A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
Public ClinicalTrials.gov record NCT03105102. 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 Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study consists of 4 sub-studies, as follows: * Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; * Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; * Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; * Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab. * OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.
Study identification
- NCT ID
- NCT03105102
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,336 participants
Conditions and interventions
Conditions
Interventions
- Placebo for Risankizumab SC Drug
- Risankizumab IV Drug
- Placebo for Risankizumab IV Drug
- Risankizumab SC Drug
- Risankizumab On-Body Injector (OBI) 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
- Apr 9, 2018 (Actual)
- Primary completion
- Feb 2029 (Estimated)
- Completion
- Feb 2029 (Estimated)
- Last update posted
- Aug 14, 2026
2018 – 2029
United States locations
- U.S. sites
- 111
- U.S. states
- 31
- U.S. cities
- 94
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884 | Mesa | Arizona | 85206 | — |
| Phoenix VA Health Care System /ID# 162264 | Phoenix | Arizona | 85012 | — |
| Banner - University Medical Center Tucson /ID# 158502 | Tucson | Arizona | 85719 | — |
| Atria Clinical Research /ID# 164505 | Little Rock | Arkansas | 72209-7040 | — |
| Southern California Res. Ctr. /ID# 211991 | Coronado | California | 92118-1408 | — |
| Duplicate_Newport Huntington Medical Group /ID# 213035 | Huntington Beach | California | 92648 | — |
| UC San Diego Health Systems /ID# 155555 | La Jolla | California | 92093 | — |
| United Medical Doctors /ID# 207888 | Los Alamitos | California | 90720-3309 | — |
| TLC Clinical Research Inc /ID# 212719 | Los Angeles | California | 90048 | — |
| Gastrointestinal Biosciences Clinical Trials /ID# 162657 | Los Angeles | California | 90067-2001 | — |
| United Medical Doctors - Murrieta /ID# 158300 | Murrieta | California | 92563 | — |
| University of California San Francisco - Mission Bay /ID# 157127 | San Francisco | California | 94158 | — |
| Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 163839 | West Hollywood | California | 90048 | — |
| Peak Gastroenterology Associates, PC /ID# 165843 | Colorado Springs | Colorado | 80907 | — |
| Rocky Mountain Pediatric Gastroenterology /ID# 207170 | Lone Tree | Colorado | 80124-6798 | — |
| Duplicate_Western Connecticut Medical Group /ID# 165879 | Danbury | Connecticut | 06810 | — |
| Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 162262 | Brandon | Florida | 33510-3107 | — |
| South Lake Pain Institute, Inc /ID# 162808 | Clermont | Florida | 34711 | — |
| Universal Axon Clinical Research /ID# 165428 | Doral | Florida | 33166 | — |
| Nature Coast Clinical Research - Inverness /ID# 159408 | Inverness | Florida | 34452-4717 | — |
| SIH Research Mumtaz, Inc /ID# 163083 | Kissimmee | Florida | 34741-4161 | — |
| Alliance Medical Research /ID# 163837 | Lighthouse PT | Florida | 33064 | — |
| Cfagi Llc /Id# 202479 | Maitland | Florida | 32751-6108 | — |
| Sylvester Comprehensive Cancer Center /ID# 155007 | Miami | Florida | 33136-1002 | — |
| Coral Research Clinic /ID# 158456 | Miami | Florida | 33186-4643 | — |
| South Florida Research Ph I-IV, Inc. /ID# 161832 | Miami | Florida | 33193 | — |
| Gastroenterology Group Naples /ID# 165204 | Naples | Florida | 34102 | — |
| Advanced Research Institute, Inc /ID# 161966 | New Port Richey | Florida | 34653 | — |
| Endoscopic Research, Inc. /ID# 205906 | Orlando | Florida | 32803 | — |
| Omega Research - Orlando /ID# 171082 | Orlando | Florida | 32808 | — |
| IMIC Inc. Medical Research /ID# 154942 | Palmetto Bay | Florida | 33157 | — |
| Duplicate_Clinical Research of West Florida, Inc /ID# 208125 | Tampa | Florida | 33606-1246 | — |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 205865 | Tampa | Florida | 33606 | — |
| Atlanta Gastro Assoc /ID# 154724 | Atlanta | Georgia | 30342 | — |
| Gastroenterology Associates of Central Georgia, LLC /ID# 154850 | Macon | Georgia | 31201 | — |
| Duplicate_Northwestern University /ID# 158261 | Chicago | Illinois | 60611-2927 | — |
| The University of Chicago Medical Center /ID# 157124 | Chicago | Illinois | 60637-1443 | — |
| NorthShore University-Endeavor Health Evanston Hospital /ID# 158265 | Evanston | Illinois | 60201 | — |
| Southwest Gastroenterology /ID# 164781 | Oak Lawn | Illinois | 60453 | — |
| Cotton O'Neil Clinical Research Center, Digestive Health /ID# 154722 | Topeka | Kansas | 66606 | — |
| Duplicate_University of Kentucky Chandler Medical Center /ID# 157120 | Lexington | Kentucky | 40536 | — |
| University of Louisville Hospital /ID# 210525 | Louisville | Kentucky | 40202 | — |
| GI Alliance /ID# 161963 | Baton Rouge | Louisiana | 70809 | — |
| Houma Digestive Health Special /ID# 158264 | Houma | Louisiana | 70360 | — |
| Delricht Research - Prytania Street - New Orleans /ID# 206644 | New Orleans | Louisiana | 70115 | — |
| Nola Research Works, LLC /ID# 161317 | New Orleans | Louisiana | 70115 | — |
| Louisiana Research Center, LLC /ID# 162237 | Shreveport | Louisiana | 71105-6800 | — |
| Metropolitan Gastroenterology Group - Chevy Chase /ID# 154832 | Chevy Chase | Maryland | 20815 | — |
| Gastro Center of Maryland /ID# 165001 | Columbia | Maryland | 21045 | — |
| University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 157126 | Ann Arbor | Michigan | 48109 | — |
| Clin Res Inst of Michigan, LLC /ID# 169179 | Chesterfield | Michigan | 48047 | — |
| Center For Digestive Health - Troy /ID# 154683 | Troy | Michigan | 48098 | — |
| Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161313 | Wyoming | Michigan | 49519 | — |
| Mayo Clinic - Rochester /ID# 163086 | Rochester | Minnesota | 55905-0001 | — |
| St. Louis University /ID# 161883 | St Louis | Missouri | 63104 | — |
| University of Nebraska Medical Center /ID# 210058 | Omaha | Nebraska | 68198-2000 | — |
| Revival Research Institute - Las Vegas /ID# 210985 | Las Vegas | Nevada | 89128-3157 | — |
| Vector Clinical Trials /ID# 160170 | Las Vegas | Nevada | 89128 | — |
| NY Scientific /ID# 158294 | Brooklyn | New York | 11235 | — |
| Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213447 | Burnt Hills | New York | 12027 | — |
| Intercity Advanced Gastroentertology Center /ID# 215205 | Fresh Meadows | New York | 11366 | — |
| Northwell Health - Great Neck /ID# 168738 | Great Neck | New York | 11021 | — |
| Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 154829 | Lake Success | New York | 11042 | — |
| Digestive Disease Care /ID# 211777 | New Hyde Park | New York | 11040 | — |
| NYU Langone Medical Center /ID# 160169 | New York | New York | 10016-6402 | — |
| Weill Cornell Medicine /ID# 165878 | New York | New York | 10022 | — |
| Icahn School of Medicine at Mount Sinai /ID# 165612 | New York | New York | 10029 | — |
| Columbia Univ Medical Center /ID# 161899 | New York | New York | 10032-3725 | — |
| Lenox Hill Hospital /ID# 168467 | New York | New York | 10075 | — |
| Duplicate_DiGiovanna Institute for Medical Education & Research /ID# 171126 | North Massapequa | New York | 11758 | — |
| Univ NC Chapel Hill /ID# 154833 | Chapel Hill | North Carolina | 27514-4220 | — |
| Atrium Health Carolinas Medical Center /ID# 158428 | Charlotte | North Carolina | 28203 | — |
| Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154873 | Raleigh | North Carolina | 27612 | — |
| Plains Clinical Research Center, LLC /ID# 169718 | Fargo | North Dakota | 58104-5925 | — |
| Tri-State Endoscopy Center /ID# 154927 | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic Main Campus /ID# 209226 | Cleveland | Ohio | 44195 | — |
| The Ohio State University /ID# 164708 | Columbus | Ohio | 43210 | — |
| Optimed Research, Ltd. /ID# 167887 | Columbus | Ohio | 43235 | — |
| Hometown Urgent Care and Resea /ID# 170464 | Dayton | Ohio | 45424 | — |
| Great Lakes Gastroenterology Research, LLC /ID# 201770 | Mentor | Ohio | 44060-6211 | — |
| Hightower Clinical /ID# 211993 | Oklahoma City | Oklahoma | 73102 | — |
| Digestive Disease Specialists /ID# 170775 | Oklahoma City | Oklahoma | 73112 | — |
| Adult Gastroenterology Associates - Gen 1 Research /ID# 208864 | Tulsa | Oklahoma | 74136-7823 | — |
| Children's Hospital of Pittsburgh of UPMC /ID# 212544 | Pittsburgh | Pennsylvania | 15224-1334 | — |
| Digestive Disease Associates, LTD - Wyomissing /ID# 208297 | Wyomissing | Pennsylvania | 19610 | — |
| Medical University of South Carolina /ID# 212858 | Charleston | South Carolina | 29425 | — |
| Gastroenterology Associates, P.A. of Greenville /ID# 154904 | Greenville | South Carolina | 29607 | — |
| Rapid City Medical Center - GI Research /ID# 163838 | Rapid City | South Dakota | 57701 | — |
| Gastro One /ID# 154726 | Cordova | Tennessee | 38018 | — |
| East Tennessee Research Institute /ID# 168739 | Johnson City | Tennessee | 37604 | — |
| Clinical Neuroscience Solutions /ID# 164180 | Memphis | Tennessee | 38119 | — |
| Vanderbilt University Medical Center /ID# 157121 | Nashville | Tennessee | 37232-0011 | — |
| TX Clinical Research Institute /ID# 159404 | Arlington | Texas | 76012 | — |
| Inquest Clinical Research /ID# 165694 | Baytown | Texas | 77521-2415 | — |
| GI Alliance /ID# 209797 | Cedar Park | Texas | 78613 | — |
| Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 159406 | Dallas | Texas | 75246 | — |
| Duplicate_DHAT Research Institute /ID# 158208 | Garland | Texas | 75044-2208 | — |
| Vilo Research Group Inc /ID# 207655 | Houston | Texas | 77017-2337 | — |
| Baylor College of Medicine /ID# 158203 | Houston | Texas | 77030 | — |
| Centex Studies, Inc. - Houston /ID# 201219 | Houston | Texas | 77058 | — |
| Clinical Associates in Research Therapeutics of America, LLC /ID# 161323 | San Antonio | Texas | 78212 | — |
| Southern Star Research Institute, LLC /ID# 168773 | San Antonio | Texas | 78229-5390 | — |
| Baylor Scott & White Center for Diagnostic Medicine /ID# 204131 | Temple | Texas | 76508 | — |
| Tyler Research Institute /ID# 166797 | Tyler | Texas | 75701 | — |
| Gastro Health & Nutrition - Victoria /ID# 164290 | Victoria | Texas | 77904 | — |
| Texas Digestive Disease Consultants /ID# 209946 | Webster | Texas | 77598 | — |
| Advanced Research Institute /ID# 154907 | Ogden | Utah | 84405 | — |
| Velocity Clinical Research - Salt Lake City /ID# 161778 | West Jordan | Utah | 84088 | — |
| Richmond VA Medical Center /ID# 159988 | Richmond | Virginia | 23249 | — |
| Duplicate_Virginia Mason Medical Center /ID# 155556 | Seattle | Washington | 98101 | — |
| West Virginia University Hospitals /ID# 167941 | Morgantown | West Virginia | 26506 | — |
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 385 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03105102, 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 Aug 14, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03105102 live on ClinicalTrials.gov.