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
- Calgary, Edmonton, Greater Sudbury, London, Montreal, Québec, and Vaughan, CanadaSee the 8 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 Canada
- University of Calgary /ID# 265524Calgary, CanadaTaking people
- University of Alberta Hospital /ID# 265614Edmonton, CanadaTaking people
- Gastroenterology and Internal Medicine Research Institute /ID# 265610Edmonton, CanadaNo longer taking part
- Medicor Research /ID# 267405Greater Sudbury, CanadaTaking people
- London Health Sciences Centre - University Hospital /ID# 267298London, CanadaTaking people
- Clinique IMD /ID# 272057Montreal, CanadaTaking people
- Diex Recherche Quebec Inc. /ID# 265611Québec, CanadaTaking people
- Toronto Digestive Disease Associates /ID# 267358Vaughan, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.