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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | All eligible participants will receive 3 intravenous (IV) infusions of KAN-101 |
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| Group 2 | Placebo Comparator | All eligible participants will receive 3 intravenous (IV) infusions of placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAN-101 | Drug | Dose KAN-101 Intravenous (IV) Infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Magnitude of Interleukin-2 (IL-2) Response From Day 15 (First Day of GC) Pre-GC to Day 15 Post GC | 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 | Baseline and Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Anokion SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | United States | ||
| Unlimited Medical Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37329900 | Background | 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. |
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A total of 55 participants were enrolled and treated, of which 50 participants completed the study, 2 participants discontinued from the treatment phase, and 3 participants discontinued from the observation phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.6 mg/kg KAN-101 | All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7 KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2024 | Oct 1, 2025 |
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The study is a randomized, double-blind, placebo-controlled study with approximately 52 participants that will receive KAN-101 or placebo
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Study participants and their caregivers, investigators and other staff, and sponsor staff involved in the study team will be blinded.
| Placebo | Drug | Placebo Intravenous (IV) Infusion |
|
|
| 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). | From the time the participant provided informed consent through Day 42. |
| Incidence by Visit of KAN-101 Antidrug Antibody (ADA) | Up to 42 days |
| KAN-101 Plasma Concentration: AUCinf | Area under the plasma-concentration time curve from time 0 extrapolated to infinite time. | 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). | 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. | 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. | 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. | 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7 |
| Hialeah Gardens |
| Florida |
| 33018 |
| United States |
| Homestead Associates in Research Inc. | Miami | Florida | 33032 | United States |
| Alliance for Multispecialty Research, LLC | Wichita | Kansas | 67207 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| McMaster University | Hamilton | Ontario | L8S 4L8 | Canada |
| LHSC | London | Ontario | N6A 5W9 | Canada |
| Centre Intégré de Santé et de Services Sociaux-Chaudière Appalaches - Hôtel-Dieu de Lévis | Lévis | Quebec | G6V 3Z1 | Canada |
| Hopital Du Sacre-Coeur De Montreal | Montreal | Quebec | H4J 1C5 | Canada |
| Diex Recherche Quebec Inc. | Québec | Quebec | G1V 4T3 | Canada |
| Tays Research Services | Tampere | Pirkanmaa | 33520 | Finland |
| Clinical Research Services Turku | Turku | Southwest Finland | 20520 | Finland |
| CRST Helsinki Oy | Helsinki | Uusimaa | 00180 | Finland |
| Studiengesellschaft BSF Unternehmergesellschaft | Halle | Saxony-Anhalt | 6108 | Germany |
| Connolly Hospital | Dublin | Dublin | D15X40D | Ireland |
| Our Lady of Lourdes Hospital | Drogheda | Louth | A92VW28 | Ireland |
| Midland Regional Hospital Mullingar | Mullingar | Westmeath | N91Na43 | Ireland |
| Rabin Medical Center | Petah Tikva | Central District | 4941492 | Israel |
| Sheba Medical Center | Ramat Gan | Central District | 5265601 | Israel |
| Shaare Zedek Medical Center | Jerusalem | Jerusalem | 9103102 | Israel |
| Soroka Medical Center | Beersheba | Southern District | 8410101 | Israel |
| Albert Schweitzer Ziekenhuis, locatie Dordwijk | Dordrecht | South Holland | 3318AT | Netherlands |
| Gastromed Sp. z o. o. | Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
| Melita Medical | Wroclaw | Lower Silesian Voivodeship | 50-449 | Poland |
| WIP Warsaw IBD Point Profesor Kierkuś | Warsaw | Masovian Voivodeship | 00-728 | Poland |
| MZ Badania Slowik Zymla Spolka Jawna | Knurów | Silesian Voivodeship | 44-190 | Poland |
| Centrum Medyczne Med-Gastr Sp. z o.o. | Lodz | Łódź Voivodeship | 91-034 | Poland |
All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7
Placebo: Placebo Intravenous (IV) Infusion
| COMPLETED |
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| NOT COMPLETED |
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| Observation Phase |
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| Follow-Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.6 mg/kg KAN-101 | All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7 KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion |
| BG001 | Placebo | All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7 Placebo: Placebo Intravenous (IV) Infusion |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||
| Time since First CeD Diagnosis | Mean | Standard Deviation | years |
| |||||||||||||||
| Time on Gluten-Free Diet (GFD) | Mean | Standard Deviation | years |
| |||||||||||||||
| Human Leukocyte Antigen (HLA) Genotype | Number | participants |
| ||||||||||||||||
| Positive Celiac Serology at Diagnosis | Number | participants |
| ||||||||||||||||
| Positive Histology at Diagnosis | Marsh 0: Normal intestinal villi with no signs of damage. Marsh 1: Increased intraepithelial lymphocytes, but no villous atrophy. Marsh 2: Increased intraepithelial lymphocytes and crypt hyperplasia. Marsh 3: The classic spectrum for celiac disease, with increased lymphocytes, crypt hyperplasia, and villous atrophy. 3a: Mild villous atrophy. 3b: Marked villous atrophy. 3c: Total villous atrophy, or complete flattening of the villi. Marsh 4: Total villous atrophy with shrunken crypts. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set - All participants who were randomly assigned to the study intervention, received all 3 doses of the study intervention, and completed at least 7 days of the 2-week GC without prohibited medications. Participants were analyzed according to the study intervention they were randomized. | Posted | Mean | Standard Deviation | ratio | Baseline and Day 29 |
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| Secondary | Change in Magnitude of Interleukin-2 (IL-2) Response From Day 15 (First Day of GC) Pre-GC to Day 15 Post GC | Biomarker Analysis Set - All participants who were randomly assigned to the study intervention, received any portion of the study intervention, and had completed the GC on Day 15 without prohibited medications. Participants were analyzed according to the study intervention they were randomized. | Posted | Mean | Standard Deviation | international unit | From Day 15 pre-GC to Day 15 post GC |
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| Secondary | Changes From Baseline in Intraepithelial Lymphocyte (IEL) Density in Duodenum Biopsy After 2-week GC | Full Analysis Set - All participants who were randomly assigned to the study intervention, received all 3 doses of the study intervention, and completed at least 7 days of the 2-week GC without prohibited medications. Participants were analyzed according to the study intervention they were randomized. | Posted | Least Squares Mean | Standard Deviation | cells per 100 epithelial cells | Baseline and Day 29 |
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| Secondary | 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). | Safety Analysis Set - All participants who received any portion of the study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | From the time the participant provided informed consent through Day 42. |
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| Secondary | Incidence by Visit of KAN-101 Antidrug Antibody (ADA) | Safety analysis set - all participants who received any portion of study intervention. Participants with at least 1 positive response post-treatment. | Posted | Number | participants | Up to 42 days |
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| Secondary | KAN-101 Plasma Concentration: AUCinf | Area under the plasma-concentration time curve from time 0 extrapolated to infinite time. | AUC could not be determined due to limited data points. Samples at the terminal elimination phase were below limit of quantification. | Posted | Mean | Standard Deviation | hr/mL | 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7 |
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| Secondary | KAN-101 Plasma Concentration: AUClast | Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast). | AUC could not be determined due to limited data points. Samples at the terminal elimination phase were below limit of quantification. | Posted | Mean | Standard Deviation | hr/mL | 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7 |
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| Secondary | KAN-101 Plasma Concentration: Cmax | Maximum plasma concentration. | PK Analysis Set - All participants who receive any portion of study intervention and have at least one post-dose concentration value. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7 |
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| Secondary | KAN-101 Plasma Concentration: Tmax | Time to reach Cmax. | PK Analysis Set - All participants who receive any portion of study intervention and have at least one post-dose concentration value. | Posted | Mean | Standard Deviation | h | 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7 |
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| Secondary | KAN-101 Plasma Concentration: T1/2 | Terminal phase half-life. | T1/2 could not be determined due to limited data points. Samples at the terminal elimination phase were below limit of quantification. | Posted | Mean | Standard Deviation | hour | 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7 |
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From the time the participant provided informed consent through Day 42.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.6 mg/kg KAN-101 | All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1 and ending on Day 7 KAN-101: 0.6 mg/kg KAN-101 Intravenous (IV) Infusion | 0 | 28 | 1 | 28 | 24 | 28 |
| EG001 | Placebo | All enrolled participants received intravenous (IV) infusions of placebo every 3 days starting on Day 1 and ending on Day 7 Placebo: Placebo Intravenous (IV) Infusion | 0 | 27 | 0 | 27 | 20 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture treatment | Surgical and medical procedures | MedDRA v27.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Brain fog | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Kanyos Bio, Inc. | +1-857-320-6607 | clinicaltrials@anokion.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2025 | Oct 1, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Negative |
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| TISSUE TRANSGLUTAMINASE IGG ANTIBODY (TTG-IGG) |
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| DEAMIDATED GLIADIN PEPTIDE IGA (DGP-IGA) |
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| DEAMIDATED GLIADIN PEPTIDE IGG (DGP-IGG) |
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| MARSH SCORE 2 |
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| MARSH SCORE 3A |
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| MARSH SCORE 3B |
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| MARSH SCORE 3C |
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| OG001 |
| Placebo |
All enrolled participants received intravenous (IV) infusions every 3 days of placebo starting on Day 1 and ending on Day 7 Placebo: Placebo Intravenous (IV) Infusion |
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