A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

Summary

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).

Timeline

Start

2017-12-07

Primary completion

2021-10-15

Completion

2022-01-13

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Upadacitinib 45 mg QD; p <0.0001; Adjusted Response Rate Difference 20.8 (95% CI 12.7 to 28.8) NCT03345849 ↗

registry analysis (superiority test); Placebo vs Upadacitinib 45 mg QD; p <0.0001; Adjusted Response Rate Difference 28.7 (95% CI 20.9 to 36.4) NCT03345849 ↗

registry analysis (superiority test); Placebo vs Upadacitinib 45 mg QD; p <0.0001; Adjusted Response Rate Difference 33.0 (95% CI 26.2 to 39.9) NCT03345849 ↗

release “positive top-line results from U-EXCEL, a Phase 3 induction study, showing upadacitinib (45 mg once daily) achieved both primary endpoints” abbvie.com ↗

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.
• Vermeire S, Colombel JF, Danese S, Panaccione R, Peyrin-Biroulet L, Beck K, Chaparro M, Gisbert JP, Dubcenco E, Klaff J, Naling G, Ford S, Remple V, Joshi N, Suravaram S, Duncan B, Wang Y, Wick-Urban B, Loftus EV. Benefit-risk profile of upadacitinib: exploratory post hoc analysis of phase 2b/3 studies in patients with moderately to severely active ulcerative colitis or Crohn's disease. J Crohns Colitis. 2026 Jan 9;20(1):jjaf198. doi: 10.1093/ecco-jcc/jjaf198.
• Dubinsky MC, D'Haens G, Dewit O, Juillerat P, Panaccione R, Fujii T, Dubcenco E, Lacerda AP, Anyanwu SI, Ford S, Cunneen C, Fish I, Joshi N, Garrison A, Loftus EV. Efficacy and Safety with Upadacitinib by Baseline Corticosteroid Use in Patients with Moderately to Severely Active Crohn's Disease. Inflamm Bowel Dis. 2026 Mar 1;32(3):498-511. doi: 10.1093/ibd/izaf250.
• Panes J, Louis E, Bossuyt P, Joshi N, Lee WJ, Lacerda AP, Kligys K, Xuan S, Shukla N, Loftus EV Jr. Induction of Endoscopic Response, Remission, and Ulcer-Free Endoscopy With Upadacitinib Is Associated With Improved Clinical Outcomes and Quality of Life in Patients With Crohn's Disease. Inflamm Bowel Dis. 2025 Feb 6;31(2):394-403. doi: 10.1093/ibd/izae200.
• Bhatnagar S, Schlachter L, Eckert D, Stodtmann S, Liu W, Lacerda AP, Mohamed MF. Pharmacokinetics and Exposure-Response Analyses to Support Dose Selection of Upadacitinib in Crohn's Disease. Clin Pharmacol Ther. 2024 Nov;116(5):1240-1251. doi: 10.1002/cpt.3359. Epub 2024 Jul 9.
• Ghosh S, Feagan BG, Parra RS, Lopes S, Steinlauf A, Kakuta Y, Joshi N, Lee WJ, Lacerda AP, Zhou Q, Xuan S, Kligys K, Shukla N, Louis E. Impact of Upadacitinib Induction and Maintenance Therapy on Health-related Quality of Life, Fatigue, and Work Productivity in Patients with Moderately-to-severely Active Crohn's Disease. J Crohns Colitis. 2024 Nov 4;18(11):1804-1818. doi: 10.1093/ecco-jcc/jjae083.
• Peyrin-Biroulet L, Panaccione R, Louis E, Atreya R, Rubin DT, Lindsay JO, Siffledeen J, Lukin DJ, Wright J, Watanabe K, Ford S, Remple VP, Lacerda AP, Dubcenco E, Garrison A, Zhou Q, Berg S, Anyanwu SI, Schreiber S. Upadacitinib Achieves Clinical and Endoscopic Outcomes in Crohn's Disease Regardless of Prior Biologic Exposure. Clin Gastroenterol Hepatol. 2024 Oct;22(10):2096-2106. doi: 10.1016/j.cgh.2024.02.026. Epub 2024 Mar 15.
• Colombel JF, Hisamatsu T, Atreya R, Bresso F, Thin L, Panaccione R, Parra RS, Ford S, Remple VP, Lacerda AP, Anyanwu SI, Mallick M, Garrison A, Regueiro M. Upadacitinib Reduces Crohn's Disease Symptoms Within the First Week of Induction Therapy. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1668-1677. doi: 10.1016/j.cgh.2024.02.027. Epub 2024 Mar 15.
• Loftus EV Jr, Panes J, Lacerda AP, Peyrin-Biroulet L, D'Haens G, Panaccione R, Reinisch W, Louis E, Chen M, Nakase H, Begun J, Boland BS, Phillips C, Mohamed MF, Liu J, Geng Z, Feng T, Dubcenco E, Colombel JF. Upadacitinib Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2023 May 25;388(21):1966-1980. doi: 10.1056/NEJMoa2212728.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Upadacitinib	Small molecule	30 mg	Oral
Subject	Upadacitinib	Small molecule	45 mg	Oral

Indications