A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallelgroup, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Janssen Pharmaceutical K.K.1 个研究点目标入组 1,340 人开始时间: 待定最近更新: 2022年12月5日

适应症

试验速览

暂无简介。

•Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
•Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
•Have screening laboratory test results within the protocol specified parameters
•A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
•Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

•Current diagnosis of ulcerative colitis or indeterminate colitis
•Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
•Unstable doses of concomitant Crohn's disease therapy
•Receipt of Crohn's disease approved biologic agents (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 8 weeks prior to baseline (or within 5 half-lives of baseline, whichever is longer)
•Prior exposure to p40 inhibitors or p19 inhibitors
•Any medical contraindications preventing study participation

发起方

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