Assessment of KAN-101 in Celiac Disease (ACeD)

• ClinicalTrials.gov Identifier: NCT04248855
• Recruitment Status: Recruiting
• First Posted: January 30, 2020
• Last Update Posted: February 11, 2021
• Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
• Information provided by (Responsible Party): Anokion SA ( Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA )

Tracking Information

• First Submitted Date: January 28, 2020
• First Posted Date: January 30, 2020
• Last Update Posted Date: February 11, 2021
• Actual Study Start Date: January 21, 2020
• Estimated Primary Completion Date: October 31, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 29, 2020): Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher [ Time Frame: Up to 28 Days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 29, 2020)

• Geometric mean of maximum plasma concentration (Cmax) [ Time Frame: Up to 15 days ]
• Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last) [ Time Frame: Up to 15 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of KAN-101 in Celiac Disease (ACeD)
• Official Title: A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients With Celiac Disease (ACeD)

Brief Summary

A safety study of KAN-101 in patients with celiac disease. The study has two parts:

1. Part A - first in human study in which patients receive a single dose of KAN-101
2. Part B - patients will receive three doses of either KAN-101 or placebo

Detailed Description

Study KAN-101-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of KAN-101 in patients with celiac disease on a gluten free diet (GFD).

An overview of the two parts and proposed dose groups is given below:

1. Part A (SAD): Patients will receive a single dose of KAN-101.
2. Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Celiac Disease

Intervention

• Drug: KAN-101
  Intravenous (IV) infusion
• Drug: Placebo
  Intravenous (IV) infusion

Study Arms

• Experimental: SAD Cohort 1
  All enrolled patients will receive one dose of KAN-101 Dose A
  Intervention: Drug: KAN-101
• Experimental: SAD Cohort 2
  All enrolled patients will receive one dose of KAN-101 Dose B
  Intervention: Drug: KAN-101
• Experimental: SAD Cohort 3
  All enrolled patients will receive one dose of KAN-101 Dose C
  Intervention: Drug: KAN-101
• Experimental: SAD Cohort 4
  All enrolled patients will receive one dose of KAN-101 Dose D
  Intervention: Drug: KAN-101
• Experimental: MAD Cohort 5
  All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo
  Interventions:

  • Drug: KAN-101
  • Drug: Placebo
• Experimental: MAD Cohort 6
  All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo
  Interventions:

  • Drug: KAN-101
  • Drug: Placebo
• Experimental: MAD Cohort 7
  All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo
  Interventions:

  • Drug: KAN-101
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 29, 2020): 36
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2021
• Estimated Primary Completion Date: October 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

1. Adults aged 18 to 70 years inclusive
2. Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy
3. Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes)
4. Has followed a GFD for > 12 months immediately prior to study entry
5. Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening
6. Male or female. Females of childbearing potential must use at least 2 acceptable birth control methods
7. Capable of understanding and complying with protocol requirements
8. Patient understands and has signed the informed consent form

Key Exclusion Criteria:

1. Refractory celiac disease
2. Selective IgA deficiency
3. Positive for HLA-DQ8 (DQA1*03, DQB1*0302)
4. Previous treatment with tolerance-inducing therapies for celiac disease
5. Known wheat allergy
6. Part B only: History of hyperacute or prolonged symptoms following gluten exposure
7. Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation
8. History of dermatitis herpetiformis
9. Pregnant or breastfeeding

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kanyos Bio, Inc.; +1 857-320-6607; clinicaltrials@anokion.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04248855
• Other Study ID Numbers: KAN-101-01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Anokion SA ( Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA )
• Study Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Anokion SA
• Verification Date: February 2021