A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 55
- Locations
- 28
- Primary Endpoint
- Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC)
Study Overview
Brief Summary
The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)
Detailed Description
Study KAN-101-03 is a multi-center, double-blind, placebo-controlled Phase 2a study to examine whether KAN-101 confers protection from gluten exposure induced histological changes in the duodenum and to further evaluate the safety/tolerability of KAN-101 in adult participants (≥18 years) with CeD on a gluten free diet. Approximately 52 participants who meet study inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Study participants and their caregivers, investigators and other staff, and sponsor staff involved in the study team will be blinded.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Previous diagnosis of celiac disease based on histology and positive celiac serology
- •HLA-DQ2.5 genotype
- •Gluten-free diet for at least 12 months
- •Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening
- •Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher
Exclusion Criteria
- •Refractory celiac disease
- •HLA-DQ8 genotype
- •Selective IgA deficiency
- •Diagnosis of type-I diabetes
- •Other Active gastrointestinal diseases
- •History of dermatitis herpetiformis
Arms & Interventions
Group 1
All eligible participants will receive 3 intravenous (IV) infusions of KAN-101
Intervention: KAN-101 (Drug)
Group 2
All eligible participants will receive 3 intravenous (IV) infusions of placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC)
Time Frame: Baseline and Day 29
KAN-101 attenuated GC-induced changes in duodenal histology as measured by the Vh:Cd ratio.
Secondary Outcomes
- KAN-101 Plasma Concentration: AUClast(0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7)
- KAN-101 Plasma Concentration: Tmax(0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7)
- Change in Magnitude of Interleukin-2 (IL-2) Response From Day 15 (First Day of GC) Pre-GC to Day 15 Post GC(From Day 15 pre-GC to Day 15 post GC)
- Changes From Baseline in Intraepithelial Lymphocyte (IEL) Density in Duodenum Biopsy After 2-week GC(Baseline and Day 29)
- KAN-101 Plasma Concentration: AUCinf(0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7)
- KAN-101 Plasma Concentration: Cmax(0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7)
- Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)(From the time the participant provided informed consent through Day 42.)
- Incidence by Visit of KAN-101 Antidrug Antibody (ADA)(Up to 42 days)
- KAN-101 Plasma Concentration: T1/2(0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7)