ClinicalTrials.gov record
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT03398148
Public ClinicalTrials.gov record NCT03398148. 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.
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 Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
Study identification
- NCT ID
- NCT03398148
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 1,558 participants
Conditions and interventions
Conditions
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
- Mar 7, 2018 (Actual)
- Primary completion
- Nov 9, 2022 (Actual)
- Completion
- May 11, 2023 (Actual)
- Last update posted
- Jan 16, 2025
2018 – 2023
United States locations
- U.S. sites
- 82
- U.S. states
- 26
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California Res. Ctr. /ID# 169660 | Coronado | California | 92118-1408 | — |
| Hoag Memorial Hosp Presbyterian /ID# 218348 | Irvine | California | 92618 | — |
| UC San Diego Health System /ID# 160452 | La Jolla | California | 92037 | — |
| United Medical Doctors /ID# 158528 | Los Alamitos | California | 90720-3309 | — |
| Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200931 | Los Angeles | California | 90067-2001 | — |
| UCSF Center for Colitis and Crohn's Disease /ID# 201210 | San Francisco | California | 94115-3011 | — |
| Cedars-Sinai Medical Center-West Hollywood /ID# 163851 | West Hollywood | California | 90048 | — |
| Peak Gastroenterology Associates, PC /ID# 165841 | Colorado Springs | Colorado | 80907 | — |
| Rocky Mountain Pediatric Gastroenterology /ID# 207174 | Lone Tree | Colorado | 80124-6798 | — |
| Medical Research Center of CT /ID# 160311 | Hamden | Connecticut | 06518 | — |
| Yale Univ Digestive Diseases /ID# 213179 | New Haven | Connecticut | 06510 | — |
| South Lake Pain Institute, Inc /ID# 162878 | Clermont | Florida | 34711 | — |
| Ctr for Advanced Gastroenterol /ID# 202811 | Maitland | Florida | 32751-6108 | — |
| University of Miami /ID# 160471 | Miami | Florida | 33136 | — |
| Coral Research Clinic /ID# 158584 | Miami | Florida | 33186-4643 | — |
| South Florida Research Ph I-IV, Inc. /ID# 161848 | Miami | Florida | 33193 | — |
| Gastroenterology Group Naples /ID# 165212 | Naples | Florida | 34102 | — |
| Advanced Research Institute, Inc /ID# 161938 | New Port Richey | Florida | 34653 | — |
| Advent Health /ID# 160433 | Orlando | Florida | 32803 | — |
| Endoscopic Research, Inc. /ID# 206711 | Orlando | Florida | 32803 | — |
| Omega Research Group /ID# 203059 | Orlando | Florida | 32808 | — |
| Lenus Research & Medical Group /ID# 169730 | Sweetwater | Florida | 33172 | — |
| Clinical Research Trials of Florida, Inc. /ID# 201783 | Tampa | Florida | 33607 | — |
| AdventHealth Tampa /ID# 170503 | Tampa | Florida | 33613-4680 | — |
| Gastroenterology Associates of Central Georgia, LLC /ID# 160523 | Macon | Georgia | 31201 | — |
| Atlanta Gastroenterology Spec /ID# 161372 | Suwanee | Georgia | 30024 | — |
| The University of Chicago Medical Center /ID# 160521 | Chicago | Illinois | 60637-1443 | — |
| DM Clinical Research/Southwest /ID# 165012 | Oak Lawn | Illinois | 60453 | — |
| Indiana University /ID# 167252 | Indianapolis | Indiana | 46202 | — |
| Univ Kansas Med Ctr /ID# 226602 | Kansas City | Kansas | 66160 | — |
| Cotton-O'Neil Clinical Res Ctr /ID# 160412 | Topeka | Kansas | 66606 | — |
| Robley Rex VA Medical Center /ID# 218648 | Louisville | Kentucky | 40206 | — |
| Houma Digestive Health Special /ID# 158317 | Houma | Louisiana | 70360 | — |
| Delricht Research /ID# 206815 | New Orleans | Louisiana | 70115 | — |
| Nola Research Works, LLC /ID# 161368 | New Orleans | Louisiana | 70115 | — |
| Louisana Research Center, LLC /ID# 201204 | Shreveport | Louisiana | 71105-6800 | — |
| Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164255 | Boston | Massachusetts | 02114 | — |
| University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 158524 | Ann Arbor | Michigan | 48109 | — |
| Clin Res Inst of Michigan, LLC /ID# 160327 | Chesterfield | Michigan | 48047 | — |
| Mayo Clinic - Rochester /ID# 200458 | Rochester | Minnesota | 55905-0001 | — |
| Quality Clinical Research Inc. /ID# 167313 | Omaha | Nebraska | 68114-3723 | — |
| Weill Cornell Medicine /ID# 165887 | New York | New York | 10022 | — |
| Columbia Univ Medical Center /ID# 161934 | New York | New York | 10032-3725 | — |
| Lenox Hill Hospital /ID# 168470 | New York | New York | 10075 | — |
| Manhattan Clinical Research, LLC /ID# 211805 | New York | New York | 10279 | — |
| DiGiovanna Institute for Medical Education & Research /ID# 171129 | North Massapequa | New York | 11758 | — |
| University of Rochester Medical Center /ID# 161664 | Rochester | New York | 14642 | — |
| Atrium Health Carolinas Medical Center /ID# 158512 | Charlotte | North Carolina | 28203 | — |
| Carolina Research /ID# 201090 | Greenville | North Carolina | 27834 | — |
| Plains Clinical Research Center, LLC /ID# 169732 | Fargo | North Dakota | 58104-5925 | — |
| Cleveland Clinic Main Campus /ID# 209232 | Cleveland | Ohio | 44195 | — |
| The Ohio State University /ID# 164714 | Columbus | Ohio | 43210 | — |
| Optimed Research, Ltd. /ID# 167113 | Columbus | Ohio | 43235 | — |
| Great Lakes Gastroenterology Research, LLC /ID# 201777 | Mentor | Ohio | 44060-6211 | — |
| ProMedica Physicians Digestive Healthcare /ID# 215623 | Sylvania | Ohio | 43560-2767 | — |
| Digestive Disease Specialists /ID# 170779 | Oklahoma City | Oklahoma | 73112 | — |
| Adult Gastroenterology Associates - Gen 1 Research /ID# 208867 | Tulsa | Oklahoma | 74136-7823 | — |
| Penn State Milton S. Hershey Medical Center /ID# 223563 | Hershey | Pennsylvania | 17033-2360 | — |
| University of Pennsylvania /ID# 166266 | Philadelphia | Pennsylvania | 19104-5502 | — |
| Digestive Disease Associates, LTD /ID# 232407 | Wyomissing | Pennsylvania | 19610-2002 | — |
| Gastroenterology Associates, P.A. of Greenville /ID# 160472 | Greenville | South Carolina | 29607 | — |
| Gastro One /ID# 160418 | Cordova | Tennessee | 38018 | — |
| East Tennessee Research Institute /ID# 168747 | Johnson City | Tennessee | 37604 | — |
| Vanderbilt University Medical Center /ID# 160580 | Nashville | Tennessee | 37232-0011 | — |
| Inquest Clinical Research /ID# 165685 | Baytown | Texas | 77521-2415 | — |
| Texas Digestive Disease Consultants /ID# 209950 | Cedar Park | Texas | 78613-5028 | — |
| GI Alliance /ID# 209798 | Cedar Park | Texas | 78613 | — |
| DHAT Research Institute /ID# 158226 | Garland | Texas | 75044-2208 | — |
| Vilo Research Group Inc /ID# 207656 | Houston | Texas | 77017-2337 | — |
| CliniCore International, LLC /ID# 158218 | Houston | Texas | 77027-6812 | — |
| Baylor College of Medicine - Baylor Medical Center /ID# 158221 | Houston | Texas | 77030-3411 | — |
| Precision Research Institute, LLC /ID# 201351 | Houston | Texas | 77036 | — |
| Centex Studies, Inc. - Houston /ID# 201222 | Houston | Texas | 77058 | — |
| Caprock Gastro Research, LLC /ID# 215432 | Lubbock | Texas | 79424-3017 | — |
| Clinical Associates in Research Therapeutics of America, LLC /ID# 161376 | San Antonio | Texas | 78212 | — |
| Southern Star Research Institute, LLC /ID# 168776 | San Antonio | Texas | 78229-5390 | — |
| Baylor Scott & White Center for Diagnostic Medicine /ID# 204130 | Temple | Texas | 76508 | — |
| Tyler Research Institute, LLC /ID# 166800 | Tyler | Texas | 75701-4464 | — |
| Gastro Health & Nutrition - Victoria /ID# 164321 | Victoria | Texas | 77904 | — |
| Advanced Research Institute /ID# 160480 | Ogden | Utah | 84403 | — |
| Gastroenterology Consultants of Southwest Virginia /ID# 218143 | Roanoke | Virginia | 24014-1372 | — |
| Virginia Mason Medical Center /ID# 160466 | 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 NCT03398148, 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 16, 2025 · Synced Oct 19, 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 public registry record, listed eligibility criteria, and available contact information for NCT03398148 live on ClinicalTrials.gov.