A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Summary
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
Timeline
- Start
- 2017-05-10
- Primary completion
- 2020-11-09
- Completion
- 2021-04-14
Outcome
Met primary endpoint
paper All coprimary endpoints at week 12 were met in both trials with both doses of risankizumab (p values ≤0·0001). PMID 35644154 ↗
registry Placebo (Period 1) vs Risankizumab 600mg (Period 1); p <0.001; Adjusted Risk Difference 20.7 (95% CI 12.4 to 29.0) NCT03105128 ↗
registry Placebo (Period 1) vs Risankizumab 600mg (Period 1); p <0.001; Adjusted Risk Difference 28.3 (95% CI 21.2 to 35.4) NCT03105128 ↗
registry Placebo (Period 1) vs Risankizumab 600mg (Period 1); p <0.001; Adjusted Risk Difference 21.9 (95% CI 13.8 to 29.9) NCT03105128 ↗
release “In ADVANCE and MOTIVATE, both doses of Skyrizi (600mg and 1200mg) met the co-primary endpoints of clinical remission and endoscopic response” abbvie.com ↗
release “ADVANCE and MOTIVATE, a significantly greater proportion of patients treated with SKYRIZI achieved endoscopic response and clinical remission compared to placebo.” abbvie.com ↗
release “In the ADVANCE and MOTIVATE induction trials, a significantly greater proportion of patients treated with SKYRIZI 600 mg IV achieved the co-primary endpoints” abbvie.com ↗
Publications
- Panaccione R, Ferrante M, Dotan I, Panes J, Hisamatsu T, Bossuyt P, Danese S, Song A, Kalabic J, Joshi N, Zambrano J, Zhang Y, Duan WR, Kligys K, Dubinsky MC, Lindsay JO, Vermeire S, Siegmund B, Irving PM, D'Haens G. Extended Risankizumab Treatment in Patients With Crohn's Disease Who Did Not Achieve Clinical Response to Induction Treatment. Clin Gastroenterol Hepatol. 2025 Oct;23(11):2012-2022.e6. doi: 10.1016/j.cgh.2024.12.023. Epub 2025 Feb 3.
- Atreya R, Ferrante M, Panaccione R, Feagan B, Shchukina O, Jairath V, Rieder F, Hisamatsu T, Siegmund B, Kligys K, Song A, Zambrano J, Mallick M, Zhang Y, Armuzzi A, D'Haens G. Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn's Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies. J Crohns Colitis. 2025 Apr 4;19(4):jjae164. doi: 10.1093/ecco-jcc/jjae164.
- Peyrin-Biroulet L, Colombel JF, Louis E, Ferrante M, Motoya S, Panaccione R, Torres J, Ungaro RC, Kligys K, Kalabic J, Zambrano J, Zhang Y, D'Haens G. Shorter Crohn's Disease Duration Is Associated With Better Clinical and Endoscopic Outcomes With Risankizumab in Phase 3 Studies. Gastro Hep Adv. 2024 Mar 7;3(4):539-550. doi: 10.1016/j.gastha.2024.02.008. eCollection 2024.
- Louis E, Lee WJ, Litcher-Kelly L, Ollis S, Pranschke E, Fitzgerald K, Lacerda AP, Neimark E, Sanchez Gonzalez Y, Panes J. Content Validity and Psychometric Evaluation of the Crohn's Symptom Severity (CSS) Questionnaire in Patients with Moderately to Severely Active Crohn's Disease. Adv Ther. 2024 Sep;41(9):3678-3705. doi: 10.1007/s12325-024-02923-9. Epub 2024 Aug 6.
- Schreiber S, Cross RK, Panaccione R, D'Haens G, Bossuyt P, Dotan I, Colombel JF, Louis E, Dubinsky MC, Kligys K, Neimark E, Song A, Zambrano J, Kalabic J, Cheng E, Zhang Y, Ferrante M. Efficacy and safety of risankizumab by baseline corticosteroid use and achievement of corticosteroid-free clinical and endoscopic outcomes in patients with moderately to severely active Crohn's disease. Aliment Pharmacol Ther. 2024 Oct;60(7):897-906. doi: 10.1111/apt.18184. Epub 2024 Jul 25.
- Dubinsky M, Ma C, Griffith J, Crowell M, Neimark E, Kligys K, O'Connell T. Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. Adv Ther. 2023 Sep;40(9):3896-3911. doi: 10.1007/s12325-023-02546-6. Epub 2023 Jun 27.
- Loftus EV Jr, Ananthakrishnan AN, Lee WJ, Gonzalez YS, Fitzgerald KA, Wallace K, Zhou W, Litcher-Kelly L, Ollis SB, Su S, Danese S. Content Validity and Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in Patients with Crohn's Disease and Ulcerative Colitis. Pharmacoecon Open. 2023 Sep;7(5):823-840. doi: 10.1007/s41669-023-00419-w. Epub 2023 Jun 9.
- D'Haens G, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, Ferrante M. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May 28;399(10340):2015-2030. doi: 10.1016/S0140-6736(22)00467-6.
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 |