A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)
Condition(s) studied
Investigational drug(s) / intervention(s)
Upadacitinib (ABT-494): Upadacitinib (ABT-494) will be administered orally.
Placebo: Placebo will be administered orally.
Study summary
This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.
Eligibility
Primary outcome measure(s)
- Assessing Treatment-Emergent Adverse Events — Up to 288 Weeks
Treatment-emergent adverse events are defined as events that begin or worsen either on or after the first dose of the study drug and within 30 days after the last dose of the study drug in the analysis period.
Trial sites (492)
| Facility | City | Region | Status |
|---|---|---|---|
| East View Medical Research, LLC /ID# 171184 | Mobile | Alabama | |
| CB Flock Research Corporation /ID# 165986 | Mobile | Alabama | |
| Delsol Research Management, Ll /Id# 170130 | Chandler | Arizona | |
| Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211886 | Mesa | Arizona | |
| Duplicate_Arizona Arthritis & Rheumatology Research, PLLC /ID# 169823 | Sun City | Arizona | |
| Adobe Clinical Research LLC /ID# 155249 | Tucson | Arizona | |
| Duplicate_University of Arizona /ID# 150568 | Tucson | Arizona | |
| Citrus Valley Gastroenterology /ID# 151915 | Covina | California | |
| Newport Huntington Medical Group /ID# 217006 | Huntington Beach | California | |
| UC San Diego Health System /ID# 155187 | La Jolla | California | |
| United Medical Doctors /ID# 207467 | Los Alamitos | California | |
| TLC Clinical Research Inc /ID# 216830 | Los Angeles | California | |
| Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157082 | Los Angeles | California | |
| Facey Medical Foundation /ID# 203135 | Mission Hills | California | |
| United Medical Doctors - Murrieta /ID# 151213 | Murrieta | California | |
| Ventura County Gastroenterology Medical Group /ID# 163417 | Oxnard | California | |
| Inland Empire Clinical Trials, LLC /ID# 216163 | Rialto | California | |
| San Diego Clinical Trials /ID# 212121 | San Diego | California | |
| Medical Assoc Research Grp /ID# 169149 | San Diego | California | |
| Univ of California San Francis /ID# 164583 | San Francisco | California | |
| Delta Waves, Inc. /ID# 151727 | Colorado Springs | Colorado | |
| South Denver Gastroenterology /ID# 151224 | Lone Tree | Colorado | |
| Western States Clinical Res /ID# 158078 | Wheat Ridge | Colorado | |
| Duplicate_Western Connecticut Medical Group /ID# 169211 | Danbury | Connecticut | |
| Gastroenterology Center of Connecticut /ID# 150534 | Hamden | Connecticut | |
| West Central Gastroenterology /ID# 155242 | Clearwater | Florida | |
| Moonshine Research Center, Inc /ID# 152534 | Doral | Florida | |
| Universal Axon Clinical Research /ID# 213463 | Doral | Florida | |
| Palmetto Research, LLC /ID# 151724 | Hialeah | Florida | |
| Nature Coast Clinical Research - Inverness /ID# 154070 | Inverness | Florida | |
| Encore Borland-Groover Clinical Research /Id# 170913 | Jacksonville | Florida | |
| SIH Research Mumtaz, Inc /ID# 163199 | Kissimmee | Florida | |
| Cfagi Llc /Id# 202018 | Maitland | Florida | |
| Duplicate_University of Miami /ID# 215443 | Miami | Florida | |
| Advanced Pharma CR, LLC /ID# 151723 | Miami | Florida | |
| New Horizon Research Center /ID# 152475 | Miami | Florida | |
| Crystal Pharmacology Research /ID# 151848 | Miami | Florida | |
| Coral Research Clinic /ID# 150524 | Miami | Florida | |
| Advanced Research Institute, Inc /ID# 163093 | New Port Richey | Florida | |
| Endoscopic Research, Inc. /ID# 151725 | Orlando | Florida |
+ 452 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03006068 on ClinicalTrials.gov ↗ ← All trials in Italy