A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease
ClinicalTrials.gov processed this data on October 8, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified October 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
NCT06001177Other Study ID Numbers: KAN-101-03
First Submitted: August 7, 2023
First Posted: August 21, 2023
Last Update Posted: October 10, 2024
Last Verified: October 2024
History of Changes
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Study Description
Study KAN-101-03 is a multi-center, double-blind, placebo-controlled Phase 2a study to examine whether KAN-101 confers protection from gluten exposure induced histological changes in the duodenum and to further evaluate the safety/tolerability of KAN-101 in adult participants (≥18 years) with CeD on a gluten free diet. Up to 52 participants who meet study inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.Condition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Anticipated Enrollment | 52 participants |
Design Allocation | Randomized |
Interventional Model | Parallel Assignment |
Masking | Triple |
Primary Purpose | Treatment |
Official Title | A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease |
Study Start Date | December 13, 2023 |
Anticipated Primary Completion Date | March 2025 |
Anticipated Study Completion Date | June 2025 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC) [29 days] Vh:Cd is the ratio of villous height to crypt depth, a histological assessment
Secondary Outcome Measures
- Change in magnitude of IL-2 response from Day 15 (first day of GC) pre GC to Day 15 post GC [15 days] IL-2 is interleukin-2
- Changes from baseline in IEL density in duodenum biopsy after 2-week GC [29 days] IEL is intraepithelial lymphocyte
- Incidence and severity of treatment emergent adverse events as assessed by the CTCAE [42 days] Common Terminology Criteria for Adverse Events (CTCAE) is a scale with 5 grades to assess Adverse Event (AE) severity
- Incidence of KAN-101 ADA [42 days] ADA is antidrug antibody
- Titer of KAN-101 ADA [42 days] ADA is antidrug antibody
- KAN-101 plasma concentration: AUCinf [7 days] Pharmacokinetic (PK) sample collection at pre and post dose timepoints
- KAN-101 plasma concentration: AUClast [7 days] PK sample collection at pre and post dose timepoints
- KAN-101 plasma concentration: Cmax [7 days] PK sample collection at pre and post dose timepoints
- KAN-101 plasma concentration: Tmax [7 days] PK sample collection at pre and post dose timepoints
- KAN-101 plasma concentration: T1/2 [7 days] PK sample collection at pre and post dose timepoints
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