Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC)

Boehringer Ingelheim Pharma GmbH & Co. KG0 个研究点目标入组 17 人开始时间: 2017年3月9日最近更新: 2022年4月19日

试验速览

暂无简介。

•- 18 – 65 years at screening
•- Diagnosis of UC =3 months prior to screening.
•- Moderately to severely active UC as confirmed by Mayo Score =6
•- Receiving conventional, non-biologic therapy for UC.
•- Negative colon cancer screening
•- Naive or experienced to TNF antagonists (but have not failed that treatment due to primary non-response or loss of response)
•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 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Patients who have previously failed treatment with any TNF antagonist due to primary non-response or loss of response
•- Prior use of any other biological treatment in the past (e.g. integrin inhibitors, IL12/23 or IL23 inhibitors , any other investigational biological drugs)
•- Extensive colonic resection
•- Evidence of infection with C. difficile or other intestinal pathogen < 30 days prior to screening
•- Active or latent tuberculosis

发起方