Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05660109
Study type Interventional
Source Topas Therapeutics GmbH
Contact Veronica Asnaghi, MD
Phone +41 (0)79 5722414
Email Asnaghi@topas-therapeutics.com
Status Recruiting
Phase Phase 2
Start date December 12, 2022
Completion date May 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT04349904 - Near-Focus NBI Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Completed NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Completed NCT05810441 - Intestinal Transglutaminase Antibodies in Celiac Disease Diagnosis
Recruiting NCT05555446 - Bovine Colostrum to Prevent Absorption of Gluten Early Phase 1
Completed NCT02754609 - Hookworm Therapy for Coeliac Disease Phase 1
Terminated NCT01902368 - Celiac Disease Screening N/A
Completed NCT02312349 - Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
Completed NCT02472704 - Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo N/A
Recruiting NCT01172665 - Celiac Disease Database
Completed NCT01100099 - HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease Phase 2/Phase 3
Completed NCT00639444 - Risk of Celiac Disease and Age at Gluten Introduction N/A
Recruiting NCT05425446 - Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients Phase 1
Enrolling by invitation NCT02202681 - Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule N/A
Completed NCT00362856 - Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects Phase 2
Terminated NCT03866538 - Budesonide in Patients With Immune Mediated Enteropathies Phase 4
Recruiting NCT05135923 - Glutenfree, Gut Microbiota and Metabolic Regulation N/A
Completed NCT05052164 - Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women N/A
Completed NCT03775499 - Probiotic BL NCC 2705 and Gluten Sensitivity N/A
Completed NCT03707730 - A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease Phase 2