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Recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT06548542

Public ClinicalTrials.gov record NCT06548542. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 11:05 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06548542
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
AbbVie
Industry
Enrollment
540 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 3, 2024
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029
Last update posted
Jun 25, 2026

2024 – 2030

United States locations

U.S. sites
64
U.S. states
26
U.S. cities
59
Facility City State ZIP Site status
Digestive Health Specialists /ID# 266216 Dothan Alabama 36301 Recruiting
East View Medical Research /ID# 270377 Mobile Alabama 36606 Recruiting
Southern California Res. Ctr /ID# 265549 Coronado California 92118 Recruiting
UC San Diego Health System /ID# 265565 La Jolla California 92037 Recruiting
uc davis medical center - patient support services building /ID# 265554 Sacramento California 95817 Recruiting
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391 San Diego California 92103 Recruiting
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557 Colorado Springs Colorado 80907 Recruiting
Danbury Hospital, Western Connecticut Health Network /ID# 265556 Danbury Connecticut 06810 Recruiting
Yale University School of Medicine /ID# 266786 New Haven Connecticut 06510 Recruiting
Novum Research /ID# 278128 Clermont Florida 34711 Recruiting
University of Florida College of Medicine /ID# 266930 Gainesville Florida 32610 Recruiting
Nature Coast Clinical Research - Inverness /ID# 265874 Inverness Florida 34452-4717 Recruiting
Atlantic Medical Research /ID# 266207 Margate Florida 33063 Recruiting
A Plus Research /ID# 265878 Miami Florida 33144 Recruiting
Sanchez Clinical Research /ID# 265887 Miami Florida 33157 Recruiting
Advanced Research Institute, Inc /ID# 265548 New Port Richey Florida 34653 Recruiting
Hillcrest Medical Research, LLC /ID# 267237 Orange City Florida 32763 Recruiting
Endoscopic Research, Inc. /ID# 267211 Orlando Florida 32803 Recruiting
Gcp Clinical Research /ID# 278126 Tampa Florida 33609 Recruiting
AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538 Tampa Florida 33613 Recruiting
Florida Medical Clinic - Zephyrhills /ID# 267392 Zephyrhills Florida 33542 Recruiting
Gastroenterology Associates of Central Georgia /ID# 265547 Macon Georgia 31201 Recruiting
Treasure Valley Medical Research /ID# 267114 Boise Idaho 83706 Recruiting
University of Chicago Medical Center /ID# 267400 Chicago Illinois 60637 Recruiting
OSF St. Francis Medical Center /ID# 266973 Peoria Illinois 61637-0001 Recruiting
Springfield Clinic Main Campus /ID# 267434 Springfield Illinois 62703-2403 Recruiting
Indiana University Health University Hospital /ID# 278129 Indianapolis Indiana 46202 Recruiting
University of Kentucky Chandler Medical Center /ID# 265564 Lexington Kentucky 40536 Recruiting
Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877 Chevy Chase Maryland 20815 Recruiting
Velocity Clinical Research - Rockville /ID# 267712 Rockville Maryland 20854 Completed
Lucida Clinical Trials /ID# 266548 New Bedford Massachusetts 02740 Recruiting
Henry Ford Medical Center - Columbus /ID# 266503 Novi Michigan 48377 Recruiting
Mayo Clinic-Rochester /ID# 265550 Rochester Minnesota 55905 Recruiting
GI Associates Research, LLC /ID# 267433 Columbia Missouri 65201 Recruiting
Bvl Research /ID# 265870 Liberty Missouri 64068 Recruiting
Washington University /ID# 266938 St Louis Missouri 63110 Recruiting
Vector Clinical Trials /ID# 265561 Las Vegas Nevada 89128 Recruiting
Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 265566 Lake Success New York 11042 Recruiting
Icahn School of Medicine at Mount Sinai /ID# 266857 New York New York 10029 Completed
Northwell Health-Lenox Hill Hospital /ID# 265527 New York New York 10075 Recruiting
Care Access - Yonkers /ID# 266781 Yonkers New York 10701 Recruiting
Digestive Health Partners - Biltmore Office /ID# 265539 Asheville North Carolina 28801 Recruiting
University of Cincinnati /ID# 265589 Cincinnati Ohio 45267-2827 Recruiting
The Ohio State University /ID# 265577 Columbus Ohio 43210 Recruiting
Digestive Disease Specialists - Oklahoma /ID# 265901 Oklahoma City Oklahoma 73112 Recruiting
Penn State Health Milton South Hershey Medical Center /ID# 267126 Hershey Pennsylvania 17033 Completed
University of Pennsylvania /ID# 265904 Philadelphia Pennsylvania 19104 Recruiting
Gastroenterology Associates of Orangeburg /ID# 267548 Orangeburg South Carolina 29118 Recruiting
GI associates of Northeast Tennessee /ID# 265567 Johnson City Tennessee 37604 Recruiting
Gi Alliance - Cedar Park /ID# 268153 Cedar Park Texas 78613 Recruiting
Proactive Clinical Research /ID# 267305 El Paso Texas 79902 Completed
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 266935 Garland Texas 75044 Completed
Houston Methodist Hospital /ID# 265533 Houston Texas 77030 Recruiting
Caprock Gastro Research - Lubbock /ID# 265541 Lubbock Texas 79424 Recruiting
GI Alliance - Mansfield /ID# 266947 Mansfield Texas 76063 Recruiting
Clinical Associates in Research Therapeutics of America, LLC /ID# 265899 San Antonio Texas 78212 Completed
Sun Research Institute /ID# 266723 San Antonio Texas 78215 Recruiting
Southern Star Research Institute /ID# 278124 San Antonio Texas 78229 Recruiting
Texas Digestive Disease Consultants - Southlake /ID# 265576 Southlake Texas 76092 Completed
Tyler Research Institute /ID# 265545 Tyler Texas 75701 Recruiting
Care Access - Ogden /ID# 266428 Ogden Utah 84403 Recruiting
Care Access - Salt Lake City /ID# 266785 Salt Lake City Utah 84124 Completed
Virginia Mason Hospital and Medical Center /ID# 265574 Seattle Washington 98101 Recruiting
Washington Gastroenterology - Tacoma /ID# 267302 Tacoma Washington 98405 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 191 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06548542, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 25, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06548542 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →