Comparing 7 approaches for Crohn's disease
Official title: Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease
Interventions
Risankizumab
Subcutaneous Injection
Lutikizumab
Subcutaneous Injection
Trosunilimab
Intravenous Infusion
Risankizumab
Intravenous Infusion
Trosunilimab
Subcutaneous Injection
ABBV-8736
Intravenous Infusion
Canadian Sites (8)
Diex Recherche Quebec Inc. /ID# 265611
Québec, Canada
University of Calgary /ID# 265524
Calgary, Alberta, Canada
Gastroenterology and Internal Medicine Research Institute /ID# 265610
Edmonton, Alberta, Canada
University of Alberta Hospital /ID# 265614
Edmonton, Alberta, Canada
Medicor Research /ID# 267405
Greater Sudbury, Ontario, Canada
London Health Sciences Centre - University Hospital /ID# 267298
London, Ontario, Canada
Toronto Digestive Disease Associates /ID# 267358
Vaughan, Ontario, Canada
Clinique IMD /ID# 272057
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for8 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants' body weight must be \>= 40 kg at BaselineBaselineYour starting measurements, taken before treatment begins.Read more →.
- +Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → must be available.
- +CDAI \>= 220 at Baseline.
- +Endoscopic evidence of mucosal inflammation as documented by an SES-CD of \>= 6 for ileocolonic or colonic disease or SES-CD of \>= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.
- +Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules.
Exclusion
- −Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
- −Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → prior to Baseline.
- −Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There are 7 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 75 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 540 people.
The study is currently expected to finish around January 2030.
The main measurement is taken over: Week 12.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percentage of Participants who Achieve Endoscopic Remission — measured over Week 12.
Number of Participants with Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Up to approximately 96 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06548542 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About RisankizumabDrug
Subcutaneous Injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LutikizumabDrug
Subcutaneous Injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About TrosunilimabDrug
Intravenous Infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About RisankizumabDrug
Intravenous Infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About TrosunilimabDrug
Subcutaneous Injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About ABBV-8736Drug
Intravenous Infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 75 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 75 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 12.
The study as a whole is currently expected to finish around 2030-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 540 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 14 locations, including: Québec, Canada; Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Greater Sudbury, Ontario, Canada; London, Ontario, Canada; Vaughan, Ontario, Canada, and 8 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD. The medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 540 participants will be enrolled in the study at approximately 300 sites worldwide. Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
Other Sites (8)
Henry Ford Medical Center - Columbus /ID# 266503
Novi, Michigan, United States
Mayo Clinic-Rochester /ID# 265550
Rochester, Minnesota, United States
Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 265566
Lake Success, New York, United States
Icahn School of Medicine at Mount Sinai /ID# 266857
New York, New York, United States
Northwell Health-Lenox Hill Hospital /ID# 265527
New York, New York, United States
Care Access - Yonkers /ID# 266781
Yonkers, New York, United States
Virginia Mason Hospital and Medical Center /ID# 265574
Seattle, Washington, United States
Washington Gastroenterology - Tacoma /ID# 267302
Tacoma, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.