RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-09-04
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06548542

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants' body weight must be \>= 40 kg at Baseline.
  2. * 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.
  3. * CDAI \>= 220 at Baseline.
  4. * 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.
  5. * Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules.
  1. * Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
  2. * 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.
  3. * 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.

Contacts and Locations

Study Contact

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

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

Digestive Health Specialists /ID# 266216
Dothan, Alabama, 36301
United States
East View Medical Research /ID# 270377
Mobile, Alabama, 36606
United States
Southern California Res. Ctr /ID# 265549
Coronado, California, 92118
United States
UC San Diego Health System /ID# 265565
La Jolla, California, 92037
United States
uc davis medical center - patient support services building /ID# 265554
Sacramento, California, 95817
United States
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391
San Diego, California, 92103
United States
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557
Colorado Springs, Colorado, 80907
United States
Danbury Hospital, Western Connecticut Health Network /ID# 265556
Danbury, Connecticut, 06810
United States
Yale University School of Medicine /ID# 266786
New Haven, Connecticut, 06510
United States
Novum Research /ID# 278128
Clermont, Florida, 34711
United States
University of Florida College of Medicine /ID# 266930
Gainesville, Florida, 32610
United States
Nature Coast Clinical Research - Inverness /ID# 265874
Inverness, Florida, 34452-4717
United States
Atlantic Medical Research /ID# 266207
Margate, Florida, 33063
United States
A Plus Research /ID# 265878
Miami, Florida, 33144
United States
Sanchez Clinical Research /ID# 265887
Miami, Florida, 33157
United States
Advanced Research Institute, Inc /ID# 265548
New Port Richey, Florida, 34653
United States
Hillcrest Medical Research, LLC /ID# 267237
Orange City, Florida, 32763
United States
Endoscopic Research, Inc. /ID# 267211
Orlando, Florida, 32803
United States
Gcp Clinical Research /ID# 278126
Tampa, Florida, 33609
United States
AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538
Tampa, Florida, 33613
United States
Florida Medical Clinic - Zephyrhills /ID# 267392
Zephyrhills, Florida, 33542
United States
Gastroenterology Associates of Central Georgia /ID# 265547
Macon, Georgia, 31201
United States
Treasure Valley Medical Research /ID# 267114
Boise, Idaho, 83706
United States
University of Chicago Medical Center /ID# 267400
Chicago, Illinois, 60637
United States
OSF St. Francis Medical Center /ID# 266973
Peoria, Illinois, 61637-0001
United States
Springfield Clinic Main Campus /ID# 267434
Springfield, Illinois, 62703-2403
United States
University of Kentucky Chandler Medical Center /ID# 265564
Lexington, Kentucky, 40536
United States
Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877
Chevy Chase, Maryland, 20815
United States
Lucida Clinical Trials /ID# 266548
New Bedford, Massachusetts, 02740
United States
Henry Ford Medical Center - Columbus /ID# 266503
Novi, Michigan, 48377
United States
Mayo Clinic-Rochester /ID# 265550
Rochester, Minnesota, 55905
United States
GI Associates Research, LLC /ID# 267433
Columbia, Missouri, 65201
United States
BVL Clinical Research /ID# 265870
Liberty, Missouri, 64068
United States
Washington University School of Medicine - St. Louis /ID# 266938
St Louis, Missouri, 63130
United States
Vector Clinical Trials /ID# 265561
Las Vegas, Nevada, 89128
United States
NYU Langone Long Island Clinical Research Association /ID# 265566
Great Neck, New York, 11021
United States
Icahn School of Medicine at Mount Sinai /ID# 266857
New York, New York, 10029
United States
Northwell Health-Lenox Hill Hospital /ID# 265527
New York, New York, 10075
United States
Care Access - Yonkers /ID# 266781
Yonkers, New York, 10701
United States
Digestive Health Partners - Biltmore Office /ID# 265539
Asheville, North Carolina, 28801
United States
Velocity Clinical Research - Durham /ID# 267712
Durham, North Carolina, 27701
United States
University of Cincinnati /ID# 265589
Cincinnati, Ohio, 45267-2827
United States
The Ohio State University /ID# 265577
Columbus, Ohio, 43210
United States
Digestive Disease Specialists - Oklahoma /ID# 265901
Oklahoma City, Oklahoma, 73112
United States
Penn State Health Milton South Hershey Medical Center /ID# 267126
Hershey, Pennsylvania, 17033
United States
University of Pennsylvania /ID# 265904
Philadelphia, Pennsylvania, 19104
United States
Gastroenterology Associates of Orangeburg /ID# 267548
Orangeburg, South Carolina, 29118
United States
GI associates of Northeast Tennessee /ID# 265567
Johnson City, Tennessee, 37604
United States
Gi Alliance - Cedar Park /ID# 268153
Cedar Park, Texas, 78613
United States
Proactive Clinical Research /ID# 267305
El Paso, Texas, 79902
United States
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 266935
Garland, Texas, 75044
United States
Houston Methodist Hospital /ID# 265533
Houston, Texas, 77030
United States
Caprock Gastro Research - Lubbock - 80th Street /ID# 265541
Lubbock, Texas, 79424
United States
GI Alliance: Mansfield /ID# 266947
Mansfield, Texas, 76063
United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 265899
San Antonio, Texas, 78212
United States
Sun Research Institute /ID# 266723
San Antonio, Texas, 78215
United States
Southern Star Research Institute /ID# 278124
San Antonio, Texas, 78229
United States
Texas Digestive Disease Consultants - Southlake /ID# 265576
Southlake, Texas, 76092
United States
Tyler Research Institute, LLC /ID# 265545
Tyler, Texas, 75701
United States
Care Access - Ogden /ID# 266428
Ogden, Utah, 84403
United States
Care Access - Salt Lake City /ID# 266785
Salt Lake City, Utah, 84124
United States
Virginia Mason Hospital & Medical Center /ID# 265574
Seattle, Washington, 98101
United States
Washington Gastroenterology - Tacoma /ID# 267302
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-04
Study Completion Date2028-08

Study Record Updates

Study Start Date2024-09-04
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Crohn's Disease