A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

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.

Timeline

Start

2017-01-31

Primary completion

2027-07

Completion

2027-07

Publications

• Panaccione R, Panes J, Peyrin-Biroulet L, Colombel JF, Lindsay JO, Baert F, Atreya R, Vermeire S, Fujii T, Dubcenco E, Klaff J, Duncan B, Suravaram S, Fish I, Lacerda AP, Vladea R, Ford S, Shah S, Anyanwu SI, Rubin DT. Long-Term Safety of Upadacitinib in Patients With Inflammatory Bowel Disease: Integrated Analysis of Phase 2/3 Studies. Clin Gastroenterol Hepatol. 2026 Feb 27:S1542-3565(26)00145-X. doi: 10.1016/j.cgh.2026.02.018. Online ahead of print.
• Panaccione R, Vermeire S, Danese S, Higgins PDR, Lichtenstein GR, Nakase H, Glover S, Colombel JF, Eccleston J, Kujawski M, Remple V, Yao X, Geng Z, Palac H, Sharma D, Suravaram S, Schreiber S. Long-term efficacy and safety of upadacitinib in patients with moderately to severely active ulcerative colitis: an interim analysis of the phase 3 U-ACTIVATE long-term extension study. Lancet Gastroenterol Hepatol. 2025 Jun;10(6):507-519. doi: 10.1016/S2468-1253(25)00017-2.

Drugs

Indications