VTP-1000 for Celiac Disease

Recruiting at 16 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Barinthus Biotherapeutics

Disqualifiers: Refractory celiac, IgA deficiency, others

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new treatment called VTP-1000 for individuals with celiac disease. The researchers aim to assess how VTP-1000 affects the immune system when exposed to gluten, comparing different doses to a placebo. Individuals with celiac disease who follow a strict gluten-free diet and have specific blood markers (HLA-DQ2.5 genotype) may be suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding how VTP-1000 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that VTP-1000 is likely to be safe for humans?

Research has shown that VTP-1000 is being tested for safety in people with celiac disease. Since this is the first human trial of VTP-1000, the researchers do not yet know how people will react to it. The main goal of this early trial is to assess how well participants tolerate the treatment and to identify any side effects. Participants receive different doses to determine which ones might be safe and effective. Because the testing process is in its early stages, researchers closely monitor all participants for any reactions.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Researchers are excited about VTP-1000 for celiac disease because it offers a novel approach compared to existing treatments. Unlike the current standard of care, which primarily involves strict adherence to a gluten-free diet, VTP-1000 may target the underlying immune response that causes the symptoms. This new mechanism of action could potentially provide relief to patients who struggle with dietary restrictions. VTP-1000 is also being tested in multiple dose levels to optimize its effectiveness and safety, which could lead to more personalized treatment options for individuals with celiac disease.

What evidence suggests that VTP-1000 might be an effective treatment for celiac disease?

Research has shown that VTP-1000 could be a promising treatment for celiac disease. It employs antigen-specific immunotherapy, which helps the immune system adapt to gluten. Gluten poses the main problem for people with celiac disease. Early studies suggest that treatments like VTP-1000 might reduce the immune system's adverse reactions to gluten. However, as this is a new treatment, further research is needed to confirm its effectiveness.¹ ⁶ ⁷ ⁸ ⁹

Are You a Good Fit for This Trial?

This trial is for adults with celiac disease who have a specific genetic marker (HLA-DQ2.5), confirmed diagnosis through tests and biopsy, are on a controlled gluten-free diet, and not pregnant or breastfeeding. They should also have low levels of certain antibodies related to celiac disease.

Inclusion Criteria

I have the HLA-DQ2.5 genotype.

Participants who are on a well controlled gluten restricted diet

I am not pregnant or breastfeeding.

See 3 more

Exclusion Criteria

My celiac disease does not improve with a gluten-free diet.

I have a condition where my body doesn't produce enough IgA antibodies.

I am positive for HLA-DQ8.

See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Single Ascending Dose (SAD)

Participants receive a single dose of VTP-1000 at escalating dose levels to assess safety and tolerability

3 weeks

Includes a 3-day domicile period following administration

Multiple Ascending Dose (MAD)

Participants receive multiple doses of VTP-1000 at escalating dose levels, followed by a gluten challenge

8 weeks

3 doses every 2 weeks, followed by gluten challenge

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

VTP-1000

Trial Overview

The trial is testing VTP-1000's safety and how well it's tolerated in different doses compared to a placebo. It includes single dose tests followed by multiple doses where participants will eat gluten to see if the drug reduces their immune response.

How Is the Trial Designed?

8Treatment groups

Experimental Treatment

Placebo Group

Group I: VTP-1000 Dose 3 (SAD)Experimental Treatment1 Intervention