RecruitingPhase IIInterventional

A study to learn if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet

Many people with coeliac disease still experience painful or disruptive symptoms—such as bloating, diarrhoea, and stomach cramps—even when following a strict gluten-free diet. This is often caused by tiny, accidental traces of gluten in everyday food. This clinical trial is testing an experimental medicine called ZED1227. Researchers want to find out whether taking this daily capsule can shield the lining of the gut from damage and stop symptoms when gluten is accidentally eaten. Participants will take either ZED1227 or a dummy capsule (placebo) once a day and eat a snack bar containing a small amount of gluten three times a week. The study lasts about 23 weeks and includes seven clinic visits, health checks, an electronic symptom diary, and two camera tests (endoscopies) to inspect the gut lining. Taking part is completely voluntary.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Dr Falk Pharma (Germany)

Enrolment target

356

Start

31 Mar 2024

Estimated completion

01 Apr 2027

Coeliac disease

What is this study about?

Coeliac disease is a lifelong condition where the body's immune system attacks the lining of the small bowel whenever gluten—a protein found in wheat, barley, and rye—is eaten. At present, the only way to manage it is to follow a strict gluten-free diet. However, even when people try their hardest, tiny hidden traces of gluten in restaurant meals or packaged foods can trigger inflammation and cause ongoing symptoms like bloating, stomach pain, and tiredness.

Researchers are developing a new capsule called ZED1227 to help solve this problem. The drug works by blocking an enzyme in the gut that triggers inflammation when gluten is present. The goal of this study is to see if ZED1227 can protect the bowel lining and reduce symptoms when small amounts of gluten enter the body.

To find out if the treatment works, the study compares ZED1227 to a 'placebo'. A placebo looks identical to the real medicine but contains no active ingredients. Comparing the study drug against a placebo helps scientists prove whether any improvements in health, or any side effects, are truly caused by ZED1227.

Key takeaways

Testing a new capsule (ZED1227) designed to protect the gut from accidental gluten.
For adults aged 18 to 80 with coeliac disease who still have symptoms on a gluten-free diet.
Participants take a daily capsule and eat a gluten snack bar three times a week.
Involves seven clinic visits, an electronic symptom diary, and two camera tests (endoscopies) over 23 weeks.
Participation is voluntary, and you can withdraw at any point.

Who may be eligible?

This study is open to adults aged 18 to 80 who have a medically confirmed diagnosis of coeliac disease. You must have been following a strict gluten-free diet for at least 12 months, but still experience moderate to severe digestive symptoms, such as regular stomach pain, bloating, sickness, or diarrhoea.

To qualify, your body mass index (BMI) needs to be between 17 and 35, and a bowel check must confirm that your gut still shows signs of coeliac disease. Women of childbearing age must not be pregnant and must agree to use an effective method of birth control throughout the study.

You cannot take part if you have a known allergy to wheat or other ingredients in the test snack bars, a recent stomach bug such as Helicobacter pylori, or other significant medical conditions that might make participation unsafe.

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 between 18 and 80 years old.
You have had a confirmed coeliac disease diagnosis for at least one year.
You have followed a gluten-free diet for at least 12 months.
You still regularly suffer from bloating, tummy pain, nausea, or diarrhoea.
You are comfortable eating a snack bar with a small amount of gluten three times a week.

Answer every question to see your result.

What does participation involve?

Taking part lasts around 23 weeks and involves roughly seven visits to a hospital or study clinic. You will be randomly assigned by a computer to take either ZED1227 capsules or placebo capsules once a day with food. Neither you nor your study doctor can choose which group you join. To see how well the medicine protects against accidental gluten, you will also be asked to eat a provided snack bar containing a small amount of gluten three times a week.

At your visits, the medical team will check your health, collect blood and urine samples, and ask about your symptoms. You will also have two upper endoscopies—one near the beginning and one at the end of the trial. During an endoscopy, a thin, flexible camera is passed down your throat to look at your bowel lining and take tiny tissue samples (biopsies). Between visits, you will keep a quick daily diary on a mobile phone or computer to track your capsules and any symptoms.

Potential risks and benefits

You may not get any direct health benefit from taking part, but your involvement could help scientists develop the first medicine to protect people with coeliac disease from hidden gluten. Because you will be asked to eat snack bars containing gluten, you may experience a temporary flare-up of your usual coeliac symptoms; these should settle once the snack bars stop. The study capsule could also cause unexpected side effects. Endoscopies are common tests, but they can cause a sore throat and carry a very small risk of bleeding or tearing in the gut wall. Blood tests may cause mild bruising or discomfort. Taking part is entirely voluntary, and you can change your mind and withdraw at any time without your regular medical care being affected.

Locations (7)

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

Royal Hallamshire Hospital
Unverified
Sheffield, England
Synexus Wales Clinical Research Centre
Unverified
Cardiff, Wales
Synexus Manchester Clinical Research Centre
Unverified
Manchester, England
Synexus Merseyside Clinical Research Centre
Unverified
Liverpool, England
Synexus North East Clinical Research Centre
Unverified
Hexham, England
John Radcliffe Hospital
Unverified
Oxford, England
Synexus Scotland Clinical Research Centre
Unverified
Bellshill, Scotland

Common questions

What is a placebo?

A placebo is an inactive dummy pill that looks just like the real medicine. It allows doctors to see whether changes in your health are genuinely caused by the drug being tested.

Will I have to eat gluten during the trial?

Yes. You will be asked to eat a specially made snack bar containing a small amount of gluten three times a week to see if the medicine protects your gut from accidental exposure.

Is the endoscopy painful?

An endoscopy can feel uncomfortable, but it is not usually painful. The clinic team will offer you a numbing throat spray or a mild sedative to help you stay relaxed.

How long will I be in the study?

Participation lasts about 23 weeks in total and involves seven appointments at the clinic.

Can I leave the study if my symptoms become too uncomfortable?

Yes. You are completely free to leave the trial at any point, for any reason, and your usual NHS care will continue as normal.

How to find out more

Beate Niemeier

Beate.niemeier@drfalkpharma.de +49 (0)761 15140 Official trial record

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