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Taking people in United StatesPhase 2

Tests targeted medicines in adults with moderate to severe Crohn's disease

Tests risankizumab, lutikizumab, trosunilimab and ABBV-8736 in adults with moderate to severe Crohn's disease.

Plain-language title generated from the registry record
Registry title: Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease

Key facts

Where
Asheville, Boise, Cedar Park, Chevy Chase, Chicago, Cincinnati, Clermont, Colorado Springs, Columbia, Columbus, Coronado, Danbury, Dothan, El Paso, Gainesville, Garland, Hershey, Houston, Indianapolis, Inverness, Johnson City, La Jolla, Lake Success, Las Vegas, Lexington, Liberty, Lubbock, Macon, Mansfield, Margate, Miami, Mobile, New Bedford, New Haven, New Port Richey, New York, Novi, Ogden, Oklahoma City, Orange City, Orangeburg, Orlando, Peoria, Philadelphia, Rochester, Rockville, Sacramento, Salt Lake City, San Antonio, San Diego, Seattle, Southlake, Springfield, St Louis, Tacoma, Tampa, Tyler, Yonkers, and Zephyrhills, United StatesSee the 64 sites
Phase
Phase 2

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT06548542, who can take part

Where in United States

  • Digestive Health Partners - Biltmore Office /ID# 265539Asheville, United StatesTaking people
  • Treasure Valley Medical Research /ID# 267114Boise, United StatesTaking people
  • Gi Alliance - Cedar Park /ID# 268153Cedar Park, United StatesTaking people
  • Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877Chevy Chase, United StatesTaking people
  • University of Chicago Medical Center /ID# 267400Chicago, United StatesTaking people
  • University of Cincinnati /ID# 265589Cincinnati, United StatesTaking people
  • Novum Research /ID# 278128Clermont, United StatesTaking people
  • Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557Colorado Springs, United StatesTaking people
  • GI Associates Research, LLC /ID# 267433Columbia, United StatesTaking people
  • The Ohio State University /ID# 265577Columbus, United StatesTaking people
  • Southern California Res. Ctr /ID# 265549Coronado, United StatesTaking people
  • Danbury Hospital, Western Connecticut Health Network /ID# 265556Danbury, United StatesTaking people
  • Digestive Health Specialists /ID# 266216Dothan, United StatesTaking people
  • Proactive Clinical Research /ID# 267305El Paso, United StatesNo longer taking part
  • University of Florida College of Medicine /ID# 266930Gainesville, United StatesTaking people
  • Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 266935Garland, United StatesNo longer taking part
  • Penn State Health Milton South Hershey Medical Center /ID# 267126Hershey, United StatesNo longer taking part
  • Houston Methodist Hospital /ID# 265533Houston, United StatesTaking people
  • Indiana University Health University Hospital /ID# 278129Indianapolis, United StatesTaking people
  • Nature Coast Clinical Research - Inverness /ID# 265874Inverness, United StatesTaking people
  • GI associates of Northeast Tennessee /ID# 265567Johnson City, United StatesTaking people
  • UC San Diego Health System /ID# 265565La Jolla, United StatesTaking people
  • Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 265566Lake Success, United StatesTaking people
  • Vector Clinical Trials /ID# 265561Las Vegas, United StatesTaking people
  • University of Kentucky Chandler Medical Center /ID# 265564Lexington, United StatesTaking people
  • Bvl Research /ID# 265870Liberty, United StatesTaking people
  • Caprock Gastro Research - Lubbock /ID# 265541Lubbock, United StatesTaking people
  • Gastroenterology Associates of Central Georgia /ID# 265547Macon, United StatesTaking people
  • GI Alliance - Mansfield /ID# 266947Mansfield, United StatesNo longer taking part
  • Atlantic Medical Research /ID# 266207Margate, United StatesTaking people
  • A Plus Research /ID# 265878Miami, United StatesTaking people
  • Sanchez Clinical Research /ID# 265887Miami, United StatesTaking people
  • East View Medical Research /ID# 270377Mobile, United StatesTaking people
  • Lucida Clinical Trials /ID# 266548New Bedford, United StatesTaking people
  • Yale University School of Medicine /ID# 266786New Haven, United StatesTaking people
  • Advanced Research Institute, Inc /ID# 265548New Port Richey, United StatesTaking people
  • Northwell Health-Lenox Hill Hospital /ID# 265527New York, United StatesTaking people
  • Icahn School of Medicine at Mount Sinai /ID# 266857New York, United StatesNo longer taking part
  • Henry Ford Medical Center - Columbus /ID# 266503Novi, United StatesTaking people
  • Care Access - Ogden /ID# 266428Ogden, United StatesTaking people
  • Digestive Disease Specialists - Oklahoma /ID# 265901Oklahoma City, United StatesTaking people
  • Hillcrest Medical Research, LLC /ID# 267237Orange City, United StatesTaking people
  • Gastroenterology Associates of Orangeburg /ID# 267548Orangeburg, United StatesTaking people
  • Endoscopic Research, Inc. /ID# 267211Orlando, United StatesTaking people
  • OSF St. Francis Medical Center /ID# 266973Peoria, United StatesTaking people
  • University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 265904Philadelphia, United StatesTaking people
  • Mayo Clinic-Rochester /ID# 265550Rochester, United StatesTaking people
  • Velocity Clinical Research - Rockville /ID# 267712Rockville, United StatesNo longer taking part
  • uc davis medical center - patient support services building /ID# 265554Sacramento, United StatesTaking people
  • Care Access - Salt Lake City /ID# 266785Salt Lake City, United StatesNo longer taking part
  • Southern Star Research Institute /ID# 278124San Antonio, United StatesTaking people
  • Sun Research Institute /ID# 266723San Antonio, United StatesTaking people
  • Clinical Associates in Research Therapeutics of America, LLC /ID# 265899San Antonio, United StatesNo longer taking part
  • Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391San Diego, United StatesNo longer taking part
  • Virginia Mason Hospital and Medical Center /ID# 265574Seattle, United StatesTaking people
  • Texas Digestive Disease Consultants - Southlake /ID# 265576Southlake, United StatesNo longer taking part
  • Springfield Clinic Main Campus /ID# 267434Springfield, United StatesTaking people
  • Washington University /ID# 266938St Louis, United StatesTaking people
  • Washington Gastroenterology - Tacoma /ID# 267302Tacoma, United StatesTaking people
  • AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538Tampa, United StatesTaking people
  • Gcp Clinical Research /ID# 278126Tampa, United StatesTaking people
  • Tyler Research Institute /ID# 265545Tyler, United StatesTaking people
  • Care Access - Yonkers /ID# 266781Yonkers, United StatesTaking people
  • Florida Medical Clinic - Zephyrhills /ID# 267392Zephyrhills, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
AbbVie
Trial code
NCT06548542EU 2024-513009-30-00
Record updated
25 September 2026
Original 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.Read full original descriptionShow less

A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease

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.

Inclusion: 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: 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; Participant with history of intolerance to p19 inhibitors, including risankizumab.

ClinicalTrials.gov NCT06548542 · EU CTIS 2024-513009-30-00