Risankizumab for Ileocolitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Ileocolitis+1 More
Risankizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Ileocolitis
  • Crohn Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: Up to 220 Weeks

Up to 220 Weeks
Number of Participants Reporting Adverse Events
Week 24
Percentage of Participants Achieving Clinical Remission at Week 24
Percentage of Participants Achieving Endoscopic Response at Week 24
Week 48
Percentage of Participants Achieving Clinical Remission (Patient Reported Outcome [PRO]-2)
Percentage of Participants Achieving Clinical Remission at Week 48
Percentage of Participants Achieving Endoscopic Remission
Percentage of Participants Achieving Endoscopic Response at Week 48
Percentage of Participants Achieving Steroid-Free Clinical Remission
Percentage of Participants Achieving Steroid-Free Endoscopic Remission
Percentage of Participants Achieving Steroid-Free Remission

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Any Risankizumab
23%Nasopharyngitis
15%Upper respiratory tract infection
7%Headache
7%Arthralgia
6%Back pain
4%Influenza
1%Basal cell carcinoma
1%Psoriasis
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT02672852) in the Any Risankizumab ARM group. Side effects include: Nasopharyngitis with 23%, Upper respiratory tract infection with 15%, Headache with 7%, Arthralgia with 7%, Back pain with 6%.

Trial Design

2 Treatment Groups

Ustekinumab
1 of 2
Risankizumab Dose A Followed by Dose B
1 of 2

Active Control

Experimental Treatment

527 Total Participants · 2 Treatment Groups

Primary Treatment: Risankizumab · No Placebo Group · Phase 3

Risankizumab Dose A Followed by Dose B
Drug
Experimental Group · 1 Intervention: Risankizumab · Intervention Types: Drug
Ustekinumab
Drug
ActiveComparator Group · 1 Intervention: Ustekinumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isopropyl alcohol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 220 weeks

Who is running the clinical trial?

AbbVieLead Sponsor
824 Previous Clinical Trials
469,176 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
295 Previous Clinical Trials
116,622 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with Crohn's disease for at least 3 months prior to Baseline.
The Crohn's disease activity index (CDAI) score is 220 - 450 at baseline.
You have demonstrated intolerance or inadequate response to one or more anti-TNF therapies.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: November 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.