Risankizumab vs Ustekinumab for Crohn's Disease
(SEQUENCE Trial)

Recruiting in Palo Alto (17 mi)

+407 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug, risankizumab, against an existing drug, ustekinumab, to see which works better for adults with moderate to severe Crohn's Disease. The drugs help by reducing gut inflammation. Participants will receive the drugs through injections and be monitored over time. Risankizumab has been studied as a maintenance therapy for moderately to severely active Crohn's disease in previous trials.

Eligibility Criteria

Adults with moderate to severe Crohn's Disease for at least 3 months, having a CDAI score of 220-450. They must have had an inadequate response or intolerance to anti-TNF therapies and cannot have used p19 or p40 inhibitors like risankizumab or ustekinumab before.

Inclusion Criteria

I have been diagnosed with moderate to severe Crohn's Disease.

My Crohn's disease is moderately active.

I have not responded well to one or more anti-TNF treatments.

+1 more

Exclusion Criteria

I have been treated with medications like risankizumab or ustekinumab.

I have not used any experimental drugs or certain approved biologic treatments before starting this study.

I have been diagnosed with ulcerative colitis or indeterminate colitis.

+1 more

Participant Groups

The trial is testing the effectiveness of Risankizumab compared to Ustekinumab in treating Crohn's Disease. Participants are randomly assigned to receive either drug via IV initially, then SC doses every eight weeks up to Week 48, with possible extension for Risankizumab recipients.

2Treatment groups

Experimental Treatment

Active Control

Group I: Risankizumab Dose A Followed by Dose BExperimental Treatment1 Intervention

Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous (SC) risankizumab dose B every 8 weeks through Week 48. Participants who complete the Week 48 visit will continue SC risankizumab for up to an additional 220 weeks.

Group II: UstekinumabActive Control1 Intervention

Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.

Risankizumab is already approved in Canada, United States, European Union for the following indications:

🇨🇦 Approved in Canada as Skyrizi for: