NCT05660109

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

A Double-blind, Randomized, Placebo-controlled, Phase 2a Study to Evaluate the Safety, Tolerability, and Pharmacodynamic (PD) Effects of Two Infusions of Escalating Doses of TPM502 in Adults Diagnosed With Celiac Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Topas Therapeutics GmbH · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a multi center, double-blind, randomized, placebo-controlled Phase 2a study to evaluate the safety, tolerability, and PD effects of two infusions of TPM502 in adult patients diagnosed with CeD. The patient´s participation in the study comprises 3 phases: screening period, treatment period and follow-up period. Patients fulfilling the eligibility criteria will be randomized to receive two infusions of TMP502 (or placebo) at the same dose level. Patients will undergo a second GC one week after the second infusion of TPM502. The study includes 4 cohorts of patients, each cohort will receive escalating doses of TPM502 (or placebo). Upon completion of the 3rd cohort, a lower dose can be investigated, if deemed relevant.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-12-12
• Primary completion: 2024-07-04
• Completion: 2024-08-08
• First posted: 2022-12-21
• Last updated: 2025-12-03

Locations

8 sites across 6 countries: Australia, Finland, Germany, Netherlands, Norway, Sweden