A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis

About this Study

To evaluate the long-term safety and efficacy of upadacitinib in subjects 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 completed Study M14-234 Substudy 3.

Sponsor Protocol ID:M14-533
IRB Number:2020-0031
Actively Enrolling
Interventional
Phase 3
February 21, 2020
Eligibility Criteria
Both Male and Female
No
No
No

Inclusion CriteriaWomen of childbearing potential (refer to Section 5.2.4) must have a negative urine pregnancy test at Week 0 visit. 

If female, subject must meet the contraception criteria as stated in this protocol. 

Must be able and willing to give written informed consent and to comply with the requirements of this study protocol. For subjects in Japan only, if the subject is

Exclusion CriteriaFor any reason subject is considered by the investigator to be an unsuitable candidate.

Subject with an active or recurrent infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.

Subjects with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure, 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.

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Digestive Conditions
Participating Locations
Belhaven Building - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Yilianys Pride
Phone Number: 601-496-2009
Email: ypride@umc.edu
Principal Investigator:Glover, Sarah C
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