Recruiting
Phase 2

Targeted Therapies

Sponsor:

AbbVie

Code:

NCT06548542

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Risankizumab

Lutikizumab

Trosunilimab

Risankizumab

Trosunilimab

Study Details

Brief summary:

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.

Conditions

Crohn's Disease

Study ID

NCT06548542

Start date

Sep 4, 2024

Status verified date

Jun, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

540 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Monotherapy: Risankizumab

Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection.

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.

experimental: Monotherapy: Trosunilimab

Participants will receive trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC 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.

experimental: Monotherapy: Lutikizumab

Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection.

experimental: Monotherapy: ABBV-8736 - OUS Only

Participants will receive ABBV-8736 as IV 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.

Interventions

Risankizumab

Subcutaneous Injection

Lutikizumab

Subcutaneous Injection

Trosunilimab

Intravenous Infusion

Risankizumab

Intravenous Infusion

Trosunilimab

Subcutaneous Injection

ABBV-8736

Intravenous Infusion

Primary outcome measure

  • Percentage of Participants who Achieve Endoscopic Remission [ Time Frame: Week 12 ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 96 weeks ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Digestive Health Specialists /ID# 266216

Recruiting

Dothan, Alabama, United States, 36301

East View Medical Research /ID# 270377

Recruiting

Mobile, Alabama, United States, 36606

Southern California Res. Ctr /ID# 265549

Recruiting

Coronado, California, United States, 92118

UC San Diego Health System /ID# 265565

Recruiting

La Jolla, California, United States, 92037

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

Recruiting

Sacramento, California, United States, 95817

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

Recruiting

San Diego, California, United States, 92103

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

Recruiting

Colorado Springs, Colorado, United States, 80907

Danbury Hospital, Western Connecticut Health Network /ID# 265556

Recruiting

Danbury, Connecticut, United States, 06810

Yale University School of Medicine /ID# 266786

Recruiting

New Haven, Connecticut, United States, 06510

Novum Research /ID# 278128

Recruiting

Clermont, Florida, United States, 34711

University of Florida College of Medicine /ID# 266930

Recruiting

Gainesville, Florida, United States, 32610

Nature Coast Clinical Research - Inverness /ID# 265874

Recruiting

Inverness, Florida, United States, 34452-4717

Atlantic Medical Research /ID# 266207

Recruiting

Margate, Florida, United States, 33063

A Plus Research /ID# 265878

Recruiting

Miami, Florida, United States, 33144

Sanchez Clinical Research /ID# 265887

Recruiting

Miami, Florida, United States, 33157

Advanced Research Institute, Inc /ID# 265548

Recruiting

New Port Richey, Florida, United States, 34653

Hillcrest Medical Research, LLC /ID# 267237

Recruiting

Orange City, Florida, United States, 32763

Endoscopic Research, Inc. /ID# 267211

Recruiting

Orlando, Florida, United States, 32803

Gcp Clinical Research /ID# 278126

Recruiting

Tampa, Florida, United States, 33609

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

Recruiting

Tampa, Florida, United States, 33613

Florida Medical Clinic - Zephyrhills /ID# 267392

Recruiting

Zephyrhills, Florida, United States, 33542

Gastroenterology Associates of Central Georgia /ID# 265547

Recruiting

Macon, Georgia, United States, 31201

Contacts

Site Coordinator

478-742-2600

Treasure Valley Medical Research /ID# 267114

Recruiting

Boise, Idaho, United States, 83706

University of Chicago Medical Center /ID# 267400

Recruiting

Chicago, Illinois, United States, 60637

OSF St. Francis Medical Center /ID# 266973

Recruiting

Peoria, Illinois, United States, 61637-0001

Springfield Clinic Main Campus /ID# 267434

Recruiting

Springfield, Illinois, United States, 62703-2403

Indiana University Health University Hospital /ID# 278129

Recruiting

Indianapolis, Indiana, United States, 46202

University of Kentucky Chandler Medical Center /ID# 265564

Recruiting

Lexington, Kentucky, United States, 40536

Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877

Recruiting

Chevy Chase, Maryland, United States, 20815

Lucida Clinical Trials /ID# 266548

Recruiting

New Bedford, Massachusetts, United States, 02740

Henry Ford Medical Center - Columbus /ID# 266503

Recruiting

Novi, Michigan, United States, 48377

Mayo Clinic-Rochester /ID# 265550

Recruiting

Rochester, Minnesota, United States, 55905

GI Associates Research, LLC /ID# 267433

Recruiting

Columbia, Missouri, United States, 65201

Bvl Research /ID# 265870

Recruiting

Liberty, Missouri, United States, 64068

Washington University /ID# 266938

Recruiting

St Louis, Missouri, United States, 63110

Vector Clinical Trials /ID# 265561

Recruiting

Las Vegas, Nevada, United States, 89128

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

Recruiting

Lake Success, New York, United States, 11042

Northwell Health-Lenox Hill Hospital /ID# 265527

Recruiting

New York, New York, United States, 10075

Care Access - Yonkers /ID# 266781

Recruiting

Yonkers, New York, United States, 10701

Digestive Health Partners - Biltmore Office /ID# 265539

Recruiting

Asheville, North Carolina, United States, 28801

University of Cincinnati /ID# 265589

Recruiting

Cincinnati, Ohio, United States, 45267-2827

The Ohio State University /ID# 265577

Recruiting

Columbus, Ohio, United States, 43210

Digestive Disease Specialists - Oklahoma /ID# 265901

Recruiting

Oklahoma City, Oklahoma, United States, 73112

University of Pennsylvania /ID# 265904

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Gastroenterology Associates of Orangeburg /ID# 267548

Recruiting

Orangeburg, South Carolina, United States, 29118

GI associates of Northeast Tennessee /ID# 265567

Recruiting

Johnson City, Tennessee, United States, 37604

Gi Alliance - Cedar Park /ID# 268153

Recruiting

Cedar Park, Texas, United States, 78613

Houston Methodist Hospital /ID# 265533

Recruiting

Houston, Texas, United States, 77030

Caprock Gastro Research - Lubbock /ID# 265541

Recruiting

Lubbock, Texas, United States, 79424

GI Alliance - Mansfield /ID# 266947

Recruiting

Mansfield, Texas, United States, 76063

Sun Research Institute /ID# 266723

Recruiting

San Antonio, Texas, United States, 78215

Southern Star Research Institute /ID# 278124

Recruiting

San Antonio, Texas, United States, 78229

Tyler Research Institute /ID# 265545

Recruiting

Tyler, Texas, United States, 75701

Care Access - Ogden /ID# 266428

Recruiting

Ogden, Utah, United States, 84403

Virginia Mason Hospital and Medical Center /ID# 265574

Recruiting

Seattle, Washington, United States, 98101

Washington Gastroenterology - Tacoma /ID# 267302

Recruiting

Tacoma, Washington, United States, 98405

University of Calgary /ID# 265524

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

University of Alberta Hospital /ID# 265614

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Medicor Research /ID# 267405

Recruiting

Greater Sudbury, Ontario, Canada, P3C 1X3

London Health Sciences Centre - University Hospital /ID# 267298

Recruiting

London, Ontario, Canada, N6A 5A5

Toronto Digestive Disease Associates /ID# 267358

Recruiting

Vaughan, Ontario, Canada, L4L 4Y7

Clinique IMD /ID# 272057

Recruiting

Montreal, Quebec, Canada, H3H 1E8

Diex Recherche Quebec Inc. /ID# 265611

Recruiting

Québec, Canada, G1V 4T3

More Information

Sponsor

AbbVie

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Crohn's Disease
  • Risankizumab
  • Trosunilimab
  • Lutikizumab
  • ABBV-8736

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-06-26.