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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (pre-gc) and 4 hours post-gc on day 15
Awards & highlights

Study Summary

This trial will test the effectiveness of a new drug for people with Celiac Disease.

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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with celiac disease confirmed by tests and biopsy.
Select...
I have the HLA-DQ2.5 gene.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,860 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

Frequently Asked Questions

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

What is the ultimate purpose of this clinical experiment?

"The primary evaluation metric of this trial, assessed over a 15-day stretch beginning at the Baseline, is to gauge Incidence and severity of TEAEs with reference to CTCAE in Part A. Secondary objectives include evaluating KAN-101 plasma exposure: Tmax through pre- dose/post dose sample collection for both Parts A and B; as well as AUClast (PK) measurements taken within the same timeframe on Part B."

Answered by AI

Is this medical research open to applicants aged 80 or above?

"For this clinical trial, the age requirements are 18 to 70 years old. Additionally, there are separate initiatives for patients younger than 18 and individuals over 65."

Answered by AI

Do I satisfy the criteria to join this medical experiment?

"This research endeavour seeks 138 individuals aged between 18 and 70, who possess a verified diagnosis of celiac disease through histology or serological testing. Additionally, applicants must have been consuming gluten-free diets for at least one year prior to participation as well as demonstrate negative/weakly positive transglutaminase IgA and DGP-IgA/IgG levels during the screening process."

Answered by AI

Can individuals still participate in this research endeavor?

"Affirmative. According to the information on clinicaltrials.gov, this research is actively recruiting participants who meet the requirements. The trial was originally published on November 9th 2022 and last amended on November 17th 2022. It requires 138 individuals from two separate sites to take part in it."

Answered by AI

What is the total participant count for this trial?

"Affirmative. Data on clinicaltrials.gov shows that this medical trial is searching for participants and was first posted on November 9th 2022 with updates made as recently as the 17th of the same month. 138 patients are needed from 2 sites in total."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
GCP Research

Why did patients apply to this trial?

medications like wellbutrin, vivance and hydroxyzine all irritate my celiac.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
2022. "A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05574010.
All > Celiac Disease Anaheim > Celiac Disease
~40 spots leftby Dec 2024
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