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Group 1 for Celiac Disease (SynCeD Trial)
Phase 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights
SynCeD Trial Summary
This trial is aiming to see if KAN-101 is effective, safe, and well-tolerated in people with Celiac Disease.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the side effects of KAN-101 are not detailed here, typical clinical trial concerns may include allergic reactions, gastrointestinal symptoms, headaches, fatigue or other unforeseen issues related to the immune system.
SynCeD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with celiac disease confirmed by tests and biopsy.
Select...
I have the HLA-DQ2.5 gene.
SynCeD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC)
Secondary outcome measures
Change in magnitude of IL-2 response from Day 15 (first day of GC) pre GC to Day 15 post GC
Changes from baseline in IEL density in duodenum biopsy after 2-week GC
Incidence and severity of treatment emergent adverse events as assessed by the CTCAE
+7 moreSide effects data
From 2021 Phase 1 trial • 41 Patients • NCT0424885543%
Diarrhea
29%
Vomiting
14%
Nausea
14%
Headache
14%
Abdominal Distension
14%
Arthralgia
14%
Cold Sweat
14%
Flushing
14%
Abdominal Pain
14%
Flatulence
14%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
MAD 0.3mg/kg
MAD 0.6mg/kg
SAD 0.6mg/kg
MAD Placebo
SAD 1.2mg/kg
SAD 0.15mg/kg
SAD 1.5mg/kg
SAD 0.3mg/kg
MAD 0.15mg/kg
SynCeD Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KAN-101
2020
Completed Phase 1
~50
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Who is running the clinical trial?
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SALead Sponsor
2 Previous Clinical Trials
167 Total Patients Enrolled
2 Trials studying Celiac Disease
167 Patients Enrolled for Celiac Disease
PfizerIndustry Sponsor
4,580 Previous Clinical Trials
14,634,151 Total Patients Enrolled
3 Trials studying Celiac Disease
52,111 Patients Enrolled for Celiac Disease
Study DirectorStudy DirectorAnokion SA
1,221 Previous Clinical Trials
499,922 Total Patients Enrolled
5 Trials studying Celiac Disease
1,230 Patients Enrolled for Celiac Disease
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