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A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease

NCT06807463 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-08

No results posted yet for this study

Summary

The primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease.

The primary safety objective of the trial is to assess the safety of TEV-53408 in adults with celiac disease.

A secondary objective is to further assess the efficacy of TEV-53408 in adults with celiac disease.

The expected trial duration per participant is approximately 86 weeks.

Conditions

Interventions

DRUG

TEV-53408

Solution for subcutaneous (sc) injection

DRUG

Placebo

Solution for subcutaneous (sc) injection

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D LLC

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-09-15
Completion
2027-09-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Finland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06807463 on ClinicalTrials.gov