A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 1B Open-label/Phase 2 Double-blind Placebo- Controlled Study for Pharmacodynamic (PD) Activity, Pharmacokinetics (PK), Safety, and Tolerability of KAN-101 In Patients With Celiac Disease (CeD)

ClinicalTrials.gov ID

NCT05574010

Acronym / sponsor ID

KAN-101-02

Conditions

Celiac Disease

Keywords

celiac disease, HLA-DQ2.5, gluten free diet

Phase

Phase 1/2

Study type

Interventional

Recruitment status

TerminatedReason stopped: Sponsor decision

Enrolment

128 participants (actual)

Lead sponsor

Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SAIndustry (pharma, biotech, devices)

Collaborators

Pfizer

Study start

15 Nov 2022 (actual)

Primary completion

29 Nov 2024 (actual)

Study completion

19 May 2025 (actual)

First posted

10 Oct 2022 (actual)

Results

Posted 10 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Triple blind (participant, investigator, outcomes assessor)

Number of arms

6

Model description

Part A: This part of the study is an open label with up to 6 participants in each dose cohort. There will be 2 dose cohorts. Part B and Part C: These parts of the study have a randomized, double- blinded, placebo-controlled, parallel study design.

Who may qualify

Ages

18 to 70 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Incidence and Severity of TEAEs as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) in Part A

   Time frame: From screening until the safety follow-up visit on Day 28

   An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated; Grade 5= death related to AE.

2. Change in Pre- and Post-Gluten Challenge (GC) IL-2 Response From Baseline to Day 15

   Time frame: From Baseline screening to Day 15

   CeD increases the circulating level of IL-2. Plasma samples were collected to assess the magnitude of biomarker response of IL-2 at the baseline screening visit pre-GC and again post-GC on Day 15 after 3 doses of KAN-101, the IL-2 response to GC is the difference of IL-2 between pre-GC and post-GC.

3. Change in IL-2 Response From Day 15 Pre-GC to Day 15 Post GC

   Time frame: 0 (pre-GC) and 4 hours post-GC on Day 15

   CeD increases the circulating level of IL-2. Plasma samples were collected to assess the magnitude of biomarker response of IL-2 at the baseline screening visit pre-GC and again post-GC on Day 15 after 3 doses of KAN-101, the IL-2 response to GC is the difference of IL-2 between pre-GC and post-GC.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Background: PubMed 37329900Murray 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.
• Derived from this study: PubMed 41758576Muhammad A, Xiao Y, Ahmad YM, Tang R, Zhang Y, Yuan Q, Xiao X. Reprogramming Pathogenic Immune Memory through Inverse Vaccination in Autoimmune Kidney Disease. J Am Soc Nephrol. 2026 Aug 1;37(8):1809-1812. doi: 10.1681/ASN.0000001070. Epub 2026 Feb 27. No abstract available.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

36 sites in 3 countries: see every site and its status.