A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)

NCT05574010 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: KAN-101-02
• Study Type: interventional
• Target: 128
• Locations: 3 countries
• Sites: 36

Brief Summary

This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).

Conditions

Celiac Disease

Keywords

celiac disease; HLA-DQ2.5; gluten free diet

Outcome Measures

Primary Outcomes (3)

• Incidence and Severity of TEAEs as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) in Part A

  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.

  From screening until the safety follow-up visit on Day 28

• Change in Pre- and Post-Gluten Challenge (GC) IL-2 Response From Baseline to Day 15

  CeD increases the circulating level of IL-2. Plasma samples were collected to assess the magnitude of biomarker response of IL-2 at the baseline screening visit pre-GC and again post-GC on Day 15 after 3 doses of KAN-101, the IL-2 response to GC is the difference of IL-2 between pre-GC and post-GC.

  From Baseline screening to Day 15

• Change in IL-2 Response From Day 15 Pre-GC to Day 15 Post GC

  CeD increases the circulating level of IL-2. Plasma samples were collected to assess the magnitude of biomarker response of IL-2 at the baseline screening visit pre-GC and again post-GC on Day 15 after 3 doses of KAN-101, the IL-2 response to GC is the difference of IL-2 between pre-GC and post-GC.

  0 (pre-GC) and 4 hours post-GC on Day 15

Secondary Outcomes (12)

• KAN-101 Plasma Exposure in Part A: AUCinf

  Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7

• KAN-101 Plasma Exposure in Part A: AUClast

  Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7

• KAN-101 Plasma Exposure in Part A: Cmax

  Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7

• KAN-101 Plasma Exposure in Part A: Tmax

  Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7

• KAN-101 Plasma Exposure in Part A: t½

  Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7

Study Arms (6)

Cohort 1 in Part A

EXPERIMENTAL

All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 1

Drug: Cohort 1 in Part A

Cohort 2 in Part A

EXPERIMENTAL

All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 2

Drug: Cohort 2 in Part A

Group 1 in Part B and Part C

PLACEBO COMPARATOR

All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of placebo

Other: Placebo: Group 1 in Part B and Part C

Group 2 in Part B and Part C

EXPERIMENTAL

All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 3

Drug: Group 2 in Part B and Part C

Group 3 in Part B and Part C

EXPERIMENTAL

All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 4

Drug: Group 3 in Part B and Part C

Group 4 in Part B and Part C

EXPERIMENTAL

All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 5

Drug: Group 4 in Part B and Part C

Interventions

Cohort 1 in Part A DRUG

Dose 1 KAN-101 Intravenous (IV) infusion

Also known as: KAN-101

Cohort 1 in Part A

Placebo: Group 1 in Part B and Part C OTHER

Placebo Intravenous (IV) infusion

Also known as: Placebo

Group 1 in Part B and Part C

Group 2 in Part B and Part C DRUG

Dose 3 KAN-101 Intravenous (IV) infusion

Also known as: KAN-101

Group 2 in Part B and Part C

Group 3 in Part B and Part C DRUG

Dose 4 KAN-101 Intravenous (IV) infusion

Also known as: KAN-101

Group 3 in Part B and Part C

Group 4 in Part B and Part C DRUG

Dose 5 KAN-101 Intravenous (IV) infusion

Also known as: KAN-101

Group 4 in Part B and Part C

Cohort 2 in Part A DRUG

Dose 2 KAN-101 Intravenous (IV) infusion

Also known as: KAN-101

Cohort 2 in Part A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refractory celiac disease
• HLA-DQ8 genotype
• Previous oral gluten challenge within 12 months
• Selective IgA deficiency
• Diagnosis of Type-1 diabetes
• Active gastrointestinal diseases
• History of dermatitis herpetiformis

Sponsors & Collaborators

• Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA: lead
• Pfizer: collaborator

Study Sites (36)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

GCP Research

St. Petersburg, Florida, 33705, United States

Location

Agile Clinical Research Trials

Sandy Springs, Georgia, 30328, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Sneeze, Wheeze & Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

Celiac Disease Center at Columbia University

New York, New York, 10032, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Aventiv Research, Inc. d/b/a Centricity Research

Columbus, Ohio, 43213, United States

Location

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

Location

Northshore Gastroenterology Research, LLC

Westlake, Ohio, 44145, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Digestive Research of Central Texas

Waco, Texas, 76712, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Campbelltown Hospital

Campbelltown, New South Wales, 2560, Australia

Location

Wesley Research Institute

Auchenflower, Queensland, 4066, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

St John of God Midland Public and Private Hospitals

Midland, Western Australia, 6056, Australia

Location

Optimal Clinical Trials

Auckland, Auckland, 1023, New Zealand

Location

PCRN Trials

Takapuna, Auckland, 0622, New Zealand

Location

P3 Research - Tauranga

Tauranga, Bay of Plenty, 3110, New Zealand

Location

Waikato Hospital

Hamilton, Hamilton, 3204, New Zealand

Location

P3 Research - Dunedin

Dunedin, Otago, 9016, New Zealand

Location

P3 Research - Palmerston North

Paraparaumu, Wellington Region, 5032, New Zealand

Location

P3 Research - Wellington

Wellington, Wellington Region, 6021, New Zealand

Location

Related Publications (2)

• 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.

  PMID: 37329900 BACKGROUND

• Muhammad A, Xiao Y, Ahmad YM, Tang R, Zhang Y, Yuan Q, Xiao X. Reprogramming Pathogenic Immune Memory through Inverse Vaccination in Autoimmune Kidney Disease. J Am Soc Nephrol. 2026 Feb 27. doi: 10.1681/ASN.0000001070. Online ahead of print. No abstract available.

  PMID: 41758576 DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Kanyos Bio, Inc.

clinicaltrials@anokion.com

+1-857-320-6607

Study Officials

• Study Director

  Anokion SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A is open label Part B and Part C are a double-blinded study. Study participants and their caregivers, investigators and other site staff, and sponsor staff involved in the study team will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: This part of the study is an open label with up to 6 participants in each dose cohort. There will be 2 dose cohorts. Part B and Part C: These parts of the study have a randomized, double- blinded, placebo-controlled, parallel study design.

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 10, 2022
• Study Start: November 15, 2022
• Primary Completion: November 29, 2024
• Study Completion: May 19, 2025
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (7); US (23); AU (6)