527 Participants Needed

Risankizumab vs Ustekinumab for Crohn's Disease

(SEQUENCE Trial)

Recruiting at 407 trial locations
AC
Overseen ByABBVIE CALL CENTER
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have received certain biologic agents before the trial, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drugs Risankizumab and Ustekinumab for treating Crohn's Disease?

Ustekinumab has been shown to help about 50% of Crohn's Disease patients achieve clinical remission after one year, and it is generally well tolerated. Risankizumab and Ustekinumab are both approved for treating moderate to severe Crohn's Disease, with ongoing studies comparing their effectiveness.12345

Is Ustekinumab safe for treating Crohn's Disease?

Ustekinumab (Stelara) is generally well tolerated for treating Crohn's Disease, with serious infections and cancers being rare. It is considered a safe option for patients who have not responded to other treatments.13467

How do the drugs Risankizumab and Ustekinumab differ from other treatments for Crohn's Disease?

Risankizumab and Ustekinumab are unique because they target specific proteins involved in inflammation, with Risankizumab focusing on IL-23 and Ustekinumab on both IL-12 and IL-23, offering alternatives for patients who haven't responded to other treatments like TNF antagonists.13489

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.

Research Team

AI

ABBVIE INC.

Principal Investigator

AbbVie

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.
See 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.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive intravenous doses of risankizumab or ustekinumab at Week 0, 4, 8 followed by subcutaneous doses every 8 weeks through Week 48

48 weeks
Regular visits at a hospital or clinic

Treatment Part 2

Participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive subcutaneous risankizumab for up to an additional 220 weeks

220 weeks
Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Risankizumab
  • Ustekinumab
Trial Overview 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.
Participant Groups
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:
  • Moderate-to-severe Crohn's disease
🇺🇸
Approved in United States as Skyrizi for:
  • Moderate-to-severe Crohn's disease
  • Moderate-to-severe plaque psoriasis
🇪🇺
Approved in European Union as Skyrizi for:
  • Moderate-to-severe Crohn's disease
  • Moderate-to-severe plaque psoriasis
  • Psoriatic arthritis

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

In a study of 36 adults with Crohn's disease, 61% responded to ustekinumab treatment after one year, but no distinct gene expression signature was found to predict response, indicating that more research is needed to identify reliable biomarkers.
Among nonresponders, an increased inflammatory response was observed, with 68 genes linked to cytokine activity and chemokine receptor binding, suggesting that these pathways may play a role in treatment resistance.
Baseline peripheral blood mononuclear cell (PBMC) transcriptomics before ustekinumab treatment is linked with Crohn Disease clinical response at 1 year.Granot, M., Braun, T., Efroni, G., et al.[2023]
In a systematic review of five randomized controlled trials involving patients with moderate-to-severe Crohn's disease who were nonresponsive or intolerant to TNF-antagonist therapy, ustekinumab and vedolizumab showed no significant differences in clinical response or remission during both induction and maintenance phases.
The safety profiles of ustekinumab and vedolizumab were also comparable, with no significant differences in the risk of adverse events, indicating that both treatments are similarly safe for patients with Crohn's disease.
An indirect comparison of ustekinumab and vedolizumab in the therapy of TNF-failure Crohn's disease patients.Kawalec, P., Moćko, P.[2019]
Ustekinumab is an effective treatment for adults with moderately to severely active Crohn's disease who have not responded to or are intolerant of other therapies, showing improved clinical response and remission rates in pivotal phase III trials.
The drug has a unique mechanism of action targeting IL-12 and IL-23 cytokines, and it is generally well tolerated, with serious side effects like infections and malignancies being rare.
Ustekinumab: A Review in Moderate to Severe Crohn's Disease.Lamb, YN., Duggan, ST.[2018]

References

Baseline peripheral blood mononuclear cell (PBMC) transcriptomics before ustekinumab treatment is linked with Crohn Disease clinical response at 1 year. [2023]
An indirect comparison of ustekinumab and vedolizumab in the therapy of TNF-failure Crohn's disease patients. [2019]
Ustekinumab: A Review in Moderate to Severe Crohn's Disease. [2018]
Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. [2023]
Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients: The SUSTAIN Study. [2022]
Real-World Effectiveness and Safety of Ustekinumab in Elderly Crohn's Disease Patients. [2023]
Ustekinumab for the treatment of paradoxical skin reactions and cutaneous manifestations of inflammatory bowel diseases. [2021]
Safety and effectiveness of ustekinumab for induction of remission in patients with Crohn's disease: A multicenter Israeli study. [2021]
Risankizumab-rzaa: A New Therapeutic Option for the Treatment of Crohn's Disease. [2023]
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