EUCTR2020-003184-25-LV进行中（未招募）1 期
A Phase 3, Multicenter , Randomized, Double-Blind Study Evaluating the Efficacy and Safety of ABP 654 Compared with Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
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
- Amgen, Inc.
- 入组人数
- 542
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. Men and women = 18 years and = 75 years of age at the time of randomization
- •2. 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)
- •3. Baseline score of PASI = 12, involvement of = 10% BSA, and sPGA = 3 at screening and at baseline
- •4. Candidate for phototherapy or systemic therapy
- •5. Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy (eg, methotrexate, cyclosporine, psoralen plus ultra-violet light [PUVA])
- •6. 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
- •7. Signed Institutional Review Board/Ethics Committee (IRB/IEC)-approved informed consent and able to complete study procedures
- •8. No known history of latent or active TB. Subject must meet any 1 of the following 3 criteria:
- •Subject has a negative test for tuberculosis during screening, defined as either:
- •o Negative purified protein derivative (PPD; < 5 mm of induration at 48 to 72 hours after test is placed) OR
- •o Negative Quantiferon®/T-spot test
- •Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon®/T-spot®
- •Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin [BCG] vaccination) or subjects with a positive or indeterminate Quantiferon®/T-spot test are allowed if they have all of the following:
- •o No symptoms per tuberculosis worksheet provided by the sponsor, Amgen
- •o Documented history of adequate prophylaxis initiation prior to receiving investigational product in accordance with local recommendations
- •o No known exposure to a case of active TB after most recent prophylaxis
- •o No evidence of active TB on chest radiograph within 3 months prior to the first dose of investigational product
- •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 435
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 107
排除标准
- •Skin disease related conditions
- •1. Erythrodermic psoriasis (PsO), pustular PsO, guttate PsO, medication induced PsO, 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 PsO
- •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:
- •a. Any active infection for which systemic anti-infectives were used within 28 days prior to randomization
- •b. A serious infection, defined as requiring hospitalization or intravenous antiinfectives within 8 weeks prior to randomization
- •c. 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. Known history of human immunodeficiency virus (HIV)
- •5. Hepatitis B surface antigen (HbsAg) or HCV antibody positivity at screening
- •6. Uncontrolled, clinically significant systemic disease such as uncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease, or hypertension
- •7. Known malignancy within the previous 5 years (except treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma)
- •8. 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. Moderate to severe heart failure (New York Heart Associate [NYHA] class III/IV)
- •10. Known hypersensitivity to the investigational product or to any of the excipients
- •11. Any concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject Laboratory abnormalities
- •12. Laboratory abnormalities at screening, including any of the following:
- •a. Hemoglobin < 9 g/dL
- •b. Platelet count < 100,000/mm3
- •c. White blood cell count (WBC) < 3,000 cells/mm3
- •d. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 2.0 × the upper limit of normal (ULN)
- •e. Creatinine clearance < 50 mL/min (Cockcroft-Gault formula)
- •f. 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
- •13. Previous treatment with any agent specifically targeting IL-12 or IL-23
- •14. Received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is the longer) prior to randomization
- •15. Received any investigational agents within the previous month or 5 drug half-lives (whichever is the longer) prior to randomization
- •16. Received non-biologic systemic psoriasis therapy within 4 weeks prior to randomization (specified in Protocol section 5.2)
- •17. Received Ultra-violet A (UVA) phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to randomization, or ultra-violet B (UVB) phototherapy within 2 weeks prior to randomization
- •18. Received topical psoriasis treatment within 2 weeks prior to randomization (exception: upper mid-strength to least potent [class III to VII] topical steroids permitted on the palms, soles, face, and intertriginous areas; bland emollients [without urea or a- or ß-hydroxy acids])
- •19. Received live viral or live bacterial vaccination within 2 we
研究者
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