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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05574010




Registration number
NCT05574010
Ethics application status
Date submitted
7/10/2022
Date registered
10/10/2022

Titles & IDs
Public title
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
Scientific 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)
Secondary ID [1] 0 0
KAN-101-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Celiac Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cohort 1 in Part A
Treatment: Drugs - Cohort 2 in Part A
Other interventions - Placebo: Group 1 in Part B and Part C
Treatment: Drugs - Group 2 in Part B and Part C
Treatment: Drugs - Group 3 in Part B and Part C
Treatment: Drugs - Group 4 in Part B and Part C

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

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

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

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

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

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


Treatment: Drugs: Cohort 1 in Part A
Dose 1 KAN-101 Intravenous (IV) infusion

Treatment: Drugs: Cohort 2 in Part A
Dose 2 KAN-101 Intravenous (IV) infusion

Other interventions: Placebo: Group 1 in Part B and Part C
Placebo Intravenous (IV) infusion

Treatment: Drugs: Group 2 in Part B and Part C
Dose 3 KAN-101 Intravenous (IV) infusion

Treatment: Drugs: Group 3 in Part B and Part C
Dose 4 KAN-101 Intravenous (IV) infusion

Treatment: Drugs: Group 4 in Part B and Part C
Dose 5 KAN-101 Intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of TEAEs as assessed by common terminology criteria for adverse events (CTCAE) in Part A
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Change in magnitude of IL-2 response pre- and post-GC in peripheral blood in Part B
Timepoint [2] 0 0
Baseline to Day 15
Primary outcome [3] 0 0
Change in magnitude of IL-2 response pre- and post-GC in peripheral blood
Timepoint [3] 0 0
0 (pre-GC) and 4 hours post-GC on Day 15
Secondary outcome [1] 0 0
KAN-101 plasma exposure in Part A: AUCinf
Timepoint [1] 0 0
0 (pre-dose) and up to 7 hours post dose
Secondary outcome [2] 0 0
KAN-101 plasma exposure in Part A: AUClast
Timepoint [2] 0 0
0 (pre-dose) and up to 7 hours post dose
Secondary outcome [3] 0 0
KAN-101 plasma exposure in Part A: Cmax
Timepoint [3] 0 0
0 (pre-dose) and up to 7 hours post dose
Secondary outcome [4] 0 0
KAN-101 plasma exposure in Part A: Tmax
Timepoint [4] 0 0
0 (pre-dose) and up to 7 hours post dose
Secondary outcome [5] 0 0
KAN-101 plasma exposure in Part A: t½
Timepoint [5] 0 0
0 (pre-dose) and up to 7 hours post dose
Secondary outcome [6] 0 0
KAN-101 plasma exposure in Part B and Part C: AUCinf
Timepoint [6] 0 0
0 (pre-dose) and up to 4 hours post dose
Secondary outcome [7] 0 0
KAN-101 plasma exposure in Part B and Part C: AUClast
Timepoint [7] 0 0
0 (pre-dose) and up to 4 hours post dose
Secondary outcome [8] 0 0
KAN-101 plasma exposure in Part B and Part C: Cmax
Timepoint [8] 0 0
0 (pre-dose) and up to 4 hours post dose
Secondary outcome [9] 0 0
KAN-101 plasma exposure in Part B and Part C: Tmax
Timepoint [9] 0 0
0 (pre-dose) and up to 4 hours post dose
Secondary outcome [10] 0 0
KAN-101 plasma exposure in Part B and Part C: t½
Timepoint [10] 0 0
0 (pre-dose) and up to 4 hours post dose
Secondary outcome [11] 0 0
Incidence and severity of TEAE as assessed by the CTCAE in Part B and Part C.
Timepoint [11] 0 0
Week 52

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Wesley Research Institute - Auchenflower
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [6] 0 0
St John of God Midland Public and Private Hospitals - Midland
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6056 - Midland
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
New Zealand
State/province [18] 0 0
Auckland
Country [19] 0 0
New Zealand
State/province [19] 0 0
Bay Of Plenty
Country [20] 0 0
New Zealand
State/province [20] 0 0
Hawke's Bay
Country [21] 0 0
New Zealand
State/province [21] 0 0
Otago
Country [22] 0 0
New Zealand
State/province [22] 0 0
Wellington
Country [23] 0 0
New Zealand
State/province [23] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Anokion SA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kanyos Bio, Inc. (a wholly owned subsidiary of Anokion S.A.)
Address 0 0
Country 0 0
Phone 0 0
+1 857-320-6607
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05574010