BI EASi-PROTKT

Working towards a new tomorrow in celiac disease research

Consider enrolling in a clinical research study

The DAISY Study is looking to see how well an investigational medication works and how safe it is for people who have intestinal damage and who are experiencing persistent celiac symptoms despite attempting a gluten-free diet for at least 1 year.

People who take part may receive*:

  • study medication at no cost
  • study-related tests, assessments, and care from local doctors at no cost
  • reimbursement for reasonable time and study-related travel.

There is no obligation, so see if you may qualify now.

Desktop - IconAbout the DAISY Study

What is the DAISY Study?

Celiac disease is caused when the body’s immune system mistakenly attacks its own healthy cells. When someone with celiac disease eats foods containing gluten, the immune system attacks the small intestine causing inflammation and damage. This leads to symptoms like diarrhea, constipation, bloating, stomach pain, nausea, vomiting, and fatigue.

Currently, the only treatment for celiac disease is attempting a strict gluten-free diet for life, which helps to heal intestinal damage and prevent symptoms. However, attempting a gluten-free diet is very challenging for some people with celiac disease. Accidental gluten exposure is also common, which leads to ongoing symptoms and intestinal damage.

The DAISY Study is a clinical research study (also called a clinical trial) looking at how well an investigational medication works and how safe it is for people with diagnosed celiac disease. This study is also aiming to learn more about how the body processes and responds to the investigational medication.

The body forms gluten peptides after eating foods containing gluten. The investigational medication is designed to potentially prevent gluten peptides from activating the immune system, which causes symptoms of celiac disease.

The DAISY Study will include people who have intestinal damage and who experience ongoing symptoms of celiac disease despite attempting a gluten-free diet for at least 1 year.

DAISY Study

What to expect

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You will be randomly assigned (by chance) to receive either the investigational medication or a placebo. The placebo looks like the investigational medication but does not contain any active medicine. The investigational medication and the placebo are together called the “study medication."
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The study medication will be given as an injection in the abdomen (preferable), thigh, or upper arm.
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You will also need to take capsules that either contain a small amount of gluten or are gluten-free. These capsules are an important part of the DAISY Study. The capsules are designed to mimic what it is like to be accidentally exposed to gluten despite attempting a gluten-free diet.
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Capsules either contain gluten (wheat) or are gluten-free. The purpose of taking the capsules is to help doctors better understand how well the investigational medication can protect against gluten exposure.
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You will have 2 upper gastrointestinal endoscopies with biopsies.
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You will take your dose of the capsules 3 times a week for 6 months during the study.
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There will be no cost to you for any study-related medications, tests, or assessments. You may be paid back (reimbursed) for reasonable time and travel costs.
The study periods

You will be in the study for about 1 year. The study will be split into 4 periods.

Icons_OrangeGrey  Screening period (about 4 weeks or 1 month)

  • We will see if you are eligible to enroll in this study.

Icons_OrangeGrey Period A (about 4 weeks or 1 month)

  • You will visit the study center at least 2 times.
  • At Visit 1, you will:
    • receive your first injection of the study medication
    • have an upper gastrointestinal endoscopy with biopsies. If the endoscopy cannot be done on this day, it can be scheduled for the following days.
  • At Visit 2, you will take your dose of the capsules.
  • If you can stay in the study, you will begin taking your dose of the capsules 3 times a week with your evening meal at home.
  • If you cannot stay in the study, you will return to the study center about 1 week after the end of Period A for a follow-up visit.

Icons_OrangeGrey Period B (study treatment period) (about 26 weeks or 6.5 months)

  • You will:
    • visit the study center about 9 times for study assessments
    • receive the study medication:
      • once every 2 weeks for the first 6 weeks and then
      • once every 4 weeks for the rest of this period
    • have an upper gastrointestinal endoscopy with biopsies
    • take your dose of the capsules 3 times a week with your evening meal.

Icons_OrangeGrey Follow-up period (about 20 weeks or 5 months)

  • You will visit the study center at least 2 times for check-ups.

Who can take partWho Can Take Part?

People who may be able to take part must:

Bullet icon be 18–75 years of age

check-circle-light-v2_final have a diagnosis of celiac disease with intestinal damage

check-circle-light-v2_final still experience symptoms of celiac disease despite attempting a gluten-free diet for at least 1 year.

Additional criteria will apply.

You must meet all other study criteria to take part in the DAISY Study.

Frequently Asked Questions (FAQs)

A clinical research study, also called a clinical trial or research study, is a carefully designed scientific evaluation of a potential new (investigational) medication. Clinical research studies are conducted by doctors and researchers. A clinical research study helps to answer important questions about a potential new medication, such as:

  • How safe is the potential new medication?
  • Does it work?

A potential new (investigational) medication, also sometimes called an investigational drug or a study medication, has been tested in a laboratory. Based on those results, it has been approved by health regulatory authorities for testing in people. An investigational medication also may be a medication that is approved for the treatment of one disease or condition but is still under investigation in other diseases or conditions. An investigational medication can only be used in clinical research studies.

All potential new medications must be tested in clinical research studies before they can be approved by health regulatory authorities to be prescribed to patients. We need people to take part in clinical research studies so that new medications can be developed.

There are always risks and benefits of participating in a clinical research study. There is always a chance that the potential new (investigational) medication could cause side effects or will not work. However, you should know that there are strict rules in place to monitor the safety of people taking part in a study. Before joining any clinical research study, it is important to consider the risks and understand them.

The study team will explain all the risks and benefits at the first study visit. Throughout the study, a team of doctors and nurses will monitor the health of the people taking part. They will be there to answer any questions you may have.

If you would like to know whether you might be able to take part in the study, please fill out the form. You will be told immediately if the study is a good match. If you pre-qualify, we will connect you to a clinical research study center in your area. We will also help schedule the first study appointment at the study center. Please note: During the screening process, the study doctor or study team will check additional criteria before someone can join the study.

The study-required potential new (investigational) medication or placebo will be provided at no cost. Everyone taking part in the study will also receive study-related care from a team of experienced doctors and nurses throughout the study at no cost.

All personal information will remain confidential, and data will only be collected and used as necessary to support an individual’s match to and participation in a study. Participants’ names will not be included in any data reported. For more information, including how and why we process personal data, please read our Privacy Policy.

Clinical research studies must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any study.

Participating in a clinical research study comes with risks as well as benefits. Before joining a study, potential participants must make sure they understand the benefits, such as getting access to study-related medical care and maybe helping others in the future. They must also understand the risks, such as unknown side effects. Potential study participants can take as much time as they need to decide whether to take part and get as much information as they can. Before joining a study, the potential study participant will be asked to sign an informed consent form, which will include a full explanation of the study, including its potential risks. If the potential study participant is not capable of giving informed consent, a legally authorized representative may provide informed consent on their behalf. In this situation, the potential study participant would provide informed assent.

It is a personal decision to take part. Participation in the study is voluntary. Please also consider:

  • If a decision is made to participate, you can withdraw at any time during the study.
  • The study team will explain the possible benefits and risks of the study during the informed consent process.
  • A person does not have to join any study if they don’t want to.
  • A team of doctors and nurses will carefully monitor the health of people taking part during the study.
  • The potential new (investigational) medication or placebo will be provided at no cost.
  • Taking part in the study may help other people with celiac disease in the future.

People taking part in the study will need to follow all the instructions from the study doctor and nurses.

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Discover If You Are Eligible

Please answer the following questions to see if the study is a good match.

You do not have to answer these questions, or take part in the study. If you come to a question you do not wish to answer, please close the web page.