A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis

Janssen-Cilag International NV0 个研究点目标入组 220 人开始时间: 2013年11月26日最近更新: 2016年4月25日

试验速览

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•- Have a clinical diagnosis of ulcerative colitis (UC) at least 3 months prior to screening
•- Have moderately to severely active UC, defined as a baseline (Week 0) Mayo score of 6 to 12 ; including an endoscopy subscore greater than or equal to 2 as determined by a central read of the video endoscopy
•- Current treatment with oral corticosteroids or have a history of failure to respond to, or tolerate, at least 1 of the following therapies oral corticosteroids (including budesonide), 6-mercaptopurine (6-MP), azathioprine (AZA), or anti-tumor necrosis factor therapy or be corticosteroid dependent (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC
•- Must discontinue 6-MP/AZA for at least 1 week before the first dose of study medication
•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 209
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 11

•- At imminent risk for colectomy
•- Have ulcerative colitis limited to the rectum only or to less than 20 centimeter of the colon
•- Presence of a stoma
•- Presence or history of a fistula
•- History or current diagnosis of active or latent tuberculosis, human immunodeficiency virus, hepatitis C virus or hepatitis B virus infection
•- Have had more than 1 herpes zoster infection or have had any diagnosis disseminated herpes zoster
•- Previous treatment with a janus kinase inhibitor (eg, tofacitinib)

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