A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/28/2019
Start Date:September 26, 2016
End Date:February 24, 2022
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

This study comprises three sub-studies. The objective of sub-study 1 is to characterize the
dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical
remission in order to identify the induction dose of upadacitinib for further evaluation in
sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of
upadacitinib compared to placebo in inducing clinical remission in participants. The
objective of sub-study 3 is to evaluate the efficacy and safety of upadacitinib compared to
placebo in achieving clinical remission in participants who had a response following
induction with upadacitinib.


Inclusion Criteria:

- Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by
colonoscopy during the Screening Period, with exclusion of current infection, colonic
dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent
with the diagnosis of UC, in the assessment of the Investigator, must be available.

- Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic
sub score of 2 to 3 (confirmed by central reader).

- Demonstrated an inadequate response to, loss of response to, or intolerance to oral
aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.

- If female, participant must meet the criteria for Contraception Recommendations.

- Female participants of childbearing potential must have a negative serum pregnancy
test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit
prior to study drug dosing.

Exclusion Criteria:

- Participant with current diagnosis of Crohn's disease (CD) or diagnosis of
indeterminate colitis (IC).

- Current diagnosis of fulminant colitis and/or toxic megacolon.

- Participant with disease limited to the rectum (ulcerative proctitis) during the
Screening endoscopy.

- Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30
days prior to Baseline.

- Participant on azathioprine or 6-mercaptopurine within 10 days of baseline.

- Received intravenous corticosteroids within 14 days prior to Screening or during the
Screening Period.

- Participant with previous exposure to JAK inhibitor (e.g., tofacitinib, baricitinib,
filgotinib, upadacitinib).

- Screening laboratory and other analyses show any abnormal results.
We found this trial at
137
sites
8530 West Sunset Road
Las Vegas, Nevada 89113
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Ann Arbor, Michigan 48197
?
mi
from
Ann Arbor, MI
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
Arlington, TX
Click here to add this to my saved trials
191 Biltmore Avenue
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
22 South Greene Street
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Baytown, TX
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
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bountiful, Utah 84010
?
mi
from
Bountiful, UT
Click here to add this to my saved trials
Bronx, New York 10467
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
2001 Oriental Boulevard
Brooklyn, New York 11235
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Cedar Park, TX
Click here to add this to my saved trials
?
mi
from
Cedar Park, TX
Click here to add this to my saved trials
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
418 Folly Road
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chesterfield, Michigan 48047
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1653 West Congress Parkway
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
924 East 57th Street
Chicago, Illinois 60637
?
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
Cincinnati, Ohio 45267
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
5835 Lehman Drive
Colorado Springs, Colorado 80918
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, Maryland 21045
?
mi
from
Columbia, MD
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43235
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Covina, CA
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
Danbury, CT
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Doral, FL
Click here to add this to my saved trials
3205 Fire Road
Egg Harbor Township, New Jersey 08234
?
mi
from
Egg Harbor Township, NJ
Click here to add this to my saved trials
?
mi
from
Englewood, OH
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
1401 Professional Boulevard
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
?
mi
from
Fargo, ND
Click here to add this to my saved trials
?
mi
from
Franklin, VA
Click here to add this to my saved trials
?
mi
from
Garland, TX
Click here to add this to my saved trials
1324 Wolf Park Drive
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
?
mi
from
Grafton, WI
Click here to add this to my saved trials
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Hamden, Connecticut 06518
?
mi
from
Hamden, CT
Click here to add this to my saved trials
2001 West 68th Street
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
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
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46237
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
411 West Highland Boulevard
Inverness, Florida 34452
?
mi
from
Inverness, FL
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Jacksonville, Florida 32258
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Johnson City, Tennessee 37604
?
mi
from
Johnson City, TN
Click here to add this to my saved trials
Kissimmee, Florida 34759
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lakewood Ranch, Florida 34211
?
mi
from
Lakewood Ranch, FL
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Leesburg, Virginia 20176
?
mi
from
Leesburg, VA
Click here to add this to my saved trials
Los Alamitos, California 90720
?
mi
from
Los Alamitos, CA
Click here to add this to my saved trials
Los Angeles, California 90067
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Maitland, FL
Click here to add this to my saved trials
?
mi
from
Mentor, OH
Click here to add this to my saved trials
?
mi
from
Mentor, OH
Click here to add this to my saved trials
2950 Northwest 83rd Street
Miami, Florida 33147
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
11880 Southwest 40th Street
Miami, Florida 33175
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33186
?
mi
from
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53215
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin 53226
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55417
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mission Hills, California 91345
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
6701 Airport Boulevard
Mobile, Alabama 36608
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Morristown, New Jersey 07960
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
?
mi
from
Murrieta, CA
Click here to add this to my saved trials
Nashville, Tennessee 37211
?
mi
from
Nashville, TN
Click here to add this to my saved trials
1211 Medical Center Drive
Nashville, Tennessee 37212
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
New Orleans, Louisiana 70125
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
7114 Congress Street
New Port Richey, Florida 34653
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
North Massapequa, New York 11758
?
mi
from
North Massapequa, NY
Click here to add this to my saved trials
5896 South Ridgeline Drive
Ogden, Utah 84405
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Oxnard, CA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15212
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
Poughkeepsie, New York 12601
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Rochester, New York 14618
?
mi
from
Rochester, NY
Click here to add this to my saved trials