Clinical trial NCT04248855: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Celiac Disease
Keywords: Phase 1
Double blind
Multicenter
Lead sponsor: Anokion SA
Sponsor class: INDUSTRY
First posted: 2020-01-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 28 Days
Secondary outcomes:
measure: Cmax
timeFrame: 0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7
measure: AUC Last
timeFrame: 0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Aventura
country: United States
facility: Innovative Medical Research of South Florida
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research
state: Florida
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Baltimore
country: United States
facility: Parexel International- EPCU Baltimore
state: Maryland
city: Wyoming
country: United States
facility: West Michigan Clinical Research Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Celiac Disease Center at Columbia University
state: New York
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
Study officials:
affiliation: Kanyos Bio, Inc.
name: Study Director
role: STUDY_DIRECTOR
References: