A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Summary

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

Timeline

Start

2018-03-07

Primary completion

2022-11-09

Completion

2023-05-11

Outcome

Met primary endpoint

registry p = 0.0324; Adjusted Risk Difference 9.6 (90% CI 2.2 to 17.0) NCT03398148 ↗

registry p <0.0001; Adjusted Risk Difference 14.0 (95% CI 10.0 to 18.0) NCT03398148 ↗

release “INSPIRE, a Phase 3 induction study, showing risankizumab (SKYRIZI ® ,1200 mg intravenous [IV], at weeks 0, 4 and 8) met the primary endpoint” abbvie.com ↗

release “INSPIRE, a Phase 3 induction study, showing Skyrizi (risankizumab, 1200 mg intravenous (IV), at weeks 0, 4 and 8) met the primary endpoint” abbvie.com ↗

release “In the INSPIRE induction trial, a significantly higher proportion of patients treated with risankizumab 1,200 mg IV achieved the primary endpoint of clinical remission” abbvie.com ↗

Publications

• Panaccione R, Melmed GY, Drobne D, Kaur M, Danese S, Hisamatsu T, Kalabic J, Chen S, Cheng L, Duan WR, Shah S, Louis E. Impact of Extended Risankizumab Treatment in Patients With Ulcerative Colitis Who Did Not Respond to Induction Treatment. Clin Gastroenterol Hepatol. 2026 May;24(5):1424-1433. doi: 10.1016/j.cgh.2025.09.007. Epub 2025 Sep 13.
• Reinisch W, Loftus EV Jr, Schreiber S, Rubin DT, Louis E, Hecht PM, Barrachina EM, Kalabic J, Vladea R, Sharma D, Duan WR, Zhang Y, Panaccione R. Corticosteroid-sparing effects of risankizumab efficacy and safety in patients with moderately to severely active ulcerative colitis. J Crohns Colitis. 2025 Apr 4;19(4):jjaf025. doi: 10.1093/ecco-jcc/jjaf025.
• Panaccione R, Louis E, Colombel JF, D'Haens G, Peyrin-Biroulet L, Dubinsky M, Takeuchi K, Rubin DT, Kalabic J, Chien KB, Chen S, Cheng L, Zhang Y, Duan WR, Vladea R, Hecht PM, Morisset P, Schreiber S, Ferrante M. Risankizumab efficacy and safety based on prior inadequate response or intolerance to advanced therapy: post hoc analysis of the INSPIRE and COMMAND phase 3 studies. J Crohns Colitis. 2025 Jan 11;19(1):jjaf005. doi: 10.1093/ecco-jcc/jjaf005.
• Louis E, Schreiber S, Panaccione R, Bossuyt P, Biedermann L, Colombel JF, Parkes G, Peyrin-Biroulet L, D'Haens G, Hisamatsu T, Siegmund B, Wu K, Boland BS, Melmed GY, Armuzzi A, Levine P, Kalabic J, Chen S, Cheng L, Shu L, Duan WR, Pivorunas V, Sanchez Gonzalez Y, D'Cunha R, Neimark E, Wallace K, Atreya R, Ferrante M, Loftus EV Jr; INSPIRE and COMMAND Study Group. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials. JAMA. 2024 Sep 17;332(11):881-897. doi: 10.1001/jama.2024.12414.
• Thakre N, Goebel A, Winzenborg I, Suleiman AA, D'Cunha R, Mensing S, Liu W, Pang Y. Population Pharmacokinetic and Exposure-Response Modeling to Inform Risankizumab Dose Selection in Patients With Ulcerative Colitis. Clin Pharmacol Ther. 2024 Sep;116(3):847-857. doi: 10.1002/cpt.3330. Epub 2024 Jun 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Risankizumab	Monoclonal antibody	180 mg	Intravenous
Subject	Risankizumab	Monoclonal antibody	360 mg	Intravenous
Subject	Risankizumab	Monoclonal antibody	600 mg	Intravenous
Subject	Risankizumab	Monoclonal antibody	1200 mg	Intravenous
Subject	Risankizumab	Monoclonal antibody	1800 mg	Intravenous

Indications