A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/6/2019
Start Date:November 29, 2017
End Date:March 17, 2021
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 Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared
to placebo as induction therapy in subjects with moderately and severely active Crohn's
disease (CD).


Inclusion Criteria:

- Confirmed diagnosis of CD for at least 3 months prior to Baseline.

- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
abdominal pain (AP) score.

- Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's
disease (SES-CD) on an endoscopy confirmed by a central reader.

- Demonstrated an inadequate response or intolerance to any biologic therapy for
infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.

- If female, subject must meet the contraception recommendations

Exclusion Criteria:

- Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

- Participant not on stable doses of CD related antibiotics, oral aminosalicylates,
corticosteroids or methotrexate (MTX).

- Participant with the following known complications of CD: abscess (abdominal or
peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any
other manifestation that might require surgery while enrolled in the study.

- Participant with ostomy or ileoanal pouch

- Participant diagnosed with short gut or short bowel syndrome

- Screening laboratory and other analyses show abnormal results.
We found this trial at
118
sites
?
mi
from
Houston, TX
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
?
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
Bountiful, Utah 84010
?
mi
from
Bountiful, UT
Click here to add this to my saved trials
?
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
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
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 28209
?
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
?
mi
from
Chevy Chase, MD
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
Chicago, Illinois 60637
?
mi
from
Chicago, IL
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
Cincinnati, Ohio 45267
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida 33765
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Clearwater, Florida 33765
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
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
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
Coronado,
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
Dayton, OH
Click here to add this to my saved trials
Downers Grove, Illinois 60515
?
mi
from
Downers Grove, IL
Click here to add this to my saved trials
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
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
Farmington Hills, MI
Click here to add this to my saved trials
?
mi
from
Garland, TX
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
Great Neck, New York 11021
?
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
Hamden, Connecticut 06518
?
mi
from
Hamden, CT
Click here to add this to my saved trials
1001 Magnolia Street
Houma, Louisiana 70360
?
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
Indianapolis, Indiana 46237
?
mi
from
Indianapolis, IN
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
?
mi
from
Las Vegas, NV
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
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
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
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
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 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
Mobile, Alabama 36608
?
mi
from
Mobile, AL
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
?
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 Albany, Indiana 47150
?
mi
from
New Albany, IN
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
New Port Richey, Florida 34653
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
407 East 61st Street
New York, New York 10021
?
mi
from
New York, NY
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 10032
?
mi
from
New York, 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
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Omaha, NE
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
Orlando, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
3100 Duraleigh Road
Raleigh, North Carolina 27612
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rapid City, South Dakota 57701
?
mi
from
Rapid City, SD
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
1045 East 3900 South
Salt Lake City, Utah 84124
?
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
San Antonio, Texas 78229
?
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
San Diego, California 92123
?
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
San Francisco, California 94158
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Pablo, California 94806
?
mi
from
San Pablo, CA
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Seattle, Washington 98101
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Seattle, Washington 98195
?
mi
from
Seattle, WA
Click here to add this to my saved trials