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RECRUITING
NCT06548542
PHASE2

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

590

Start Date

2024-09-04

Completion Date

2030-01

Last Updated

2026-09-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Risankizumab

Subcutaneous Injection

DRUG

Lutikizumab

Subcutaneous Injection

DRUG

Trosunilimab

Intravenous Infusion

DRUG

Risankizumab

Intravenous Infusion

DRUG

Trosunilimab

Subcutaneous Injection

DRUG

ABBV-8736

Intravenous Infusion

Locations (255)

Digestive Health Specialists /ID# 266216

Dothan, Alabama, United States

East View Medical Research /ID# 270377

Mobile, Alabama, United States

Southern California Res. Ctr /ID# 265549

Coronado, California, United States

UC San Diego Health System /ID# 265565

La Jolla, California, United States

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

Sacramento, California, United States

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

San Diego, California, United States

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

Colorado Springs, Colorado, United States

Danbury Hospital, Western Connecticut Health Network /ID# 265556

Danbury, Connecticut, United States

Yale University School of Medicine /ID# 266786

New Haven, Connecticut, United States

Novum Research /ID# 278128

Clermont, Florida, United States

University of Florida College of Medicine /ID# 266930

Gainesville, Florida, United States

Nature Coast Clinical Research - Inverness /ID# 265874

Inverness, Florida, United States

Atlantic Medical Research /ID# 266207

Margate, Florida, United States

A Plus Research /ID# 265878

Miami, Florida, United States

Sanchez Clinical Research /ID# 265887

Miami, Florida, United States

Advanced Research Institute, Inc /ID# 265548

New Port Richey, Florida, United States

Hillcrest Medical Research, LLC /ID# 267237

Orange City, Florida, United States

Endoscopic Research, Inc. /ID# 267211

Orlando, Florida, United States

Gcp Clinical Research /ID# 278126

Tampa, Florida, United States

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

Tampa, Florida, United States

Florida Medical Clinic - Zephyrhills /ID# 267392

Zephyrhills, Florida, United States

Gastroenterology Associates of Central Georgia /ID# 265547

Macon, Georgia, United States

Treasure Valley Medical Research /ID# 267114

Boise, Idaho, United States

University of Chicago Medical Center /ID# 267400

Chicago, Illinois, United States

OSF St. Francis Medical Center /ID# 266973

Peoria, Illinois, United States

Springfield Clinic Main Campus /ID# 267434

Springfield, Illinois, United States

Indiana University Health University Hospital /ID# 278129

Indianapolis, Indiana, United States

University of Kentucky Chandler Medical Center /ID# 265564

Lexington, Kentucky, United States

Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877

Chevy Chase, Maryland, United States

Velocity Clinical Research - Rockville /ID# 267712

Rockville, Maryland, United States

Lucida Clinical Trials /ID# 266548

New Bedford, Massachusetts, United States

Henry Ford Medical Center - Columbus /ID# 266503

Novi, Michigan, United States

Mayo Clinic-Rochester /ID# 265550

Rochester, Minnesota, United States

GI Associates Research, LLC /ID# 267433

Columbia, Missouri, United States

Bvl Research /ID# 265870

Liberty, Missouri, United States

Washington University /ID# 266938

St Louis, Missouri, United States

Vector Clinical Trials /ID# 265561

Las Vegas, Nevada, United States

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

Lake Success, New York, United States

Icahn School of Medicine at Mount Sinai /ID# 266857

New York, New York, United States

Northwell Health-Lenox Hill Hospital /ID# 265527

New York, New York, United States

Care Access - Yonkers /ID# 266781

Yonkers, New York, United States

Digestive Health Partners - Biltmore Office /ID# 265539

Asheville, North Carolina, United States

University of Cincinnati /ID# 265589

Cincinnati, Ohio, United States

The Ohio State University /ID# 265577

Columbus, Ohio, United States

Digestive Disease Specialists - Oklahoma /ID# 265901

Oklahoma City, Oklahoma, United States

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

Hershey, Pennsylvania, United States

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

Philadelphia, Pennsylvania, United States

Gastroenterology Associates of Orangeburg /ID# 267548

Orangeburg, South Carolina, United States

GI associates of Northeast Tennessee /ID# 265567

Johnson City, Tennessee, United States

Gi Alliance - Cedar Park /ID# 268153

Cedar Park, Texas, United States

Proactive Clinical Research /ID# 267305

El Paso, Texas, United States

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

Garland, Texas, United States

Houston Methodist Hospital /ID# 265533

Houston, Texas, United States

Caprock Gastro Research - Lubbock /ID# 265541

Lubbock, Texas, United States

GI Alliance - Mansfield /ID# 266947

Mansfield, Texas, United States

Clinical Associates in Research Therapeutics of America, LLC /ID# 265899

San Antonio, Texas, United States

Sun Research Institute /ID# 266723

San Antonio, Texas, United States

Southern Star Research Institute /ID# 278124

San Antonio, Texas, United States

Texas Digestive Disease Consultants - Southlake /ID# 265576

Southlake, Texas, United States

Tyler Research Institute /ID# 265545

Tyler, Texas, United States

Care Access - Ogden /ID# 266428

Ogden, Utah, United States

Care Access - Salt Lake City /ID# 266785

Salt Lake City, Utah, United States

Virginia Mason Hospital and Medical Center /ID# 265574

Seattle, Washington, United States

Washington Gastroenterology - Tacoma /ID# 267302

Tacoma, Washington, United States

Medizinische Universitaet Graz /ID# 275453

Graz, Styria, Austria

Medizinische Universitaet Innsbruck /ID# 265930

Innsbruck, Tyrol, Austria

Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 265929

Linz, Upper Austria, Austria

Klinikum Wels-Grieskirchen Gmbh /ID# 266035

Wels, Upper Austria, Austria

Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 265928

Salzburg, Austria

Medizinische Universitaet Wien /ID# 265926

Vienna, Austria

Imelda Ziekenhuis /ID# 265995

Bonheiden, Antwerpen, Belgium

Universite Libre de Bruxelles - Hopital Erasme /ID# 265993

Anderlecht, Brussels Capital, Belgium

CHU Saint-Pierre /ID# 266431

Brussels, Brussels Capital, Belgium

Cliniques Universitaires UCL Saint-Luc /ID# 265521

Brussels, Brussels Capital, Belgium

Groupe Sante CHC - Clinique du MontLegia /ID# 265522

Liège, Liege, Belgium

Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 265517

Yvoir, Namur, Belgium

Universitair Ziekenhuis Leuven /ID# 265519

Leuven, Vlaams-Brabant, Belgium

AZ Groeninge /ID# 265544

Kortrijk, West-Vlaanderen, Belgium

AZ Oostende /ID# 275534

Ostend, West-Vlaanderen, Belgium

CHU de Liege /ID# 265542

Liège, Belgium

Hospital Tsaritsa Yoanna /ID# 266235

Sofiya, Sofia, Bulgaria

Medical Center - Doverie /ID# 267050

Sofiya, Sofia, Bulgaria

ACIBADEM City Clinic Diagnostic-Consultative Center /ID# 266239

Sofiya, Sofia, Bulgaria

Umbal Kaspela /ID# 266234

Plovdiv, Bulgaria

MHAT Knyaginya Klementina /ID# 266238

Sofia, Bulgaria

Acibadem City Clinic Tokuda University Hospital EAD /ID# 267437

Sofia, Bulgaria

Military Medical Academy Multiprofile Hospital /ID# 267051

Sofia, Bulgaria

UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 266237

Varna, Bulgaria

University of Calgary /ID# 265524

Calgary, Alberta, Canada

Gastroenterology and Internal Medicine Research Institute /ID# 265610

Edmonton, Alberta, Canada

University of Alberta Hospital /ID# 265614

Edmonton, Alberta, Canada

Medicor Research /ID# 267405

Greater Sudbury, Ontario, Canada

London Health Sciences Centre - University Hospital /ID# 267298

London, Ontario, Canada

Toronto Digestive Disease Associates /ID# 267358

Vaughan, Ontario, Canada

Clinique IMD /ID# 272057

Montreal, Quebec, Canada

Diex Recherche Quebec Inc. /ID# 265611

Québec, Canada

Klinicki Bolnicki Centar Zagreb /ID# 265502

Grad Zagreb, City of Zagreb, Croatia

Poliklinika Solmed /ID# 265509

Zagreb, City of Zagreb, Croatia

Poliklinika Borzan d.o.o. /ID# 265503

Osijek, County of Osijek-Baranja, Croatia

Specialty Hospital Medico /ID# 265504

Rijeka, Primorje-Gorski Kotar County, Croatia

And 155 more locations on ClinicalTrials.gov