celiac disease
Conditions
Brief summary
Changes from baseline in Vh:Cd ratio as assessed by esophagogastroduodenoscopy (EGD) with biopsy after 2-week GC (at Day 29).
Detailed description
IL-2 change from Day 15 (first day of GC) pre GC to Day 15 post GC., Changes from baseline in IEL density in duodenum biopsy after 2-week GC (at Day 29)., •Incidence and severity of treatment emergent AEs as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (or higher). •Incidence and titer of KAN-101 anti-drug antibodies (ADA)., Plasma concentration of KAN-101, and associated KAN-101 parameters: AUCinf, AUClast, Cmax, Tmax and t½.
Interventions
DRUGSODIUM CHLORIDE
Sponsors
Kanyos Bio Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in Vh:Cd ratio as assessed by esophagogastroduodenoscopy (EGD) with biopsy after 2-week GC (at Day 29). | — |
Secondary
| Measure | Time frame |
|---|---|
| IL-2 change from Day 15 (first day of GC) pre GC to Day 15 post GC., Changes from baseline in IEL density in duodenum biopsy after 2-week GC (at Day 29)., •Incidence and severity of treatment emergent AEs as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (or higher). •Incidence and titer of KAN-101 anti-drug antibodies (ADA)., Plasma concentration of KAN-101, and associated KAN-101 parameters: AUCinf, AUClast, Cmax, Tmax and t½. | — |
Countries
Finland, Germany, Ireland, Netherlands, Poland
Outcome results
None listed