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New treatment option for Celiac Disease
Official title VTP-1000 in Adults With Celiac Disease
ClinicalTrials.gov ID: NCT06310291
What this study is testing
What is VTP-1000?
VTP-1000 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for celiac disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Non-pregnant or breast feeding females
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Colorado Springs, Colorado, United States
- Jacksonville, Florida, United States
- St. Petersburg, Florida, United States
- Baltimore, Maryland, United States
- Clinton Township, Michigan, United States
- Wyoming, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Raleigh, North Carolina, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- West Jordan, Utah, United States
- Richmond, Virginia, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Colorado Springs, Colorado, United States; Jacksonville, Florida, United States; St. Petersburg, Florida, United States; Baltimore, Maryland, United States; Clinton Township, Michigan, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.