Frequently Asked Questions

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, 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 investigational drug been taken before?


The investigational drug was previously evaluated for safety and efficacy in eight clinical studies involving more than 750 patients.




Will I have to ingest gluten?


No, there is no gluten challenge in this trial.




What does "Solutions" in Solutions for Celiac mean? Is this a cure?


The investigational medication in this study is not a cure and is in the investigational phase of the clinical trial process. "Solutions" carries two meanings: 1. The study involves a drink-based investigational medication - latiglutenase. 2. The study seeks to assess the ability of the latiglutenase to relieve common symptoms suffered by celiac disease patients after exposure to gluten.





About Clinical Trials

What is a clinical trial?


After passing extensive pre-clinical testing, an investigational drug's safety and efficacy must be evaluated in human subjects. Clinical trials occur in four phases with increasing populations of volunteers. After each phase, the FDA must approve of the trial's results to allow the drug to move on to the next phase. Solutions for Celiac is a Phase 2 study designed to test efficacy using a randomized and blinded population of volunteers.

For more information on clinical trials, please visit the National Institutes of Health website.




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?


Clinical trials are conducted under strict, formalized guidelines of the FDA and operate under the oversight of Institutional Review Boards (IRBs) to ensure that patients’ rights,

safety, and privacy are protected.




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.





Compensation

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.





Participation & Privacy

What can I expect if I pre-qualify and decide to participate?


After qualifying through our screening questionnaire, you will be contacted by a member of the research staff to discuss study details, your qualifications, and any questions that you may have. You will receive a copy of an Informed Consent Form which outlines, in detail, the qualification requirements, the purpose and structure of the study, and all associated risks, legal information, and safety precautions.

Should you continue to qualify and remain interested in participating, you will be scheduled to attend a prescreening visit (Visit 0). This visit may take place either remotely (your place of work, home or other convenient location) or at a study clinic. Based upon the results of the prescreening visit, should you continue to qualify and remain interested you will be scheduled to attend 5 additional in-clinic visits that will occur over the course of 22 consecutive weeks.




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. Participants within a 100-mile radius of a clinical site location will receive reimbursement for travel-associated 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.





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