A 24-week, multicenter, proSpective, open-label stUdy to evaluate the efficacy in terms of non-inferiority with respect to PASI 90 response rate and the safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive patients with moderate to severe chronic plaque-typepsoriasis (SUPREME) - SUPREME

OVARTIS FARMA S.p.A.0 个研究点目标入组 406 人开始时间: 2014年9月15日最近更新: 2018年3月12日

适应症

试验速览

暂无简介。

•1. Subject must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed.
•2. Men or women at least 18 years of age at time of screening.
•3. Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months.
•4. Psoriasis of the scalp, hands or diagnosis of concomitant psoriatic arthritis as per CASPAR criteria.
•5. Moderate to severe psoriasis as defined at enrollment by:
•? PASI score = 10
•? PASI score > 5 but < 10 and DLQI =10
•6. Failed response to at least two systemic therapies (i.e. cyclosporine, methotrexate and PUVA) or to an anti-TNFa (or is intolerant and/or has a contraindication to these).
•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 350
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 56

•1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis).
•2. Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1.
•3. Anti-TNFa therapy within timelines depending on drug half-life.
•4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
•5. Previous exposure to ustekinumab or any other biologic drug for the treatment of psoriasis that is not anti-TNFa therapy.
•6. Intravenous or intramuscular steroids within 2 weeks prior to screening and during screening.
•7. Ongoing use of corticosteroid topical treatments or UV therapy.

发起方

OVARTIS FARMA S.p.A.