Protected: Home2024-08-22T08:43:17-07:00

Could immune tolerance be on the horizon?

You can help us get there.

AVALON is a Phase 1 clinical trial assessing VTP-1000, an investigational immunotherapy designed to prevent or reduce celiac disease symptoms from accidental gluten exposure by promoting tolerance to gluten. Compensation for time and travel may be available.

Requirements

18–65 years old

Celiac disease confirmed by biopsy within the past 10 years

On a gluten-free diet for 12+ months
Live in the US
Additional eligibility criteria apply

About

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 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.

What to expect with participation in this research study:

If you qualify and choose to participate, you will be assigned to either Part A or Part B based on the timing of your enrollment. You will be screened to confirm eligibility during a visit that will take place up to 28 days before you receive the study drug or placebo.

Part A lasts 22 days (with 5 visits to the study site)

You will receive 1 dose of the study drug or placebo during a 3-night stay at the study site, then attend 4 follow-up visits. There is no gluten challenge.

Part B lasts 2 months (with 9 visits to the study site)

You will receive 3 doses of the study drug or placebo over 30 days (1 dose every 2 weeks) on Days 1, 15, and 29 and complete 1 single-day gluten challenge on Day 43. Follow-up visits and phone calls will take place after each dose and the gluten challenge.

You will also be asked to complete other activities (e.g., symptom diary, blood tests) to monitor symptoms and health.

FAQs

What is the study medication (VTP-1000)?2024-08-14T16:18:44-07:00

  • VTP-1000 is an investigational targeted immunotherapy designed to prevent or reduce celiac disease symptoms caused by accidental gluten exposure. The goal of the study drug is to promote tolerance to gluten while preserving the immune system’s overall protective function.
I have additional questions, who can I contact?2024-08-14T16:18:23-07:00

How will the study medication be administered?2024-08-14T16:18:00-07:00

  • VTP-1000 is administered as an injection to the upper arm. Participants will receive 1 or 2 injections depending on the dose level they receive.
Has the study medication been tested in humans before?2024-08-14T16:17:46-07:00

  • 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.
What is a placebo, and why is it used?2024-08-14T16:17:33-07:00

  • 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.
What is a clinical trial?2024-08-14T16:17:18-07:00

  • 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.
Who is the study sponsor?2024-08-14T16:17:04-07:00

  • Barinthus Biotherapeutics North America, Inc. is the study sponsor.
Where is this study located?2024-08-14T16:16:52-07:00

  • 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 I pre-qualify, what happens next?2024-08-21T14:47:46-07:00

  • If you pre-qualify through the online screening survey and live near a study site, you will be invited to schedule a phone call with a study representative to discuss your eligibility and potential participation. If you are interested, you will be contacted by the study site to 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.
Can I change my mind about participating once I am enrolled in the study?2024-08-14T16:16:07-07:00

  • Yes. Your participation is completely voluntary. You can change your mind and withdraw from the study at any time.
Will I be given the study medication or placebo?2024-08-14T16:04:48-07:00

  • In Part A, 66% (2 of 3) participants will receive the study drug and 33% (1 of 3) of participants will receive the placebo.
  • 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.
Is there a gluten challenge in this study?2024-08-14T16:15:17-07:00

  • In Part A, there is no gluten challenge.
  • In Part B, there is one single-dose gluten challenge on one day. 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.
How does the overnight stay at the study site work?2024-08-14T16:14:55-07:00

  • If you are assigned to Part A, you will be admitted to the study clinic for a 3-night stay, during which you will receive one dose of study medication or placebo and be observed and assessed by the study doctors. If you qualify through the online screening survey, a study team representative will discuss more details about the overnight stay when you speak with them.
  • Part B does not involve an overnight stay at the study clinic.
Are there endoscopies in this study?2024-08-14T16:14:41-07:00

  • There are no endoscopies in this study.
How long will my participation in the study last?2024-08-14T16:14:28-07:00

  • Depending on whether you are enrolled in Part A or Part B, your total participation in this study will last either 2 or 3 months.
    • There will first be a screening visit to confirm your eligibility in the 28 days before you receive study drug or placebo.
    • After screening, Part A lasts 22 days with 5 visits to the study site.
    • After screening, Part B lasts 2 months with 9 visits to the study site and 4 phone calls.
Will I have to pay to participate?2024-08-14T16:14:13-07:00

  • No. All study visits, materials, and medication directly related to your participation in the study will be provided to you at no cost.
Will I be reimbursed for study-related travel?2024-08-14T16:13:56-07:00

  • 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.
Will I be compensated for my time?2024-08-14T16:12:05-07:00

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

Contact

Contact the AVALON Study Team at icureceliac@celiac.org

Go to Top