Evaluation of the eFfect of early Initiation of secukinumab in systemic treatment-naïve patients with moderate to severe plaque psoriasis Requiring Systemic Treatment (FIRST) - F1RST - Evaluation of early initiation of secukinumab

ovartis Pharmaceuticals UK Limited0 个研究点目标入组 0 人开始时间: 2016年10月17日最近更新: 2019年6月30日

试验速览

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•1.Men or women aged >18 years at time of Screening.
•2.Chronic plaque-type psoriasis diagnosed for at least 4months prior to Screening.
•3.Moderate to severe plaque-type psoriasis and candidate for systemic therapy as defined by: a.PASI score =10 and DLQI >10 at Baseline, and b. Psoriasis that is inadequately controlled by topical treatment (including topical corticosteroids) and/or phototherapy/PUVA
•4.Patients must be able to understand and communicate with the Investigator and comply with the requirements of the study (including administration of s.c. injections) and must provide written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
•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 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•1. Any forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. ,pustular, erythrodermic, guttate and drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at Screening.
•2.Previous treatment with any systemic therapy for psoriasis, including methotrexate, ciclosporin, acitretin and biologic therapies.
•3.Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UVB/PUVA); washout periods detailed in the protocol must be adhered to.
•4.Ongoing use of non-psoriasis prohibited treatments (e.g., immunosuppressants); washout periods detailed in the protocol must be adhered to.
•5.Allergy to rubber or latex or a history of hypersensitivity to any of the study drugs, any of their excipients or to drugs of similar chemical classes.
•6.Pregnant or nursing (lactating) women.
•7.Women of child-bearing potential (WOCBP).
•8.History of an ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection

发起方

ovartis Pharmaceuticals UK Limited