EUCTR2016-003867-21-DE进行中（未招募）1 期
A phase 4 trial comparing the efficacy of subcutaneous injections of brodalumab to oral administrations of fumaric acid esters in adults with moderate to severe plaque psoriasis
EO Pharma A/S0 个研究点目标入组 204 人开始时间: 2017年8月15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
- 204
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
入选标准
- •- Men or women =18 years of age at the time of screening
- •- Subjects with chronic plaque type psoriasis diagnosed for at least 6 months before randomisation
- •- Subjects with moderate to severe plaque psoriasis in whom topical therapy is not adequate and who are candidates for systemic therapy, defined at randomisation by PASI >10, affected BSA >10% and DLQI >10
- •- Subject has no known history of active tuberculosis
- •- Subject has a negative test for tuberculosis taken at screening (negative QuantiFERON test)
- •- Subject and/or subject’s designee is/are capable of administering subcutaneous 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 204
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous or current systemic treatment of plaque psoriasis or known contraindication for systemic therapy.
- •Previous or current PUVA (psoralens and ultraviolet A) therapy.
- •Washouts and non-permitted drugs:
- •a) Have received phototherapy (UVA light therapy without psoralens, UVB light therapy, excimer laser, tanning beds etc. within 4 weeks of baseline
- •b) Have had topical psoriasis treatment within 2 weeks of baseline (exceptions: bland emollients without urea or beta or alpha hydroxy acids).
- •c) Have received any biologic immune modulating treatment used for indication other than psoriasis within 4 weeks of baseline or within a period of 5 half-lifes of the received treatment,
- •whichever is longer
- •d) Have received any other systemic immune modulating treatment (including but not limited to oral retinoids, methotrexate, calcineurin inhibitors, oral or parenteral corticosteroids etc. used
- •for indication other than psoriasis) within 4 weeks of baseline or within a period of 5 half-lifes of the received treatment, whichever is longer.
- •Subjects with any of the following laboratory abnormalities at screening:
- •a) Leukocyte cell count below 3×109/L or lymphocyte count below 0.7×109/L.
- •b) Aspartate aminotransferase (AST) or alanine transferase (ALT) > 2× ULN (upper level of normal limit).
- •c) Absolute neutrophil count < 2× 109/L.
- •d) Serum creatinine > ULN.
- •History of depressive disorder within the last 2 years including current anti-depressive treatment.
- •Any positive finding in history of suicidal behaviour (e.g., ‘actual suicide attempts’, ‘interrupted attempts’, ‘aborted attempts’, or ‘preparatory actions’) based on the eC-SSRS questionnaire at screening or baseline.
- •Any positive finding in suicidal ideation of level 4 or 5 (‘some intent to act, no plan’ or ‘specific plan and intent’) based on the eC-SSRS questionnaire at screening or baseline.
- •A PHQ-8 score of =10 corresponding to moderate to severe depression at screening or baseline.
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