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.

About this Study

This is a Phase 2b/3, multi center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and pharmacokinetics of upadacitinib as
induction and maintenance therapy in subjects with moderately to severely active Ulcerative Colitis.
The study comprises 3 sub studies: a Phase 2b dose-ranging induction sub study (Sub study 1), a Phase 3 dose-confirming induction sub study (Sub study 2), and a Phase 3 maintenance sub study (Sub study 3).

Sponsor Protocol ID:2016-000641-31
IRB Number:2020-0025
Actively Enrolling
Interventional
Phase 2
February 21, 2020
Eligibility Criteria
18 years old
75 years old
Both Male and Female
No
No
No

Inclusion Criteria1. Male or female between 18 and 75 years of age at Baseline.

2. Female subjects of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit. 

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


Exclusion Criteria1. Subject with current diagnosis of Crohn's disease. 

Categories Click category to view its trials.
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, D.O.
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