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Assessment of KAN-101 in Celiac Disease (ACeD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04248855
Recruitment Status : Completed
First Posted : January 30, 2020
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Anokion SA ( Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA )

Study Description
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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

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: KAN-101 Drug: Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 21, 2020
Actual Primary Completion Date : October 8, 2021
Actual Study Completion Date : October 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: SAD Cohort 1
All enrolled patients will receive one dose of KAN-101 Dose A
 Drug: KAN-101
Intravenous (IV) infusion
Experimental: SAD Cohort 2
All enrolled patients will receive one dose of KAN-101 Dose B
 Drug: KAN-101
Intravenous (IV) infusion
Experimental: SAD Cohort 3
All enrolled patients will receive one dose of KAN-101 Dose C
 Drug: KAN-101
Intravenous (IV) infusion
Experimental: SAD Cohort 4
All enrolled patients will receive one dose of KAN-101 Dose D
 Drug: KAN-101
Intravenous (IV) infusion
Experimental: MAD Cohort 5
All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo
 Drug: KAN-101
Intravenous (IV) infusion

Drug: Placebo
Intravenous (IV) infusion
Experimental: MAD Cohort 6
All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo
 Drug: KAN-101
Intravenous (IV) infusion

Drug: Placebo
Intravenous (IV) infusion
Experimental: MAD Cohort 7
All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo
 Drug: KAN-101
Intravenous (IV) infusion

Drug: Placebo
Intravenous (IV) infusion


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248855


Locations
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United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Florida
GCP Research
Saint Petersburg, Florida, United States, 33705
United States, Louisiana
Tandem Clinical Research
Marrero, Louisiana, United States, 70072
United States, Maryland
Parexel International- EPCU Baltimore
Baltimore, Maryland, United States, 21225
United States, Michigan
West Michigan Clinical Research Center
Wyoming, Michigan, United States, 49519
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Celiac Disease Center at Columbia University
New York, New York, United States, 10032
United States, North Carolina
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
United States, Ohio
Aventiv Research
Columbus, Ohio, United States, 43213
United States, Utah
Advanced Clinical Research
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
More Information
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Responsible Party: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
ClinicalTrials.gov Identifier: NCT04248855    
Other Study ID Numbers: KAN-101-01
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anokion SA ( Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA ):
Phase 1
Double blind
Multicenter
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases