55 Participants Needed

KAN-101 for Celiac Disease

(SynCeD Trial)

Recruiting at 27 trial locations
KB
JC
Overseen ByJeff Conlon
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)

Research Team

SD

Study Director

Principal Investigator

Anokion SA

Eligibility Criteria

This trial is for people with Celiac Disease who have been on a gluten-free diet for at least a year. They should have certain genetic markers (HLA-DQ2.5), a previous diagnosis confirmed by tests, and specific biopsy results showing intestinal damage.

Inclusion Criteria

I have been diagnosed with celiac disease confirmed by tests and biopsy.
You have been on a gluten-free diet for at least 12 months.
Intestinal biopsy screening reveals a Vh:Cd ratio of at least 2.3.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 intravenous (IV) infusions of KAN-101 or placebo

6 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Treatment Details

Interventions

  • KAN-101
Trial Overview The study is testing KAN-101 against a placebo to see if it's effective, safe, and tolerable for those with Celiac Disease. Participants will randomly receive either the actual drug or an inactive substance to compare outcomes.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1Experimental Treatment1 Intervention
All eligible participants will receive 3 intravenous (IV) infusions of KAN-101
Group II: Group 2Placebo Group1 Intervention
All eligible participants will receive 3 intravenous (IV) infusions of placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
3
Recruited
220+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

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