Overview

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Status:
Active, not recruiting

Trial end date:
2022-01-13

Target enrollment:

Participant gender:

Summary

This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission in order to identify the induction dose of upadacitinib for further evaluation in sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of sub-study 3 is to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

Phase:

Phase 3

Details

Lead Sponsor:

AbbVie

Treatments:

Upadacitinib