Early Phase 1 Coeliac Disease Trial, Recruiting NCT06310291 Sponsor: Barinthus Biotherapeutics Condition: Coeliac Disease
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Early Phase 1 Coeliac Disease Trial, Recruiting

NCT06310291
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with celiac disease, confirmed by both a blood test and a small bowel (intestinal) biopsy
  • You carry a specific gene type called HLA-DQ2.5, which is linked to celiac disease (confirm with trial site)
  • You are currently following a strict gluten-free diet and it is well managed
  • Your celiac-related blood test levels (specific antibodies) are within an acceptable low range (confirm exact values with trial site)
  • You are female and are not currently pregnant or breastfeeding
  • You do not have any other significant health issues found at your initial screening appointment

Who may not be able to join:

  • Your celiac disease does not improve even when following a strict gluten-free diet (sometimes called "refractory" celiac disease)
  • You have a condition where your body does not produce enough of a certain immune protein called IgA
  • You carry a different gene type called HLA-DQ8 (confirm with trial site)
  • You have a known allergy to wheat, including a serious allergic reaction type known as Type I hypersensitivity
  • You currently have inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or another condition that causes symptoms similar to celiac disease

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

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Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Barinthus Biotherapeutics
Registry
ClinicalTrials.gov
Start date
1 August 2024
Est. completion
1 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs); Changes from baseline and clinically significant abnormalities in standard Clinical Chemistry laboratory safety parameters; Changes from baseline and clinically significant abnormalities in standard Coagulation laboratory safety parameters; Changes from baseline and clinically significant abnormalities in standard hematology laboratory safety parameters; Changes from baseline and clinically significant abnormalities in standard urinalysis laboratory safety parameters; Changes from baseline...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov