ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

ClinicalTrials.gov ID: NCT03398135

Public ClinicalTrials.gov record NCT03398135. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis

Study identification

NCT ID
NCT03398135
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
AbbVie
Industry
Enrollment
1,242 participants

Conditions and interventions

Interventions

  • placebo for risankizumab Drug
  • risankizumab Drug

Drug

Eligibility (public fields only)

Age range
16 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 27, 2018
Primary completion
Aug 31, 2028
Completion
Jan 31, 2029
Last update posted
Jan 19, 2026

2018 – 2029

United States locations

U.S. sites
78
U.S. states
26
U.S. cities
63
Facility City State ZIP Site status
Southern California Res. Ctr. /ID# 169659 Coronado California 92118-1408
Hoag Memorial Hosp Presbyterian /ID# 218347 Irvine California 92618
UC San Diego Health System /ID# 160430 La Jolla California 92037
United Medical Doctors /ID# 158574 Los Alamitos California 90720-3309
Cedars-Sinai Medical Center /ID# 163848 Los Angeles California 90048
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934 Los Angeles California 90067-2001
UCSF Medical Center - Mount Zion /ID# 201209 San Francisco California 94115
Peak Gastroenterology Associates, PC /ID# 165838 Colorado Springs Colorado 80907
Rocky Mountain Pediatric Gastroenterology /ID# 207173 Lone Tree Colorado 80124-6798
Duplicate_Medical Research Center of CT /ID# 160287 Hamden Connecticut 06518
Yale Univ Digestive Diseases /ID# 213265 New Haven Connecticut 06510
South Lake Pain Institute, Inc /ID# 162859 Clermont Florida 34711
Ctr for Advanced Gastroenterol /ID# 202820 Maitland Florida 32751-6108
University of Miami /ID# 160456 Miami Florida 33136
Coral Research Clinic /ID# 158608 Miami Florida 33186-4643
South Florida Research Ph I-IV, Inc. /ID# 161844 Miami Florida 33193
Gastroenterology Group Naples /ID# 165210 Naples Florida 34102
Advanced Research Institute, Inc /ID# 161945 New Port Richey Florida 34653
Advent Health /ID# 160393 Orlando Florida 32803
Endoscopic Research, Inc. /ID# 206709 Orlando Florida 32803
Omega Research Group /ID# 203105 Orlando Florida 32808
Duplicate_Lenus Research & Medical Group /ID# 169727 Sweetwater Florida 33172
Clinical Research Trials of Florida, Inc. /ID# 201794 Tampa Florida 33607
Duplicate_AdventHealth Tampa /ID# 170482 Tampa Florida 33613-4680
Gastroenterology Associates of Central Georgia, LLC /ID# 160513 Macon Georgia 31201
The University of Chicago Medical Center /ID# 160511 Chicago Illinois 60637-1443
DM Clinical Research/Southwest /ID# 165009 Oak Lawn Illinois 60453
Indiana University /ID# 167250 Indianapolis Indiana 46202
Univ Kansas Med Ctr /ID# 226601 Kansas City Kansas 66160
Cotton O'Neil Clinical Research Center, Digestive Health /ID# 160367 Topeka Kansas 66606
Duplicate_Robley Rex VA Medical Center /ID# 218647 Louisville Kentucky 40206
Houma Digestive Health Special /ID# 158377 Houma Louisiana 70360
Delricht Research /ID# 206817 New Orleans Louisiana 70115
Nola Research Works, LLC /ID# 161356 New Orleans Louisiana 70115
Louisiana Research Center, LLC /ID# 201205 Shreveport Louisiana 71105-6800
Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164257 Boston Massachusetts 02114
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 159430 Ann Arbor Michigan 48109
Clin Res Inst of Michigan, LLC /ID# 160300 Chesterfield Michigan 48047
Mayo Clinic - Rochester /ID# 200455 Rochester Minnesota 55905-0001
Quality Clinical Research Inc. /ID# 167312 Omaha Nebraska 68114-3723
Weill Cornell Medicine /ID# 165884 New York New York 10022
Columbia Univ Medical Center /ID# 161929 New York New York 10032-3725
Lenox Hill Hospital /ID# 168469 New York New York 10075
Manhattan Clinical Research, LLC /ID# 211803 New York New York 10279
Duplicate_DiGiovanna Institute for Medical Education & Research /ID# 171128 North Massapequa New York 11758
Duplicate_University of Rochester Medical Center /ID# 161660 Rochester New York 14642
Atrium Health Carolinas Medical Center /ID# 158543 Charlotte North Carolina 28203
Plains Clinical Research Center, LLC /ID# 169729 Fargo North Dakota 58104-5925
Cleveland Clinic Main Campus /ID# 209235 Cleveland Ohio 44195
The Ohio State University /ID# 164713 Columbus Ohio 43210
Optimed Research, Ltd. /ID# 167112 Columbus Ohio 43235
Great Lakes Gastroenterology Research, LLC /ID# 201778 Mentor Ohio 44060-6211
ProMedica Physicians Digestive Healthcare /ID# 215622 Sylvania Ohio 43560-2767
Digestive Disease Specialists /ID# 170777 Oklahoma City Oklahoma 73112
Adult Gastroenterology Associates - Gen 1 Research /ID# 208873 Tulsa Oklahoma 74136-7823
Penn State Milton S. Hershey Medical Center /ID# 230474 Hershey Pennsylvania 17033-2360
University of Pennsylvania /ID# 166262 Philadelphia Pennsylvania 19104-5502
Digestive Disease Associates, LTD - Wyomissing /ID# 232406 Wyomissing Pennsylvania 19610
Gastroenterology Associates, P.A. of Greenville /ID# 160457 Greenville South Carolina 29607
Gastro One /ID# 160373 Cordova Tennessee 38018
Duplicate_East Tennessee Research Institute /ID# 168744 Johnson City Tennessee 37604
Vanderbilt University Medical Center /ID# 160567 Nashville Tennessee 37232-0011
Inquest Clinical Research /ID# 165686 Baytown Texas 77521-2415
Texas Digestive Disease Consultants /ID# 209951 Cedar Park Texas 78613-5028
GI Alliance /ID# 209799 Cedar Park Texas 78613
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 158235 Garland Texas 75044
Vilo Research Group Inc /ID# 207657 Houston Texas 77017-2337
Baylor College of Medicine /ID# 158230 Houston Texas 77030
Centex Studies, Inc. - Houston /ID# 201221 Houston Texas 77058
Duplicate_Caprock Gastro Research, LLC /ID# 215433 Lubbock Texas 79424-3017
Clinical Associates in Research Therapeutics of America, LLC /ID# 161364 San Antonio Texas 78212
Southern Star Research Institute, LLC /ID# 168774 San Antonio Texas 78229-5390
Baylor Scott & White Center for Diagnostic Medicine /ID# 204132 Temple Texas 76508
Tyler Research Institute, LLC /ID# 166799 Tyler Texas 75701
Gastro Health & Nutrition - Victoria /ID# 164308 Victoria Texas 77904
Advanced Research Institute /ID# 160465 Ogden Utah 84405
Gastroenterology Consultants of Southwest Virginia /ID# 218142 Roanoke Virginia 24014-1372
Virginia Mason Hospital & Medical Center /ID# 160432 Seattle Washington 98101

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 348 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03398135, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 19, 2026 · Synced May 6, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03398135 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →