A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study).

VHsquared Ltd0 个研究点目标入组 126 人开始时间: 2017年1月6日最近更新: 2019年4月30日

研究概览

暂无简介。

•1. History of CD (confirmed by ileocolonoscopy) of at least three
•months duration prior to Visit 1
•2. CDAI score of =220 to =450 during Screening
•3. CRP =5 mg/L (or, if CRP is normal, FCP= 250 µg/g ) at Screening
•4. Active CD of ileum and/or colon as determined by the baseline
•ileocolonoscopy
•5. Female subjects must not be pregnant and male and female subjects must agree to use effective contraception throughout the study and for 90 days after the last dose of study drug.
•6. Subject must have failed or experienced intolerance to at least
•one of the following: aminosalicylates, corticosteroids; immunosuppressants
•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 111
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•The main criteria for exclusion are:
•1. CD of mouth, stomach, oesophagus or duodenum which, in the
•opinion of the Investigator, is likely to be causing symptoms
•2. Known history of or suspicion of ulcerative colitis, indeterminate colitis, microscopic colitis, ischaemic co litis or radiation-induced colitis, based on medical history, endoscopy and/or histological findings.
•3. Any gastrointestinal (GI) manifestations of CD that might affect
•the evaluation of efficacy
•4. Prior primary efficacy failure of o r secondary loss of response to
•anti-TNFa therapy, or any contraindication to anti-TNFa therapy
•5. The use of medications prior to the study or during the study
•with the potential to affect the evaluation of efficacy

发起方