A Phase 1B Open-label/Phase 2 Double-blind Placebo- Controlled Study for Pharmacodynamic (PD) Activity, Pharmacokinetics (PK), Safety, and Tolerability of KAN-101 In Patients With Celiac Disease (CeD)
ClinicalTrials.gov processed this data on August 16, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified August 2024 by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA, Pfizer
Sponsor
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SAInformation Provided by (Responsible Party)
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SAClinicaltrials.gov Identifier
NCT05574010Other Study ID Numbers: KAN-101-02
First Submitted: October 7, 2022
First Posted: October 10, 2022
Last Update Posted: August 19, 2024
Last Verified: August 2024
History of Changes
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Study 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.
Condition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Anticipated Enrollment | 126 participants |
Design Allocation | Randomized |
Interventional Model | Parallel Assignment |
Masking | Triple |
Primary Purpose | Treatment |
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) |
Study Start Date | November 15, 2022 |
Anticipated Primary Completion Date | December 31, 2024 |
Anticipated Study Completion Date | December 31, 2025 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Incidence and severity of TEAEs as assessed by common terminology criteria for adverse events (CTCAE) in Part A [28 days] Primary endpoint in Part A. CTCAE is a scale with 5 grades to assess AE severity.
- Change in magnitude of IL-2 response pre- and post-GC in peripheral blood in Part B [Baseline to Day 15] Primary endpoint in Part B
- Change in magnitude of IL-2 response pre- and post-GC in peripheral blood [0 (pre-GC) and 4 hours post-GC on Day 15] Primary endpoint in Part C
Secondary Outcome Measures
- KAN-101 plasma exposure in Part A: AUCinf [0 (pre-dose) and up to 7 hours post dose] PK sample collection at pre- dose and post dose timepoints in Part A.
- KAN-101 plasma exposure in Part A: AUClast [0 (pre-dose) and up to 7 hours post dose] PK sample collection at pre- dose and post dose timepoints in Part A.
- KAN-101 plasma exposure in Part A: Cmax [0 (pre-dose) and up to 7 hours post dose] PK sample collection at pre- dose and post dose timepoints in Part A.
- KAN-101 plasma exposure in Part A: Tmax [0 (pre-dose) and up to 7 hours post dose] PK sample collection at pre- dose and post dose timepoints in Part A.
- KAN-101 plasma exposure in Part A: t½ [0 (pre-dose) and up to 7 hours post dose] PK sample collection at pre- dose and post dose timepoints in Part A.
- KAN-101 plasma exposure in Part B and Part C: AUCinf [0 (pre-dose) and up to 4 hours post dose] PK sample collection at pre- dose and post dose timepoints in Part B and Part C
- KAN-101 plasma exposure in Part B and Part C: AUClast [0 (pre-dose) and up to 4 hours post dose] PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
- KAN-101 plasma exposure in Part B and Part C: Cmax [0 (pre-dose) and up to 4 hours post dose] PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
- KAN-101 plasma exposure in Part B and Part C: Tmax [0 (pre-dose) and up to 4 hours post dose] PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
- KAN-101 plasma exposure in Part B and Part C: t½ [0 (pre-dose) and up to 4 hours post dose] PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
- Incidence and severity of TEAE as assessed by the CTCAE in Part B and Part C. [Week 52] Secondary endpoint in Part B and Part C
Eligibility Criteria
Ages Eligible for Study | 18 Years to 70 Years (Adult, Older Adult) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA, Pfizer |
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Pfizer | |
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Investigators |
More Information
Publications
Additional Relevant MeSH Terms
- Celiac Disease
- Malabsorption Syndromes
- Intestinal Diseases
- Gastrointestinal Diseases
- Digestive System Diseases
- Metabolic Diseases