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TerminatedNCT05574010Updated Mar 10, 2026Results posted

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

A Phase 1/2 interventional study of Cohort 1 in Part A and Cohort 2 in Part A in Celiac Disease, sponsored by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA. Terminated at 36 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Sponsor decision
Phase
Phase 1/2
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).

Read the detailed description

The study is a 3-part, multicenter Phase 1b/2 study of KAN-101 in participants with Celiac Disease (CeD) on a gluten free diet (GFD). The 3 parts include:

  • Part A - Open-label, multiple ascending dose
  • Part B - Double-blind, placebo-controlled, parallel design
  • Part C - Double-blind, placebo-controlled, parallel design

Part A is a Phase 1b, open-label, multiple ascending dose (MAD) study design to assess the safety, tolerability, and pharmacokinetics (PK) of KAN-101 in adult participants (18 to 70 years inclusive) with histology-confirmed CeD. Up to 12 participants who meet study inclusion/exclusion criteria will receive 1 of 2 dose levels of KAN-101. The overall study duration will be about 56 days, including up to 28 days of screening, 7 days of treatment and 21 days of follow up. There will be a gluten challenge test (GC) on Day 15.

Parts B and C are Phase 2, double-blind, placebo-controlled, parallel design study to characterize the biomarker response following GC, safety, tolerability, and PK of KAN-101 in adult participants with histology-confirmed CeD. Approximately 16 participants (4 participants per dose group) will be enrolled in Part B and 104 participants (26 participants per dose group) enrolled into Part C. Participants will be randomized 1:1:1:1 and stratified by participation in a biopsy substudy to 4 treatment groups: placebo and 3 treatment groups with KAN-101 doses based on information obtained from Part A.

02

Conditions studied

  • Celiac Disease

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Keywords

  • celiac disease
  • HLA-DQ2.5
  • gluten free diet
03

In context

Celiac Disease

333 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.

This study's enrollment of 128 is above the median of 50 across 203 interventional studies indexed under Celiac Disease.

Browse Celiac Disease studies →

Lead sponsor

Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

Exclusion criteria

Exclusion Criteria:

  • Refractory celiac disease
  • HLA-DQ8 genotype
  • Previous oral gluten challenge within 12 months
  • Selective IgA deficiency
  • Diagnosis of Type-1 diabetes
  • Active gastrointestinal diseases
  • History of dermatitis herpetiformis
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
128 participants (actual)

Study arms

  • Experimental
    Cohort 1 in Part A

    All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 1

    Drug: Cohort 1 in Part A

  • Experimental
    Cohort 2 in Part A

    All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 2

    Drug: Cohort 2 in Part A

  • Placebo comparator
    Group 1 in Part B and Part C

    All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of placebo

    Other: Placebo: Group 1 in Part B and Part C

  • Experimental
    Group 2 in Part B and Part C

    All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 3

    Drug: Group 2 in Part B and Part C

  • Experimental
    Group 3 in Part B and Part C

    All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 4

    Drug: Group 3 in Part B and Part C

  • Experimental
    Group 4 in Part B and Part C

    All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 5

    Drug: Group 4 in Part B and Part C

Interventions

  • DrugCohort 1 in Part A

    Dose 1 KAN-101 Intravenous (IV) infusion

    Also known as: KAN-101

  • DrugCohort 2 in Part A

    Dose 2 KAN-101 Intravenous (IV) infusion

    Also known as: KAN-101

  • OtherPlacebo: Group 1 in Part B and Part C

    Placebo Intravenous (IV) infusion

    Also known as: Placebo

  • DrugGroup 2 in Part B and Part C

    Dose 3 KAN-101 Intravenous (IV) infusion

    Also known as: KAN-101

  • DrugGroup 3 in Part B and Part C

    Dose 4 KAN-101 Intravenous (IV) infusion

    Also known as: KAN-101

  • DrugGroup 4 in Part B and Part C

    Dose 5 KAN-101 Intravenous (IV) infusion

    Also known as: KAN-101

06

What researchers measure

Primary outcomes

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

    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.

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

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

    Time frame: From Baseline screening to Day 15

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

    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.

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

Secondary outcomes

  1. KAN-101 Plasma Exposure in Part A: AUCinf

    PK sample collection at pre- dose and post dose timepoints in Part A.

    Time frame: Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7

  2. KAN-101 Plasma Exposure in Part A: AUClast

    PK sample collection at pre- dose and post dose timepoints in Part A.

    Time frame: Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7

  3. KAN-101 Plasma Exposure in Part A: Cmax

    PK sample collection at pre- dose and post dose timepoints in Part A.

    Time frame: Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7

  4. KAN-101 Plasma Exposure in Part A: Tmax

    PK sample collection at pre- dose and post dose timepoints in Part A.

    Time frame: Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7

  5. KAN-101 Plasma Exposure in Part A: t½

    PK sample collection at pre- dose and post dose timepoints in Part A.

    Time frame: Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7

  6. KAN-101 Plasma Exposure in Part B and Part C: AUCinf

    PK sample collection at pre- dose and post dose timepoints in Part B and Part C.

    Time frame: Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7

  7. KAN-101 Plasma Exposure in Part B and Part C: AUClast

    PK sample collection at pre- dose and post dose timepoints in Part B and Part C.

    Time frame: Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7

  8. KAN-101 Plasma Exposure in Part B and Part C: Cmax

    PK sample collection at pre- dose and post dose timepoints in Part B and Part C.

    Time frame: Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7

  9. KAN-101 Plasma Exposure in Part B and Part C: Tmax

    PK sample collection at pre- dose and post dose timepoints in Part B and Part C.

    Time frame: Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7

  10. KAN-101 Plasma Exposure in Part B and Part C: t½

    PK sample collection at pre- dose and post dose timepoints in Part B and Part C.

    Time frame: Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7

  11. Incidence and Severity of TEAE as Assessed by the CTCAE in Part B

    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.

    Time frame: From the time the participant provided informed consent through Week 52

  12. Incidence and Severity of TEAE as Assessed by the CTCAE in Part C

    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.

    Time frame: From the time the participant provided informed consent through Week 52

07

Results

Posted Mar 10, 2026

Participant flow

Participant flow — Overall Study
MilestonePart A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101Part B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B PlaceboPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C Placebo
Started33433527262628
Completed32432526222127
Not completed0100101451
Withdrew: Withdrawal by subject0100000000
Withdrew: Adverse event0000101441
Withdrew: Other0000000010

Outcome measures

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

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.

Time frame:
From screening until the safety follow-up visit on Day 28
Reported as:
Count of participants · Participants
Incidence and Severity of TEAEs as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) in Part A
ParticipantsPart A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101
TEAE33
SAE00
Grade 2 TEAE01
Grade 3 or 4 TEAE00
Grade 5 TEAE00
PrimaryChange in Pre- and Post-Gluten Challenge (GC) IL-2 Response From Baseline 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.

Time frame:
From Baseline screening to Day 15
Reported as:
Mean · international unit
Change in Pre- and Post-Gluten Challenge (GC) IL-2 Response From Baseline to Day 15
international unitPart B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B Placebo
Change in Pre- and Post-Gluten Challenge (GC) IL-2 Response From Baseline to Day 15-2.3 ± 7.8025.3 ± 26.31-1.9 ± 5.09146.2 ± 380.81
PrimaryChange in IL-2 Response From Day 15 Pre-GC to Day 15 Post GC

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.

Time frame:
0 (pre-GC) and 4 hours post-GC on Day 15
Reported as:
Mean · international unit
Change in IL-2 Response From Day 15 Pre-GC to Day 15 Post GC
international unitPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C Placebo
Change in IL-2 Response From Day 15 Pre-GC to Day 15 Post GC13.2 ± 31.76.5 ± 10.310.5 ± 19.7119.1 ± 402.7
SecondaryKAN-101 Plasma Exposure in Part A: AUCinf

PK sample collection at pre- dose and post dose timepoints in Part A.

Time frame:
Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7
Reported as:
Mean · ng.hr/ml
KAN-101 Plasma Exposure in Part A: AUCinf
ng.hr/mlPart A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101
Day 17585.0 ± 2227.3929833.3 ± 6986.65
Day 75025.0 ± 1152.5827600.0 ± 5656.85
SecondaryKAN-101 Plasma Exposure in Part A: AUClast

PK sample collection at pre- dose and post dose timepoints in Part A.

Time frame:
Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7
Reported as:
Mean · ng.hr/mL
KAN-101 Plasma Exposure in Part A: AUClast
ng.hr/mLPart A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101
Day 16413.3 ± 2486.8529633.3 ± 6940.70
Day 74770.0 ± 918.8627600.0 ± 5656.85
SecondaryKAN-101 Plasma Exposure in Part A: Cmax

PK sample collection at pre- dose and post dose timepoints in Part A.

Time frame:
Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7
Reported as:
Mean · ng/mL
KAN-101 Plasma Exposure in Part A: Cmax
ng/mLPart A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101
Day 18200.0 ± 2317.6727333.3 ± 8788.82
Day 76083.3 ± 2654.6225900.0 ± 4808.33
SecondaryKAN-101 Plasma Exposure in Part A: Tmax

PK sample collection at pre- dose and post dose timepoints in Part A.

Time frame:
Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7
Reported as:
Mean · hr
KAN-101 Plasma Exposure in Part A: Tmax
hrPart A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101
Day 10.6 ± 0.010.6 ± 0.03
Day 70.6 ± 0.030.6 ± 0.05
SecondaryKAN-101 Plasma Exposure in Part A: t½

PK sample collection at pre- dose and post dose timepoints in Part A.

Time frame:
Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7
Reported as:
Mean · hr
KAN-101 Plasma Exposure in Part A: t½
hrPart A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101
Day 10.3 ± 0.060.4 ± 0.01
Day 70.2 ± 0.090.3 ± 0.00
SecondaryKAN-101 Plasma Exposure in Part B and Part C: AUCinf

PK sample collection at pre- dose and post dose timepoints in Part B and Part C.

Time frame:
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
Reported as:
Mean · ng.hr/mL
KAN-101 Plasma Exposure in Part B and Part C: AUCinf
ng.hr/mLPart B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101
KAN-101 Plasma Exposure in Part B and Part C: AUCinfNANANANANANA
SecondaryKAN-101 Plasma Exposure in Part B and Part C: AUClast

PK sample collection at pre- dose and post dose timepoints in Part B and Part C.

Time frame:
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
Reported as:
Mean · ng.hr/mL
KAN-101 Plasma Exposure in Part B and Part C: AUClast
ng.hr/mLPart B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101
Day 1NANA19700.0 ± 10748.0NANA29607.1 ± 6854.58
Day 7NANA26600.06930.05380.029808.3 ± 7079.74
SecondaryKAN-101 Plasma Exposure in Part B and Part C: Cmax

PK sample collection at pre- dose and post dose timepoints in Part B and Part C.

Time frame:
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
Reported as:
Mean · ng/mL
KAN-101 Plasma Exposure in Part B and Part C: Cmax
ng/mLPart B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101
Day 13707.5 ± 760.5912263.3 ± 7755.9020166.7 ± 8903.004208.8 ± 1761.1010099.5 ± 2696.1730243.2 ± 6909.18
Day 72805.0 ± 1001.488536.7 ± 3174.5924450.0 ± 9404.525016.8 ± 1314.398906.3 ± 2456.7330816.7 ± 7084.88
SecondaryKAN-101 Plasma Exposure in Part B and Part C: Tmax

PK sample collection at pre- dose and post dose timepoints in Part B and Part C.

Time frame:
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
Reported as:
Mean · hr
KAN-101 Plasma Exposure in Part B and Part C: Tmax
hrPart B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101
Day 10.5 ± 0.010.6 ± 0.010.5 ± 0.030.6 ± 0.090.5 ± 0.130.6 ± 0.06
Day 70.6 ± 0.040.6 ± 0.040.5 ± 0.010.5 ± 0.050.6 ± 0.220.5 ± 0.06
SecondaryKAN-101 Plasma Exposure in Part B and Part C: t½

PK sample collection at pre- dose and post dose timepoints in Part B and Part C.

Time frame:
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
Reported as:
Mean · hr
KAN-101 Plasma Exposure in Part B and Part C: t½
hrPart B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101
KAN-101 Plasma Exposure in Part B and Part C: t½NANANANANANA
SecondaryIncidence and Severity of TEAE as Assessed by the CTCAE in Part B

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.

Time frame:
From the time the participant provided informed consent through Week 52
Reported as:
Count of participants · Participants
Incidence and Severity of TEAE as Assessed by the CTCAE in Part B
ParticipantsPart B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B Placebo
TEAE4335
SAE1120
Grade 2 TEAE1214
Grade 3 or higher TEAE1120
SecondaryIncidence and Severity of TEAE as Assessed by the CTCAE in Part C

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.

Time frame:
From the time the participant provided informed consent through Week 52
Reported as:
Count of participants · Participants
Incidence and Severity of TEAE as Assessed by the CTCAE in Part C
ParticipantsPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C Placebo
TEAE24242526
SAE0110
Grade 2 TEAE16131313
Grade 3 or higher TEAE4153

Adverse events

Collected over From screening until the safety follow-up visit on Week 52.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part A, Cohort 1 1.2 mg/kg KAN-1010/3 (0%)0/3 (0%)3/3 (100%)
Part A, Cohort 2 3.0 mg/kg KAN-1010/3 (0%)0/3 (0%)3/3 (100%)
Part B 0.6 mg/kg KAN-1010/4 (0%)1/4 (25%)4/4 (100%)
Part B 1.2 mg/kg KAN-1010/3 (0%)1/3 (33.3%)3/3 (100%)
Part B 3.0 mg/kg KAN-1010/3 (0%)2/3 (66.7%)3/3 (100%)
Part B Placebo0/5 (0%)0/5 (0%)5/5 (100%)
Part C 0.6 mg/kg KAN-1010/27 (0%)0/27 (0%)23/27 (85.2%)
Part C 1.2 mg/kg KAN-1010/26 (0%)1/26 (3.8%)23/26 (88.5%)
Part C 3.0 mg/kg KAN-1010/26 (0%)1/26 (3.8%)24/26 (92.3%)
Part C Placebo0/28 (0%)0/28 (0%)24/28 (85.7%)
Most frequent serious events
Most frequent serious events
EventPart A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101Part B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B PlaceboPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C Placebo
SyncopeNervous system disorders0/30/31/40/31/30/50/270/260/260/28
Bladder perforationRenal and urinary disorders0/30/30/41/30/30/50/270/260/260/28
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/30/30/40/31/30/50/270/260/260/28
DiarrhoeaGastrointestinal disorders0/30/31/40/30/30/50/270/260/260/28
VomitingGastrointestinal disorders0/30/31/40/30/30/50/270/260/260/28
Infusion related hypersensitivity reactionImmune system disorders0/30/30/40/30/30/50/271/260/260/28
Limb injuryInjury, poisoning and procedural complications0/30/30/40/30/30/50/270/261/260/28
Most frequent other events
Showing 10 of 66
Most frequent other events
EventPart A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101Part B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B PlaceboPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C Placebo
NauseaGastrointestinal disorders0/33/34/42/33/34/514/2715/2618/2617/28
VomitingGastrointestinal disorders1/31/34/43/33/32/56/276/2611/2610/28
Abdominal painGastrointestinal disorders0/30/34/43/32/31/510/279/2611/263/28
FatigueGeneral disorders1/30/33/42/31/31/511/279/267/269/28
HeadacheNervous system disorders0/32/32/42/30/33/57/279/2612/267/28
DiarrhoeaGastrointestinal disorders0/30/32/41/32/32/510/2711/269/2613/28
PyrexiaGeneral disorders1/30/32/40/31/30/50/270/260/260/28
ChillsGeneral disorders0/30/32/41/30/30/52/273/260/260/28
Decreased appetiteMetabolism and nutrition disorders0/30/32/40/31/31/50/271/262/260/28
Abdominal distensionGastrointestinal disorders1/30/31/41/31/32/59/276/2610/266/28

Baseline characteristics

Age, Continuous
Age, Continuous(years)Part A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101Part B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B PlaceboPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C PlaceboTotal
Mean42.7 ± 23.0341.7 ± 18.7735.75 ± 9.5441.00 ± 15.7239.67 ± 12.6656.80 ± 11.8841.70 ± 15.1935.96 ± 15.6140.08 ± 16.1438.71 ± 14.0239.91 ± 15.21
Sex: Female, Male
Sex: Female, Male(Participants)Part A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101Part B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B PlaceboPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C PlaceboTotal
Female2311332116192594
Male1032026107334
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Part A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101Part B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B PlaceboPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C PlaceboTotal
Hispanic or Latino00000000000
Not Hispanic or Latino33433526252628126
Unknown or Not Reported00000011002
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Part A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101Part B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B PlaceboPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C PlaceboTotal
White33433526262528126
Asian00000010001
Native Hawaiian or Other Pacific Islander00000000101
Height
Height(cm)Part A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101Part B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B PlaceboPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C PlaceboTotal
Mean163.43 ± 3.024165.73 ± 3.573178.00 ± 10.22171.53 ± 2.41168.80 ± 10.17167.26 ± 8.33169.90 ± 11.18169.85 ± 10.59167.75 ± 8.61167.15 ± 8.29168.77 ± 9.42
Weight
Weight(kg)Part A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101Part B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B PlaceboPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C PlaceboTotal
Mean62.00 ± 11.34581.10 ± 26.38085.53 ± 30.6078.60 ± 23.7378.73 ± 15.2973.04 ± 9.4480.71 ± 19.0178.78 ± 21.6078.35 ± 19.9482.69 ± 18.6779.60 ± 19.54
Body Mass Index
Body Mass Index(kg/m2)Part A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101Part B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B PlaceboPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C PlaceboTotal
Mean23.12 ± 3.48929.32 ± 8.49826.47 ± 6.9526.58 ± 7.3627.47 ± 3.4826.08 ± 2.6427.84 ± 5.6127.30 ± 7.0827.65 ± 5.4929.70 ± 7.0927.87 ± 6.19
Time since First CeD Diagnosis
Time since First CeD Diagnosis(years)Part A, Cohort 1 1.2 mg/kg KAN-101Part A, Cohort 2 3.0 mg/kg KAN-101Part B 0.6 mg/kg KAN-101Part B 1.2 mg/kg KAN-101Part B 3.0 mg/kg KAN-101Part B PlaceboPart C 0.6 mg/kg KAN-101Part C 1.2 mg/kg KAN-101Part C 3.0 mg/kg KAN-101Part C PlaceboTotal
Mean5.5 ± 2.767.5 ± 7.695.54 ± 5.619.51 ± 4.807.83 ± 6.2412.82 ± 5.026.89 ± 5.649.46 ± 7.618.05 ± 5.746.69 ± 4.877.86 ± 5.95

3 further baseline measures are reported on the registry.

08

Study locations

36 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
  • Anaheim Clinical Trials, LLC
    Anaheim, California 92801, United States
  • GCP Research
    St. Petersburg, Florida 33705, United States
  • Agile Clinical Research Trials
    Sandy Springs, Georgia 30328, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Sneeze, Wheeze & Itch Associates, LLC
    Normal, Illinois 61761, United States
  • Indiana University Health University Hospital
    Indianapolis, Indiana 46202, United States
  • University of Iowa
    Iowa City, Iowa 52242, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Prism Research LLC dba Nucleus Network
    Saint Paul, Minnesota 55114, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Quality Clinical Research
    Omaha, Nebraska 68114, United States
  • Celiac Disease Center at Columbia University
    New York, New York 10032, United States
  • North Carolina Clinical Research
    Raleigh, North Carolina 27607, United States
  • Aventiv Research, Inc. d/b/a Centricity Research
    Columbus, Ohio 43213, United States
  • Great Lakes Gastroenterology Research, LLC
    Mentor, Ohio 44060, United States
  • Northshore Gastroenterology Research, LLC
    Westlake, Ohio 44145, United States
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212, United States
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
  • Digestive Research of Central Texas
    Waco, Texas 76712, United States
  • Advanced Research Institute
    Ogden, Utah 84405, United States
  • Velocity Clinical Research, Salt Lake City
    West Jordan, Utah 84088, United States
  • Campbelltown Hospital
    Campbelltown, New South Wales 2560, Australia
  • Wesley Research Institute
    Auchenflower, Queensland 4066, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • Box Hill Hospital
    Box Hill, Victoria 3128, Australia
  • The Royal Melbourne Hospital
    Parkville, Victoria 3050, Australia
  • St John of God Midland Public and Private Hospitals
    Midland, Western Australia 6056, Australia
  • Optimal Clinical Trials
    Auckland, Auckland 1023, New Zealand
  • PCRN Trials
    Takapuna, Auckland 0622, New Zealand
  • P3 Research - Tauranga
    Tauranga, Bay of Plenty 3110, New Zealand
  • Waikato Hospital
    Hamilton, Hamilton 3204, New Zealand
  • P3 Research - Dunedin
    Dunedin, Otago 9016, New Zealand
  • P3 Research - Palmerston North
    Paraparaumu, Wellington Region 5032, New Zealand
  • P3 Research - Wellington
    Wellington, Wellington Region 6021, New Zealand
09

References and documents

Publications

  • 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. PubMed 37329900 ↗
  • Muhammad 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 Feb 27. doi: 10.1681/ASN.0000001070. Online ahead of print. No abstract available. PubMed 41758576 ↗

Study documents

  • Study protocol · Jan 30, 2024
  • Statistical analysis plan · Jun 13, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05574010
Lead sponsor
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Oct 10, 2022
Start date
Nov 15, 2022
Primary completion
Nov 29, 2024
Completion
May 19, 2025
Results posted
Mar 10, 2026
Last update
Mar 10, 2026

Study contacts

Study Director
study director · Anokion SA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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