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Cancer Vaccine

VTP-1000 for Celiac Disease

Phase < 1

Recruiting

Research Sponsored by Barinthus Biotherapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of celiac disease as confirmed by positive serology and intestinal histology

Presence of Human Leukocyte Antigen (HLA)-DQ2.5 genotype

Must not have

Refractory celiac disease

Selective IgA deficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).

Summary

"This trial is testing the safety of a new drug called VTP-1000 for adults with celiac disease. Participants will receive different doses of VTP-1000 or a placebo to see how

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at various organ systems as monitored by adverse events reporting, changes in blood test results indicating an immune response, or physical symptoms noted during exams after taking VTP-1000.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with celiac disease through blood tests and a biopsy.

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I have the HLA-DQ2.5 genotype.

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I am not pregnant or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am positive for HLA-DQ8.

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I have an active inflammatory bowel condition or symptoms like celiac disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes from baseline and clinically significant abnormalities 12-lead electrocardiogram (ECG) parameters

Changes from baseline and clinically significant abnormalities in standard Clinical Chemistry laboratory safety parameters

Changes from baseline and clinically significant abnormalities in standard Coagulation laboratory safety parameters

+6 more

Secondary study objectives

AUC extrapolated to infinity (AUC0-∞)of rapamycin component

AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component

Clearance of rapamycin component

+10 more

Other study objectives

Cytokine Whole Blood Stimulation

Gluten Antigen-specific T Cell Responses - Enzyme linked immunospot (ELISpot)

Gluten Antigen-specific T Cell Responses - Intracellular cytokine staining (ICS)

+2 more

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

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