A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn*s disease<br> - V56502 - HARBOR

VHsquared Ltd0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年2月28日

研究概览

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•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 *g/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

•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-TNF* therapy, or any contraindication to anti-TNF* therapy
•5. The use of medications prior to the study or during the study with the potential to affect the evaluation of efficacy

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