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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 220 weeks
Awards & highlights

SEQUENCE Trial Summary

This trial will assess how well risankizumab works compared to ustekinumab for the treatment of Crohn's disease.

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.Check my eligibility
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.See study design
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.

SEQUENCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with moderate to severe Crohn's Disease.
Select...
My Crohn's disease is moderately active.
Select...
I have not responded well to one or more anti-TNF treatments.

SEQUENCE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Reporting Adverse Events
Percentage of Participants Achieving Clinical Remission at Week 24
Percentage of Participants Achieving Endoscopic Remission
Secondary outcome measures
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 2022 Phase 3 trial • 244 Patients • NCT04102007
9%
COVID-19
6%
NASOPHARYNGITIS
1%
OSTEOARTHRITIS
1%
MYOCARDIAL INFARCTION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risankizumab

SEQUENCE 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 3
~3140

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,578 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,412 Total Patients Enrolled

Media Library

Risankizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04524611 — Phase 3
Crohn's Disease Research Study Groups: Risankizumab Dose A Followed by Dose B, Ustekinumab
Crohn's Disease Clinical Trial 2023: Risankizumab Highlights & Side Effects. Trial Name: NCT04524611 — Phase 3
Risankizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04524611 — Phase 3
Crohn's Disease Patient Testimony for trial: Trial Name: NCT04524611 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What patients does Risankizumab show the most improvement in?

"Risankizumab is often used as an intervention for patients that may require systemic therapy. It can also treat conditions such as infection, invasive procedure, and dental plaque."

Answered by AI

Does this research involve any elderly individuals?

"Eligibility for this trial is restricted to patients that are between 18 and 80 years old."

Answered by AI

Is this study available in many hospitals within the city limits?

"This trial is being conducted by Digestive Disease Specialists in Oklahoma City, OK; Mayo Clinic - Rochester in Minnesota; Covenant Health in Edmonton, AB; and 55 other locations."

Answered by AI

What primary goals has this clinical trial outlined?

"The primary objective of this study, which will be evaluated over the course of 24 weeks, is to assess the percentage of patients who achieve endoscopic remission. Secondary objectives include measuring the percentage of participants who are able to achieve steroid-free remission (defined as discontinuation of corticosteroid use for 90 days while also achieving clinical remission at 48 weeks for those taking steroids at baseline), the percentage of participants who are able to achieve both endoscopic and steroid-free remission (defined as meeting criteria for both endoscopic remission and not receiving steroids at Week 48), and the percentage of participants who experience an endoscopic response at Week 24 (defined"

Answered by AI

How many test subjects are included in this clinical research?

"This specific clinical trial is no longer looking for new patients, however there are 258 other trials related to ileocolitis and 61 studies involving Risankizumab that are currently enrolling participants."

Answered by AI

Might I be a candidate for participating in this research study?

"This clinical trial is testing a potential new medication for ileocolitis. The study requires that patients are between 18-80 years old and around 527 people will be accepted in total."

Answered by AI

Is Risankizumab known to have any serious side effects?

"Safety is always our top priority. Risankizumab has undergone Phase 3 trials, which means that there is data to support its efficacy and safety. We've given it a score of 3."

Answered by AI

Are patients being recruited for this clinical trial at this time?

"The clinical trial in question, which was created on September 30th 2020 and edited most recently on August 24th 2022, is not presently looking for participants. That being said, there are 319 other medical trials that are currently recruiting patients."

Answered by AI

What other research has been conducted with Risankizumab?

"Risankizumab was first investigated in 2011 by the researchers at Memorial Sloan Kettering Cancer Center. Since then, 175 clinical trials have been completed while 61 are ongoing. The majority of these live trials are being conducted out of Oklahoma City, Oklahoma."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
TLC Clinical Research Inc /ID# 223467
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I haven’t been on medication since 2020. I was on humira then remicade. Remicade worked.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
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)
2020. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04524611.
All > Crohns Disease
~269 spots leftby Feb 2028
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