EUCTR2017-002012-13-IT进行中（未招募）1 期
EXPLORATIVE STUDY ON THE BIOLOGICAL MECHANISMS INVOLVED IN THE PATHOGENESIS OF PSORIASIS - n.a.
IRCCS ISTITUTO CLINICO HUMANITAS0 个研究点目标入组 60 人开始时间: 2021年1月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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 ¿ 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 surface area (BSA) ¿ 10%, PASI ¿ 10, at baseline
- •5. For women, except those at least 2 years post-menopausal (defined as no menses for 12 months without an alternative medical cause) or surgically sterile: a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline.
- •6. Women with child bearing potential must agree to use Highly effective method of contraception during the treatment and until the end of relevant systemic exposure including: - 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; intrauterine device (IUD); intrauterine hormone-releasing system ( IUS).
- •7. Males with women of childbear potential partners must agree to use contraception during the treatment and until the end of relevant systemic exposure.
- •8.Subject has no known history of active tuberculosis
- •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
- •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
- •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 the first dose of investigational product
- •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, cyclosporine, psoralen plus ultraviolet light [UV] A)
- •12.Subject should not be previously treated with methotrexate or ustekinumab
- •13.Subject is able to complete study procedures, including self-assessments and self-injections.
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
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 or HIV 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 any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma
- •8.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
- •9.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
- •10.Subject has moderate to severe heart failure (New York Heart Association [NYHA] class III/IV)
- •11.Subject has a history of hypersensitivity to the active substance or to any of the excipients of adalimumab
- •12.Subject has any concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject
- •Laboratory abnormalities
- •13.Laboratory abnormalities at screening, including any of the following:
- •Hemoglobin < 9 g/dL
- •Platelet count < 100,000/mm3
- •White blood cell count < 3,000 cells/mm3
- •Absolute neutrophil count (ANC) < 1000/mm3
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ¿ 1.5 x the upper limit of normal
- •Creatinine clearance < 50 mL/min (Cockroft-Gault formula)
- •Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
- •Washouts and non-permitted drugs
- •14.Subject has used UV B therapy within 14 days before first dose of investigational product
- •15.Subject has used topical therapy for psoriasis as follows:
- •superpotent (class I) or potent (class II) topical steroids or topical anthralin within 14 days before first dose of investigational product
- •any other formulation or potency of topical therapy or UV B phototherapy within 14 days before first dose of investigational product (exception: upper mid-strength to least potent [class III to VII] topical steroids permitted on the palms, soles, face and intertriginous areas)
- •16.Subject has used the following within 28 days of first dose of investigational product:
- •UV A light therapy (with or without psoralen) or excimer laser;
- •non-biologic syste
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