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Who can participate in this research study?
The ILLUMINATE-101 Study is looking for participants to determine the safety and effectiveness of an investigational medication for celiac disease.
You may be eligible to participate in the ILLUMINATE-101 Study if you:
- Are between 18 and 75 years old
- Have biopsy-confirmed celiac disease that is generally well controlled
- Have been on a gluten-free diet for at least 6 months
- DON’T have another inflammatory gastrointestinal disorder (such as Crohn’s disease)
There are additional criteria that are included in the questionnaire here and some that are reviewed by the team at the study center at the first visit.
What’s involved with study participation?
The ILLUMINATE-101 Study will involve attending up to 10 study visits and 1 follow-up phone call over up to 34 weeks, but 7 of these visits may take place at your home or in the study center.
If pre-qualified, what can I expect on my first visit to the study center?
This initial appointment is an opportunity for you to:
- Learn more about the ILLUMINATE-101 Study. You’ll be speaking with a study coordinator at the study center to learn more regarding your participation in this study.
- Ask any questions you may have. These can be any questions you may have about this study or clinical research in general.
- Determine if the ILLUMINATE-101 Study may be right for you. After speaking with the study coordinator and learning details about this study, the research staff will perform a series of screening tests to determine if you are eligible to participate. If you’re eligible, you will be given an opportunity to decide if participation is right for you. If you agree to take part, the center will ask you to review and sign an informed consent form.
How long is this research study? / How many visits are there?
If eligible, you will be in the study for up to 34 weeks. Participants will be required to attend up to 10 study visits and 1 follow-up phone call, but 7 of these visits may take place at your home or in the study center.
Is there a placebo?
If you qualify, there is a 20% chance of receiving placebo and an 80% chance of receiving investigational medication in the beginning of the study. Neither you nor the study team will know which study medication (investigational or placebo) you are assigned to take. However, at the end of the study, all participants will be offered investigational medication.
What about my current medications?
Do not discontinue any medication unless you are advised to do so by the study center staff or your primary care physician.
Where are the study centers located?
The study centers are located throughout the United States, Canada, Australia, and New Zealand.
Does participating in this study cost me anything?
Qualified participants will receive study-required medical care and study medication at no cost. A travel stipend and compensation for time and effort may be provided. The study will not pay for other medical care or current medication(s) needed to support your daily health care routine.
Do I need health insurance to participate?
For U.S. residents: Health insurance is not needed to participate in this study.
Why did I disqualify?
Research studies are designed in specific ways to test the investigational medication for safety and effectiveness. One or more of the answers that you provided were outside of the guidelines for this study. This does not mean you will not qualify for different research studies. Please visit clinicaltrials.takeda.com to see what other celiac disease studies are available.
About Clinical Research
What is a clinical research study?
A clinical research study, also called a clinical trial, is a carefully designed scientific evaluation of an investigational medication or treatment. Clinical trials are conducted by doctors and researchers.
Why is clinical research important?
Clinical research helps doctors and scientists determine if an investigational medication or therapies are safe and/or effective for use in humans to potentially treat a condition, disease or disorder. Clinical studies often require a large number of volunteers to participate in a single study, sometimes thousands are needed to obtain reliable information.
Where can people find out about research studies?
One way to find information about clinical trials is by searching this website: www.clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research. ClinicalTrials.gov is updated regularly and offers information on each trial's purpose, who is eligible to participate, locations, and phone numbers to call for more information.
Why should I consider participating in a research study?
For those who are eligible, taking part in research studies offers several benefits:
- Getting actively involved in their own health care
- Having access to investigative research treatments
- Having access to study-relayed care for the condition being studied
- Helping others by contributing to medical research
It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments.
For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers.
Where are research studies conducted?
Research studies can be sponsored by an organization such as a pharmaceutical company, a federal agency such as the Veterans Administration, or an individual, such as a physician or health care provider. The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, doctor's offices, and/or at hospitals.
What is “informed consent”?
“Informed Consent” is a process of information exchange before an adult agrees to participate in research. Potential research participants will be asked to read and sign an informed consent document, but will also be given instructions, verbally and in writing, question/answer sessions and other reading materials to assure the potential study participants understanding and willingness to voluntarily enroll in the research.
Before you agree to volunteer for the study, the study doctor or staff is required to explain all the details of the study, which will include the risks and benefits, and address your questions. After all of your questions have been answered, and if you wish to participate, then you will sign a document called the informed consent form to ensure:
- You agree to volunteer
- You understand the study, including the study procedures, risks and potential side effects of the investigational medication
- You understand that you can leave the study at any time, for any reason
If you don’t understand what is expected of you or the document, you should continue to ask questions and talk with the study doctor, your family or others that you trust, until you feel that you understand.
