At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Risankizumab (drug), Lutikizumab (drug), Trosunilimab (drug), Risankizumab (drug)
- How long the study runs
- Study runs about 64 months (dates as stated)
- About the drug or intervention
- Risankizumab — drug: Subcutaneous Injection · Lutikizumab — drug: Subcutaneous Injection · Trosunilimab — drug: Intravenous Infusion · Risankizumab — drug: Intravenous Infusion · Trosunilimab — drug: Subcutaneous Injection · ABBV-8736 — drug: Intravenous Infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 590
- Started
- 2024-09-04
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for crohn's disease
- • Phase2 - 590 participants
- • Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with crohn's disease
Where?
- • Edinburgh - Western General Hospital /ID# 266333
- • Glasgow - Gartnavel General Hospital /ID# 266407
- • London - Barts Health NHS Trust /ID# 266410
- • London - Royal Free Hospital /ID# 268065
- • +8 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓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...
- ✓CDAI \>= 220 at Baseline.
- ✓Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs...
Who cannot take part
- ✗Participant with history of intolerance to p19 inhibitors, including risankizumab.
See the full criteria
Where Is This Study? (12 UK sites)
Western General Hospital /ID# 266333
Edinburgh EH4 2XU, United Kingdom
Gartnavel General Hospital /ID# 266407
Glasgow G12 0YN, United Kingdom
Barts Health NHS Trust /ID# 266410
London E1 2ES, United Kingdom
Royal Free Hospital /ID# 268065
London NW3 2QG, United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 266336
London SE1 9RT, United Kingdom
St George University Hospitals NHS Foundation Trust /ID# 266335
London SW17 0QT, United Kingdom
The John Radcliffe Hospital /ID# 266334
Oxford OX3 9DU, United Kingdom
University Hospital Coventry & Warwickshire NHS Trust /ID# 267128
Coventry CV2 2DX, United Kingdom
The Royal Wolverhampton NHS Trust /ID# 268158
Wolverhampton WV10 0QP, United Kingdom
Velocity Clinical Research - Bristol /ID# 275736
Bristol BS8 2RA, United Kingdom
University Hospital of Wales /ID# 275702
Cardiff CF14 4XW, United Kingdom
Royal Victoria Infirmary /ID# 268064
Newcastle upon Tyne NE1 4LP, United Kingdom
How to Get in Touch
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