Clinical trial NCT06001177: A Study of Efficacy, Safety, and Tolerability of KAN-101 in People with Celiac Disease
Official title: A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 in Participants with Celiac Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Celiac Disease
Coeliac Disease
Keywords: celiac disease
HLA-DQ2.5
gluten free diet
Lead sponsor: Anokion SA
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2023-08-21
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized, double-blind, placebo-controlled study with approximately 52 participants that will receive KAN-101 or placebo
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC)
timeFrame: 29 days
Secondary outcomes:
measure: Change in magnitude of IL-2 response from Day 15 (first day of GC) pre GC to Day 15 post GC
timeFrame: 15 days
measure: Changes from baseline in IEL density in duodenum biopsy after 2-week GC
timeFrame: 29 days
measure: Incidence and severity of treatment emergent adverse events as assessed by the CTCAE
timeFrame: 42 days
measure: Incidence of KAN-101 ADA
timeFrame: 42 days
measure: Titer of KAN-101 ADA
timeFrame: 42 days
measure: KAN-101 plasma concentration: AUCinf
timeFrame: 7 days
measure: KAN-101 plasma concentration: AUClast
timeFrame: 7 days
measure: KAN-101 plasma concentration: Cmax
timeFrame: 7 days
measure: KAN-101 plasma concentration: Tmax
timeFrame: 7 days
measure: KAN-101 plasma concentration: T1/2
timeFrame: 7 days
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Hialeah Gardens
country: United States
facility: Unlimited Medical Research Group
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research Inc.
state: Florida
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: London
country: Canada
facility: LHSC
state: Ontario
city: Lévis
country: Canada
facility: Centre Intégré de Santé et de Services Sociaux-Chaudière Appalaches - Hôtel-Dieu de Lévis
state: Quebec
city: Montréal
country: Canada
facility: Hopital Du Sacre-Coeur De Montreal
state: Quebec
city: Québec
country: Canada
facility: Diex Recherche Quebec Inc.
state: Quebec
city: Tampere
country: Finland
facility: Tays Research Services
state: Pirkanmaa
city: Helsinki
country: Finland
facility: CRST Helsinki Oy
state: Uusimaa
city: Turku
country: Finland
facility: Clinical Research Services Turku
state: Varsinais-Suomi
city: Halle
country: Germany
facility: Studiengesellschaft BSF Unternehmergesellschaft
state: Sachsen-Anhalt
city: Drogheda
country: Ireland
facility: Our Lady of Lourdes Hospital
state: Louth
city: Mullingar
country: Ireland
facility: Midland Regional Hospital Mullingar
state: Westmeath
city: Dublin
country: Ireland
facility: Connolly Hospital
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
state: Hadarom
city: Petah tikva
country: Israel
facility: Rabin Medical Center
state: Hamerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: Hamerkaz
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis, locatie Dordwijk
state: Zuid-Holland
city: Wrocław
country: Poland
facility: Melita Medical
state: Dolnośląskie
city: Toruń
country: Poland
facility: Gastromed Sp. z o. o.
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkuś
state: Mazowieckie
city: Łódź
country: Poland
facility: Centrum Medyczne Med-Gastr Sp. z o.o.
state: Łódzkie
city: Knurów
country: Poland
facility: MZ Badania Slowik Zymla Spolka Jawna
state: Śląskie
Study officials:
affiliation: Anokion SA
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Murray JA, Wassaf D, Dunn K, Arora S, Winkle P, Stacey H, Cooper S, Goldstein KE, Manchanda R, Kontos S, Grebe KM. Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):735-747. doi: 10.1016/S2468-1253(23)00107-3. Epub 2023 Jun 14.