Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
45 participants
INTERVENTIONAL
2024-08-01
2026-06-30
Brief Summary
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Detailed Description
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The goal of treatment with VTP-1000 is to induce tolerance to gluten in patients with coeliac disease by activating antigen-specific regulatory T (Treg) cells that promote tolerance and reducing pre-existing, pathogenic antigen-specific effector T (Teff) cells that underly disease pathogenesis. In turn, this may allow for better management of the condition.
GLU001 is a multi-center phase I first in human study to assess the safety and tolerability of VTP-1000 in adults with celiac disease. The trial also aims to demonstrate proof-of-principle of induction of immune tolerance and early proof-of-concept for VTP-1000 as a potential treatment for coeliac disease based on assessment of pharmacodynamics and preliminary efficacy determined by means of a controlled gluten challenge.
GLU001 will be conducted as a randomized double-blind placebo-controlled study in two parts - Part A and Part B. Part A will be a single ascending dose (SAD) followed by Part B a multiple ascending dose (MAD) which incorporates a gluten challenge.
Part A (Single Ascending Dose)
A stepwise single dose escalation of 3 dose levels of VTP-1000 is planned. A total of 6 participants will be treated at each dose level (4 will receive VTP-1000 and 2 will receive matched placebo). A sentinel dosing approach will be followed, with the first 2 participants randomized to receive VTP1000 or placebo in a 1:1 ratio. Subsequent participants will be randomized in a 3:1 ratio at least 7 days after the second sentinel participant has received trial intervention. Participants will be screened for eligibility up to 28 days prior treatment. Participants will be followed for 21 days after dosing including a 3-day domicile period following administration of VTP-1000.
Part B (Multiple Ascending Dose)
A stepwise multiple dose escalation of up to 3 dose levels of VTP-1000 is planned. A total of 8 participants will be treated at each dose level (6 will receive VTP-1000 and 2 will receive matched placebo). A sentinel dosing approach will be followed, with the first 2 participants randomized to receive VTP1000 or placebo in a 1:1 ratio. Subsequent participants will be randomized in a 3:1 ratio at least 7 days after the second sentinel participant has received trial intervention. Participants will be screened for eligibility up to 28 days prior to the start of treatment. Eligible participants will receive 3 doses of trial intervention every 2 weeks at a given dose level with and followed for 57 days. After completion of the third dose of trial intervention, participants will undergo a gluten challenge.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Matched Placebo (SAD)
2 placebo comparators; 1 for each part of the study
Matched Placebo
Intramuscular (IM) injection comprised of saline solution
VTP-1000 Dose 1 (SAD)
3 dose levels in SAD and MAD parts of trial
VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
VTP-1000 Dose 2 (SAD)
3 dose levels in SAD and MAD parts of trial
VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
VTP-1000 Dose 3 (SAD)
3 dose levels in SAD and MAD parts of trial
VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
Matched Placebo (MAD)
2 placebo comparators; 1 for each part of the study
Matched Placebo
Intramuscular (IM) injection comprised of saline solution
VTP-1000 Dose 1 (MAD)
3 dose levels in SAD and MAD parts of trial
VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
VTP-1000 Dose 2 (MAD)
3 dose levels in SAD and MAD parts of trial
VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
VTP-1000 Dose 3 (MAD)
3 dose levels in SAD and MAD parts of trial
VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
Interventions
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VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
Matched Placebo
Intramuscular (IM) injection comprised of saline solution
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Barinthus Biotherapeutics
INDUSTRY
Responsible Party
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Locations
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Parexel EPCU LA
Los Angeles, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
GCP Research
St. Petersburg, Florida, United States
Parexel EPCU Baltimore
Baltimore, Maryland, United States
Clinical Research Institute of Michigan
Clinton Township, Michigan, United States
West Michigan Clinical Research Center
Wyoming, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone - Gastroenterology Associates
New York, New York, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Centricity Research
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
PPD Research Unit
Austin, Texas, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Clinical Research Partners
Richmond, Virginia, United States
Velocity Clinical Research, Seattle
Seattle, Washington, United States
Countries
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Facility Contacts
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Other Identifiers
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GLU001
Identifier Type: -
Identifier Source: org_study_id
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