ClinicalTrials.gov record
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
ClinicalTrials.gov ID: NCT03104413
Public ClinicalTrials.gov record NCT03104413. 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 Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
Study identification
- NCT ID
- NCT03104413
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 618 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
- Dec 18, 2017 (Actual)
- Primary completion
- Nov 30, 2020 (Actual)
- Completion
- May 19, 2021 (Actual)
- Last update posted
- Jun 14, 2022
2017 – 2021
United States locations
- U.S. sites
- 114
- U.S. states
- 31
- U.S. cities
- 92
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix VA Health Care System /ID# 162261 | Phoenix | Arizona | 85012 | — |
| HonorHealth Research Institute - Shea /ID# 165825 | Scottsdale | Arizona | 85258 | — |
| Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882 | Tempe | Arizona | 85284-2604 | — |
| University of Arizona /ID# 158305 | Tucson | Arizona | 85724 | — |
| Duplicate_Atria Clinical Research /ID# 164504 | Little Rock | Arkansas | 72209-7040 | — |
| Southern California Res. Ctr. /ID# 211989 | Coronado | California | 92118-1408 | — |
| Newport Huntington Medica /ID# 213034 | Huntington Beach | California | 92648-5994 | — |
| UC San Diego Health Systems /ID# 155576 | La Jolla | California | 92093 | — |
| United Medical Doctors /ID# 207887 | Los Alamitos | California | 90720-3309 | — |
| TLC Clinical Research Inc /ID# 212501 | Los Angeles | California | 90048 | — |
| Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162655 | Los Angeles | California | 90067-2001 | — |
| United Medical Doctors - Murrieta /ID# 158278 | Murrieta | California | 92563 | — |
| Peak Gastroenterology Associates, PC /ID# 165832 | Colorado Springs | Colorado | 80907 | — |
| Rocky Mountain Pediatric Gastroenterology /ID# 207171 | Lone Tree | Colorado | 80124-6798 | — |
| Western Connecticut Medical Group /ID# 165874 | Danbury | Connecticut | 06810-6000 | — |
| Seffner Premier Health Care, PA /ID# 162259 | Brandon | Florida | 33510 | — |
| Clinical Research of West Florida, Inc /ID# 205864 | Clearwater | Florida | 33765 | — |
| Clinical Research of West Florida, Inc /ID# 208127 | Clearwater | Florida | 33765 | — |
| South Lake Pain Institute, Inc /ID# 162798 | Clermont | Florida | 34711 | — |
| Omega Research Maitland, LLC /ID# 171080 | DeBary | Florida | 32713-2260 | — |
| Universal Axon Clinical Research /ID# 165426 | Doral | Florida | 33166 | — |
| SIH Research Mumtaz, Inc /ID# 163081 | Kissimmee | Florida | 34741-4161 | — |
| Alliance Medical Research /ID# 163834 | Lighthouse PT | Florida | 33064 | — |
| Cfagi Llc /Id# 202482 | Maitland | Florida | 32751-6108 | — |
| University of Miami /ID# 155011 | Miami | Florida | 33136 | — |
| Vista Health Research, LLC /ID# 212828 | Miami | Florida | 33176-1032 | — |
| ITB Research /ID# 161278 | Miami | Florida | 33176 | — |
| Coral Research Clinic /ID# 158330 | Miami | Florida | 33186-4643 | — |
| South Florida Research Ph I-IV, Inc. /ID# 161825 | Miami | Florida | 33193 | — |
| Gastroenterology Group Naples /ID# 165192 | Naples | Florida | 34102 | — |
| Advanced Research Institute, Inc /ID# 161973 | New Port Richey | Florida | 34653 | — |
| Endoscopic Research, Inc. /ID# 205903 | Orlando | Florida | 32803 | — |
| IMIC Inc. Medical Research /ID# 154944 | Palmetto Bay | Florida | 33157 | — |
| Clinical Research Trials of Florida, Inc. /ID# 201606 | Tampa | Florida | 33607 | — |
| Atlanta Gastro Assoc /ID# 154755 | Atlanta | Georgia | 30342 | — |
| Gastroenterology Associates of Central Georgia, LLC /ID# 154865 | Macon | Georgia | 31201 | — |
| Northwestern University Division of GI/Hepatology /ID# 158250 | Chicago | Illinois | 60611-2927 | — |
| The University of Chicago Medical Center /ID# 157113 | Chicago | Illinois | 60637-1443 | — |
| NorthShore University HealthSystem /ID# 158254 | Evanston | Illinois | 60201 | — |
| Southwest Gastroenterology /ID# 164764 | Oak Lawn | Illinois | 60453 | — |
| Cotton-O'Neil Clinical Res Ctr /ID# 154753 | Topeka | Kansas | 66606 | — |
| University of Kentucky Chandler Medical Center /ID# 157109 | Lexington | Kentucky | 40536 | — |
| University of Louisville /ID# 210523 | Louisville | Kentucky | 40202 | — |
| Gastroenterology Associates LLC - Jefferson Hwy /ID# 161970 | Baton Rouge | Louisiana | 70809 | — |
| Houma Digestive Health Special /ID# 158253 | Houma | Louisiana | 70360 | — |
| Delricht Research /ID# 206567 | New Orleans | Louisiana | 70115 | — |
| Nola Research Works, LLC /ID# 161271 | New Orleans | Louisiana | 70115 | — |
| Louisana Research Center, LLC /ID# 162239 | Shreveport | Louisiana | 71105-6800 | — |
| MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154846 | Chevy Chase | Maryland | 20815 | — |
| Gastro Center of Maryland /ID# 164766 | Columbia | Maryland | 21045 | — |
| Center for Digestive Health /ID# 154697 | Troy | Michigan | 48098-6363 | — |
| Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161267 | Wyoming | Michigan | 49519 | — |
| Mayo Clinic - Rochester /ID# 163084 | Rochester | Minnesota | 55905-0001 | — |
| University of Nebraska Medical Center /ID# 210056 | Omaha | Nebraska | 68198-2000 | — |
| Las Vegas Medical Research /ID# 160167 | Las Vegas | Nevada | 89113 | — |
| Revival Research Institute, Inc /ID# 210986 | Las Vegas | Nevada | 89128-3157 | — |
| NY Scientific /ID# 158272 | Brooklyn | New York | 11235 | — |
| Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213446 | Burnt Hills | New York | 12027 | — |
| Intercity Advanced Gastroentertology Center /ID# 215204 | Fresh Meadows | New York | 11366 | — |
| Duplicate_Long Island Clinical Research /ID# 154843 | Great Neck | New York | 11021-5343 | — |
| Digestive Disease Care /ID# 211776 | New Hyde Park | New York | 11040 | — |
| North Shore University Hospital /ID# 168734 | New Hyde Park | New York | 11040 | — |
| NYU Langone Medical Center /ID# 160166 | New York | New York | 10016-6402 | — |
| Weill Cornell Medicine /ID# 165856 | New York | New York | 10022 | — |
| Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165610 | New York | New York | 10029 | — |
| Columbia Univ Medical Center /ID# 167545 | New York | New York | 10032-3725 | — |
| Lenox Hill Hospital /ID# 168466 | New York | New York | 10075 | — |
| DiGiovanna Institute for Medical Education & Research /ID# 171130 | North Massapequa | New York | 11758 | — |
| Atrium Health Carolinas Medical Center /ID# 158364 | Charlotte | North Carolina | 28203 | — |
| Vidant Multispecialty Clinic - Kinston /ID# 161109 | Kinston | North Carolina | 28501-1589 | — |
| Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154891 | Raleigh | North Carolina | 27612 | — |
| Plains Clinical Research Center, LLC /ID# 169712 | Fargo | North Dakota | 58104-5925 | — |
| Tri-State Endoscopy /ID# 154939 | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic Main Campus /ID# 209225 | Cleveland | Ohio | 44195 | — |
| The Ohio State University /ID# 164706 | Columbus | Ohio | 43210 | — |
| Optimed Research, Ltd. /ID# 167877 | Columbus | Ohio | 43235 | — |
| Hometown Urgent Care and Resea /ID# 170447 | Dayton | Ohio | 45424 | — |
| Great Lakes Medical Research, LLC /ID# 201774 | Mentor | Ohio | 44060-6211 | — |
| Hightower Clinical /ID# 211992 | Oklahoma City | Oklahoma | 73102 | — |
| Digestive Disease Specialists /ID# 170772 | Oklahoma City | Oklahoma | 73112 | — |
| Adult Gastroenterology Associates - Gen 1 Research /ID# 208857 | Tulsa | Oklahoma | 74136-7823 | — |
| Northwest Gastroenterology Clinic /ID# 158255 | Portland | Oregon | 97210 | — |
| PennState Milton S.Hershey Med /ID# 154894 | Hershey | Pennsylvania | 17033 | — |
| Children's Hospital of Pittsburgh of UPMC /ID# 212543 | Pittsburgh | Pennsylvania | 15224-1334 | — |
| Digestive Disease Associates, LTD /ID# 208296 | Wyomissing | Pennsylvania | 19610-2002 | — |
| Medical University of South Carolina /ID# 212859 | Charleston | South Carolina | 29425 | — |
| Gastroenterology Associates, P.A. of Greenville /ID# 154919 | Greenville | South Carolina | 29615-3593 | — |
| Rapid City Medical Center - GI Research /ID# 163835 | Rapid City | South Dakota | 57701 | — |
| Gastro One /ID# 154757 | Germantown | Tennessee | 38138 | — |
| East Tennessee Research Institute /ID# 168735 | Johnson City | Tennessee | 37604 | — |
| Duplicate_Clinical Neuroscience Solutions, Inc /ID# 164179 | Memphis | Tennessee | 38119 | — |
| Vanderbilt University Medical Center /ID# 157110 | Nashville | Tennessee | 37232-0011 | — |
| TX Clinical Research Institute /ID# 159396 | Arlington | Texas | 76012 | — |
| Inquest Clinical Research /ID# 165696 | Baytown | Texas | 77521-2415 | — |
| Texas Digestive Disease Consultants /ID# 209781 | Cedar Park | Texas | 78613-5028 | — |
| Texas Digestive Disease Consultants /ID# 209945 | Cedar Park | Texas | 78613-5028 | — |
| DHAT Research Institute /ID# 158199 | Garland | Texas | 75044-2208 | — |
| Vilo Research Group Inc /ID# 207654 | Houston | Texas | 77017-2337 | — |
| CliniCore International, LLC /ID# 158191 | Houston | Texas | 77027-6812 | — |
| Baylor College of Medicine - Baylor Medical Center /ID# 158194 | Houston | Texas | 77030-3411 | — |
| Precision Research Institute, LLC /ID# 201072 | Houston | Texas | 77036 | — |
| Centex Studies, Inc. - Houston /ID# 201218 | Houston | Texas | 77058 | — |
| Clinical Associates in Research Therapeutics of America, LLC /ID# 161307 | San Antonio | Texas | 78212 | — |
| Southern Star Research Institute, LLC /ID# 168772 | San Antonio | Texas | 78229-5390 | — |
| Baylor Scott & White Medical Center- Temple /ID# 204129 | Temple | Texas | 76508-0001 | — |
| Tyler Research Institute, LLC /ID# 166795 | Tyler | Texas | 75701-4464 | — |
| Gastro Health & Nutrition - Victoria /ID# 164284 | Victoria | Texas | 77904 | — |
| HP Clinical Research /ID# 162992 | Bountiful | Utah | 84010 | — |
| Advanced Research Institute /ID# 154922 | Ogden | Utah | 84403 | — |
| Velocity Clinical Research - Salt Lake City /ID# 161775 | West Jordan | Utah | 84088 | — |
| Hunter Holmes McGuire VA Medical Center /ID# 159977 | Richmond | Virginia | 23249 | — |
| Washington Gastroenterology Associates /ID# 162101 | Bellevue | Washington | 98004 | — |
| Virginia Mason - Seattle Orthapedics /ID# 155577 | Seattle | Washington | 98101 | — |
| WVU Medicine /ID# 167942 | Morgantown | West Virginia | 26506-1200 | — |
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 289 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03104413, 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 Jun 14, 2022 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03104413 live on ClinicalTrials.gov.