VTP-1000 treatment for adults with celiac disease
A Phase 1, First in Human, Randomized, Placebo-controlled Trial With a Controlled Gluten Challenge to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VTP-1000 in Adults With Celiac Disease
EARLY_PHASE1 · Barinthus Biotherapeutics · NCT06310291
This study is testing a new treatment called VTP-1000 to see if it can help adults with celiac disease tolerate gluten better.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Barinthus Biotherapeutics (industry) |
| Drugs / interventions | immunotherapy |
| Locations | 16 sites (Los Angeles, California and 15 other locations) |
| Trial ID | NCT06310291 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of VTP-1000, a gluten-derived peptide immunotherapy, in adults diagnosed with celiac disease. The study is designed as a randomized, double-blind, placebo-controlled trial, consisting of two parts: a single ascending dose (SAD) and a multiple ascending dose (MAD) phase. Participants will undergo a gluten challenge to assess the immunological effects of VTP-1000 on their condition. The goal is to induce immune tolerance to gluten by activating regulatory T cells and reducing pathogenic effector T cells.
Who should consider this trial
Good fit: Ideal candidates include adults with a confirmed diagnosis of celiac disease who are on a well-controlled gluten-restricted diet and possess the HLA-DQ2.5 genotype.
Not a fit: Patients with refractory celiac disease, selective IgA deficiency, or those with a known wheat allergy may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of celiac disease by allowing patients to tolerate gluten without adverse effects.
How similar studies have performed: While this approach is novel, previous studies have explored immunotherapy for celiac disease, indicating potential pathways for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of celiac disease as confirmed by positive serology and intestinal histology * Presence of Human Leukocyte Antigen (HLA)-DQ2.5 genotype * Participants who are on a well controlled gluten restricted diet * Negative or weak positive anti-tissue transglutaminase (tTG) IgA antibodies and negative or weak positive anti-deamidated gliadin peptide IgG (anti-DGP)-IgA/IgA antibodies * Non-pregnant or breast feeding females * No other clinical significant findings at screening Exclusion Criteria: * Refractory celiac disease * Selective IgA deficiency * Positive for HLA-DQ8 * Known wheat allergy or that is Type I hypersensitivity * Active inflammatory bowel disease or other condition with symptoms that will be similar to celiac disease
Where this trial is running
Los Angeles, California and 15 other locations
- Parexel EPCU LA — Los Angeles, California, United States (RECRUITING)
- Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (RECRUITING)
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (RECRUITING)
- GCP Research — St. Petersburg, Florida, United States (RECRUITING)
- Parexel EPCU Baltimore — Baltimore, Maryland, United States (RECRUITING)
- Clinical Research Institute of Michigan — Clinton Township, Michigan, United States (RECRUITING)
- West Michigan Clinical Research Center — Wyoming, Michigan, United States (RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- NYU Langone - Gastroenterology Associates — New York, New York, United States (RECRUITING)
- North Carolina Clinical Research — Raleigh, North Carolina, United States (RECRUITING)
- Centricity Research — Columbus, Ohio, United States (RECRUITING)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
- PPD Research Unit — Austin, Texas, United States (RECRUITING)
- Velocity Clinical Research, Salt Lake City — West Jordan, Utah, United States (RECRUITING)
- Clinical Research Partners — Richmond, Virginia, United States (RECRUITING)
- Velocity Clinical Research, Seattle — Seattle, Washington, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Celiac Disease