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, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide. Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period. 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 Genders: 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 TaTs including biologics

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 ABBV-382	Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and ABBV-382 Dose A as IV infusion and ABBV-382 Dose B as SC injection.	Drug: Risankizumab Subcutaneous Injection Drug: ABBV-382 Intravenous Infusion Drug: Risankizumab Intravenous Infusion Drug: ABBV-382 Subcutaneous Injection
Experimental Monotherapy: ABBV-382	Participants will receive ABBV-382 Dose A as IV infusion and ABBV-382 Dose B as SC injection.	Drug: ABBV-382 Intravenous Infusion Drug: ABBV-382 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 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, Alabama 36301

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

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

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

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

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

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

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

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

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

Atlantic Medical Research /ID# 266207
Margate, Florida 33063

A Plus Research /ID# 265878
Miami, Florida 33144

Sanchez Clinical Research /ID# 265887
Miami, Florida 33157

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

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

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

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

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

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

Contact:
Site Coordinator
478-742-2600

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

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

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

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

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

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

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

BVL Clinical Research /ID# 265870
Liberty, Missouri 64068

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

Vector Clinical Trials /ID# 265561
Las Vegas, Nevada 89128-0435

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

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

Lenox Hill Hospital /ID# 265527
New York, New York 10075

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

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

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

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

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

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

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

University of Pennsylvania /ID# 265904
Philadelphia, Pennsylvania 19104

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

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

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

Proactive Clinical Research /ID# 267305
El Paso, Texas 79902

Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 266935
Garland, Texas 75044

Houston Methodist Hospital /ID# 265533
Houston, Texas 77030

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

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

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

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

Texas Digestive Disease Consultants - Southlake /ID# 265576
Southlake, Texas 76092

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

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

Washington Gastroenterology - Tacoma /ID# 267302
Tacoma, Washington 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.