Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
Recruiting · NCT06548542 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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 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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 26 US states.
- 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 /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
Showing 60 of 255 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →