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

Recruiting now · Phase 2

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID: NCT06548542
Run by: AbbVie
People needed: 540
Starts: 2024-09-04
Expected to finish: 2030-01-01
Last updated by the study team: 2026-06-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 it is running

East View Medical Research /ID# 270377 — Mobile, Alabama, United States (enrolling)
Southern California Res. Ctr /ID# 265549 — Coronado, California, United States (enrolling)
UC San Diego Health System /ID# 265565 — La Jolla, California, United States (enrolling)
uc davis medical center - patient support services building /ID# 265554 — Sacramento, California, United States (enrolling)
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391 — San Diego, California, United States (enrolling)
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557 — Colorado Springs, Colorado, United States (enrolling)
Danbury Hospital, Western Connecticut Health Network /ID# 265556 — Danbury, Connecticut, United States (enrolling)
Yale University School of Medicine /ID# 266786 — New Haven, Connecticut, United States (enrolling)
Novum Research /ID# 278128 — Clermont, Florida, United States (enrolling)
University of Florida College of Medicine /ID# 266930 — Gainesville, Florida, United States (enrolling)
Nature Coast Clinical Research - Inverness /ID# 265874 — Inverness, Florida, United States (enrolling)
Atlantic Medical Research /ID# 266207 — Margate, Florida, United States (enrolling)
A Plus Research /ID# 265878 — Miami, Florida, United States (enrolling)
Sanchez Clinical Research /ID# 265887 — Miami, Florida, United States (enrolling)
Advanced Research Institute, Inc /ID# 265548 — New Port Richey, Florida, United States (enrolling)
Hillcrest Medical Research, LLC /ID# 267237 — Orange City, Florida, United States (enrolling)
Endoscopic Research, Inc. /ID# 267211 — Orlando, Florida, United States (enrolling)
Gcp Clinical Research /ID# 278126 — Tampa, Florida, United States (enrolling)
AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538 — Tampa, Florida, United States (enrolling)
Florida Medical Clinic - Zephyrhills /ID# 267392 — Zephyrhills, Florida, United States (enrolling)
Gastroenterology Associates of Central Georgia /ID# 265547 — Macon, Georgia, United States (enrolling)
Treasure Valley Medical Research /ID# 267114 — Boise, Idaho, United States (enrolling)
University of Chicago Medical Center /ID# 267400 — Chicago, Illinois, United States (enrolling)
OSF St. Francis Medical Center /ID# 266973 — Peoria, Illinois, United States (enrolling)
Digestive Health Specialists /ID# 266216 — Dothan, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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