Clinical trial for people with celiac disease

Study 151

Have you been diagnosed with celiac disease and are still experiencing symptoms despite following a gluten-free diet? Consider joining a clinical trial for people living with celiac disease.

About the study

This is a global study that plans to recruit up to 140 people diagnosed with celiac disease in approximately 14 countries—including your country.

The only treatment currently available for celiac disease is a strict gluten-free diet. Unfortunately, many people with celiac disease still experience symptoms even when they try to stick to a gluten-free diet, because sometimes even very small amounts of gluten can be enough to trigger symptoms.

The purpose of this study (CEC-013/CEL) is to determine whether the investigational drug (ZED1227), in combination with a gluten-free diet, can alleviate the symptoms caused by celiac disease by reducing damage to the small intestine.

To date, more than 300 people have received the investigational treatment (ZED1227) in various clinical trials.

The study consists of three periods:

1. Screening period: 4 weeks:

• A study physician assesses suitability for the study
• You will be asked to sign an informed consent form before any study procedures begin

2. Treatment period: 14 weeks:

• You will take the study drug or placebo in capsule form
• You are asked to eat a snack bar with a low gluten content several times a week
• During your study visits, the study physician will perform various tests to assess how well you are responding to the study drug. This includes, among other things, an endoscopic examination of the gastrointestinal tract with intestinal tissue sampling twice during the study.
• You fill out a journal every day

3. Follow-up period: 4 weeks:

• A final visit to the study clinic 4 weeks after the last dose of the study drug.

You may be a good fit for this program if you:

• are between the ages of 18 and 80
• has had a confirmed diagnosis of celiac disease for at least 12 months
• have been on a gluten-free diet for at least 12 months but still experience symptoms
• are not pregnant or breastfeeding

You will receive all study-related visits, tests, and study medications at no cost. In addition, you may be eligible for reimbursement of your travel expenses. The study is being conducted at our clinics in Uppsala and Stockholm.

More information and registration

Would you like to participate or receive more information? Call 018-30 33 99 or submit an expression of interest below.

The study is approved by the Ethical Review Authority and the Swedish Medical Products Agency. Your participation is voluntary, and you can withdraw at any time. The information you provide will be processed in accordance with the General Data Protection Regulation (GDPR).

Register your interest