About the Study
What is celiac disease?
Celiac disease is a genetic autoimmune disorder. When gluten, the name for a set of proteins found in wheat, barley, and rye, is ingested, celiac patients develop an immune response which causes damage to the villi of the small intestine leading to a broad spectrum of gastrointestinal and non-gastrointestinal symptoms such as abdominal pain, bloating, diarrhea, tiredness, headache, and others. Damaged villi can lead to malnourishment and a number of diseases including thyroid disorders, autoimmune conditions, and cancer. A lifelong gluten-free diet is the only treatment currently available for people with celiac disease.
Who is the sponsor?
The NIH-funded study is being sponsored by ImmunogenX, Inc., a biopharmaceutical company in Newport Beach, California founded in 2013. ImmunogenX is focused on improving the health of people suffering from celiac disease through the exploration of new therapies and diagnostic tools. Learn more at immunogenx.com.
Has the study medication been taken before?
The study medication was previously evaluated for safety and efficacy in eight clinical studies involving more than 750 patients.
Will I have to ingest gluten?
A study-provided snack is required to be eaten once per week for seventeen (17) weeks (the study is 26 weeks long). This snack may periodically contain gluten, equal to about one-half slice of bread.
What does "Solutions" in Solutions for Celiac mean? Is this a cure?
About Clinical Trials
What is a clinical trial?
Why should I join a clinical trial?
Clinical trials are the best way to discover new technologies for preventing, detecting, and treating diseases. Advances in medicine would not be possible without the participation of volunteers.
Are clinical trials safe?
What is a placebo?
Determining an investigational drug's effectiveness quickly and reliably requires a comparison to an inactive drug that provides no effect, or a placebo. In blind trials, participants, and often researchers, do not know who is given an active drug or a placebo to avoid any potential bias.
Do I have to pay to participate?
There is no cost to you to participate in this study.
Is travel to the study site reimbursed?
Travel and lodging expenses may be reimbursed upon qualification. A member of our team will discuss reimbursement options with you.
Will I receive compensation?
Qualified participants may receive compensation after enrollment.
What can I expect if I pre-qualify and decide to participate?
How long will I participate in the study?
Qualified study participants will be required to attend up to six visits over the course of 26 weeks.
Where does the study take place? Do I have to be located within a specific distance from the study site to participate?
You must be able to travel reliably to/from a clinical site location for up to six study site visits. Qualified participants may be reimbursed for travel-related costs.
Can I withdraw during the study?
As your participation is voluntary, you can withdraw from the study at any time. You will be asked to attend a final site visit, and return any study-related supplies if you decide to withdraw.