A Phase 3b, multicenter, interventional, open-label study of adult subjects with moderate to severe plaque psoriasis who have a suboptimal response to secukinumab or ixekizumab and are switched to risankizumab. - RISA Raise Standard of Care Study M19-164

AbbVie0 个研究点目标入组 244 人开始时间: 2019年9月9日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•* Adult subjects 18 years and older at screening;
•* Diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0);
•* Subject must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing a sub-optimal response at time of Screening and Baseline visits
•* Sub-optimal response to Secukinumab and Ixekizumab inhibitors is defined as:
•- Body Surface Area (BSA) 3% - <10% and
•- Static Physician Global Assessment 2/3
•* Subject must be eligible for continued biologic therapy as assessed by the investigator
•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 220
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•* History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis, psoriatic arthritis;
•* No active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis;
•* History of chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB /PPD test result may participate in the study if further work up (according to local
•practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines;
•* Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold) as assessed by the investigator;
•* History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix;
•* History of major surgery performed within 12 weeks prior to randomization or planned to be performed during the conduct of the trial as assessed by the investigator;
•* Previous exposure to risankizumab or any IL-23 inhibitors.

发起方

AbbVie