VTP-1000 for Adults with Celiac Disease
This study is testing a new treatment called VTP-1000 for adults with celiac disease. VTP-1000 is an intramuscular (IM) injection made of tiny particles containing gluten peptides and a medicine called rapamycin. It aims to help your immune system become more tolerant to gluten. Researchers want to see if VTP-1000 is safe and how well it's tolerated compared to a placebo (a saline solution injection). You might be able to join if you are 18 to 70 years old, have a confirmed diagnosis of celiac disease, and are on a well-controlled gluten-restricted diet. The study will also look at how VTP-1000 affects your immune system and if it can help manage celiac disease after a controlled gluten challenge. The current status of this study is unclear.
- Study design
- This is a randomized, double-blind, placebo-controlled study with an unclear phase, aiming to enroll 45 participants. It will compare different doses of VTP-1000 to a placebo.
- What's involved
- Participants will receive intramuscular injections and be assessed for safety through blood tests and physical exams. Those in the multiple dose part of the study will also undergo a controlled gluten challenge.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be assessed for up to 21 days after the first dose in the single dose part, and up to 57 days after the first dose in the multiple dose part of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
VTP-1000 in Adults With Celiac Disease
At a glance
Conditions
NCT06310291
Where you'd take part
This study runs at 16 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Centricity Research
Columbus, Ohiostudy coordinator listed
Recruiting
Clinical Research Institute of Michigan
Clinton Township, Michiganstudy coordinator listed
Recruiting
Clinical Research Partners
Richmond, Virginiastudy coordinator listed
Recruiting
GCP Research
St. Petersburg, Floridastudy coordinator listed
Recruiting
Jacksonville Center for Clinical Research
Jacksonville, Floridastudy coordinator listed
Recruiting
Mayo Clinic
Rochester, Minnesotastudy coordinator listed
Recruiting
North Carolina Clinical Research
Raleigh, North Carolinastudy coordinator listed
Recruiting
NYU Langone - Gastroenterology Associates
New York, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Inclusion
Exclusion
What this trial measures
- Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs)Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
Incidence and severity of treatment-emergent adverse events (TEAEs) , Serious Adverse Events (SAEs) , Adverse Events of Special Interest (AESIs) and adverse events leading to trial intervention discontinuation or trial withdrawal according to NCI CTCAE Version 5.0
- Changes from baseline and clinically significant abnormalities in standard Clinical Chemistry laboratory safety parametersParticipants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
Changes from baseline and clinically significant abnormalities in standard clinical laboratory safety parameters according to NCI CTCAE Version 5.0
- Changes from baseline and clinically significant abnormalities in standard Coagulation laboratory safety parametersParticipants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
Measurement of in standard clinical laboratory safety parameters according to NCI CTCAE Version 5.0
- Changes from baseline and clinically significant abnormalities in standard hematology laboratory safety parametersParticipants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
Measurement of standard hematology clinical laboratory safety parameters according to NCI CTCAE Version 5.0
- Changes from baseline and clinically significant abnormalities in standard urinalysis laboratory safety parametersParticipants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
Measurement of standard urinalysis clinical laboratory safety parameters according to NCI CTCAE Version 5.0
- Changes from baseline and clinically significant abnormalities 12-lead electrocardiogram (ECG) parametersParticipants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
Changes from baseline and clinically significant abnormalities in 12-lead ECG parameters recorded according to NCI CTCAE Version 5.0
- Changes from baseline and clinically significant abnormalities in vital signsParticipants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
Changes from baseline and clinically significant abnormalities in vital signs according to NCI CTCAE Version 5.0
- Number of participants with changes from baseline in anti-tissue transglutaminase (anti-tTG) immunoglobulin A (IgA) antibodiesParticipants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
Measurement of anti tTG immunoglobulin at screening and post treatment
- Changes in physical examination findingsParticipants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
Full physical examination required at screening; symptom-directed physical examination at all other clinic visits. Each physical examination must include a review of the administration sites.