RecruitingPHASE2INTERVENTIONAL

NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease

Crohn's disease causes gut inflammation that can lead to tough scar tissue over time. This scarring narrows the bowel, creating tight sections known as strictures. Strictures can cause cramping, sickness after eating, and often lead to surgery. Currently, there are few medical treatments that specifically target bowel scarring. The NOV-ERA trial is studying an experimental medicine called ontunisertib to see if it can safely reduce bowel narrowing and relieve symptoms. Adults taking part will be randomly assigned to receive either ontunisertib (at a high, medium, or low dose) or a placebo (dummy pill) for 52 weeks. The study lasts up to 60 weeks in total. Participants will attend hospital clinics every six to eight weeks for health checks, blood tests, scans, and camera tests of the bowel. Your health and safety will be carefully checked throughout the trial.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Agomab Spain S.L.U.

Enrolment target

320

Start

30 Oct 2026

Estimated completion

30 Jun 2029

Fibrostenotic Crohn's Disease

What is this study about?

Crohn's disease is a lifelong condition that causes painful swelling in parts of the digestive system. For many people, repeated swelling leads to thick scar tissue in the small bowel. This scarring can make the bowel much narrower than usual, forming what doctors call a 'stricture'. When food struggles to pass through these narrow areas, it can lead to severe stomach ache, nausea, and vomiting. Many people end up needing an operation to remove the blocked piece of bowel.

While existing medicines help calm down inflammation, they do not usually shrink or stop the scar tissue itself. Ontunisertib is a new, experimental treatment designed to tackle bowel scarring directly. Researchers hope it will help keep the bowel open, improve day-to-day digestion, and help people avoid surgery.

This study is a 'Phase 2' trial, which means researchers are checking how well the drug works, what dose is best, and whether it causes any unwanted side effects. To make sure the results are fair, ontunisertib is being compared with a placebo, which looks identical but contains no active medicine. Neither you nor your study doctor will choose or know which tablet you are taking.

Key takeaways

The trial is testing ontunisertib to see if it can treat scar tissue and narrowings in the small bowel.
It is for adults with Crohn's disease who have symptoms or food restrictions caused by a bowel stricture.
Participants will take either ontunisertib (at one of three doses) or a dummy pill (placebo) for one year.
The total study time is up to 60 weeks, with clinic visits every six to eight weeks.
Taking part involves regular health checks, blood tests, an MRI scan, and three camera tests.

Who may be eligible?

You may be able to join this trial if you are aged 18 or over and have Crohn's disease affecting your small bowel (the ileum) that was diagnosed at least 12 weeks ago. You must have at least one narrowed section of bowel that is tight enough that a standard camera cannot pass through it. You should also be experiencing symptoms of a blockage (such as stomach cramps or sickness) or needing to change what you eat to stop your food getting stuck.

You will need to be on a steady dose of your usual anti-inflammatory Crohn's medication and be in generally stable health. Your body mass index (BMI) should be between 18 and 35.

You will not be able to take part if you have had surgery or a balloon stretching procedure on your narrowed bowel in the past six months, or if you currently have a stoma bag, short bowel syndrome, or an untreated abscess. People with other bowel conditions, such as ulcerative colitis, are also not eligible.

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.

I am 18 years old or older.
I have been diagnosed with Crohn's disease in my small bowel (ileum) for at least 12 weeks.
My doctor has told me I have a narrowed section (stricture) in my bowel.
I get stomach pain, sickness, or have to alter my diet to avoid blockages.
I have not had bowel surgery or balloon stretching on my stricture in the last six months.
I do not have a stoma bag or short bowel syndrome.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for up to 60 weeks in total. It begins with a six-week screening period to run health checks and confirm whether your bowel narrowing is suitable for the study. If you qualify, you will enter a 52-week treatment period where you will take your assigned study tablets daily. You will then have a final safety check two weeks after finishing the tablets.

During the treatment year, you will visit the hospital clinic every six to eight weeks. These visits will include physical examinations, blood and urine tests, heart traces (ECGs), and symptom questionnaires. You will also have an MRI scan of your bowel at the start, as well as three camera tests (colonoscopies) with small tissue samples taken: one during screening, one around week 24, and one at week 52.

Potential risks and benefits

A potential benefit of joining this study is that ontunisertib may help reduce the scarring in your bowel, improve your digestive symptoms, and potentially delay the need for surgery, although this cannot be guaranteed. However, because ontunisertib is still being tested, there is a risk of side effects, and there is also a chance you may receive the placebo instead of the real medicine. You will also need to undergo several hospital tests, such as colonoscopies, which can be uncomfortable. Taking part is completely voluntary, and you can change your mind and leave the study at any time without it affecting your regular NHS care.

Locations (11)

GI Alliance
Verified postcode
Sun City, United States· Recruiting
Synergy Healthcare, LLC
Verified postcode
Bradenton, United States· Recruiting
Albany Gastroenterology Consultants
Verified postcode
Albany, United States· Recruiting
University Gastroenterology
Verified postcode
Providence, United States· Recruiting
GI Alliance
Verified postcode
Cedar Park, United States· Recruiting
GI Alliance - Fort Worth
Verified postcode
Fort Worth, United States· Recruiting
Amel Med LLC
Verified postcode
Georgetown, United States· Recruiting
Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje"
Verified postcode
Belgrade, Serbia· Recruiting
Clinical Hospital Center Bezanijska Kosa
Verified postcode
Belgrade, Serbia· Recruiting
Clinical Hospital Center Zvezdara (CHCZ)
Verified postcode
Belgrade, Serbia· Recruiting
Royal London Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a placebo?

A placebo is a dummy pill that looks, smells, and tastes just like the real medicine but contains no active ingredients. It helps scientists see if any health improvements are genuinely caused by the study drug.

Will I have to stop my usual Crohn's medication?

No. In fact, you must be on a stable background treatment for your Crohn's disease and agree to stay on that same treatment for the duration of the trial.

How often will I need to visit the clinic?

After your initial screening checks, you will visit the study clinic roughly once every six to eight weeks during the one-year treatment period.

Are the camera tests (colonoscopies) essential?

Yes. The trial requires three colonoscopies (at screening, week 24, and week 52) to check the stricture directly and see whether the medicine is healing the bowel wall.

Can I leave the trial if I want to stop?

Yes, you can leave the trial at any point, for any reason. Your normal medical team will support you and continue your regular Crohn's care.

How to find out more

Agomab Clinical Operations

clinicalstudies@agomab.com 0032 3318 91 70 Official trial record

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