Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

Rövid összefoglaló (regiszter, angolul)

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Mit vállalsz

• Vizsgálat típusa: Beavatkozással járó · 3. fázis
• Bevont résztvevők: 527
• 2020. szept. 30. és az elsődleges befejezés (2028. febr.) között
• 243 helyszín, 31 országban
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Helyszínek (243)

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Kapcsolódó publikációk

• Corticosteroid-sparing effects of risankizumab versus ustekinumab in patients with moderately to severely active Crohn's disease: post hoc results from the phase 3b SEQUENCE trial.J Crohns Colitis · 2026 · PMID 42479626
• Efficacy and safety of risankizumab in patients with moderately to severely active Crohn's disease: interim results from the SEQUENCE open-label extension study.J Crohns Colitis · 2025 · PMID 41344313