A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:16 - 80
Updated:3/23/2019
Start Date:May 10, 2017
End Date:March 14, 2021
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus
placebo during induction therapy in subjects with moderately to severely active Crohn's
disease (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 conventional or 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 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
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3100 Duraleigh Road
Raleigh, North Carolina 27612
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Baton Rouge, Louisiana 70809
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Bellevue, Washington 98004
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Bountiful, Utah 84010
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2001 Oriental Boulevard
Brooklyn, New York 11235
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Cedar Park, TX
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Chapel Hill, North Carolina 27514
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Charlotte, North Carolina 28203
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Chicago, Illinois 60611
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Chicago, Illinois 60637
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Cincinnati, Ohio 45219
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Clearwater, Florida 33765
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Clearwater, Florida 33765
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Colorado Springs, Colorado 80907
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Columbia, Maryland 21045
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Columbus, Ohio 43235
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Fargo, ND
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1324 Wolf Park Drive
Germantown, Tennessee 38138
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Great Neck, New York 11021
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200 Patewood Drive
Greenville, South Carolina 29615
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Hershey, Pennsylvania 17033
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Hickory, North Carolina 28601
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411 West Highland Boulevard
Inverness, Florida 34452
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Jackson, MS
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Johnson City, Tennessee 37604
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Kinston, NC
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Kissimmee, Florida 34759
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Lighthouse Point, Florida 33064
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Little Rock, Arkansas 72209
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Los Alamitos, California 90720
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Los Angeles, California 90067
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Louisville, Kentucky 40202
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Memphis, Tennessee 38119
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9220 Southwest 72nd Street
Miami, Florida 33173
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Miami, Florida 33186
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Morgantown, West Virginia 26506
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1064 Goodlette-Frank Road
Naples, Florida 34102
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1211 Medical Center Drive
Nashville, Tennessee 37212
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New Hyde Park, New York 11040
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New Orleans, Louisiana 70111
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7114 Congress Street
New Port Richey, Florida 34653
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New York, New York 10016
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North Massapequa, New York 11758
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9921 Southwest Highway
Oak Lawn, Illinois 60453
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5896 South Ridgeline Drive
Ogden, Utah 84405
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Oklahoma City, Oklahoma 73112
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Orlando, Florida 32803
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Palmetto Bay, Florida 33157
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Phoenix, Arizona 85012
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2820 Mount Rushmore Road
Rapid City, South Dakota 57701
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1201 Broad Rock Boulevard
Richmond, Virginia 23249
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Riverside, California 92501
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Rochester, Minnesota 55905
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Rosario, Santa Fe
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1800 East 70th Street
Shreveport, Louisiana 71105
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4600 Investment Drive
Troy, Michigan 48098
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