Phase 2 study for people with Coeliac Disease

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 2

Sponsor Chugai Pharmaceutical

Registry number NCT07239336

Started 16 December 2025 Today 16 October 2026 Estimated completion 15 June 2027

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Sydney Clinical Trials Pty Ltd	Campbelltown	NSW	Recruiting
Pioneer Clinical Research	North Sydney	NSW	Recruiting
University of the Sunshine Coast Clinical Trials Centre	Morayfield	QLD	Recruiting
University of The Sunshine Coast Clinical Trials Centre (Sippy Downs)	Sippy Downs	QLD	Recruiting
Mater	South Brisbane	QLD	Recruiting
University of the Sunshine Coast Clinical Trials Centre (SouthBank)	South Brisbane	QLD	Recruiting
Box Hill Hospital	Box Hill	VIC	Recruiting
Royal Melbourne Hospital	Parkville	VIC	Recruiting
St John of God Midland	Midland	WA	Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years to 75 Years

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 92

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Body mass index (BMI) of 18 to 40 (kg/m2) at screening.

* Willingness to ingest a gluten-free product and Simulated Inadvertent Gluten Exposure (SIGE) products as per the study protocol.

* History of medically diagnosed, and adequately documented (i.e., included in the participant's medical records), CeD

* Attempting a GFD for at least 12 months prior to the screening visit.

\- The participants should be instructed not to alter dietary habits including a GFD during the study period.

* Valid results from central testing of blood documenting a positive result for the HLA DQ2.5 genotype (HLA-DQA1\*05 and HLA-DQB1\*02) (homozygous or heterozygous).

* Experienced at least 2 gluten-related symptom events (i.e., 2 different gluten-related symptoms which are diarrhea, abdominal pain, bloating, nausea, tiredness or 1 gluten-related symptom occurred twice) within a month before the screening.

* Willingness to undergo 2 on-study upper gastrointestinal endoscopies with duodenal biopsies.

* Presence of ongoing duodenal mucosal damage defined as Vh:Cd of 2.5 or less

Exclusion Criteria:

* Participants with documented history (i.e., included in the participant's medical records) of medically diagnosed Refractory Celiac Disease (RCD) or suspected RCD by the investigator.

* History of IgE-mediated reactions to wheat, barley, rye, or other ingredients in gluten-free and SIGE products used in this study (i.e., methylcellulose, and gelatin).

* History of cancer, including hematological malignancy and solid tumors, within 5 years prior to the screening visit, or history of T cell lymphoma or B cell lymphoma ever.

* History of hypersensitivity reactions including anaphylaxis to a biological medical product or any of the excipients.

* Participants who carry the HLA-DQ8 (HLA-DQA1\*03 and DQB1\*0302) genotype (homozygous or heterozygous).

* Any other chronic, active gastrointestinal disease (e.g., inflammatory bowel disease, microscopic colitis, eosinophilic esophagitis, peptic ulcer, gastroesophageal reflux disease, functional dyspepsia, or irritable bowel syndrome) that might in the investigator's opinion, interfere with the assessment of GI symptoms or small intestinal histology.

* Helicobacter pylori tests that indicate current infection.

* Positive either human immunodeficiency virus (HIV) antigen or antibody test at screening.

* Positive hepatitis B surface antigen (HBsAg) test or total hepatitis B core (HBc) antibody test at screening.

* Positive hepatitis C virus (HCV) antibody test at screening, except in participants who have negative results for HCV ribonucleic acid (RNA) test at screening.

* Positive for QuantiFERON-TB Gold test at screening that indicates active tuberculosis (TB) at screening.

Dates on the record

Started 16 December 2025

Estimated completion 15 June 2027

Registry last updated 14 August 2026

Checked by Voxsanity 11 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 14 August 2026.
This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT07239336

Sponsor: Chugai Pharmaceutical

Phase: Phase 2

Status: Recruiting

Condition: Coeliac Disease

More information: https://clinicaltrials.gov/study/NCT07239336

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

Body mass index (BMI) of 18 to 40 (kg/m2) at screening.
Willingness to ingest a gluten-free product and Simulated Inadvertent Gluten Exposure (SIGE) products as per the study protocol.
History of medically diagnosed, and adequately documented (i.e., included in the participant's medical records), CeD
Attempting a GFD for at least 12 months prior to the screening visit.

- The participants should be instructed not to alter dietary habits including a GFD during the study period.
Valid results from central testing of blood documenting a positive result for the HLA DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygous or heterozygous).
Experienced at least 2 gluten-related symptom events (i.e., 2 different gluten-related symptoms which are diarrhea, abdominal pain, bloating, nausea, tiredness or 1 gluten-related symptom occurred twice) within a month before the screening.
Willingness to undergo 2 on-study upper gastrointestinal endoscopies with duodenal biopsies.
Presence of ongoing duodenal mucosal damage defined as Vh:Cd of 2.5 or less

Exclusion Criteria:

Participants with documented history (i.e., included in the participant's medical records) of medically diagnosed Refractory Celiac Disease (RCD) or suspected RCD by the investigator.
History of IgE-mediated reactions to wheat, barley, rye, or other ingredients in gluten-free and SIGE products used in this study (i.e., methylcellulose, and gelatin).
History of cancer, including hematological malignancy and solid tumors, within 5 years prior to the screening visit, or history of T cell lymphoma or B cell lymphoma ever.
History of hypersensitivity reactions including anaphylaxis to a biological medical product or any of the excipients.
Participants who carry the HLA-DQ8 (HLA-DQA1*03 and DQB1*0302) genotype (homozygous or heterozygous).
Any other chronic, active gastrointestinal disease (e.g., inflammatory bowel disease, microscopic colitis, eosinophilic esophagitis, peptic ulcer, gastroesophageal reflux disease, functional dyspepsia, or irritable bowel syndrome) that might in the investigator's opinion, interfere with the assessment of GI symptoms or small intestinal histology.
Helicobacter pylori tests that indicate current infection.
Positive either human immunodeficiency virus (HIV) antigen or antibody test at screening.
Positive hepatitis B surface antigen (HBsAg) test or total hepatitis B core (HBc) antibody test at screening.
Positive hepatitis C virus (HCV) antibody test at screening, except in participants who have negative results for HCV ribonucleic acid (RNA) test at screening.
Positive for QuantiFERON-TB Gold test at screening that indicates active tuberculosis (TB) at screening.

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.