Secukinumab In patients with moderate to severe active, chronic plaque psoriasis who have failed on TNFa antaGoNists: A clinical Trial EvalUating Treatment REsults - SIGNATURE

ovartis Pharmaceuticals UK Limited0 个研究点目标入组 235 人开始时间: 2013年8月15日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•- Chronic plaque-type psoriasis diagnosed for at least 6 months prior to screening
•- Moderate to severe disease severity at randomisation
•PASI =10 and
•- Failed to respond to systemic therapies including ciclosporin, methotrexate and PUVA/Phototherapy (or is intolerant and/or has a contraindication to these)
•- Previously treated with at least one anti-TNFa for moderate or severe psoriasis but is a primary or secondary non-responder.
•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 258
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis)
•- Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium)
•- Use of prohibited psoriasis or non-psoriasis treatments
•- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor
•- Pregnant or nursing (lactating) women
•- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use 2 (two) effective forms of contraception during the study and for 16 weeks after stopping treatment.
•- Men with a female partner of child bearing potential defined as all women physiologically capable of becoming pregnant unless they use 1 (one) effective form of contraception during the study and for 16 weeks after stopping treatment.
•- Plans for administration of live vaccines during the study period or 6 weeks prior to initiation of study drug.

发起方

ovartis Pharmaceuticals UK Limited