Trials Today

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

Purpose

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.

Condition

Crohn's Disease

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Monotherapy: Risankizumab	Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection.	Drug: Risankizumab Subcutaneous Injection Drug: Risankizumab Intravenous Infusion
Experimental Combination Therapy: Risankizumab and Trosunilimab	Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.	Drug: Risankizumab Subcutaneous Injection Drug: Trosunilimab Intravenous Infusion Drug: Risankizumab Intravenous Infusion Drug: Trosunilimab Subcutaneous Injection
Experimental Monotherapy: Trosunilimab	Participants will receive trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.	Drug: Trosunilimab Intravenous Infusion Drug: Trosunilimab Subcutaneous Injection
Experimental Combination Therapy: Risankizumab and Lutikizumab	Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and Lutikizumab Dose A, Dose B and Dose C as SC injection.	Drug: Risankizumab Subcutaneous Injection Drug: Lutikizumab Subcutaneous Injection Drug: Risankizumab Intravenous Infusion
Experimental Monotherapy: Lutikizumab	Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection.	Drug: Lutikizumab Subcutaneous Injection
Experimental Monotherapy: ABBV-8736 - OUS Only	Participants will receive ABBV-8736 as IV infusion.	Drug: ABBV-8736 Intravenous Infusion
Experimental Long-Term Extension: Risankizumab Monotherapy	Participants will receive Risankizumab Dose A as IV infusion and/or Risankizumab Dose B as SC injection for up to 72 weeks.	Drug: Risankizumab Subcutaneous Injection Drug: Risankizumab Intravenous Infusion

Recruiting Locations

Digestive Health Specialists /ID# 266216
Dothan 4059102, Alabama 4829764 36301

East View Medical Research /ID# 270377
Mobile 4076598, Alabama 4829764 36606

Southern California Res. Ctr /ID# 265549
Coronado 5339663, California 5332921 92118

UC San Diego Health System /ID# 265565
La Jolla 5363943, California 5332921 92037

uc davis medical center - patient support services building /ID# 265554
Sacramento 5389489, California 5332921 95817

Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391
San Diego 5391811, California 5332921 92103

Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557
Colorado Springs 5417598, Colorado 5417618 80907

Danbury Hospital, Western Connecticut Health Network /ID# 265556
Danbury 4832353, Connecticut 4831725 06810

Yale University School of Medicine /ID# 266786
New Haven 4839366, Connecticut 4831725 06510

Novum Research /ID# 278128
Clermont 4151352, Florida 4155751 34711

University of Florida College of Medicine /ID# 266930
Gainesville 4156404, Florida 4155751 32610

Nature Coast Clinical Research - Inverness /ID# 265874
Inverness 4159786, Florida 4155751 34452-4717

Atlantic Medical Research /ID# 266207
Margate 4163407, Florida 4155751 33063

A Plus Research /ID# 265878
Miami 4164138, Florida 4155751 33144

Sanchez Clinical Research /ID# 265887
Miami 4164138, Florida 4155751 33157

Advanced Research Institute, Inc /ID# 265548
New Port Richey 4165869, Florida 4155751 34653

Hillcrest Medical Research, LLC /ID# 267237
Orange City 4167055, Florida 4155751 32763

Endoscopic Research, Inc. /ID# 267211
Orlando 4167147, Florida 4155751 32803

Gcp Clinical Research /ID# 278126
Tampa 4174757, Florida 4155751 33609

AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538
Tampa 4174757, Florida 4155751 33613

Florida Medical Clinic - Zephyrhills /ID# 267392
Zephyrhills 4178941, Florida 4155751 33542

Gastroenterology Associates of Central Georgia /ID# 265547
Macon 4207400, Georgia 4197000 31201

Contact:
Site Coordinator
478-742-2600

Treasure Valley Medical Research /ID# 267114
Boise 5586437, Idaho 5596512 83706

University of Chicago Medical Center /ID# 267400
Chicago 4887398, Illinois 4896861 60637

OSF St. Francis Medical Center /ID# 266973
Peoria 4905687, Illinois 4896861 61637-0001

Springfield Clinic Main Campus /ID# 267434
Springfield 4250542, Illinois 4896861 62703-2403

University of Kentucky Chandler Medical Center /ID# 265564
Lexington 4297983, Kentucky 6254925 40536

Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877
Chevy Chase 4351335, Maryland 4361885 20815

Lucida Clinical Trials /ID# 266548
New Bedford 4945121, Massachusetts 6254926 02740

Henry Ford Medical Center - Columbus /ID# 266503
Novi 5004062, Michigan 5001836 48377

Mayo Clinic-Rochester /ID# 265550
Rochester 5043473, Minnesota 5037779 55905

GI Associates Research, LLC /ID# 267433
Columbia 4381982, Missouri 4398678 65201

BVL Clinical Research /ID# 265870
Liberty 4395052, Missouri 4398678 64068

Washington University School of Medicine - St. Louis /ID# 266938
St Louis 4407066, Missouri 4398678 63130

Vector Clinical Trials /ID# 265561
Las Vegas 5506956, Nevada 5509151 89128

NYU Langone Long Island Clinical Research Association /ID# 265566
Great Neck 5119218, New York 5128638 11021

Icahn School of Medicine at Mount Sinai /ID# 266857
New York 5128581, New York 5128638 10029

Northwell Health-Lenox Hill Hospital /ID# 265527
New York 5128581, New York 5128638 10075

Care Access - Yonkers /ID# 266781
Yonkers 5145215, New York 5128638 10701

Digestive Health Partners - Biltmore Office /ID# 265539
Asheville 4453066, North Carolina 4482348 28801

Velocity Clinical Research - Durham /ID# 267712
Durham 4464368, North Carolina 4482348 27701

University of Cincinnati /ID# 265589
Cincinnati 4508722, Ohio 5165418 45267-2827

The Ohio State University /ID# 265577
Columbus 4509177, Ohio 5165418 43210

Digestive Disease Specialists - Oklahoma /ID# 265901
Oklahoma City 4544349, Oklahoma 4544379 73112

Penn State Health Milton South Hershey Medical Center /ID# 267126
Hershey 5193342, Pennsylvania 6254927 17033

University of Pennsylvania /ID# 265904
Philadelphia 4560349, Pennsylvania 6254927 19104

Gastroenterology Associates of Orangeburg /ID# 267548
Orangeburg 4590184, South Carolina 4597040 29118

GI associates of Northeast Tennessee /ID# 265567
Johnson City 4633419, Tennessee 4662168 37604

Gi Alliance - Cedar Park /ID# 268153
Cedar Park 4679867, Texas 4736286 78613

Houston Methodist Hospital /ID# 265533
Houston 4699066, Texas 4736286 77030

Caprock Gastro Research - Lubbock - 80th Street /ID# 265541
Lubbock 5525577, Texas 4736286 79424

GI Alliance: Mansfield /ID# 266947
Mansfield 4709013, Texas 4736286 76063

Clinical Associates in Research Therapeutics of America, LLC /ID# 265899
San Antonio 4726206, Texas 4736286 78212

Sun Research Institute /ID# 266723
San Antonio 4726206, Texas 4736286 78215

Southern Star Research Institute /ID# 278124
San Antonio 4726206, Texas 4736286 78229

Tyler Research Institute, LLC /ID# 265545
Tyler 4738214, Texas 4736286 75701

Care Access - Ogden /ID# 266428
Ogden 5779206, Utah 5549030 84403

Virginia Mason Hospital & Medical Center /ID# 265574
Seattle 5809844, Washington 5815135 98101

Washington Gastroenterology - Tacoma /ID# 267302
Tacoma 5812944, Washington 5815135 98405

More Details

NCT ID: NCT06548542
Status: Recruiting
Sponsor: AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.