A Study of Safety, Tolerability, Pharmacodynamics, and Ph... | NCT05574010 | Trialant
NCT05574010
Sponsor
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Status
Terminated
Last Update Posted
Mar 10, 2026Actual
Enrollment
128Actual
Phase
Phase 1Phase 2
Conditions
Celiac Disease
Interventions
Cohort 1 in Part A
Cohort 2 in Part A
Placebo: Group 1 in Part B and Part C
Group 2 in Part B and Part C
Group 3 in Part B and Part C
Group 4 in Part B and Part C
Countries
United States
Australia
New Zealand
Protocol Section
Identification Module
NCT ID
NCT05574010
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
KAN-101-02
Secondary IDs
Not provided
Brief Title
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
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)
Acronym
Not provided
Organization
Anokion SAINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor decision
Expanded Access Info
No
Start Date
Nov 15, 2022Actual
Primary Completion Date
Nov 29, 2024Actual
Completion Date
May 19, 2025Actual
First Submitted Date
Oct 7, 2022
First Submission Date that Met QC Criteria
Oct 7, 2022
First Posted Date
Oct 10, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Dec 10, 2025
Results First Submitted that Met QC Criteria
Mar 9, 2026
Results First Posted Date
Mar 10, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 9, 2026
Last Update Posted Date
Mar 10, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SAINDUSTRY
Collaborators
Name
Class
Pfizer
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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).
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.
Conditions Module
Conditions
Celiac Disease
Keywords
celiac disease
HLA-DQ2.5
gluten free diet
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
128Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1 in Part A
Experimental
All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 1
Drug: Cohort 1 in Part A
Cohort 2 in Part A
Experimental
All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 2
Drug: Cohort 2 in Part A
Group 1 in Part B and Part C
Placebo Comparator
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
Group 2 in Part B and Part C
Experimental
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
Group 3 in Part B and Part C
Experimental
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
Group 4 in Part B and Part C
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Cohort 1 in Part A
Drug
Dose 1 KAN-101 Intravenous (IV) infusion
Cohort 1 in Part A
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
From screening until the safety follow-up visit on Day 28
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.
From Baseline screening to Day 15
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.
0 (pre-GC) and 4 hours post-GC on Day 15
Secondary Outcomes
Measure
Description
Time Frame
KAN-101 Plasma Exposure in Part A: AUCinf
PK sample collection at pre- dose and post dose timepoints in Part A.
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
KAN-101 Plasma Exposure in Part A: AUClast
Other Outcomes
Not provided
Eligibility Module
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
Safety Analysis Set includes all participants who received any portion of study intervention in Parts A, B and C. Participants were analyzed according to the intervention they actually received. In Part B, a total of 11 participants were assigned to the KAN-101 treatment groups, and only 10 received study intervention. In Part C, a total of 80 participants were assigned to the KAN-101 treatment groups, and only 79 received study intervention.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A, Cohort 1 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
FG001
Part A, Cohort 2 3.0 mg/kg KAN-101
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 30, 2024
Nov 21, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Part A is open label Part B and Part C are a double-blinded study. Study participants and their caregivers, investigators and other site staff, and sponsor staff involved in the study team will be blinded.
Who Masked
ParticipantInvestigatorOutcomes Assessor
Experimental
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
KAN-101
Cohort 2 in Part A
Drug
Dose 2 KAN-101 Intravenous (IV) infusion
Cohort 2 in Part A
KAN-101
Placebo: Group 1 in Part B and Part C
Other
Placebo Intravenous (IV) infusion
Group 1 in Part B and Part C
Placebo
Group 2 in Part B and Part C
Drug
Dose 3 KAN-101 Intravenous (IV) infusion
Group 2 in Part B and Part C
KAN-101
Group 3 in Part B and Part C
Drug
Dose 4 KAN-101 Intravenous (IV) infusion
Group 3 in Part B and Part C
KAN-101
Group 4 in Part B and Part C
Drug
Dose 5 KAN-101 Intravenous (IV) infusion
Group 4 in Part B and Part C
KAN-101
PK sample collection at pre- dose and post dose timepoints in Part A.
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
KAN-101 Plasma Exposure in Part A: Cmax
PK sample collection at pre- dose and post dose timepoints in Part A.
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
KAN-101 Plasma Exposure in Part A: Tmax
PK sample collection at pre- dose and post dose timepoints in Part A.
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
KAN-101 Plasma Exposure in Part A: t½
PK sample collection at pre- dose and post dose timepoints in Part A.
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
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.
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 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.
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
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.
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
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.
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
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.
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
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.
From the time the participant provided informed consent through Week 52
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.
From the time the participant provided informed consent through Week 52
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
Derived
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.
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
FG002
Part B 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
FG003
Part B 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
FG004
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
FG005
Part B Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
FG006
Part C 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
FG007
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
FG008
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
FG009
Part C Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
FG0003 subjects
FG0013 subjects
FG0024 subjects
FG0033 subjects
FG0043 subjects
FG0055 subjects
FG00627 subjects
FG00726 subjects
FG00826 subjects
FG00928 subjects
COMPLETED
FG0003 subjects
FG0012 subjects
FG0024 subjects
FG0033 subjects
FG0042 subjects
FG0055 subjects
FG00626 subjects
FG00722 subjects
FG00821 subjects
FG00927 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0074 subjects
FG0085 subjects
FG0091 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A, Cohort 1 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
BG001
Part A, Cohort 2 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
BG002
Part B 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
BG003
Part B 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
BG004
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
BG005
Part B Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
BG006
Part C 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
BG007
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
BG008
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
BG009
Part C Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0024
BG0033
BG0043
BG0055
BG00627
BG00726
BG00826
BG00928
BG010128
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.7± 23.03
BG00141.7± 18.77
BG00235.75± 9.54
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0003
BG0013
BG002
Height
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000163.43± 3.024
BG001165.73± 3.573
BG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00062.00± 11.345
BG00181.10± 26.380
BG002
Body Mass Index
Mean
Standard Deviation
kg/m2
Title
Denominators
Categories
Title
Measurements
BG00023.12± 3.489
BG00129.32± 8.498
BG002
Time since First CeD Diagnosis
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0005.5± 2.76
BG0017.5± 7.69
BG002
Time on GFD
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0005.5± 2.83
BG0016.9± 6.99
BG002
Positive Celiac Serology at Diagnosis
Count of Participants
Participants
Title
Denominators
Categories
TISSUE TRANSGLUTAMINASE IGA ANTIBODY (TTG-IGA)
Title
Measurements
BG0003
BG0013
BG002
Positive Histology at Diagnosis
Marsh 1: Diffuse intraepithelial lymphocytosis, normal villi, consistent with celiac disease (CD); Marsh 2: Diffuse intraepithelial lymphocytosis and crypt hyperplasia, consistent with CD; 3a: Partial villus atrophy, crypt hyperplasia and intraepithelial lymphocytosis, consistent with CD; 3b: Subtotal villus atrophy, crypt hyperplasia and intraepithelial lymphocytosis, consistent with CD; 3c: Total villus atrophy, crypt hyperplasia and intraepithelial lymphocytosis, consistent with CD; Marsh 4: Villus atrophy, crypt hypoplasia and intraepithelial lymphocytosis, consistent with CD
Count of Participants
Participants
Title
Denominators
Categories
EVIDENCE OF VILLOUS ATROPHY (NO MARSH SCORE REPORTED)
Title
Measurements
BG0002
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Posted
Count of Participants
Participants
From screening until the safety follow-up visit on Day 28
ID
Title
Description
OG000
Part A, Cohort 1 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
OG001
Part A, Cohort 2 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
Units
Counts
Participants
OG0003
OG0013
Title
Denominators
Categories
TEAE
Title
Measurements
OG0003
OG0013
SAE
Title
Measurements
OG000
Primary
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.
Full analysis set - All participants who were randomly assigned to study intervention and received any portion of study intervention in Part B. Participants were analyzed according to the intervention they were randomized.
Posted
Mean
Standard Deviation
international unit
From Baseline screening to Day 15
ID
Title
Description
OG000
Part B 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG001
Part B 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG002
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
Primary
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.
Full Analysis set - All participants who were randomly assigned to study intervention and received any portion of study intervention in Part C. Participants were analyzed according to the intervention they were randomized.
Posted
Mean
Standard Deviation
international unit
0 (pre-GC) and 4 hours post-GC on Day 15
ID
Title
Description
OG000
Part C 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG001
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG002
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
Secondary
KAN-101 Plasma Exposure in Part A: AUCinf
PK sample collection at pre- dose and post dose timepoints in Part A.
PK Analysis Set - All participants who receive any portion of study intervention and have at least one concentration value in Part A.
Posted
Mean
Standard Deviation
ng.hr/ml
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
ID
Title
Description
OG000
Part A, Cohort 1 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
OG001
Part A, Cohort 2 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
Units
Counts
Participants
OG000
Secondary
KAN-101 Plasma Exposure in Part A: AUClast
PK sample collection at pre- dose and post dose timepoints in Part A.
PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part A.
Posted
Mean
Standard Deviation
ng.hr/mL
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
ID
Title
Description
OG000
Part A, Cohort 1 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
OG001
Part A, Cohort 2 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
Units
Counts
Participants
OG000
Secondary
KAN-101 Plasma Exposure in Part A: Cmax
PK sample collection at pre- dose and post dose timepoints in Part A.
PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part A.
Posted
Mean
Standard Deviation
ng/mL
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
ID
Title
Description
OG000
Part A, Cohort 1 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
OG001
Part A, Cohort 2 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
Units
Counts
Participants
OG000
Secondary
KAN-101 Plasma Exposure in Part A: Tmax
PK sample collection at pre- dose and post dose timepoints in Part A.
PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part A.
Posted
Mean
Standard Deviation
hr
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
ID
Title
Description
OG000
Part A, Cohort 1 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
OG001
Part A, Cohort 2 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
Units
Counts
Participants
OG000
Secondary
KAN-101 Plasma Exposure in Part A: t½
PK sample collection at pre- dose and post dose timepoints in Part A.
PK Analysis Set - All participants who received any portion of study intervention and had at least 1 concentration value in Part A.
Posted
Mean
Standard Deviation
hr
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
ID
Title
Description
OG000
Part A, Cohort 1 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
OG001
Part A, Cohort 2 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
Units
Counts
Participants
OG000
Secondary
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.
PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part B and C.
Posted
Mean
Standard Deviation
ng.hr/mL
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
ID
Title
Description
OG000
Part B 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG001
Part B 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG002
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG003
Part C 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
Secondary
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.
PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part B and C. Due to the short half-life of KAN-101, for majority of the samples in Parts B and C, the terminal elimination phase was measured as 'below level of detection'. Results of AUClast which are shown as N/A are due to the majority of samples being below level of quantification.
Posted
Mean
Standard Deviation
ng.hr/mL
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
ID
Title
Description
OG000
Part B 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG001
Part B 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG002
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
Secondary
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.
PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part B and C.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
ID
Title
Description
OG000
Part B 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG001
Part B 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG002
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG003
Part C 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
Secondary
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.
PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part B and C.
Posted
Mean
Standard Deviation
hr
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
ID
Title
Description
OG000
Part B 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG001
Part B 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG002
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG003
Part C 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
Secondary
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.
Posted
Mean
Standard Deviation
hr
Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7
ID
Title
Description
OG000
Part B 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG001
Part B 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG002
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG003
Part C 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG004
Secondary
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.
Posted
Count of Participants
Participants
From the time the participant provided informed consent through Week 52
ID
Title
Description
OG000
Part B 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG001
Part B 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG002
Part B 3.0 mg/kg KAN-101
Secondary
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.
Posted
Count of Participants
Participants
From the time the participant provided informed consent through Week 52
ID
Title
Description
OG000
Part C 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG001
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
OG002
Part C 3.0 mg/kg KAN-101
Time Frame
From screening until the safety follow-up visit on Week 52.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A, Cohort 1 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
0
3
0
3
3
3
EG001
Part A, Cohort 2 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
0
3
0
3
3
3
EG002
Part B 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
0
4
1
4
4
4
EG003
Part B 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
0
3
1
3
3
3
EG004
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
0
3
2
3
3
3
EG005
Part B Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
0
5
0
5
5
5
EG006
Part C 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
0
27
0
27
23
27
EG007
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
0
26
1
26
23
26
EG008
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
0
26
1
26
24
26
EG009
Part C Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
0
28
0
28
24
28
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Infusion related hypersensitivity reaction
Immune system disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG004
Limb injury
Injury, poisoning and procedural complications
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Bladder perforation
Renal and urinary disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected3 at risk
EG0024 affected4 at risk
EG0032 affected3 at risk
EG0043 affected3 at risk
EG0054 affected5 at risk
EG00614 affected27 at risk
EG00715 affected26 at risk
EG00818 affected26 at risk
EG00917 affected28 at risk
Vomiting
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0024 affected4 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0022 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (28.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA (28.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0023 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA (28.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected4 at risk
EG003
COVID-19
Infections and infestations
MedDRA (28.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (28.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0024 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Faeces pale
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Brain fog
Nervous system disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Chills
General disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected4 at risk
EG003
Pain
General disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Feeling cold
General disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Malaise
General disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hordeolum
Infections and infestations
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA (28.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)