Actively Recruiting
VTP-1000 in Adults With Celiac Disease
Led by Barinthus Biotherapeutics · Updated on 2026-01-09
45
Participants Needed
16
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VTP-1000 in Adults With Celiac Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of celiac disease confirmed by positive serology and intestinal histology
- Presence of Human Leukocyte Antigen (HLA)-DQ2.5 genotype
- 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 clinically significant findings at screening
You will not qualify if you...
- Refractory celiac disease
- Selective IgA deficiency
- Positive for HLA-DQ8
- Known wheat allergy or Type I hypersensitivity
- Active inflammatory bowel disease or other conditions with symptoms similar to celiac disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Parexel EPCU LA
Los Angeles, California, United States, 91206
Actively Recruiting
2
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
3
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Actively Recruiting
4
GCP Research
St. Petersburg, Florida, United States, 33705
Actively Recruiting
5
Parexel EPCU Baltimore
Baltimore, Maryland, United States, 21225
Actively Recruiting
6
Clinical Research Institute of Michigan
Clinton Township, Michigan, United States, 48038
Actively Recruiting
7
West Michigan Clinical Research Center
Wyoming, Michigan, United States, 49159
Actively Recruiting
8
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
NYU Langone - Gastroenterology Associates
New York, New York, United States, 10016
Actively Recruiting
10
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
Actively Recruiting
11
Centricity Research
Columbus, Ohio, United States, 43213
Actively Recruiting
12
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
PPD Research Unit
Austin, Texas, United States, 78744
Actively Recruiting
14
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States, 84088
Actively Recruiting
15
Clinical Research Partners
Richmond, Virginia, United States, 23226
Actively Recruiting
16
Velocity Clinical Research, Seattle
Seattle, Washington, United States, 98105
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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