Could immune tolerance be on the horizon?

You can help us get there.

AVALON is a Phase 1 clinical trial that aims to assess the safety and tolerability of the investigational drug VTP-1000 in adults with celiac disease.

VTP-1000 is an investigational targeted immunotherapy designed to prevent or reduce celiac disease symptoms caused by accidental gluten exposure. The goal of this investigational targeted immunotherapy is to train the immune system to tolerate gluten while preserving its overall protective function.

You may qualify to participate if:

• You are 18–65 years old.
• You have celiac disease confirmed by biopsy within the past 10 years.
• You have been on a gluten-free diet for 12+ months.
• You live in the US.

Additional eligibility criteria apply.

VTP-1000 is administered as an injection to the upper arm. Patients will receive 1 or 2 injections at each dosing visit depending on the dose level they receive.

This study is the first time VTP-1000 is being tested in humans. VTP-1000 has previously been tested in animal studies. Based on what we have learned about VTP-1000 in animal studies, we are now advancing VTP-1000 to be tested in humans. To date, VTP-1000 has not been approved by a regulatory authority for any indication.

A placebo is an inactive substance with no therapeutic effect that is used to help determine whether results observed are due to the study medication.

According to the FDA, clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs. Clinical trials help regulators, like the FDA, assess whether new drugs are safe and effective for people to use and to understand how treatments may potentially be used. All medications must go through multiple phases of clinical trials before they can be approved by regulators for use in people. The AVALON Study is a Phase 1 clinical trial, which means the study medication is being tested in a small group of patients with celiac disease for the first time. The purpose of this trial is to evaluate the safety and tolerability of the study medication, as well as how the body responds to it.

This study has multiple locations across the US. For more information about the study site locations, please complete the screening survey to see if you may qualify. If you live near a study site, you will be invited to schedule a phone call with a study team representative to discuss your eligibility, potential participation, and the nearest study site location.

If you pre-qualify through the online screening survey and live near a study site, you will be contacted by a study representative to discuss your eligibility and potential participation. If you are interested, you will schedule a screening visit. At this visit, you will speak to the study doctor and receive all the information you need to decide if you want to participate.

In Part B, 75% (3 of 4) of participants will receive the study drug and 25% (1 of 4) of participants will receive the placebo.

In Part B, there is a one-day single-dose gluten challenge. The gluten challenge in this study is used to measure how your body responds to a dose of gluten after receiving the study medication or placebo.

There are no endoscopies in this study.

There will first be a screening visit to confirm your eligibility in the 35 days before you receive study drug or placebo.

After screening, Part B lasts 2 months with 9 visits to the study site and 4 phone calls.

No. All study visits, materials, and medication directly related to your participation in the study will be provided to you at no cost.

Reimbursement for eligible study-related travel may be available. The study team at your location will provide additional details about this before you agree to participate.

Compensation for your time may be available. The study team at your location will provide additional details about this before you agree to participate.

researchcoordinator@beyondceliac.org