VTP-1000 in Adults With Celiac Disease
← catalyst calendarNCT06310291 · readout ≤ 103 d
Sponsored by Barinthus Biotherapeutics (industry) · BRNS — their whole pipeline →.
Phase
Early Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
45estimated
Sites
16
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-01 | actual | When the study began enrolling |
| Primary completion | Nov 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2024-03-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Celiac Disease
Interventions
- Biological: VTP-1000
- Other: Matched Placebo
Primary outcomes
what the primary-completion date above is the date OFTreatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs)
measured Participants 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 Chemistry laboratory safety parameters
measured Participants 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 Coagulation laboratory safety parameters
measured Participants 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 hematology laboratory safety parameters
measured Participants 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 urinalysis laboratory safety parameters
measured Participants 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 12-lead electrocardiogram (ECG) parameters
measured Participants 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
measured Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
Number of participants with changes from baseline in anti-tissue transglutaminase (anti-tTG) immunoglobulin A (IgA) antibodies
measured Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
Changes in physical examination findings
measured Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
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