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
- Vedolizumab (drug), Upadacitinib (drug), Placebo (drug)
- How long the study runs
- Study runs about 43 months (dates as stated)
- About the drug or intervention
- Vedolizumab — drug: Vedolizumab IV infusion. · Upadacitinib — drug: Upadacitinib over-encapsulated tablets. · Placebo — drug: Upadacitinib matched placebo capsules.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at adults with moderate to severe Crohn's disease, a condition that causes inflammation in the gut. It tests a medicine called vedolizumab, taken with or without another medicine called upadacitinib. It is run by Takeda.
Who can take part
- Diagnosed with Crohn's disease at least 3 months before screening, based on symptoms, a camera test (endoscopy) and a tissue report.
- Crohn's disease is moderately to severely active, measured by a symptom score (CDAI) of 220 to 450.
- Signs of gut inflammation on a camera test, with a score (SES-CD) of 6 or more (or 4 or more if only the small bowel end is affected), checked by an expert reader.
- Current treatments have not worked well enough or have caused problems — these include steroids, immunomodulators (medicines that calm the immune system) or biologic medicines.
Who may not be able to
- A diagnosis of ulcerative colitis or indeterminate colitis (where the type of bowel disease is unclear).
- A recent infection needing treatment through a drip (in the last 30 days) or by mouth/injection into a muscle (in the last 14 days), an active infection during screening, a significant infection in the last 30 days, or an ongoing long-term infection.
- Past repeated or widespread shingles (herpes zoster), or widespread cold sore infection (herpes simplex).
- Certain Crohn's disease problems: an abscess in the tummy or around the back passage; narrowed bowel causing symptoms; two whole sections of bowel missing from the five checked; very severe colitis; a very swollen colon (toxic megacolon); or any other problem that might need surgery during the study.
- Having a stoma (an opening on the tummy for waste) or an ileoanal pouch.
- Severe kidney problems (a filtration rate below 30 mL/min/1.73 m²).
- Severe liver problems (Child-Pugh C).
What taking part involves
- • Taking vedolizumab, with or without upadacitinib (medicines that affect the immune system to reduce gut inflammation).
- • How the medicines are given, the doses and how they are compared: Not stated — ask the trial team.
Time commitment: Number of visits, how long the study lasts and what taking part involves: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 65 Years
- Who
- All
- Number of participants
- 396
- Started
- 2025-01-02
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for crohn's disease
- • Phase3 - 396 participants
- • The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment
Who can take part?
- • Ages 18 Years to 65 Years
- • Diagnosed with crohn's disease
Where?
- • London - St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
- • London - The Royal London Hospital - Barts Health NHS Trust
- • Edinburgh - Western General Hospital
- • Glasgow - Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants. All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks. Participants responding to the treatment will then receive vedolizumab only (monotherapy) for an additional 40 weeks. During the study, participants will visit their study clinic 15 times.
More detail
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderately to severely active CD. The study will look at the efficacy and safety of vedolizumab with and without upadacitinib. The study will enroll approximately 396 patients. Participants will be assigned in a 1:1 ratio to one of the two treatment groups in the 12-weeks Induction Phase: * Induction Phase: Vedolizumab + Upadacitinib * Induction Phase: Vedolizumab + Placebo Participants who achieve a Crohn's disease activity index (CDAI) reduction of greater than or equal to (\>=)70 points from baseline at Week 12 will enter the main study Maintenance Phase (40 weeks) of the study to receive vedolizumab monotherapy. Participants will be followed for a further 18-week safety follow-up period up to Week 70. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 70 weeks.
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 - 65 Years
- Who can join: All genders
What the study is looking for
- ✓The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic...
- ✓The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450.
- ✓The participant has evidence of mucosal inflammation based on the SES-CD: SES-CD score of \>=6 (or \>=4 for...
- ✓The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids,...
Who cannot take part
- ✗The participant has a current diagnosis of ulcerative colitis or indeterminate colitis.
- ✗The participant has infection(s) requiring treatment with IV anti-infectives within 30 days prior to baseline or...
- ✗The participant has evidence of an active infection during the screening period, or clinically significant infection...
- ✗The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or...
- ✗The participant has an ostomy or ileoanal pouch.
See the full criteria
Where Is This Study? (4 UK sites)
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
London SE1 7EH, United Kingdom
The Royal London Hospital - Barts Health NHS Trust
London E1 1BB, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division
Glasgow G51 4TF, United Kingdom
How to Get in Touch
Takeda Contact
Sponsor contactCONTACT