A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:16 - 80
Updated:4/6/2019
Start Date:December 18, 2017
End Date:August 13, 2020
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 to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus
placebo during induction therapy in subjects with moderately to severely active CD.


Inclusion Criteria:

- Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to
local regulations, at the Baseline Visit. Where locally permissible, subjects 16 to <
18 years of age who meet the definition of Tanner stage 5 for development at the
Baseline Visit

- 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, and Simple Endoscopic Score for Crohn's Disease (SES-CD)

- Demonstrated intolerance or inadequate response to biologic therapy for CD

- If female, subject must meet the contraception recommendations

Exclusion Criteria:

- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis

- Subjects with unstable doses of concomitant Crohn's disease therapy

- Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab,
certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab
within 12 weeks prior to Baseline), or any investigational biologic or other agent or
procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is
longer.

- Prior exposure to p19 inhibitors (e.g., risankizumab).

- Complications of Crohn's disease (strictures, stenosis, short bowel, etc)

- Having an ostomy or ileoanal pouch
We found this trial at
107
sites
9220 Southwest 72nd Street
Miami, Florida 33176
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
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
Brandon, FL
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
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chevy Chase, MD
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
Chicago, Illinois 60637
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45219
?
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
Clermont, 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
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
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
DeBary, FL
Click here to add this to my saved trials
?
mi
from
Doral, FL
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
?
mi
from
Fargo, ND
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
Great Neck, New York 11021
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
200 Patewood Drive
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
?
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
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
Johnson City, Tennessee 37604
?
mi
from
Johnson City, TN
Click here to add this to my saved trials
?
mi
from
Kinston, NC
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
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
800 Rose Street
Lexington, Kentucky 40536
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Lighthouse Point, Florida 33064
?
mi
from
Lighthouse Point, FL
Click here to add this to my saved trials
Little Rock, Arkansas 72209
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Lone Tree, CO
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
?
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
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Mentor, OH
Click here to add this to my saved trials
Miami, Florida 33136
?
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
Morgantown, West Virginia 26506
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
?
mi
from
Murrieta, CA
Click here to add this to my saved trials
1064 Goodlette-Frank Road
Naples, Florida 34102
?
mi
from
Naples, FL
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 Hyde Park, New York 11040
?
mi
from
New Hyde Park, NY
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 Orleans, Louisiana 70111
?
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
New York, New York 10016
?
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 10022
?
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
?
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
North Massapequa, New York 11758
?
mi
from
North Massapequa, NY
Click here to add this to my saved trials
9921 Southwest Highway
Oak Lawn, Illinois 60453
?
mi
from
Oak Lawn, IL
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
Oklahoma City, Oklahoma 73102
?
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
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Palmetto Bay, Florida 33157
?
mi
from
Palmetto Bay, FL
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
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
3100 Duraleigh Road
Raleigh, North Carolina 27612
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
2820 Mount Rushmore Road
Rapid City, South Dakota 57701
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
?
mi
from
Richmond, VA
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
?
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
?
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 98109
?
mi
from
Seattle, WA
Click here to add this to my saved trials
1800 East 70th Street
Shreveport, Louisiana 71105
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
?
mi
from
Temple, TX
Click here to add this to my saved trials
?
mi
from
Topeka, KS
Click here to add this to my saved trials
4600 Investment Drive
Troy, Michigan 48098
?
mi
from
Troy, MI
Click here to add this to my saved trials