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Targeted therapies for treating moderate to severe Crohn's disease in adults

A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease

Phase 2 Interventional AbbVie · NCT06548542

This study is testing new targeted treatments for adults with moderate to severe Crohn's disease who haven't found relief with current options to see if they can improve symptoms and reduce inflammation.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment540 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsrisankizumab, trosunilimab, lutikizumab
Locations254 sites (Dothan, Alabama and 253 other locations)
Trial IDNCT06548542 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of targeted therapies for adults suffering from moderate to severe Crohn's disease. Participants will be randomized into treatment groups receiving either risankizumab, ABBV-382, or lutikizumab, administered through injections or infusions. The study aims to enroll around 500 participants across approximately 300 sites worldwide, focusing on those who have not responded adequately to existing treatments. The primary goal is to assess the impact of these therapies on disease symptoms and inflammation.

Who should consider this trial

Good fit: Ideal candidates include adults with a confirmed diagnosis of Crohn's disease who have not responded to previous treatments.

Not a fit: Patients who have shown intolerance to p19 inhibitors, including risankizumab, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new effective treatment options for patients with moderate to severe Crohn's disease.

How similar studies have performed: Other studies have shown promise with targeted therapies for Crohn's disease, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Dothan, Alabama and 253 other locations

+204 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's DiseaseRisankizumabTrosunilimabLutikizumabABBV-8736
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.