A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors



Status:Active, not recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:2/17/2019
Start Date:August 12, 2014
End Date:August 20, 2020

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

Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors

This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter
study will investigate the efficacy and safety of etrolizumab in maintenance of remission in
participants with moderately to severely active UC who are naive to TNF inhibitors and
refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.


Inclusion Criteria:

- Moderately to severely active UC as determined by an MCS of 6-12 with an endoscopic
subscore greater than or equal to (>=) 2 as determined by the central reading
procedure (endoscopy to be performed 4-16 days prior to Day 1), a rectal bleeding
subscore >=1, and a stool frequency subscore >= 1 during the screening period (prior
to Day 1)

- Evidence of UC extending a minimum of 20 centimeters (cm) from the anal verge as
determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed
during screening, 4-16 days prior to Day 1

- Naive to treatment with any anti-TNF therapy

- Participants must have had an inadequate response, loss of response, or intolerance to
prior corticosteroid and/or immunosuppressant treatment

- Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral
corticosteroids, budesonide multi-matrix system (MMX), probiotics, azathioprine (AZA),
6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the
screening period

- Use of highly effective contraception

- Must have received a colonoscopy within the past year or be willing to undergo a
colonoscopy in lieu of a flexible sigmoidoscopy at screening

Exclusion Criteria:

- A history of or current conditions and diseases affecting the digestive tract, such as
indeterminate colitis, Crohn's disease, fistulas or abdominal abscesses, colonic
mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous
colonic polyps

- Prior or planned surgery for UC

- Past or present ileostomy or colostomy

- Have received non-permitted inflammatory bowel disease (IBD) therapies (including
natalizumab, vedolizumab, and efalizumab) as stated in the protocol

- Prior treatment with anti-adhesion molecules (such as mucosal addressin cell adhesion
molecule [MAdCAM-1])

- Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), or
tuberculosis (active or latent)
We found this trial at
76
sites
701 West Morse Boulevard
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials
5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
4800 Belfort Rd # 2
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
?
mi
from
Kinston, NC
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
1690 Dunlawton Ave # 220
Port Orange, Florida 32127
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Aventura, FL
Click here to add this to my saved trials
Bellevue, Washington 98004
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
Belton, Missouri 64012
?
mi
from
Belton, MO
Click here to add this to my saved trials
Brockton, Massachusetts 02302
?
mi
from
Brockton, MA
Click here to add this to my saved trials
Brownsburg, Indiana
?
mi
from
Brownsburg, IN
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
1215 Lee Street
Charlottesville, Virginia 22908
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
30795 23 Mile Rd # 206
Chesterfield, Michigan 48047
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
10123 Alliance Road
Cincinnati, Ohio 45014
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
3001 Executive Drive
Clearwater, Florida 33762
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Clinton, Utah 84015
?
mi
from
Clinton, UT
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, South Carolina 29203
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Coral Springs, Florida 33071
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
3409 Worth Street
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Decatur, Alabama 35601
?
mi
from
Decatur, AL
Click here to add this to my saved trials
1378 Northwest 124th Street
Des Moines, Iowa 50312
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Dothan, Alabama 36305
?
mi
from
Dothan, AL
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Homestead, Florida 33030
?
mi
from
Homestead, FL
Click here to add this to my saved trials
LaFayette, Colorado 80026
?
mi
from
LaFayette, CO
Click here to add this to my saved trials
Limerick, Pennsylvania 19468
?
mi
from
Limerick, PA
Click here to add this to my saved trials
2080 Century Park East
Los Angeles, California 90067
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Beach, Florida 33140
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
5000 West National Avenue
Milwaukee, Michigan 53295
?
mi
from
Milwaukee, MI
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Miramar, Florida 33025
?
mi
from
Miramar, FL
Click here to add this to my saved trials
Modesto, California 95355
?
mi
from
Modesto, CA
Click here to add this to my saved trials
2630 Grant Line Road
New Albany, Indiana 47150
?
mi
from
New Albany, IN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Norman, Oklahoma 73069
?
mi
from
Norman, OK
Click here to add this to my saved trials
North Miami Beach, Florida 33162
?
mi
from
North Miami Beach, FL
Click here to add this to my saved trials
Oak Lawn, Illinois 60453
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
?
mi
from
Orange, CA
Click here to add this to my saved trials
111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Saint Louis, Michigan 63122
?
mi
from
Saint Louis, MI
Click here to add this to my saved trials
30 North 1900 East
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Salvador,
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
1221 Madison Street
Seattle, Washington 98104
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
7510 Arkansas 107
Sherwood, Arkansas 72120
?
mi
from
Sherwood, AR
Click here to add this to my saved trials
Shreveport, Louisiana 71103
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Southfield, Michigan 58304
?
mi
from
Southfield, MI
Click here to add this to my saved trials
505 Nolen Drive
Southlake, Texas 76092
?
mi
from
Southlake, TX
Click here to add this to my saved trials
Towson, Maryland 21204
?
mi
from
Towson, MD
Click here to add this to my saved trials
Trinity, Florida 34655
?
mi
from
Trinity, FL
Click here to add this to my saved trials
Troy, Michigan 48098
?
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
Vancouver, Washington 98664
?
mi
from
Vancouver, WA
Click here to add this to my saved trials
Ventura, California 93003
?
mi
from
Ventura, CA
Click here to add this to my saved trials
502 Centennial Boulevard
Voorhees, New Jersey 08043
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials