What side effects are associated with this type of intervention?

Common treatments for Celiac Disease primarily involve strict adherence to a gluten-free diet, which generally has minimal side effects but can be challenging to maintain. Emerging treatments like KAN-101, which aim to induce immune tolerance to gluten, are still under investigation. Known side effects from similar immunotherapy treatments can include gastrointestinal symptoms such as nausea, abdominal pain, and diarrhea, as well as potential allergic reactions. Long-term safety and efficacy data are still being gathered for these novel therapies.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for inducing immune tolerance to gluten in Celiac Disease. The primary management strategy remains a strict gluten-free diet. Research is ongoing, including studies on drugs like KAN-101, which aim to induce immune tolerance to gluten, but these are still in the trial phase and have not yet received FDA approval.

What other types of research exist?

Promising novel alternatives to KAN-101 for Celiac Disease patients include: 1) Transamidated gliadins, which have shown potential in reducing the inflammatory immune response to gluten. 2) Peptide immunotherapy, which uses overlapping peptides to induce immune tolerance without activating mast cells. Both approaches aim to modulate the immune response to gluten and are currently under investigation.

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Unknown

KAN-101 for Celiac Disease

Phase 1 & 2

Recruiting

Research Sponsored by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previous diagnosis of celiac disease based on histology and positive celiac serology

HLA-DQ2.5 genotype

Must not have

Diagnosis of Type-1 diabetes

Active gastrointestinal diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 (pre-gc) and 4 hours post-gc on day 15

Summary

This trial tests KAN-101, a new drug for adults with Celiac Disease on a gluten-free diet. Researchers are studying its safety, tolerance, and effects on the body and blood markers after gluten exposure.

Who is the study for?

This trial is for people with Celiac Disease who have a specific genetic marker (HLA-DQ2.5), are on a gluten-free diet for at least one year, and have certain levels of celiac disease antibodies. It's not open to those with other active gut diseases, skin conditions related to celiac disease, Type-1 diabetes, or those who've had a gluten challenge recently.

What is being tested?

The study tests KAN-101's effects in Celiac Disease patients. Participants will receive different doses of KAN-101 or placebo to assess the drug’s safety, how it affects the body (pharmacodynamics), how the body processes it (pharmacokinetics), and its impact on blood markers.

What are the potential side effects?

While specific side effects aren't listed here, common ones may include reactions at injection sites, gastrointestinal symptoms like nausea or diarrhea, headaches, fatigue and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with celiac disease confirmed by tests and biopsy.

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I have the HLA-DQ2.5 gene.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Type-1 diabetes.

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I have an active stomach or intestine disease.

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My celiac disease has not improved with a gluten-free diet.

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I have the HLA-DQ8 genotype.

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I have a condition where my body doesn't produce enough IgA antibodies.

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I have had dermatitis herpetiformis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 (pre-gc) and 4 hours post-gc on day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 (pre-gc) and 4 hours post-gc on day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (pre-gc) and 4 hours post-gc on day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in magnitude of IL-2 response pre- and post-GC in peripheral blood

Classical Lissencephaly

Incidence and severity of TEAEs as assessed by common terminology criteria for adverse events (CTCAE) in Part A

Secondary study objectives

Incidence and severity of TEAE as assessed by the CTCAE in Part B and Part C.

KAN-101 plasma exposure in Part A: AUCinf

KAN-101 plasma exposure in Part A: AUClast

+8 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 4 in Part B and Part CExperimental Treatment1 Intervention

All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 5

Group II: Group 3 in Part B and Part CExperimental Treatment1 Intervention

All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 4

Group III: Group 2 in Part B and Part CExperimental Treatment1 Intervention

All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 3

Group IV: Cohort 2 in Part AExperimental Treatment1 Intervention

All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 2

Group V: Cohort 1 in Part AExperimental Treatment1 Intervention

All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 1

Group VI: Group 1 in Part B and Part CPlacebo Group1 Intervention

All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of placebo

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Celiac Disease is a strict gluten-free diet, which eliminates the ingestion of gluten and prevents the autoimmune response triggered by gluten in the small intestine. Emerging treatments, such as KAN-101, aim to induce immune tolerance to gluten. KAN-101 works by targeting the immune system to reduce its reactivity to gluten, potentially allowing patients to tolerate gluten without triggering harmful inflammation. This approach is significant for Celiac Disease patients as it could improve their quality of life by reducing the need for a highly restrictive diet and minimizing the risk of accidental gluten exposure.