RecruitingPhase IIIInterventional

Additional treatment for improving severe colitis

Ulcerative colitis is a long-term condition causing inflammation and ulcers in the bowel. During a severe flare-up, people often need urgent hospital treatment with strong steroids given through a drip. However, steroids only work for about half of patients. Those who do not improve may need other powerful medicines or surgery to remove the large bowel. This NHS study is testing whether adding an anti-inflammatory tablet called upadacitinib to standard steroid treatment helps patients recover faster. Upadacitinib is already an approved medicine for ulcerative colitis, but doctors want to see if using it early during a hospital stay prevents complications. Half of the participants will receive upadacitinib and half will receive a dummy tablet (placebo) for the first 10 days, alongside their normal steroid care. The goal is to safely control symptoms and reduce the need for major bowel surgery.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Hull University Teaching Hospitals NHS Trust

Enrolment target

300

Start

30 Apr 2025

Estimated completion

30 Jun 2027

Acute severe ulcerative colitis

What is this study about?

Ulcerative colitis is a long-term gut condition where the lining of the large bowel becomes inflamed and swollen. People living with the condition often have times when they feel well, followed by flare-ups where symptoms like severe diarrhoea, bleeding, and pain return. In some cases, a flare-up can be so intense that a person needs urgent admission to an NHS hospital.

Standard hospital treatment involves giving high doses of steroids through a drip to quickly calm the inflammation. While steroids can be very effective, they only work for about half of patients admitted with a severe flare. If steroids do not work, doctors must try other strong medicines, and if these also fail, emergency surgery to remove the large bowel (a colectomy) may be needed. Finding a treatment that works quickly alongside steroids could spare many people from needing surgery.

This trial, called the ACESO study, is testing whether adding a daily tablet called upadacitinib to steroid treatment gives better results. Upadacitinib is already used safely in the NHS for ulcerative colitis. It works by blocking specific signals in the body that drive inflammation. Researchers want to find out if starting upadacitinib right away helps hospitalised patients recover sooner and prevents long-term complications.

Key takeaways

The ACESO study looks at whether adding upadacitinib tablets to standard steroid treatment helps severe ulcerative colitis flares.
The main aim is to see if early treatment reduces the need for emergency bowel surgery or extra medicines.
The trial takes place across NHS hospitals in the UK and aims to recruit 300 adults aged 18 to 65.
For the first 10 days, half of the participants receive upadacitinib and half receive a dummy tablet (placebo).
All participants continue to receive standard NHS steroid care and daily medical monitoring.

Who may be eligible?

This study is open to adults aged between 18 and 65 who have been admitted to an NHS hospital with a confirmed or suspected severe flare-up of ulcerative colitis. Participants must need treatment with steroids through a drip and be able to start the trial medication within 36 hours of coming to the hospital.

You cannot take part if you are pregnant or breastfeeding, or if your bowel symptoms are caused by an active gut infection (such as C. difficile). People with a dangerous widening of the bowel called toxic megacolon, recent cancer, or severe liver, kidney, or blood problems will also be excluded.

Because upadacitinib can interact with other substances, people taking certain medicines (such as specific antifungal drugs or antibiotics) or consuming grapefruit products cannot join. Those with a past history of blood clots who are not currently on effective blood-thinning medication will also be excluded for safety reasons.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

You are aged between 18 and 65 years old.
You are currently hospitalised with a severe flare-up of ulcerative colitis.
Your doctor has prescribed steroid treatment through a vein (drip).
You can start the trial tablets within 36 hours of your hospital admission.
You are not pregnant or breastfeeding.
You do not have an active gut infection such as C. difficile.

Answer every question to see your result.

What does participation involve?

If you take part, you will be randomly placed into one of two groups. One group receives upadacitinib tablets, while the other receives an identical dummy tablet (placebo). Neither you nor your hospital doctors will know which group you are in for the first 10 days. Throughout this time, you will still receive all your standard hospital steroid treatment and routine care.

On Day 10, your treatment will be revealed. Depending on how well your bowel has responded, you may continue taking study medication for up to 8 weeks. Your doctors will monitor your health every day while you are in hospital. Most tests done for the study are part of your usual NHS care, though you may be asked to give extra blood samples at the same time as routine blood draws. You will also be asked to complete a short questionnaire at three points over a 12-month period to see how you are feeling.

Potential risks and benefits

Taking part may help calm your severe flare-up faster and reduce your chance of needing bowel surgery, although direct benefit cannot be guaranteed. Upadacitinib is an approved medicine with known side effects, including a slightly higher chance of infections or blood clots. Because hospitalised patients with severe colitis are already given routine blood-thinning injections to prevent clots, this risk is kept as low as possible. Your medical team will monitor you closely every day. Joining the study is completely voluntary; you can choose to leave at any time without your normal NHS care or relationship with your healthcare team being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hull University Teaching Hospitals NHS Trust
City only
Hull, England

Common questions

Will taking part delay my normal hospital treatment?

No. You will receive your standard steroid treatment through a drip as normal. The study medication is given alongside your usual hospital care.

What is a placebo and why is it used?

A placebo is a dummy tablet that looks identical to the real medicine but contains no active ingredients. It helps researchers prove whether upadacitinib works better than standard care alone.

When will I find out which tablet I was given?

You and your doctors will find out after 10 days. If an emergency arises sooner, your medical team can find out immediately to guide your care.

What happens if my symptoms get worse during the trial?

Your hospital team checks on you daily. If your condition worsens or the treatment is not working, your doctors will step in right away with other proven NHS treatments.

Can I leave the study if I change my mind?

Yes. You are free to withdraw at any point. Your decision will not change the quality of care or treatment options offered by your NHS doctors.

How to find out more

Mahboobeh Haji Sadeghi

Mahboobeh.HajiSadeghi@hyms.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.