ClinicalTrials.gov record
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
ClinicalTrials.gov ID: NCT02819635
Public ClinicalTrials.gov record NCT02819635. 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 Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.
Study identification
- NCT ID
- NCT02819635
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 1,302 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 75 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
- Sep 26, 2016 (Actual)
- Primary completion
- Dec 13, 2021 (Actual)
- Completion
- Dec 13, 2021 (Actual)
- Last update posted
- Jun 30, 2022
2016 – 2021
United States locations
- U.S. sites
- 149
- U.S. states
- 37
- U.S. cities
- 117
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Gastroenterology Associates P.C /ID# 151276 | Birmingham | Alabama | 35209 | — |
| East View Medical Research, LLC /ID# 171183 | Mobile | Alabama | 36606 | — |
| CB Flock Research Corporation /ID# 165980 | Mobile | Alabama | 36608 | — |
| Delsol Research Management, Ll /Id# 170131 | Chandler | Arizona | 85224 | — |
| Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885 | Mesa | Arizona | 85206 | — |
| Arizona Arthritis & Rheumatology Research, PLLC /ID# 169822 | Sun City | Arizona | 85306 | — |
| Adobe Clinical Research LLC /ID# 155250 | Tucson | Arizona | 85712 | — |
| University of Arizona /ID# 150553 | Tucson | Arizona | 85724 | — |
| Citrus Valley Gastroenterology /ID# 151914 | Covina | California | 91722-3797 | — |
| Newport Huntington Medical Group /ID# 217005 | Huntington Beach | California | 92648-5994 | — |
| UC San Diego Health System /ID# 155185 | La Jolla | California | 92093 | — |
| United Medical Doctors /ID# 207464 | Los Alamitos | California | 90720-3309 | — |
| TLC Clinical Research Inc /ID# 216829 | Los Angeles | California | 90048 | — |
| Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157080 | Los Angeles | California | 90067-2001 | — |
| Facey Medical Foundation /ID# 203133 | Mission Hills | California | 91345 | — |
| United Medical Doctors - Murrieta /ID# 151211 | Murrieta | California | 92563 | — |
| InSite Digestive Health Care - Oxnard /ID# 163414 | Oxnard | California | 93030 | — |
| Inland Empire Clinical Trials, LLC /ID# 216038 | Rialto | California | 92377 | — |
| San Diego Clinical Trials /ID# 212120 | San Diego | California | 92120 | — |
| Medical Assoc Research Grp /ID# 169148 | San Diego | California | 92123 | — |
| Univ of California San Francis /ID# 164581 | San Francisco | California | 94158 | — |
| Delta Waves, Inc. /ID# 151721 | Colorado Springs | Colorado | 80918 | — |
| South Denver Gastroenterology /ID# 151223 | Lone Tree | Colorado | 80124 | — |
| Western States Clinical Res /ID# 158076 | Wheat Ridge | Colorado | 80033-2896 | — |
| Western Connecticut Medical Group /ID# 169210 | Danbury | Connecticut | 06810 | — |
| Medical Research Center of CT /ID# 150482 | Hamden | Connecticut | 06518 | — |
| Gastro Florida /ID# 155245 | Clearwater | Florida | 33756 | — |
| Moonshine Research Center, Inc /ID# 152533 | Doral | Florida | 33166 | — |
| Universal Axon Clinical Research /ID# 213461 | Doral | Florida | 33166 | — |
| Palmetto Research, LLC /ID# 151716 | Hialeah | Florida | 33016 | — |
| Nature Coast Clinical Research - Inverness /ID# 154064 | Inverness | Florida | 34452-4717 | — |
| Encore Borland-Groover Clinical Research /Id# 170912 | Jacksonville | Florida | 32256 | — |
| SIH Research Mumtaz, Inc /ID# 163319 | Kissimmee | Florida | 34741-4161 | — |
| Cfagi Llc /Id# 202017 | Maitland | Florida | 32751-6108 | — |
| University of Miami /ID# 215441 | Miami | Florida | 33136 | — |
| Advanced Pharma /ID# 151719 | Miami | Florida | 33147 | — |
| New Horizon Research Center /ID# 152474 | Miami | Florida | 33165-3372 | — |
| Crystal Pharmacology Research /ID# 151841 | Miami | Florida | 33165 | — |
| Coral Research Clinic /ID# 150444 | Miami | Florida | 33186-4643 | — |
| Advanced Research Institute, Inc /ID# 163098 | New Port Richey | Florida | 34653 | — |
| Endoscopic Research, Inc. /ID# 151720 | Orlando | Florida | 32803 | — |
| Omega Research Maitland, LLC /ID# 200269 | Orlando | Florida | 32808 | — |
| Clinical Research Trials of Florida, Inc. /ID# 201790 | Tampa | Florida | 33607 | — |
| University of South Florida /ID# 214493 | Tampa | Florida | 33612 | — |
| AdventHealth Tampa /ID# 200272 | Tampa | Florida | 33613-4680 | — |
| Gastroenterology Associates of Central Georgia, LLC /ID# 165782 | Macon | Georgia | 31201 | — |
| Infinite Clinical Trials /ID# 215340 | Riverdale | Georgia | 30274 | — |
| Atlanta Gastroenterology Spec /ID# 150548 | Suwanee | Georgia | 30024 | — |
| Next Innovative Clinical Research - Chicago /ID# 216060 | Chicago | Illinois | 60605-2168 | — |
| The University of Chicago DCAM /ID# 150547 | Chicago | Illinois | 60637 | — |
| NorthShore University HealthSystem /ID# 150555 | Evanston | Illinois | 60201 | — |
| Northwest Health Care Associates /ID# 151590 | Hoffman Estates | Illinois | 60169 | — |
| Carle Foundation Hospital /ID# 151137 | Urbana | Illinois | 61801 | — |
| MediSphere Medical Research Center /ID# 152064 | Evansville | Indiana | 47714-8011 | — |
| Indianapolis Gastroenterology /ID# 162901 | Indianapolis | Indiana | 46237 | — |
| University of Iowa Hospitals and Clinics /ID# 157058 | Iowa City | Iowa | 52242 | — |
| Cotton-O'Neil Clinical Res Ctr /ID# 167182 | Topeka | Kansas | 66606 | — |
| Tri-State Gastroenterology /ID# 169811 | Crestview Hills | Kentucky | 41017 | — |
| Houma Digestive Health Special /ID# 151844 | Houma | Louisiana | 70360 | — |
| Nola Research Works, LLC /ID# 153356 | New Orleans | Louisiana | 70115 | — |
| Louisana Research Center, LLC /ID# 150446 | Shreveport | Louisiana | 71105-6800 | — |
| University of Maryland Med Ctr /ID# 150449 | Baltimore | Maryland | 21201 | — |
| Gastro Center of Maryland /ID# 200022 | Columbia | Maryland | 21045 | — |
| Massachusetts General Hospital /ID# 165676 | Boston | Massachusetts | 02114 | — |
| University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 151140 | Ann Arbor | Michigan | 48109 | — |
| Huron Gastroenterology Assoc /ID# 152710 | Ann Arbor | Michigan | 48197 | — |
| Clin Res Inst of Michigan, LLC /ID# 153027 | Chesterfield | Michigan | 48047 | — |
| Revival Research Institute, LLC /ID# 207280 | Southfield | Michigan | 48034-1659 | — |
| Center for Digestive Health /ID# 161984 | Troy | Michigan | 48098-6363 | — |
| Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157484 | Wyoming | Michigan | 49519 | — |
| Mayo Clinic - Rochester /ID# 151677 | Rochester | Minnesota | 55905-0001 | — |
| Minnesota Gastroenterology PA /ID# 151678 | Saint Paul | Minnesota | 55114 | — |
| University of Mississippi Medical Center /ID# 213139 | Jackson | Mississippi | 39216-4500 | — |
| Southern Therapy and Advanced Research (STAR) LLC /ID# 170712 | Jackson | Mississippi | 39216 | — |
| Washington University-School of Medicine /ID# 150485 | St Louis | Missouri | 63110 | — |
| Las Vegas Medical Research /ID# 153044 | Las Vegas | Nevada | 89113 | — |
| Dartmouth-Hitchcock Medical Center /ID# 150549 | Lebanon | New Hampshire | 03756 | — |
| AGA Clinical Research Associates, LLC /ID# 153040 | Egg Harbor | New Jersey | 08234 | — |
| Atlantic Digestive Health Inst /ID# 150447 | Morristown | New Jersey | 07960 | — |
| Rutgers Robert Wood Johnson /ID# 155248 | New Brunswick | New Jersey | 08901 | — |
| Duplicate_University of New Mexico Department of Internal Medicine /ID# 214396 | Albuquerque | New Mexico | 87131 | — |
| NY Scientific /ID# 152707 | Brooklyn | New York | 11235 | — |
| NYU Langone Long Island Clinical Research Association /ID# 155272 | Great Neck | New York | 11021 | — |
| Columbia Univ Medical Center /ID# 163410 | New York | New York | 10032-3725 | — |
| DiGiovanna Institute for Medical Education & Research /ID# 201533 | North Massapequa | New York | 11758 | — |
| Premier Medical Group - GI Division /ID# 153357 | Poughkeepsie | New York | 12601 | — |
| Gastoenterology Group of Rochester /ID# 151079 | Rochester | New York | 14618-5703 | — |
| Richmond University Medical Center /ID# 201859 | Staten Island | New York | 10310-1664 | — |
| Montefiore Medical Center - Moses Campus /ID# 150543 | The Bronx | New York | 10467 | — |
| Advantage Clinical Trials /ID# 163938 | The Bronx | New York | 10468 | — |
| Digestive Health Partners, P.A /ID# 167237 | Asheville | North Carolina | 28801 | — |
| Atrium Health Carolinas Medical Center /ID# 156971 | Charlotte | North Carolina | 28203 | — |
| Charlotte Gastroenterology and Hepatology, PLLC /ID# 150545 | Charlotte | North Carolina | 28207 | — |
| Atlantic Gastroenterology Clinical Research /ID# 151899 | Greenville | North Carolina | 27834 | — |
| Clinical Trials of America /ID# 153448 | Winston-Salem | North Carolina | 27103 | — |
| Wake Forest Baptist Medical Center /ID# 150448 | Winston-Salem | North Carolina | 27157-0001 | — |
| Plains Clinical Research Center, LLC /ID# 170290 | Fargo | North Dakota | 58104-5925 | — |
| Consultants for Clinical Research /ID# 151679 | Cincinnati | Ohio | 45219 | — |
| University of Cincinnati /ID# 164582 | Cincinnati | Ohio | 45267-0585 | — |
| The Ohio State University /ID# 169416 | Columbus | Ohio | 43210 | — |
| Optimed Research, Ltd. /ID# 169696 | Columbus | Ohio | 43235 | — |
| Hometown Urgent Care and Resea /ID# 200065 | Dayton | Ohio | 45424 | — |
| Dayton Gastroenterology, Inc. /ID# 167631 | Englewood | Ohio | 45415 | — |
| Great Lakes Medical Research, LLC /ID# 201772 | Mentor | Ohio | 44060-6211 | — |
| Ohio Clinical Research Partner /ID# 154068 | Mentor | Ohio | 44060 | — |
| Hightower Clinical /ID# 216337 | Oklahoma City | Oklahoma | 73102 | — |
| Digestive Disease Specialists /ID# 201056 | Oklahoma City | Oklahoma | 73112 | — |
| Options Health Research, LLC /ID# 150554 | Tulsa | Oklahoma | 74104 | — |
| Healthcare Research Consultant /ID# 163100 | Tulsa | Oklahoma | 74135 | — |
| Northwest Gastroenterology Clinic /ID# 152527 | Portland | Oregon | 97210 | — |
| Guthrie Medical Group, PC /ID# 150481 | Sayre | Pennsylvania | 18840 | — |
| Penn State Health Colonnade /ID# 150259 | State College | Pennsylvania | 16803-2309 | — |
| Pharmacorp Clinical Trials /ID# 153354 | Charleston | South Carolina | 29412 | — |
| Gastroenterology Associates, P.A. of Greenville /ID# 150541 | Greenville | South Carolina | 29615-3593 | — |
| Gastro One /ID# 151144 | Germantown | Tennessee | 38138 | — |
| East Tennessee Research Institute /ID# 203610 | Johnson City | Tennessee | 37604 | — |
| Quality Medical Research /ID# 203426 | Nashville | Tennessee | 37211 | — |
| Vanderbilt University Medical Center /ID# 153355 | Nashville | Tennessee | 37232-0011 | — |
| TX Clinical Research Institute /ID# 151526 | Arlington | Texas | 76012 | — |
| Inquest Clinical Research /ID# 164635 | Baytown | Texas | 77521-2415 | — |
| Texas Digestive Disease Consultants /ID# 209947 | Cedar Park | Texas | 78613-5028 | — |
| Texas Digestive Disease Consultants /ID# 209804 | Cedar Park | Texas | 78613 | — |
| Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200770 | Dallas | Texas | 75246 | — |
| DHAT Research Institute /ID# 151218 | Garland | Texas | 75044-2208 | — |
| Vilo Research Group Inc /ID# 212624 | Houston | Texas | 77017-2337 | — |
| CliniCore International, LLC /ID# 152062 | Houston | Texas | 77027-6812 | — |
| Baylor College of Medicine - Baylor Medical Center /ID# 150486 | Houston | Texas | 77030-3411 | — |
| Centex Studies, Inc. - Houston /ID# 201216 | Houston | Texas | 77058 | — |
| GI Specialists of Houston /ID# 202327 | Houston | Texas | 77070-4347 | — |
| Caprock Gastro Research, LLC /ID# 214754 | Lubbock | Texas | 79424-3017 | — |
| Clinical Associates in Research Therapeutics of America, LLC /ID# 201260 | San Antonio | Texas | 78212 | — |
| Southern Star Research Institute, LLC /ID# 169396 | San Antonio | Texas | 78229-5390 | — |
| Carl R. Meisner Medical Clinic /ID# 171061 | Sugar Land | Texas | 77478 | — |
| Baylor Scott & White Center for Diagnostic Medicine /ID# 204499 | Temple | Texas | 76508 | — |
| Tyler Research Institute, LLC /ID# 169146 | Tyler | Texas | 75701-4464 | — |
| Gastro Health & Nutrition - Victoria /ID# 167761 | Victoria | Texas | 77904 | — |
| HP Clinical Research /ID# 163939 | Bountiful | Utah | 84010 | — |
| Advanced Research Institute /ID# 162624 | Ogden | Utah | 84403 | — |
| Utah Gastroenternology - St. Mark's Office /ID# 163101 | Salt Lake City | Utah | 84124 | — |
| Velocity Clinical Research - Salt Lake City /ID# 163181 | West Jordan | Utah | 84088 | — |
| Ctr for Gastrointestinal Healt /ID# 153360 | Franklin | Virginia | 23851 | — |
| Emeritas Research Group, LLC /ID# 150258 | Leesburg | Virginia | 20176 | — |
| Washington Gastroenterology /ID# 163629 | Bellevue | Washington | 98004 | — |
| Virginia Mason Medical Center /ID# 153026 | Seattle | Washington | 98101 | — |
| The Polyclinic /ID# 164369 | Seattle | Washington | 98122-4201 | — |
| The Vancouver Clinic, INC. PS /ID# 162333 | Vancouver | Washington | 98664 | — |
| Aurora Medical Center - Grafto /ID# 151717 | Grafton | Wisconsin | 53024 | — |
| Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 151838 | Milwaukee | Wisconsin | 53215 | — |
| Medical College of Wisconsin /ID# 151843 | Milwaukee | Wisconsin | 53226-3522 | — |
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 347 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02819635, 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 30, 2022 · Synced Oct 31, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02819635 live on ClinicalTrials.gov.