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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04248855
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Anokion SA ( Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA )

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 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
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 for tTG and negative or weak positive for DGP-IgA/IgG during screening
  6. Male or female, and using at least 2 acceptable birth control methods or who are sterile or postmenopausal
  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

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


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

Locations
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United States, California
Anaheim Clinical Trials Recruiting
Anaheim, California, United States, 92801
Contact: Peter Winkle, Dr.         
Contact: Hee Sung Ko    714-774-7777 ext 1089      
Diablo Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact: Helen Stacey, Dr.         
Contact: Caitlin Sheets    925-930-7267      
United States, Florida
Innovative Medical Research of South Florida, Inc Recruiting
Miami, Florida, United States, 33180
Contact: Isaac Bassan, Dr.         
Contact: Gabriel Barba    305-759-1881      
United States, Maryland
Parexel International- EPCU Baltimore Recruiting
Baltimore, Maryland, United States, 21225
Contact: Ronald Goldwater, Dr.    800-797-2448      
United States, Michigan
West Michigan Clinical Research Center Recruiting
Wyoming, Michigan, United States, 49519
Contact: Allan Coates, Dr.         
Contact: Kayla Hinson    616-328-5319      
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Joseph Murray, Dr.         
Contact: Carol Van Dyke    507-266-7842      
United States, New York
Celiac Disease Center at Columbia University Recruiting
New York, New York, United States, 10032
Contact: Benjamin Lebwohl, Dr.    212-305-5422      
United States, Ohio
Aventiv Research Not yet recruiting
Columbus, Ohio, United States, 43213
Contact: Jessica Spear    614-501-6164 ext 2007      
Principal Investigator: Samir Arora, MD         
United States, Tennessee
WR-ClinSearch, LLC Recruiting
Chattanooga, Tennessee, United States, 37421
Contact: Mark McKenzie, Dr.    423-698-4584      
United States, Utah
Advanced Clinical Research Recruiting
West Jordan, Utah, United States, 84088
Contact: Barbara Rizzardi, Dr.         
Contact: Marissa Lyons    801-542-8190      
Sponsors and Collaborators
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
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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: September 30, 2020
Last Verified: September 2020
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