EUCTR2016-001531-12-HU进行中（未招募）1 期
A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, and Safety of LNP1955 in Patients with Moderate-to-Severe Plaque Psoriasis
upin Limited0 个研究点目标入组 40 人开始时间: 2016年6月15日最近更新:
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
- 40
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
- •Patients will be enrolled in the Main part and MTX Add-on part of the
- •study only if they meet all of the following criteria:
- •1. Male or female ambulatory patients aged 18 to 75 years (both
- •inclusive) diagnosed with moderate-to-severe chronic stable plaque
- •psoriasis with active disease, PASI score of = 10 and affected BSA =
- •10% and willing to provide informed consent;
- •2. Plaque psoriasis for at least 6 months prior to first dose of IP;
- •3. Are a candidate for phototherapy, photochemotherapy, or systemic
- •therapy of plaque psoriasis (either naive or history of previous
- •treatment);
- •4. Have not taken biologics within 6 months prior to administration of IP
- •in this study;
- •5. Have not received systemic non-biologic psoriasis therapy (including,
- •but not limited to, retinoids or vitamin D analogs, cyclophosphamide,
- •cyclosporine, fumaric acid esters, pimecrolimus, or psoralen plus
- •ultraviolet A light [PUVA]) or phototherapy within 4 weeks before the
- •first dose of IP;
- •6. Have not received topical psoriasis treatment within 2 weeks before
- •the first dose of IP;
- •7. Sexually active women of childbearing potential and men must be
- •willing to use a reliable means of contraception (e.g. combined or
- •progestogen only hormonal contraception, intrauterine devices [IUDs],
- •surgical sterilization, double barrier, or vasectomized partner) during
- •participation in this study and at least 2 months after the last dose of the
- •IP OR postmenopausal women (aged greater than 45 years) with a
- •history of amenorrhea for at least 1 year from the time of last menstrual
- •cycle and have follicle-stimulating hormone (FSH) value indicating
- •menopause with high reliability. Additional Inclusion Criteria for Main
- •part: 1. Have not received MTX within 6 weeks prior to first dose of IP.
- •Additional Inclusion Criteria for MTX Add-on part:
- •1. MTX naive and eligible to receive 7.5 mg MTX per week after having
- •tolerated at least one dose (OR);
- •2. Patients receiving stable dose of 7.5 mg MTX per week.
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •Patients who meet any of the following criteria will not be eligible for the
- •1. Current diagnosis of non-plaque forms of psoriasis, e.g.,
- •erythrodermic, guttate, or pustular psoriasis;
- •2. Known allergies or hypersensitivities that can have potential impact
- •on patient's participation as determined by the Investigator;
- •3. Receiving drugs that are known to exacerbate psoriasis such as beta
- •blockers, calcium channel blockers, antimalarial drugs or lithium;
- •4. Receiving oral or injectable (e.g., intraarticular, intramuscular, or
- •intravenous) corticosteroids for any other condition;
- •5. Women who are pregnant, lactating, or planning pregnancy while
- •enrolled in the study and at least 2 months after last dose of the IP; 6.
- •History of infection requiring hospitalization, parenteral antimicrobial
- •therapy, or
- •otherwise judged clinically significant by the Investigator within 1
- •month prior to first dose of IP;
- •7. History of infection requiring oral antimicrobial therapy within 2
- •weeks prior to first dose of IP;
- •8. Patients with active tuberculosis, prior history of unsuccessfully
- •treated tuberculosis (TB), latent TB (patients who are positive for test
- •for latent TB e.g. QuantiFERON®-TB Gold test or appropriate test), or
- •those who are at risk of developing TB;
- •9. History of any lymphoproliferative disorder (such as Epstein Barr
- •Virus [EBV] - related lymphoproliferative disorder), history of
- •lymphoma, leukemia, or signs and symptoms suggestive of current
- •lymphatic disease;
- •10. Patients suffering from significant acute or chronic, localized or
- •disseminated infections (bacterial/fungal/viral) or sepsis, or patients
- •with a history of recurring infections except Herpes simplex within 3
- •months prior to screening, or those who are at an increased risk of
- •developing infections or sepsis as determined by the Investigator;
- •11. History or presence of any immunological disease or use of
- •immunosuppressive or any therapy within a period that can have a 12. Recent live vaccine administration within 4 weeks prior to screening
- •and during the study;
- •13. Have any known condition affecting oral absorption of drug e.g.,
- •(malabsorption syndrome), or not able to swallow IP for any reason;
- •14. History of abuse of alcohol, recreational, or illegal drugs within 1
- •year prior to screening;
- •15. Tested seropositive for Hepatitis B [Hepatitis B surface antigen
- •(HBsAg)], and Hepatitis C virus (HCV), or human immunodeficiency virus
- •16. History of malignancy in the last five years prior to screening, except
- •curatively treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin;
- •17. Severe anemia (hemoglobin < 8 g/dL), leukopenia or thrombocytopenia (white blood cell [WBC] < 3,500/µL; platelet count < 100,000/µL), biochemistry (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3x upper limit of normal [ULN]; serum creatinine > 1.5 mg/dL (133 µmol/L) up to age 65 years and > ULN if age > 65 years) and serum bilirubin > 2 x ULN;
- •18. Significant abnormalities in the ECG;
- •19. Current or recent history of a severe, progressive, or uncontrolled
- •disease or any clinically significant laboratory abnormality, which in the
- •opinion of investigator makes the patient inappropriate for inclusion in
- •this study.
- •Additional Exclusion Criteria for MTX Add-on part:
- •1. Intolerance to MTX;
- •2. Contraindication to MTX (e.g., hypersensitivity to MTX or its
- 另有 3 项未显示
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