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

Completed · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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

Key facts

Study ID

NCT01959282

Run by

Janssen Research & Development, LLC

People needed

219

Starts

2013-11-15

Expected to finish

2015-12-05

Last updated by the study team

2019-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Thornton, Colorado, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Tupelo, Mississippi, United States
• Study site — Egg Harbor, New Jersey, United States
• Study site — Salisbury, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Lima, Ohio, United States
• Study site — Norman, Oklahoma, United States
• Study site — Germantown, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — San Antonio, Texas, United States
• Study site — Chesapeake, Virginia, United States
• Study site — Fairfax, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Bankstown, Australia
• Study site — Bedford, Australia
• Study site — Concord, Australia
• Study site — Herston, Australia
• Study site — Launceston, Australia
• Study site — Melbourne, Australia
• Study site — Penrith, Australia
• Study site — South Brisbane, Australia
• Study site — Brussels, Belgium
• Study site — Ghent, Belgium
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.