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VTP-1000 in Adults With Celiac Disease

RecruitingEARLY Phase 1Ages 18 Years - 70 YearsAllBarinthus Biotherapeutics
NCT06310291 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000.

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📋 Eligibility rules (as published)
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 * Anti-tissue transglutaminase (tTG) IgA antibodies less than 2 times the upper limit of normal and anti-deamidated gliadin peptide IgG (anti-DGP)-IgA/IgA antibodies less than 3 times the upper limit of normal * 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
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What it tests

  • VTP-1000
  • Matched Placebo
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Where

16 sites
Parexel EPCU LA
Los Angeles, United States
Peak Gastroenterology Associates
Colorado Springs, United States
Jacksonville Center for Clinical Research
Jacksonville, United States
GCP Research
St. Petersburg, United States
Parexel EPCU Baltimore
Baltimore, United States
Clinical Research Institute of Michigan
Clinton Township, United States
West Michigan Clinical Research Center
Wyoming, United States
Mayo Clinic
Rochester, United States

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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