A Study to Assess the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Celiac Disease Patients

Overview

About this study

The purpose of this study is to assess the safety and tolerable of single and multiple doses of KAN-101 in patients with Celiac disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults aged 18 to 80 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 for tTG and negative or weak positive for DGP-IgA/IgG during screening.
  • Male or female, and using at least 2 acceptable birth control methods or who are sterile or postmenopausal.
  • Capable of understanding and complying with protocol requirements.
  • Patient understands and has signed the informed consent form.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Murray, M.D.

Open for enrollment

Contact information:

Carol Van Dyke CCRP

(507) 266-7842

VanDyke.Carol@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available