EUCTR2013-000537-12-HU进行中（未招募）不适用
A Phase 3, Multicenter, randomized, double-blind study evaluating the efficacy and safety of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psoriasis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 340
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. Subject has provided informed consent
- •2. Subject is between 18 and 75 years of age at time of screening
- •3. Subject has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the Investigator)
- •4. Subject has involved body BSA more than or equal to 10%, PASI more than or equal to 12, and static Physician’s Global Assessment (sPGA) more than or equal to 3 at screening and at baseline
- •5. For women (except those at least 2 years postmenopausal or surgically sterile): a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline
- •6. Subject has no known history of active tuberculosis
- •7. Subject has a negative test for tuberculosis during screening defined as either:
- •-negative purified protein derivative (PPD) (< 5 mm of induration at 48 to 72 hours
- •after test is placed)
- •-negative Quantiferon test
- •8. Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test
- •9. Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate Quantiferon test are allowed if they have all of the following:
- •-no symptoms per tuberculosis worksheet provided by the Sponsor, Amgen
- •-documented history of adequate prophylaxis initiation prior to receiving study drug in
- •accordance with local recommendations
- •-no known exposure to a case of active tuberculosis after most recent prophylaxis
- •-no evidence of active tuberculosis on chest radiograph within 3 months prior to screening
- •10. Subject is a candidate for systemic therapy or phototherapy
- •11. Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy (eg, methotrexate, cyclosporine, psoralen plus ultraviolet light [UV] A)
- •12. Subject is able to complete study procedures
- •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 310
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Skin disease related
- •1. Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis
- •Other medical conditions
- •2. Subject has a planned surgical intervention during the duration of the study
- •3. Subject has an active infection or history of infections as follows:
- •-any active infection for which systemic anti-infectives were used within 28 days prior to first dose of investigational product
- •-a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product
- •-recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject
- •4. Subject has known history of human immunodeficiency virus
- •5. Hepatitis B surface antigen or Hepatitis C antibody positivity at screening
- •6. Subject has uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease, renal failure, liver disease, or hypertension
- •7. Subject has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma
- •8.Subject has active neurological disease such as multiple sclerosis, Guillain-Barre syndrome, optic neuritis, transverse myelitis or history of neurologic symptoms suggestive of central nervous system demyelinating disease
- •9.Subject has moderate to severe heart failure (New York Heart Association [NYHA] class III/IV)
- •10.Subject has a history of hypersensitivity to the active substance or to any of the excipients of adalimumab or ABP 501
- •11.Subject has any concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject
研究者
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