Clinical trial

A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease

Name

KAN-101-03

Description

The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)

Trial arms

Trial start

2023-12-13

Estimated PCD

2025-03-01

Trial end

2025-06-01

Status

Recruiting

Phase

Early phase I

Treatment

KAN-101

Dose KAN-101 Intravenous (IV) Infusion

Arms:

Group 1

Other names:

Group 1, Treatment Arm

Placebo

Placebo Intravenous (IV) Infusion

Arms:

Group 2

Other names:

Group 2, Placebo Comparator Arm

Size

Primary endpoint

Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC)

29 days

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a randomized, double-blind, placebo-controlled study with up to 52 participants that will receive KAN-101 or placebo', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Study participants and their caregivers, investigators and other staff, and sponsor staff involved in the study team will be blinded.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 52, 'type': 'ESTIMATED'}}

Updated at

2024-06-11

1 organization

1 product

1 drug

2 indications

Organization

Product

Indication

Indication

Drug