NCT06548542From ClinicalTrials.govRecruiting

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

Crohn's Disease

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: AbbVie
Enrolment target: 590
Started: 4 September 2024
Main results due: January 2030
Study sites: 255
Registry updated: 25 September 2026

Can you take part?

Ages 18 years to 75 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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 with history of intolerance to p19 inhibitors, including risankizumab.
* 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 study is about

In the sponsor’s own words, from the registry.

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 590 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.

Study sites(255)

Digestive Health Specialists /ID# 266216
Dothan, Alabama, United States
Recruiting
East View Medical Research /ID# 270377
Mobile, Alabama, United States
Recruiting
Southern California Res. Ctr /ID# 265549
Coronado, California, United States
Recruiting
UC San Diego Health System /ID# 265565
La Jolla, California, United States
Recruiting
uc davis medical center - patient support services building /ID# 265554
Sacramento, California, United States
Recruiting
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391
San Diego, California, United States
Completed
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557
Colorado Springs, Colorado, United States
Recruiting
Danbury Hospital, Western Connecticut Health Network /ID# 265556
Danbury, Connecticut, United States
Recruiting
Yale University School of Medicine /ID# 266786
New Haven, Connecticut, United States
Recruiting
Novum Research /ID# 278128
Clermont, Florida, United States
Recruiting
University of Florida College of Medicine /ID# 266930
Gainesville, Florida, United States
Recruiting
Nature Coast Clinical Research - Inverness /ID# 265874
Inverness, Florida, United States
Recruiting
Atlantic Medical Research /ID# 266207
Margate, Florida, United States
Recruiting
A Plus Research /ID# 265878
Miami, Florida, United States
Recruiting
Sanchez Clinical Research /ID# 265887
Miami, Florida, United States
Recruiting
Advanced Research Institute, Inc /ID# 265548
New Port Richey, Florida, United States
Recruiting
Hillcrest Medical Research, LLC /ID# 267237
Orange City, Florida, United States
Recruiting
Endoscopic Research, Inc. /ID# 267211
Orlando, Florida, United States
Recruiting
Gcp Clinical Research /ID# 278126
Tampa, Florida, United States
Recruiting
AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538
Tampa, Florida, United States
Recruiting
Florida Medical Clinic - Zephyrhills /ID# 267392
Zephyrhills, Florida, United States
Recruiting
Gastroenterology Associates of Central Georgia /ID# 265547
Macon, Georgia, United States
Recruiting
Treasure Valley Medical Research /ID# 267114
Boise, Idaho, United States
Recruiting
University of Chicago Medical Center /ID# 267400
Chicago, Illinois, United States
Recruiting
OSF St. Francis Medical Center /ID# 266973
Peoria, Illinois, United States
Recruiting
Springfield Clinic Main Campus /ID# 267434
Springfield, Illinois, United States
Recruiting
Indiana University Health University Hospital /ID# 278129
Indianapolis, Indiana, United States
Recruiting
University of Kentucky Chandler Medical Center /ID# 265564
Lexington, Kentucky, United States
Recruiting
Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877
Chevy Chase, Maryland, United States
Recruiting
Velocity Clinical Research - Rockville /ID# 267712
Rockville, Maryland, United States
Completed
Lucida Clinical Trials /ID# 266548
New Bedford, Massachusetts, United States
Recruiting
Henry Ford Medical Center - Columbus /ID# 266503
Novi, Michigan, United States
Recruiting
Mayo Clinic-Rochester /ID# 265550
Rochester, Minnesota, United States
Recruiting
GI Associates Research, LLC /ID# 267433
Columbia, Missouri, United States
Recruiting
Bvl Research /ID# 265870
Liberty, Missouri, United States
Recruiting
Washington University /ID# 266938
St Louis, Missouri, United States
Recruiting
Vector Clinical Trials /ID# 265561
Las Vegas, Nevada, United States
Recruiting
Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 265566
Lake Success, New York, United States
Recruiting
Icahn School of Medicine at Mount Sinai /ID# 266857
New York, New York, United States
Completed
Northwell Health-Lenox Hill Hospital /ID# 265527
New York, New York, United States
Recruiting
Care Access - Yonkers /ID# 266781
Yonkers, New York, United States
Recruiting
Digestive Health Partners - Biltmore Office /ID# 265539
Asheville, North Carolina, United States
Recruiting
University of Cincinnati /ID# 265589
Cincinnati, Ohio, United States
Recruiting
The Ohio State University /ID# 265577
Columbus, Ohio, United States
Recruiting
Digestive Disease Specialists - Oklahoma /ID# 265901
Oklahoma City, Oklahoma, United States
Recruiting
Penn State Health Milton South Hershey Medical Center /ID# 267126
Hershey, Pennsylvania, United States
Completed
University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 265904
Philadelphia, Pennsylvania, United States
Recruiting
Gastroenterology Associates of Orangeburg /ID# 267548
Orangeburg, South Carolina, United States
Recruiting
GI associates of Northeast Tennessee /ID# 265567
Johnson City, Tennessee, United States
Recruiting
Gi Alliance - Cedar Park /ID# 268153
Cedar Park, Texas, United States
Recruiting
Proactive Clinical Research /ID# 267305
El Paso, Texas, United States
Completed
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 266935
Garland, Texas, United States
Completed
Houston Methodist Hospital /ID# 265533
Houston, Texas, United States
Recruiting
Caprock Gastro Research - Lubbock /ID# 265541
Lubbock, Texas, United States
Recruiting
GI Alliance - Mansfield /ID# 266947
Mansfield, Texas, United States
Completed
Clinical Associates in Research Therapeutics of America, LLC /ID# 265899
San Antonio, Texas, United States
Completed
Sun Research Institute /ID# 266723
San Antonio, Texas, United States
Recruiting
Southern Star Research Institute /ID# 278124
San Antonio, Texas, United States
Recruiting
Texas Digestive Disease Consultants - Southlake /ID# 265576
Southlake, Texas, United States
Completed
Tyler Research Institute /ID# 265545
Tyler, Texas, United States
Recruiting

Showing 60 of 255 sites — filter to narrow it down. 230 of the 255 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06548542. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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