)
Placebo
Placebo Comparator
Subjects will receive placebo doses administered by subcutaneous injection at Weeks 0, 1 and 2 followed by placebo EOW thereafter.
干预措施: Placebos (Drug)
结局指标
主要结局
The aortic wall inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.
时间窗: 16 weeks
The average of maximum TBR values (MeanTBRmax) of the entire aorta at baseline and at week 16
次要结局
- The aortic wall subsegment inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.(16 weeks)
- The splenic inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.(16 weeks)
- The skin inflammation at baseline and at week 16 in brodalumab treated psoriasis subjects compared to placebo.(16 weeks)
研究者
Anne Bregnhøj
MD, PhD
Aarhus University Hospital
研究点 (1)
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