Project
Abbvie M14-234
Automatically Closed · 2016 until 2018
Dora Barbara, Knellwolf Christina, Krieger-Grübel Claudia, Sulz Michael
Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Automatically Closed
Start Date
2016
End Date
2018
Financing
Industry
Study Design
This is a Phase 2b/3, multicenter, randomized, double-blind, placebo-controlled study consisting of the
following Substudies:
Substudy 1 is a Phase 2b dose-ranging study designed to evaluate the efficacy and safety of different oral
doses of ABT-494 compared to placebo as induction therapy for 8 weeks in subjects with moderately to
severely active ulcerative colitis (UC).
Substudy 2 is a Phase 3 dose-confirming study designed to evaluate the efficacy and safety of oral
administration of one dose of ABT-494, based on the dose identified from Substudy 1, compared to
placebo as induction therapy for 8 weeks in subjects with moderately to severely active UC.
Substudy 3 is a Phase 3 study designed to evaluate the efficacy and safety of oral administration of
two doses of ABT-494 compared to placebo as maintenance therapy for 44 weeks in subjects with
moderately to severely active ulcerative colitis who achieved response following induction with
ABT-494 in Substudy 1 or 2.
Brief description/objective
A Multicenter, Randomized, Double-Blind,
Placebo-Controlled Study to Evaluate the Safety and
Efficacy of ABT-494 for Induction and Maintenance
Therapy in Subjects with Moderately to Severely
Active Ulcerative Colitis