A Phase II, randomised, double-blind, placebo-controlled, parallel-group, dose-ranging, efficacy and safety trial of BI 730357 given for 12 weeks in patients with active psoriatic arthritis

Boehringer Ingelheim Pty Ltd0 个研究点目标入组 160 人开始时间: 2020年10月20日最近更新: 2021年6月28日

适应症

试验速览

暂无简介。

•Males or females, aged >/= 18 years and <= 75 years at screening
•- Have PsA symptoms for at least 6 months prior to screening, as assessed by the investigator
•- Have PsA on the basis of the CASPAR with peripheral symptoms at screening visit, as assessed by the investigator
•- Have at least 3 tender joints and at least 3 swollen joints at screening and randomisation visits, as assessed by the investigator
•- At least one PsO skin or nail lesion or a documented personal history of PsO at screening, as assessed by the investigator
•- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

•- Major chronic inflammatory or connective tissue disease other than PsA (e.g. rheumatoid arthritis, systemic lupus
•erythematosus, ankylosing spondylitis, Lyme disease, gout) or fibromyalgia, as assessed by the investigator
•- Active uveitis or uveitis within 4 weeks prior to randomisation disease assessed by the investigator
•- Suspected or diagnosed inflammatory bowel disease assessed by the investigator
•- Previous exposure to BI 730357
•- Prior use of any therapeutic agent directly targeted to IL-12/23, IL-23 or IL-17
•- Prior use of more than two different TNFi agents

发起方