A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
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| ClinicalTrials.gov Identifier: NCT05574010 |
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Recruitment Status :
Recruiting
First Posted : October 10, 2022
Last Update Posted : April 4, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Celiac Disease | Drug: Cohort 1 in Part A Drug: Cohort 2 in Part A Other: Placebo: Group 1 in Part B and Part C Drug: Group 2 in Part B and Part C Drug: Group 3 in Part B and Part C Drug: Group 4 in Part B and Part C | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 126 participants |
| Allocation: | 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. |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| 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. |
| 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) |
| Actual Study Start Date : | November 15, 2022 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | December 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort 1 in Part A
All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 1
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Drug: Cohort 1 in Part A
Dose 1 KAN-101 Intravenous (IV) infusion
Other Name: KAN-101 |
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Experimental: Cohort 2 in Part A
All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 2
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Drug: Cohort 2 in Part A
Dose 2 KAN-101 Intravenous (IV) infusion
Other Name: KAN-101 |
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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
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Other: Placebo: Group 1 in Part B and Part C
Placebo Intravenous (IV) infusion
Other Name: Placebo |
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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
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Drug: Group 2 in Part B and Part C
Dose 3 KAN-101 Intravenous (IV) infusion
Other Name: KAN-101 |
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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
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Drug: Group 3 in Part B and Part C
Dose 4 KAN-101 Intravenous (IV) infusion
Other Name: KAN-101 |
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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
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Drug: Group 4 in Part B and Part C
Dose 5 KAN-101 Intravenous (IV) infusion
Other Name: KAN-101 |
- Incidence and severity of TEAEs as assessed by common terminology criteria for adverse events (CTCAE) in Part A [ Time Frame: 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 [ Time Frame: Baseline to Day 15 ]Primary endpoint in Part B
- Change in magnitude of IL-2 response pre- and post-GC in peripheral blood [ Time Frame: 0 (pre-GC) and 4 hours post-GC on Day 15 ]Primary endpoint in Part C
- KAN-101 plasma exposure in Part A: AUCinf [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: Week 52 ]Secondary endpoint in Part B and Part C
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | 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:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05574010
| Contact: Kanyos Bio, Inc. (a wholly owned subsidiary of Anokion S.A.) | +1 857-320-6607 | clinicaltrials@anokion.com |
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| Study Director: | Study Director | Anokion SA |
| Responsible Party: | Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA |
| ClinicalTrials.gov Identifier: | NCT05574010 |
| Other Study ID Numbers: |
KAN-101-02 |
| First Posted: | October 10, 2022 Key Record Dates |
| Last Update Posted: | April 4, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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celiac disease HLA-DQ2.5 gluten free diet |
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Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |