Phase 1 N=41 Randomized Double-blind Treatment

Assessment of KAN-101 in Celiac Disease (ACeD)

Celiac Disease

Bottom Line

View on ClinicalTrials.gov: NCT04248855 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) — 4; 3; 2; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: KAN-101 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Primary completion: Oct 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)	4; 3; 2; 3; 1; 6	—
SECONDARY Cmax	839; 1796; 10900; 19470; 22350; 967	—
SECONDARY AUC Last	366.8; 646.3; 5365; 13920; 16340; 322.5	—

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

Eligibility Criteria

Key Inclusion Criteria

Adults aged 18 to 70 years inclusive
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
Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes)
Has followed a GFD for > 12 months immediately prior to study entry
Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening
Male or female. Females of childbearing potential must use at least 2 acceptable birth control methods
Capable of understanding and complying with protocol requirements
Patient understands and has signed the informed consent form

Key Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04248855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.