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RecruitingPhase 2

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

AbbVie · NCT06548542

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
590
US sites recruiting
54
Study start
September 4, 2024
Record last updated
September 25, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Risankizumab; Lutikizumab; Trosunilimab; Risankizumab; Trosunilimab; ABBV-8736

Conditions: Crohn's Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Digestive Health Specialists /ID# 266216

    Dothan, AL 36301

  • East View Medical Research /ID# 270377

    Mobile, AL 36606

  • Southern California Res. Ctr /ID# 265549

    Coronado, CA 92118

  • UC San Diego Health System /ID# 265565

    La Jolla, CA 92037

  • uc davis medical center - patient support services building /ID# 265554

    Sacramento, CA 95817

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

    Colorado Springs, CO 80907

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

    Danbury, CT 06810

  • Yale University School of Medicine /ID# 266786

    New Haven, CT 06510

  • Novum Research /ID# 278128

    Clermont, FL 34711

  • University of Florida College of Medicine /ID# 266930

    Gainesville, FL 32610

  • Nature Coast Clinical Research - Inverness /ID# 265874

    Inverness, FL 34452-4717

  • Atlantic Medical Research /ID# 266207

    Margate, FL 33063

  • A Plus Research /ID# 265878

    Miami, FL 33144

  • Sanchez Clinical Research /ID# 265887

    Miami, FL 33157

  • Advanced Research Institute, Inc /ID# 265548

    New Port Richey, FL 34653

  • Hillcrest Medical Research, LLC /ID# 267237

    Orange City, FL 32763

  • Endoscopic Research, Inc. /ID# 267211

    Orlando, FL 32803

  • Gcp Clinical Research /ID# 278126

    Tampa, FL 33609

  • AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538

    Tampa, FL 33613

  • Florida Medical Clinic - Zephyrhills /ID# 267392

    Zephyrhills, FL 33542

  • Gastroenterology Associates of Central Georgia /ID# 265547

    Macon, GA 31201

    Site contact: Site Coordinator · 478-742-2600

  • Treasure Valley Medical Research /ID# 267114

    Boise, ID 83706

  • University of Chicago Medical Center /ID# 267400

    Chicago, IL 60637

  • OSF St. Francis Medical Center /ID# 266973

    Peoria, IL 61637-0001

  • Springfield Clinic Main Campus /ID# 267434

    Springfield, IL 62703-2403

  • Indiana University Health University Hospital /ID# 278129

    Indianapolis, IN 46202

  • University of Kentucky Chandler Medical Center /ID# 265564

    Lexington, KY 40536

  • Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877

    Chevy Chase, MD 20815

  • Lucida Clinical Trials /ID# 266548

    New Bedford, MA 02740

  • Henry Ford Medical Center - Columbus /ID# 266503

    Novi, MI 48377

  • Mayo Clinic-Rochester /ID# 265550

    Rochester, MN 55905

  • GI Associates Research, LLC /ID# 267433

    Columbia, MO 65201

  • Bvl Research /ID# 265870

    Liberty, MO 64068

  • Washington University /ID# 266938

    St Louis, MO 63110

  • Vector Clinical Trials /ID# 265561

    Las Vegas, NV 89128

  • Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 265566

    Lake Success, NY 11042

  • Northwell Health-Lenox Hill Hospital /ID# 265527

    New York, NY 10075

  • Care Access - Yonkers /ID# 266781

    Yonkers, NY 10701

  • Digestive Health Partners - Biltmore Office /ID# 265539

    Asheville, NC 28801

  • University of Cincinnati /ID# 265589

    Cincinnati, OH 45267-2827

  • The Ohio State University /ID# 265577

    Columbus, OH 43210

  • Digestive Disease Specialists - Oklahoma /ID# 265901

    Oklahoma City, OK 73112

  • University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 265904

    Philadelphia, PA 19104

  • Gastroenterology Associates of Orangeburg /ID# 267548

    Orangeburg, SC 29118

  • GI associates of Northeast Tennessee /ID# 265567

    Johnson City, TN 37604

  • Gi Alliance - Cedar Park /ID# 268153

    Cedar Park, TX 78613

  • Houston Methodist Hospital /ID# 265533

    Houston, TX 77030

  • Caprock Gastro Research - Lubbock /ID# 265541

    Lubbock, TX 79424

  • Sun Research Institute /ID# 266723

    San Antonio, TX 78215

  • Southern Star Research Institute /ID# 278124

    San Antonio, TX 78229

  • Tyler Research Institute /ID# 265545

    Tyler, TX 75701

  • Care Access - Ogden /ID# 266428

    Ogden, UT 84403

  • Virginia Mason Hospital and Medical Center /ID# 265574

    Seattle, WA 98101

  • Washington Gastroenterology - Tacoma /ID# 267302

    Tacoma, WA 98405

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
Study of Targeted Therapies for the Treatment of Adult… (NCT06548542) | Bored Studies