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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
Awards & highlights

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 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

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.

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,638 Previous Clinical Trials
17,740,000 Total Patients Enrolled
3 Trials studying Celiac Disease
52,037 Patients Enrolled for Celiac Disease
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SALead Sponsor
2 Previous Clinical Trials
93 Total Patients Enrolled
2 Trials studying Celiac Disease
93 Patients Enrolled for Celiac Disease
Alison Long, MD, PhDStudy DirectorAnokion SA

Media Library

KAN-101 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05574010 — Phase 1 & 2
Celiac Disease Research Study Groups: Group 3 in Part B and Part C, Cohort 2 in Part A, Cohort 1 in Part A, Group 1 in Part B and Part C, Group 2 in Part B and Part C, Group 4 in Part B and Part C
Celiac Disease Clinical Trial 2023: KAN-101 Highlights & Side Effects. Trial Name: NCT05574010 — Phase 1 & 2
KAN-101 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05574010 — Phase 1 & 2
Celiac Disease Patient Testimony for trial: Trial Name: NCT05574010 — Phase 1 & 2
~10 spots leftby Dec 2024