Phase 2 Coeliac Disease Trial, Recruiting NCT06982963 Sponsor: Forte Biosciences, Inc. Condition: Coeliac Disease
Back to Coeliac Disease

Phase 2 Coeliac Disease Trial, Recruiting

NCT06982963
Recruiting Phase 2 🇦🇺 Australian site

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 are a man or woman between 18 and 70 years old at the time of screening
  • You have been officially diagnosed with celiac disease, confirmed by an intestinal biopsy and a positive blood test for celiac disease, at least 12 months before the start of the study (the biopsy and blood test do not need to have been done at the same time)
  • Your body mass index (a measure of body weight relative to height) falls between 16.0 and 40.0
  • You report that you have been following a gluten-free diet for at least 12 months before screening, and you are willing to continue following a gluten-free diet throughout the study, except when you are given a small amount of gluten as part of a planned study procedure

Who may not be able to join:

  • Your celiac disease is not well-controlled, or you are currently experiencing active celiac disease symptoms, as judged by the study doctor
  • You have a history of, or currently have, neurological or mental health symptoms specifically caused by gluten exposure — such as problems with balance or coordination, seizures, severe nerve pain or numbness, memory or thinking problems, or depression

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
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

The Royal Melbourne Hospital, Melbourne,
61 3 9342 7000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Forte Biosciences, Inc.
Registry
ClinicalTrials.gov
Start date
4 August 2025
Est. completion
28 February 2027

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change from baseline in the VCIEL

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