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Study of Targeted Therapies for Moderate to Severe Crohn's Disease

This study is looking into new ways to treat moderate to severe Crohn's disease (CD), a long-lasting condition causing inflammation in your digestive tract. Current treatments don't work for everyone or may stop working over time. This trial will test the effectiveness and side effects of several targeted therapies: risankizumab, lutikizumab, and trosunilimab. You may be able to join if you are an adult between 18 and 75 years old with a confirmed diagnosis of CD for at least 3 months and a specific disease activity score (CDAI >= 220). The study will consider the treatment successful if participants achieve endoscopic remission (healing of the digestive tract lining) by Week 12. The study aims to enroll 540 participants, but its current recruitment status is unclear.

Study design
This interventional study will involve 540 participants who will be randomly assigned to different treatment groups. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events (side effects) for up to approximately 96 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06548542

Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease

Recruiting
PHASE2Ages 18–75InterventionalTreatment
AbbVie
~540 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:RisankizumabLutikizumabTrosunilimabABBV-8736

At a glance

Recruiting sites
233 of 255 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants who Achieve Endoscopic Remission
Measured over Week 12
+1 more outcome measured

Conditions

Crohn's Disease

Explore related trials

Crohn Disease

Where it's being run

255 sites across 145 states
Florida12
Texas11
Bulgaria5
Portugal5
Spain5
California4
New York4
Hungary4

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants' body weight must be \>= 40 kg at Baseline.
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 Investigator 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 Baseline, 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 washout 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.

What this trial measures

  • Percentage of Participants who Achieve Endoscopic RemissionWeek 12

    The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Remission is defined as SES-CD ≤ 4 and no sub score greater than 1 in any individual variable, as scored by a central reader.

  • Number of Participants with Adverse Events (AEs)Up to approximately 96 weeks

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.