About This Study - INNOVATE BIOPHARM 4051-0004
Learn more about the CeD-LA-3001 study, a phase 3 research study for people with Celiac Disease.
FREQUENTLY ASKED QUESTIONS
How can I participate in this research study?
You will first need to participate in a screening visit for a series of medical tests to determine whether you qualify for this research study. Tests will include blood and urine samples, a physical exam, questions about your health and treatments, and a full review of your medical history. If you qualify and agree to participate, you will enroll into the research study.
What will i be asked to do
If you qualify to take part in this research study and you agree to participate, you may be in the study for approximately 29 weeks, including about 8 visits to the study center. There are three phases to the study:
- Initial Screening
Period (about 14
- During this period, the study doctor will conduct various health examinations to confirm eligibility to participate in the study. This includes a full physical exam, medical history and laboratory tests from blood and urine samples taken. Participants may also be asked to undergo an endoscopy with or without biopsy.
- Symptom Eligibility
Period (about 21
- During this time, participants will need to track their symptoms in a daily electronic diary. This ensures participants understand the diary system and gives doctors a baseline of symptoms to determine the effect of the study drug once treatment starts.
- Treatment Period
(about 24 weeks):
- To take the study drug three times daily.
- To undergo various health exams, including blood and urine sample collection, to monitor your health.
- To track their health in an electronic diary.
- Participants will be asked:
You can choose to leave the study at any time for any reason, without penalty to you.
What is the investigational drug
The study drug being studied is a capsule taken by mouth to determine:
- Whether it can reduce symptoms of Celiac Disease in patients who are on a gluten-free diet.
- If it can reduce the autoimmune response in patients with Celiac Disease who are on a gluten-free diet.
Is there any cost to participate?
If you qualify to participate, the oral study drug and all study-related procedures will be provided to you at no charge.
what are the risks and benfits of taking part?
There are risks and benefits of taking part in any clinical research study. For example, you may benefit from the frequent health checks. You may also benefit from taking the study drug, although this cannot be guaranteed. Your health may get better, it may stay the same, or it may get worse. You should discuss the risks and benefits of participation with your health care providers. These risk and benefits are outlined in detail in the informed consent form (ICF) that you must read and sign before you can take part in the study.
Study-related health assessments, along with any study-related drug, equipment, and supplies are provided at no charge to you. Often, reasonable study-related expenses (such as time and travel) will be reimbursed.