A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis

• Status: Completed
• Trial end date: 2015-12-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Niacinamide; Peficitinib

Criteria

Inclusion Criteria:

• 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 sub score 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

Exclusion Criteria:

• 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 of disseminated herpes zoster

• Previous treatment with a janus kinase inhibitor (eg, tofacitinib)