A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis



Status:Active, not recruiting
Conditions:Colitis, Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:July 10, 2015
End Date:November 26, 2021

Use our guide to learn which trials are right for you!

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as
intravenous (IV: into the vein) infusion in induction study in participants with moderately
to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in
maintenance study in participants with moderately to severely active Ulcerative Colitis (UC)
who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

This is a Phase 3, randomized (assignment of study drug by chance), double-blind (neither the
participant or study staff will know the identity of study drugs), placebo-controlled
(placebo is an inactive substance that is compared with a drug to test whether the drug has a
real effect in a clinical trial), parallel-group (a medical research study comparing the
response in 2 or more groups of participants receiving different interventions), multi-center
(more than one clinical site will work on a medical research study), protocol of ustekinumab.
The protocol will consist of 2 studies: an Induction study and a Maintenance study with
unique endpoints. Screening period will be up to 8 Weeks. Induction study will be at least 8
weeks duration for each participant. Participant with clinical response in the Induction
study will be eligible for the Maintenance study. The Maintenance study will be 44 weeks
duration. After completion of the maintenance study, a long term extension will follow
eligible participants for an additional 3 years. Clinical remission will be evaluated at Week
8 in the Induction study. Clinical remission among ustekinumab Induction responders will be
evaluated at week 44 in the Maintenance study. Participants' safety will be monitored
throughout.

Inclusion Criteria:

- Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening

- Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6
to 12, including a Screening endoscopy subscore of the Mayo score greater than or
equal to (>=) 2 as determined by a central reading of the video endoscopy

- Have failed biologic therapy, that is, have received treatment with 1 or more tumour
necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment
of UC, and have a documented history of failure to respond to or tolerate such
treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) or have
received biologic therapy but have not demonstrated a history of failure to respond
to, or tolerate, a biologic therapy and have a prior or current UC medication history
that includes at least 1 of the following: a. Inadequate response to or failure to
tolerate current treatment with oral corticosteroids or immunomodulators
(6-mercaptopurine [6-MP] or azathioprine [AZA]) OR b. History of failure to respond
to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or
immunomodulators (6-MP or AZA) OR c. History of corticosteroid dependence (that is, an
inability to successfully taper corticosteroids without a return of the symptoms of
UC)

- Before the first administration of study agent, the following conditions must be met:
vedolizumab must have been discontinued for at least 4 months and anti-tumor necrosis
factors (TNFs) for at least 8 weeks

Exclusion Criteria:

- Has severe extensive colitis and is at imminent risk of colectomy

- Has UC limited to the rectum only or to < 20 centimeters (cm) of the colon

- Presence of a stoma or history of a fistula

- Participants with history of extensive colonic resection (for example, less than 30 cm
of colon remaining) that would prevent adequate evaluation of the effect of study
agent on clinical disease activity

- Participants with history of colonic mucosal dysplasia. Participants will not be
excluded from the study because of a pathology finding of "indefinite dysplasia with
reactive atypia''
We found this trial at
69
sites
?
mi
from
Sayre, PA
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Bedford,
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbia, MD
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
?
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
?
mi
from
Doylestown, PA
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
?
mi
from
Farmington, CT
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Germantown, TN
Click here to add this to my saved trials
?
mi
from
Hershey, PA
Click here to add this to my saved trials
?
mi
from
Houma, LA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Irving, TX
Click here to add this to my saved trials
?
mi
from
Jackson, MS
Click here to add this to my saved trials
?
mi
from
La Mirada, CA
Click here to add this to my saved trials
?
mi
from
Largo, FL
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Lone Tree, CO
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Macon, GA
Click here to add this to my saved trials
?
mi
from
Marlton, NJ
Click here to add this to my saved trials
?
mi
from
Mentor, OH
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Mineola, NY
Click here to add this to my saved trials
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport Beach, California 92660
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
?
mi
from
Pratt, KS
Click here to add this to my saved trials
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
?
mi
from
Southlake, TX
Click here to add this to my saved trials
?
mi
from
Suwanee, GA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Torrance, CA
Click here to add this to my saved trials
?
mi
from
Troy, MI
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
?
mi
from
Urbana, IL
Click here to add this to my saved trials
?
mi
from
Vallejo, CA
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
West Jordan, UT
Click here to add this to my saved trials
?
mi
from
Winter Park, FL
Click here to add this to my saved trials
?
mi
from
Ypsilanti, MI
Click here to add this to my saved trials
?
mi
from
Zephyrhills, FL
Click here to add this to my saved trials