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
- IV Tulisokibart (drug), SC Tulisokibart (drug), IV Placebo (other), SC Placebo (other)
- How long the study runs
- Study runs about 65 months (dates as stated)
- About the drug or intervention
- IV Tulisokibart — drug: Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously · SC Tulisokibart — drug: Humanized monoclonal antibody that binds human TL1A, administered subcutaneously · IV Placebo — other: Placebo matching IV tulisokibart · SC Placebo — other: Placebo matching SC tulisokibart
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 16 Years to 80 Years
- Who
- All
- Number of participants
- 1,200
- Started
- 2024-06-05
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for crohn's disease
- • Phase3 - 1,200 participants
- • The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease
Who can take part?
- • Ages 16 Years to 80 Years
- • Diagnosed with crohn's disease
Where?
- • Cambridge - Addenbrooke's Hospital ( Site 2400)
- • Exeter - Royal Devon & Exeter Hospital ... ( Site 2407)
- • Doncaster - Doncaster Royal Infirmary ( Site 2401)
- • Huddersfield - Huddersfield Royal Infirmary ( Site 2409)
- • +6 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
More detail
The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.
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: 16 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
- ✓Has moderately to severely active CD.
- ✓Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health...
Who cannot take part
- ✗Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- ✗Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- ✗Has current stoma or need for colostomy or ileostomy.
- ✗Is missing \>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left...
- ✗Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
See the full criteria
Where Is This Study? (10 UK sites)
Addenbrooke's Hospital ( Site 2400)
Cambridge CB2 2QQ, United Kingdom
Royal Devon & Exeter Hospital ... ( Site 2407)
Exeter EX2 5DW, United Kingdom
Doncaster Royal Infirmary ( Site 2401)
Doncaster DN2 5LT, United Kingdom
Huddersfield Royal Infirmary ( Site 2409)
Huddersfield HD3 3EA, United Kingdom
Whipps Cross University Hospital-Clinical Research Unit ( Site 2404)
London E11 1NR, United Kingdom
Southampton General Hospital ( Site 2402)
Southampton SO16 6YD, United Kingdom
University College London Hospital-Clinical Research Facility ( Site 2405)
London NW1 2PG, United Kingdom
The John Radcliffe Hospital ( Site 2406)
Oxford OX3 9DU, United Kingdom
Southmead Hospital ( Site 2403)
Bristol BS10 5NB, United Kingdom
Walsall Manor Hospital ( Site 2410)
West Midlands WS2 9PS, United Kingdom
How to Get in Touch
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