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A Study to Assess the Safety of TPM502 in Adults With Celiac Disease

NCT05660109 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-12-03

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about the safety and the pharmacodynamic (PD) effects of TPM502 in adults with celiac disease. The main questions it aims to answer are:

* if TPM502 is safe and well tolerated
* if TPM502 can induce modifications in parameters indicating that it may induce tolerance to gluten

Participants will:

* undergo 1-day gluten challenge during screening and after administration of TPM502 or placebo.
* receive 2 infusions of TPM502 or placebo, 2 weeks apart

Conditions

Interventions

DRUG

TPM502

TPM502 contains 3 peptides each consisting of two overlapping T cell epitopes that encompass the major gluten epitopes for HLA-DQ2.5

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Topas Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Knut Lundin, MD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2024-07-04
Completion
2024-08-08

Countries

  • Australia
  • Finland
  • Germany
  • Netherlands
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

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 NCT05660109 on ClinicalTrials.gov