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Clinical Trial for Adults with Coeliac Disease

An opportunity to take part in a clinical trial for adults with coeliac disease on a gluten free diet.

The only current treatment for coeliac disease is a gluten free diet. For many adults with coeliac disease, it is not entirely effective with some people experiencing ongoing symptoms.

Dr Falk is a pharmaceutical company that is currently looking for adults with coeliac disease to take part in a clinical trial across the UK. The trial aims to evaluate whether an oral treatment can reduce symptoms linked to coeliac disease and aid gut healing.

To understand our communities’ views on clinical trials, we conducted a survey in 2021 asking our members for their thoughts. Out of 2406 respondents, 61.7% said they would consider participating in a clinical trial for a coeliac disease therapeutic. With this in mind, we feel it is important to communicate and raise awareness about the opportunities to get involved with current research studies.

Dr Falk has previously led the phase 1 trial for their treatment and is now looking to recruit people for phase 2. Phase 2 is where the study medication is given to a group of people to investigate how well it works and at what dosage, as well as how safe it is to use for people with coeliac disease. The trial is looking for adults with a medical diagnosis of coeliac disease who have been on a gluten free diet for at least 12 months but are still facing symptoms.

What type of trial is this?

The trial is double blind, randomised and placebo controlled. To explain this, firstly a placebo is a substance that has no clinical effect. It will be used in this trial as a control, so that the effects of the treatment can be compared to the effects of the placebo.

The placebo and the treatment will be administered in the same way, and patients will be randomly assigned one or the other. Neither you nor the clinician will be aware of whether you are taking the placebo or the treatment until the end of the study to eliminate bias (unintentional change in behaviour or judgement).

Eligibility

To be eligible for this trial you must:

  • Be between 18-80 years old
  • Have received a biopsy proven diagnosis of coeliac disease more than 12 months ago
  • Have been following a gluten free diet for at least 12 months but still experiencing symptoms
  • Not be pregnant or breastfeeding

The study consists of 3 periods

Screening

Screening period (4 weeks)

  1. A study doctor will assess your eligibility to further take part in the study. You will have time to ask any questions you might have.

  2. You will be asked to sign an informed consent document before any study procedure is started.

What are the next steps if I am interested in taking part in the study?

You must contact a study site directly using the contact details below.

Before deciding if you want to take part in this clinical study, the study doctor will provide you with information about the study and what it means to participate (in writing and orally). Part of the study information provided by the study doctor is an informed consent document. Please take your time and read this information carefully. It is important that you ask your study doctor if something is unclear or if you have any questions about the study before you sign the Informed Consent Form. Please be aware that by getting in contact or showing interest, you are not obligated to take part.

Contacts

Sheffield — Dominic Nash — [email protected]

Cardiff — Nichola Dale — [email protected]

Manchester — Hannah Venables — [email protected]

Oxford — Clinical Trials Facility — [email protected]

FAQs

Find out more about the programme here

Clinical trials are research studies that aim to find out if health interventions can improve human health. Investigational medicines are tested on human participants to make sure they are effective and safe for people who may need them. They are an important step in providing new treatments for patients.

This clinical trial will investigate whether a drug called ZED1227 can reduce symptoms in coeliac disease patients who experience ongoing symptoms despite following a gluten free diet.

All clinical trials must be approved by a research ethics committee. This involves a group of experienced individuals who review the research studies to ensure and protect the safety, rights and wellbeing of people participating in the trial.

Pharmaceutical organisations are responsible for ensuring all interested individuals are well-informed to make a clear decision whether to participate or not. Please note that taking interest and making contact to collect more information does not mean you are obliged to take part.

Dr Falk Pharma is a research-based family business working across the globe. The company focuses on the development and delivery of new, innovative medicines to help improve patients’ health and wellbeing. For more information, please visit their website here.

This clinical trial is phase 2, double blind, randomised and placebo controlled.

This means the particular treatment is being trialed in humans for the second time. Phase 1 was the initial testing in humans and primarily looked at safe dosage and side effects. This phase 2 trial now aims to look at how effective the treatment is at treating coeliac disease.

A control will be used in this trial to determine outcomes specifically made by the treatment ZED1227. The control is a placebo, which is a substance that has no clinical effect but looks just like the real treatment. Some participants will be treated with the treatment, and some will have the placebo. The determination of this is randomised to eliminate bias. You and the investigator administering the treatment will not know which you are receiving, placebo or treatment ZED1227.

Unfortunately, treatment cannot be continued after the trial has ended. After the phase 2 trial has ended, phase 3 trials are needed to further investigate the treatment with a larger group of people.

Unfortunately, we are unable to predict the time frame if the treatment is to be successful. The results of a clinical trial can take a long time to collect and analyse.

Yes. A small, monitored level of gluten will need to be ingested for the trial. This exposure to gluten is needed to measure how your body responds after receiving the treatment or placebo.

From our therapeutics and clinical trials survey in 2021, results showed that 61.7% of 2406 participants reported that they would participate in a clinical trial for a coeliac disease therapeutic. Clinical trials can only go ahead with patient volunteers. We are providing people with coeliac disease information about the opportunity to participate in the trial, but it is up to them whether to get involved.

For this study, you will be asked to follow your usual gluten free diet, including eating out at restaurants and other people’s homes if this is something you usually do.

In all research study cases, the medication and procedures used may involve unknown risks. A study doctor will talk through any potential study related risks and side effects. Based on the information, it is always your own personal decision to join the trial.

Reading the information or getting in contact to ask further questions does not commit you to participating in the study. If you do not want to be a part of the study or wish to withdraw at a later stage, you may do so without providing a reason.

All information about you will be safe and secure. Once the study is over, any published reports will be written in a way that no one can work out that you took part in the study. You can stop being a part of the study at any time, but your information will still be held.

For further questions about the trial, please get in touch with the trial team members or access their information available on their website here. We encourage you to ask as many questions as necessary to make sure you can make a well informed decision on whether to participate.