What is the mechanism of action of this treatment?

Common treatments for Crohn's Disease include biologic therapies such as anti-TNF agents (e.g., infliximab, adalimumab), which block tumor necrosis factor-alpha (TNF-α), a cytokine involved in systemic inflammation. Ustekinumab targets both interleukin-12 (IL-12) and interleukin-23 (IL-23), which are key cytokines in the inflammatory process. Risankizumab, an IL-23 inhibitor, specifically targets IL-23 to reduce inflammation. These treatments are essential for Crohn's Disease patients as they help to control the immune response, reduce inflammation, and maintain remission, thereby improving quality of life and preventing complications.

What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, such as Interleukin-23 inhibitors (e.g., Risankizumab, Ustekinumab), generally have a well-tolerated safety profile but can cause several side effects. These include nasopharyngitis, headache, and injection site reactions. Ustekinumab, another IL-23 inhibitor, has been associated with infections and nasopharyngitis. Other biologics like anti-TNF agents may cause dermatological side effects, such as hidradenitis suppurativa and folliculitis. Methotrexate, an alternative treatment, can lead to gastrointestinal distress, hepatotoxicity, hematologic toxicity, and pulmonary toxicity.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of moderate to severe Crohn's Disease. These include anti-TNF agents such as Infliximab, Adalimumab, and Certolizumab pegol, which target tumor necrosis factor-alpha to reduce inflammation. Ustekinumab, an approved drug similar to Risankizumab, targets interleukin-12 and interleukin-23 to modulate the immune response. Vedolizumab, another approved biologic, targets the alpha-4-beta-7 integrin to prevent inflammatory cells from entering the gut. These treatments offer various mechanisms to manage the inflammation and symptoms associated with Crohn's Disease.

What other types of research exist?

Promising alternatives to Risankizumab for Crohn's Disease patients include Ustekinumab, an anti-IL-12/23 monoclonal antibody, and anti-TNF agents such as Infliximab and Adalimumab. Ustekinumab has shown efficacy in patients with moderate to severe Crohn's Disease, while Infliximab and Adalimumab are well-established treatments with proven effectiveness in inducing and maintaining remission.

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Monoclonal Antibodies

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

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of moderate to severe Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).

Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.

Must not have

Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).

Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 220 weeks

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include immune system reactions, injection site reactions, infections due to lowered immunity, and possibly others not listed here. Regular medical assessments will monitor these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My Crohn's disease is moderately active.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with medications like risankizumab or ustekinumab.

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

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I have been diagnosed with ulcerative colitis or indeterminate colitis.

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I am aware of my Crohn's disease complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 220 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 220 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 220 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Reporting Adverse Events

Percentage of Participants Achieving Clinical Remission at Week 24

Percentage of Participants Achieving Endoscopic Remission

Secondary study objectives

Percentage of Participants Achieving Clinical Remission at Week 48

Percentage of Participants Achieving Endoscopic Response at Week 24

Percentage of Participants Achieving Endoscopic Response at Week 48

+2 more

Side effects data

From 2023 Phase 4 trial • 352 Patients • NCT04908475

14%

COVID-19

NASOPHARYNGITIS

HEADACHE

NAUSEA

UPPER RESPIRATORY TRACT INFECTION

DIARRHOEA

CORONARY ARTERY DISEASE

PROSTATE CANCER

100%

80%

60%

40%

20%

Study treatment Arm

Period B: APR/APR

Period A: APR

Period A: RZB

Period B: RZB/RZB

Period B: APR/RZB

Period B: APR/APR/RZB

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Risankizumab

2021

Completed Phase 4

~3190

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Crohn's Disease include biologic therapies such as anti-TNF agents (e.g., infliximab, adalimumab), which block tumor necrosis factor-alpha (TNF-α), a cytokine involved in systemic inflammation. Ustekinumab targets both interleukin-12 (IL-12) and interleukin-23 (IL-23), which are key cytokines in the inflammatory process. Risankizumab, an IL-23 inhibitor, specifically targets IL-23 to reduce inflammation. These treatments are essential for Crohn's Disease patients as they help to control the immune response, reduce inflammation, and maintain remission, thereby improving quality of life and preventing complications.