BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.

Boehringer Ingelheim International GmbH0 个研究点目标入组 365 人开始时间: 2016年9月5日最近更新: 2022年1月24日

适应症

试验速览

暂无简介。

•1. Males and females aged =18 and =80 years who have a diagnosis of moderate to severely active CD, confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following:
•a. CDAI score of =220 and =450
•b. A diagnosis of CD confirmed by ileocolonoscopy during Screening
•c. Presence of mucosal ulcers in at least one segment of the ileum or
•colon and a SES-CD score >=7 (for patients with isolated ileal disease
•SES-CD score >=4), as assessed by ileocolonoscopy and confirmed by
•central independent reviewer(s) before randomisation.
•2. Anti-TNF naïve patients or previously treated with infliximab who had
•initially responded and who meet one of the following criteria:
•a. Responded and developed secondary resistance due confirmed anti-infliximab ADA formation, which caused infliximab depletion
•b. Responded and became intolerant
•3. Willing to undergo up to 3 endoscopies
•4. For participants of reproductive potential, a reliable means of contraception has to be used throughout trial participation.
•5. Signed and dated written informed consent.
•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 124
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•1. Ulcerative colitis or indeterminate colitis
•2. Symptomatic known obstructive strictures
•3. Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while in the trial
•4. Ostomy or ileoanal pouch
•5. Short bowel syndrome

发起方