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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

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 more

Side effects data

From 2021 Phase 1 trial • 41 Patients • NCT04248855
67%
Nausea
50%
Vomiting
50%
Diarrhea
33%
Abdominal Pain
33%
Headache
33%
Abdominal Distension
33%
Fatigue
17%
Flatulence
17%
Dyspepsia
100%
80%
60%
40%
20%
0%
Study treatment Arm
MAD 0.15mg/kg
MAD 0.3mg/kg
SAD 0.6mg/kg
MAD Placebo
SAD 1.2mg/kg
SAD 0.15mg/kg
SAD 1.5mg/kg
SAD 0.3mg/kg
MAD 0.6mg/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

Find a Location

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
4,570 Previous Clinical Trials
10,915,974 Total Patients Enrolled
3 Trials studying Celiac Disease
52,111 Patients Enrolled for Celiac Disease
Study DirectorStudy DirectorAnokion SA
1,211 Previous Clinical Trials
489,220 Total Patients Enrolled
5 Trials studying Celiac Disease
1,230 Patients Enrolled for Celiac Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Group 1 received official endorsement from the FDA?

"Based on the classification as a Phase 2 trial, Group 1's safety is estimated to be at level 2. This indicates that there is existing data supporting its safety, although no evidence yet supports its efficacy."

Answered by AI

Are individuals above the age of 45 eligible to participate in this medical study?

"To be considered for this clinical trial, interested individuals should fall within the age range of 18 to 70 years old. It is worth noting that there are also 15 trials available specifically for participants under the age of 18 and an additional 28 trials dedicated to those over the age of 65."

Answered by AI

What is the upper limit on the number of participants involved in this medical study?

"Indeed, as indicated by the information on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The initial posting of the trial took place on December 13th, 2023, and it was most recently updated on December 18th, 2023. The study aims to enroll a total of 52 participants from one designated site."

Answered by AI

Are there any ongoing efforts to enroll participants in this clinical study at the moment?

"Indeed, the details on clinicaltrials.gov indicate that this trial is presently in need of participants. The study was initially published on December 13th, 2023, and recently updated on December 18th, 2023. A total of 52 individuals will be enrolled for this trial at a single location."

Answered by AI

Who else is applying?

What site did they apply to?
Peak Gastroenterology Associates
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
2023. "A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001177.
All > Celiac Disease Miami > Celiac Disease
~35 spots leftby Mar 2025
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