Celiac DiseasePhase 2SynCeDNCT06001177
A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
A Phase 2 study testing KAN-101 in people with Celiac Disease and Coeliac Disease, run by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA at 28 sites in 8 countries.
Trial summary
The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Celiac Disease, Coeliac Disease
- What is being tested?
- KAN-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 28 sitesin 8 countries
- Study dates
- 13 Dec 2023to 13 Jan 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous diagnosis of celiac disease based on histology and positive celiac serology
- HLA-DQ2.5 genotype
- Gluten-free diet for at least 12 months
- Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening
- Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher
Who cannot join
- Refractory celiac disease
- HLA-DQ8 genotype
- Selective IgA deficiency
- Diagnosis of type-I diabetes
- Other Active gastrointestinal diseases
- History of dermatitis herpetiformis
Trial locations and contacts
28 sites in 8 countries.
28 sites in 8 countries
United States6 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Unlimited Medical Research Group
Hialeah Gardens, Florida, 33018
Homestead Associates in Research Inc.
Miami, Florida, 33032
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Alliance for Multispecialty Research, LLC
Wichita, Kansas, 67207
Canada5 sites
McMaster University
Hamilton, Ontario, L8S 4L8
Centre Intégré de Santé et de Services Sociaux-Chaudière Appalaches - Hôtel-Dieu de Lévis
Lévis, Quebec, G6V 3Z1
LHSC
London, Ontario, N6A 5W9
Hopital Du Sacre-Coeur De Montreal
Montreal, Quebec, H4J 1C5
Diex Recherche Quebec Inc.
Québec, Quebec, G1V 4T3
Poland5 sites
MZ Badania Slowik Zymla Spolka Jawna
Knurów, Silesian Voivodeship, 44-190
Centrum Medyczne Med-Gastr Sp. z o.o.
Lodz, Łódź Voivodeship, 91-034
Gastromed Sp. z o. o.
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship, 00-728
Melita Medical
Wroclaw, Lower Silesian Voivodeship, 50-449
Israel4 sites
Soroka Medical Center
Beersheba, Southern District, 8410101
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102
Rabin Medical Center
Petah Tikva, Central District, 4941492
Sheba Medical Center
Ramat Gan, Central District, 5265601
Finland3 sites
CRST Helsinki Oy
Helsinki, Uusimaa, 00180
Tays Research Services
Tampere, Pirkanmaa, 33520
Clinical Research Services Turku
Turku, Southwest Finland, 20520
Ireland3 sites
Our Lady of Lourdes Hospital
Drogheda, Louth, A92VW28
Connolly Hospital
Dublin, Dublin, D15X40D
Midland Regional Hospital Mullingar
Mullingar, Westmeath, N91Na43
Germany1 site
Studiengesellschaft BSF Unternehmergesellschaft
Halle, Saxony-Anhalt, 6108
Netherlands1 site
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Dordrecht, South Holland, 3318AT
About this study
Official title: A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease
The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)
Read the detailed description
Study KAN-101-03 is a multi-center, double-blind, placebo-controlled Phase 2a study to examine whether KAN-101 confers protection from gluten exposure induced histological changes in the duodenum and to further evaluate the safety/tolerability of KAN-101 in adult participants (≥18 years) with CeD on a gluten free diet. Approximately 52 participants who meet study inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.
- Conditions
- Celiac Disease, Coeliac Disease
- Being tested
- KAN-101, Placebo
- Keywords
- celiac disease, HLA-DQ2.5, gluten free diet
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAN-101Drug
Also called Group 1, Treatment Arm
Dose KAN-101 Intravenous (IV) Infusion
PlaceboDrug
Also called Group 2, Placebo Comparator Arm
Placebo Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | All eligible participants will receive 3 intravenous (IV) infusions of KAN-101 Receives: Drug: KAN-101 |
| Group 2 | Placebo comparator | All eligible participants will receive 3 intravenous (IV) infusions of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC)
KAN-101 attenuated GC-induced changes in duodenal histology as measured by the Vh:Cd ratio.
Measured: Baseline and Day 29
Secondary outcomes (9)
Change in Magnitude of Interleukin-2 (IL-2) Response From Day 15 (First Day of GC) Pre-GC to Day 15 Post GC
Measured: From Day 15 pre-GC to Day 15 post GC
Changes From Baseline in Intraepithelial Lymphocyte (IEL) Density in Duodenum Biopsy After 2-week GC
Measured: Baseline and Day 29
Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated; Grade 5= death related to AE. An AE was considered treatment-emergent relative to a given treatment if the event start date is during the on-treatment period (including on the date of first dose).
Measured: From the time the participant provided informed consent through Day 42.
Incidence by Visit of KAN-101 Antidrug Antibody (ADA)
Measured: Up to 42 days
KAN-101 Plasma Concentration: AUCinf
Area under the plasma-concentration time curve from time 0 extrapolated to infinite time.
Measured: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
KAN-101 Plasma Concentration: AUClast
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).
Measured: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
KAN-101 Plasma Concentration: Cmax
Maximum plasma concentration.
Measured: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
KAN-101 Plasma Concentration: Tmax
Time to reach Cmax.
Measured: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
KAN-101 Plasma Concentration: T1/2
Terminal phase half-life.
Measured: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start13 Dec 2023
- Primary completion3 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized, double-blind, placebo-controlled study with approximately 52 participants that will receive KAN-101 or placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Anokion SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001177
- Sponsor's protocol ID
- KAN-101-03
- Acronym
- SynCeD
- Status last verified
- Feb 2025
- First submitted
- 7 Aug 2023
- Last updated
- 18 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murray JA, Wassaf D, Dunn K, Arora S, Winkle P, Stacey H, Cooper S, Goldstein KE, Manchanda R, Kontos S, Grebe KM. Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):735-747. doi: 10.1016/S2468-1253(23)00107-3. Epub 2023 Jun 14.
PubMed 37329900
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease
- ClinicalTrials.gov ID
- NCT06001177
- Acronym / sponsor ID
- SynCeD / KAN-101-03
- Conditions
- Celiac Disease, Coeliac Disease
- Keywords
- celiac disease, HLA-DQ2.5, gluten free diet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SAIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Posted 18 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)
Detailed description
Study KAN-101-03 is a multi-center, double-blind, placebo-controlled Phase 2a study to examine whether KAN-101 confers protection from gluten exposure induced histological changes in the duodenum and to further evaluate the safety/tolerability of KAN-101 in adult participants (≥18 years) with CeD on a gluten free diet. Approximately 52 participants who meet study inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a randomized, double-blind, placebo-controlled study with approximately 52 participants that will receive KAN-101 or placebo
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: KAN-101All eligible participants will receive 3 intravenous (IV) infusions of KAN-101 |
| Group 2 | Placebo comparator | Drug: PlaceboAll eligible participants will receive 3 intravenous (IV) infusions of placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previous diagnosis of celiac disease based on histology and positive celiac serology
- HLA-DQ2.5 genotype
- Gluten-free diet for at least 12 months
- Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening
- Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher
Key exclusion criteria (6 listed)
- Refractory celiac disease
- HLA-DQ8 genotype
- Selective IgA deficiency
- Diagnosis of type-I diabetes
- Other Active gastrointestinal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KAN-101Also: Group 1, Treatment ArmDose KAN-101 Intravenous (IV) Infusion | Drug | Group 1 |
| PlaceboAlso: Group 2, Placebo Comparator ArmPlacebo Intravenous (IV) Infusion | Drug | Group 2 |
Primary outcome
Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC)
Time frame: Baseline and Day 29
KAN-101 attenuated GC-induced changes in duodenal histology as measured by the Vh:Cd ratio.
9 secondary outcomes
Change in Magnitude of Interleukin-2 (IL-2) Response From Day 15 (First Day of GC) Pre-GC to Day 15 Post GC
Time frame: From Day 15 pre-GC to Day 15 post GC
Changes From Baseline in Intraepithelial Lymphocyte (IEL) Density in Duodenum Biopsy After 2-week GC
Time frame: Baseline and Day 29
Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: From the time the participant provided informed consent through Day 42.
Incidence by Visit of KAN-101 Antidrug Antibody (ADA)
Time frame: Up to 42 days
KAN-101 Plasma Concentration: AUCinf
Time frame: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
KAN-101 Plasma Concentration: AUClast
Time frame: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
KAN-101 Plasma Concentration: Cmax
Time frame: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
KAN-101 Plasma Concentration: Tmax
Time frame: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
KAN-101 Plasma Concentration: T1/2
Time frame: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37329900Murray JA, Wassaf D, Dunn K, Arora S, Winkle P, Stacey H, Cooper S, Goldstein KE, Manchanda R, Kontos S, Grebe KM. Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):735-747. doi: 10.1016/S2468-1253(23)00107-3. Epub 2023 Jun 14.
- Individual participant dataSharing planned: No
Related trials for Celiac Disease
Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Anokion SA
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KAN-101 in people with Celiac Disease and Coeliac Disease, run by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA at 28 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada, Poland, Israel, Finland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC) (time frame: Baseline and Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06001177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.