Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial (NCT05574010) tested a drug called KAN-101 in people with coeliac disease. The trial was run in three parts (A, B, and C) and enrolled a total of 128 participants across ten groups, receiving either different doses of KAN-101 (0.6, 1.2, or 3.0 mg per kilogram of body weight) or a placebo (a dummy treatment with no active ingredient). Part A looked at unwanted medical events (called adverse events) that occurred after dosing. Parts B and C measured changes in a blood protein called IL-2 — a substance that tends to rise in people with coeliac disease when they are exposed to gluten — before and after a deliberate gluten challenge. The reported data shows that in Part A, all 3 participants in the lower-dose group and all 3 in the higher-dose group experienced at least one adverse event of some kind. No participants in either group experienced what would be classified as a severe or higher-grade event, although one participant in the higher-dose group had a moderate (Grade 2) event. For the IL-2 blood marker measured in Parts B and C, the reported data shows that participants receiving the placebo had noticeably larger increases in IL-2 after the gluten challenge compared to those in the KAN-101 dose groups. For example, in Part B the placebo group's IL-2 change was reported as 146.2 international units, while the two KAN-101 groups showed changes of −2.3 and −1.9 (meaning little to no rise). Similar patterns were reported in Part C, where the placebo group's change was 119.1 international units compared to figures of 6.5 to 13.2 in the KAN-101 groups. The reported data also includes blood concentration measurements for KAN-101, which showed higher levels in the body at the higher dose, as would generally be expected. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 41758576) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Coeliac Disease Trial, Terminated
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 previously been diagnosed with celiac disease, confirmed through a gut tissue sample (biopsy) and a positive blood test for celiac disease
- You carry a specific gene variant called HLA-DQ2.5 (a genetic marker linked to celiac disease)
- You have been following a strict gluten-free diet for at least 12 months
- Your recent blood tests show low or no signs of celiac disease activity (negative or only weakly positive results for certain celiac antibodies called transglutaminase IgA and DGP-IgA/IgG)
Who may not be able to join:
- You have a severe form of celiac disease that does not improve on a gluten-free diet (known as refractory celiac disease)
- You carry a different gene variant called HLA-DQ8
- You have taken part in a test where you ate gluten on purpose (a "gluten challenge") within the past 12 months
- You have a condition where your body does not produce enough of a particular immune protein called IgA
- You have been diagnosed with Type 1 diabetes
- You currently have an active digestive or gut-related illness
- You have a history of a skin condition called dermatitis herpetiformis, which is related 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.
Contact this trial
Principal Investigator: Study Director, Anokion SA
Australian sites
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
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Incidence and Severity of TEAEs as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) in Part A; Change in Pre- and Post-Gluten Challenge (GC) IL-2 Response From Baseline to Day 15; Change in IL-2 Response From Day 15 Pre-GC to Day 15 Post GC
Can't join this trial?
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.