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
- Conditions
- Bowel infectionUlcerative Colitis10017969
- Registration Number
- NL-OMON40180
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
- 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
- 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 (An exception is made for
subjects who have a history of latent TB and are currently receiving treatment for latent
TB) , 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy evaluations will include:<br /><br>* Mayo score and partial Mayo score<br /><br>* Inflammatory Bowel Disease Questionnaire (IBDQ)<br /><br>* C-reactive protein (CRP)<br /><br>* Fecal lactoferrin and fecal calprotectin<br /><br>* Ulcerative Colitis Endoscopic Index of Severity (UCEIS)<br /><br><br /><br>Primary Endpoint<br /><br>The primary endpoint is the change from baseline in the Mayo score at Week 8.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are as follows:<br /><br>1. To evaluate the efficacy of JNJ-54781532 in inducing clinical response at<br /><br>Week 8.<br /><br>2. To evaluate the efficacy of JNJ-54781532 in inducing clinical remission at<br /><br>Week 8.<br /><br>3. To evaluate the efficacy of JNJ-54781532 in inducing mucosal healing at Week<br /><br>8.<br /><br>Exploratory Objectives<br /><br>The exploratory objectives are as follows:<br /><br>1. To explore the optimal treatment duration of JNJ-54781532 for the primary<br /><br>and major secondary endpoints.<br /><br>2. To explore the response to treatment through Week 32 among subjects who are<br /><br>in clinical response to JNJ-54781532 at Week 8.<br /><br>3. To explore the efficacy of JNJ-54781532 in achieving partial Mayo score<br /><br>response (or partial Mayo score remission) and eliminating corticosteroid use<br /><br>at Week 32 among subjects who are in clinical response and receiving<br /><br>concomitant corticosteroids at Week 8.</p><br>