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Clinical Trials in the USA / NCT03006068
Active, not recruiting Phase 3

A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

NCT03006068 · tracked via the Priya Life Science USA tracker
Sponsor
AbbVie
Phase
Phase 3
Started
2017-01-31
Last updated
2026-01-12

Condition(s) studied

Ulcerative Colitis (UC)

Investigational drug(s) / intervention(s)

Upadacitinib (ABT-494)Placebo

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

Sex
ALL
Min age
16 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: Note: Participants aged 16 or 17 may enroll in M14-234 or M14-675 where locally permissible * Participant has not achieved clinical response at the end of the induction period (Week 8) in Study M14-234 Substudy 1, has had loss of response during the maintenance period of Study M14-234 Substudy 3, or has successfully completed Study M14-234 Substudy 3. During the COVID-19 pandemic, for participants with missing endoscopy at Week 8, Week 16 or Week 52 due to the COVID-19 pandemic in Studies M14-234 Substudy 2, M14-234 Substudy 3 and M14-675, participants may be enrolled if certain criteria are met. * If female, participant must meet the contraception criteria. * Women of childbearing potential must have a negative urine pregnancy test at Week 0 visit. * Participant is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study (Study M14-234). * Must be able and willing to give written informed consent and to comply with the requirements of this study protocol. Exclusion Criteria: * For any reason participant is considered by the investigator to be an unsuitable candidate. * Female participant with a positive pregnancy test at the final visit of Study M14-234 or who is considering becoming pregnant during the study or within 30 days after the last dose of study drug. * Known hypersensitivity to upadacitinib or its excipients or had any adverse event (AE) during the preceding studies, that in the investigator's judgment makes the participant unsuitable for this study. * Participant with an active or recurrent infection that based on the investigator's clinical assessment makes the participant an unsuitable candidate for the study. Participants with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated. * Current evidence of active tuberculosis (TB); current evidence of latent tuberculosis and for any reason the participant cannot take full course of TB prophylaxis treatment as required per protocol. * Participant with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure (New York Heart Association class III or IV), recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study. * Participants have malignancy, high-grade dysplasia, un-removed low-grade dysplasia of the gastrointestinal tract diagnosed at the endoscopy performed at the final visit of Study M14-234. * History of any malignancy except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix from evaluations performed in Study M14-234.

Primary outcome measure(s)

Trial sites (492)

FacilityCityRegionStatus
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.

Official registry record

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 the USA