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)
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
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.
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