A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.
Study identification
- NCT ID
- NCT03398135
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,242 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
- Aug 28, 2018 (Actual)
- Primary completion
- Sep 2028 (Estimated)
- Completion
- Feb 2029 (Estimated)
- Last update posted
- Jan 20, 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 20, 2026 · Synced Oct 27, 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 NCT03398135 live on ClinicalTrials.gov.