A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Trial to Characterize the Efficacy and Safety of TEV-53408 in Adults with Celiac Disease While Undergoing Oral Gluten Exposure

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517081-42-00

Acronym

TV53408-IMM-20042

Enrollment

Registered

2025-04-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Brief summary

Change from baseline in villous atrophy, as assessed by Vh:Cd, at week 8., Incidence of treatment-emergent adverse events up to week 28., Incidence of serious adverse events up to week 28., Incidence of PDAESIs up to week 28., Incidence of early discontinuations during the treatment period (up to week 28) due to an adverse event.

Detailed description

Change from baseline in IEL density at week 8., Change from baseline in a composite measure of VCIEL at week 8.

Interventions

DRUGPlacebo to match TEV-53408

DRUGTEV-53408

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in villous atrophy, as assessed by Vh:Cd, at week 8., Incidence of treatment-emergent adverse events up to week 28., Incidence of serious adverse events up to week 28., Incidence of PDAESIs up to week 28., Incidence of early discontinuations during the treatment period (up to week 28) due to an adverse event.	—

Secondary

Measure	Time frame
Change from baseline in IEL density at week 8., Change from baseline in a composite measure of VCIEL at week 8.	—

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026