Comparing 22 approaches for Crohn's disease
Official title: Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
- Phase 2
- 22 groups
- One site, in Québec
- Recruiting
Interventions
- Medication
Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
- Medication
Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
- Medication
ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Diex Recherche Quebec Inc. /ID# 282307
Québec
Eligibility Criteria
See who this study is looking for19 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3
- +CD specific:
- +Crohn's Disease Activity Index (CDAI) score of ≥ 220
- +Confirmed diagnosis of CD at least 90 days prior to BaselineBaselineYour starting measurements, taken before treatment begins.Read more →
- +Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.
- +Demonstrated failure of 1 or more therapy for CD
- +UC specific:
- +Confirmed diagnosis of UC at least 90 days prior to Baseline
- +Demonstrated failure of 1 or more therapy for UC
Exclusion
- −Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)
- −Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment
- −Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocolProtocolThe detailed plan a study must follow.Read more → specified time frame
- −Participants with surgical bowel resection within the past 3 months prior to BaselineBaselineYour starting measurements, taken before treatment begins.Read more →
- −CD specific:
- −Participants with \>3 prior bowel resections
- −Participants with previous small bowel resection(s) of combined length \>100 cm
- −UC specific:
- −Participants with prior colectomy (total or subtotal)
- −Participants with extent of disease limited to \< 10 cm of rectum
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 →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 22 groups in this study.
Groups A, B, K and L receive Risankizumab.
Registry label: A: Substudy 1: UC Arm 1 Risankizumab monotherapy · B: Substudy 1: CD Arm 1 Risankizumab monotherapy · K: Substudy 2: UC Arm 1 Risankizumab monotherapy · L: Substudy 2: CD Arm 1 Risankizumab monotherapy
Groups C, D, E and F receive Trosunilimab.
Registry label: C: Substudy 1: UC Arm 2 Trosunilimab monotherapy · D: Substudy 1: CD Arm 2 Trosunilimab monotherapy · E: Substudy 1: UC Arm 3 Trosunilimab monotherapy · F: Substudy 1: CD Arm 3 Trosunilimab monotherapy
Groups G, H, I and J receive Risankizumab and Trosunilimab.
Registry label: G: Substudy 1: UC Arm 4 ABBV-466 (Risankizumab/Trosunilimab) · H: Substudy 1: CD Arm 4 ABBV-466 (Risankizumab/Trosunilimab) · I: Substudy 1: UC Arm 5 ABBV-466 (Risankizumab/Trosunilimab) · J: Substudy 1: CD Arm 5 ABBV-466 (Risankizumab/Trosunilimab)
Groups M, N, O and P receive ABBV-701.
Registry label: M: Substudy 2: UC Arm 2 ABBV-701 monotherapy · N: Substudy 2: CD Arm 2 ABBV-701 monotherapy · O: Substudy 2: UC Arm 3 ABBV-701 monotherapy · P: Substudy 2: CD Arm 3 ABBV-701 monotherapy
Groups Q, R, S, T, U and V receive Risankizumab and ABBV-701.
Registry label: Q: Substudy 2: UC Arm 4 ABBV-7066 (Risankizumab/ABBV-701) · R: Substudy 2: CD Arm 4 ABBV-7066 (Risankizumab/ABBV-701) · S: Substudy 2: UC Arm 5 ABBV-7066 (Risankizumab/ABBV-701) · T: Substudy 2: CD Arm 5 ABBV-7066 (Risankizumab/ABBV-701) · U: Substudy 2: UC Arm 6 ABBV-7066 (Risankizumab/ABBV-701) · V: Substudy 2: CD Arm 6 ABBV-7066 (Risankizumab/ABBV-701)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
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.
Neither you nor the study team would know which group you are in until the study ends.
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.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
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 2,000 people.
The study is currently expected to finish around October 2031.
The main measurement is taken over: At Week 28.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission — measured over At Week 28.
Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission — measured over At Week 28.
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 98 Weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07697456 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
Intravenous/Subcutaneous/Intramuscular Injection/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
Intravenous/Subcutaneous/Intramuscular Injection/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 ABBV-701Drug
Intravenous/Subcutaneous/Intramuscular Injection/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?
Neither you nor the study team would know which group you are in until the study ends.
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: At Week 28.
The study as a whole is currently expected to finish around 2031-10.
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 2,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Québec, Canada; Wyoming, Michigan, United States; New York, New York, United States; Bellevue, Washington, United States; Tacoma, Washington, United States; Vancouver, Washington, United States.
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) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC). This study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide. 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, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
Other Sites (5)
West Michigan Clinical Research Center /ID# 280480
Wyoming, Michigan, United States
New York Gastroenterology Associates - Upper East Side /ID# 281767
New York, New York, United States
Washington Gastroenterology - Bellevue /ID# 283966
Bellevue, Washington, United States
Washington Gastroenterology - Tacoma /ID# 284143
Tacoma, Washington, United States
The Vancouver Clinic /ID# 280497
Vancouver, Washington, United States
If this study interests you
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This 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.