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

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660109
• Other study ID #: TCeD21
• Status: Recruiting
• Phase: Phase 2
• Start date: December 12, 2022
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Topas Therapeutics GmbH
• Contact: Veronica Asnaghi, MD
• Phone: +41 (0)79 5722414
• Email: Asnaghi[@]topas-therapeutics.com
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Availability of a documented biopsy-confirmed diagnosis of CeD OR documented tissue transglutaminase >10x ULN and documented positive IgA anti-endomysial antibody (EMA) at time of CeD diagnosis (as per local guidelines)

• Serum anti-tissue transglutaminase 2 immunoglobin A antibodies within normal range (i.e., <15 U/mL) at screening

• Serum IL-2 levels (AUC1-6h) above a pre-defined threshold following the GC at screening

• Patients must have been on GFD for = 6 months

• Patients must have well-controlled CeD, defined as mild or with no ongoing signs or symptoms felt to be related to active CeD, as per investigator's assessment

• HLA-DQ2.5 positive

Exclusion Criteria:

• Known or suspected refractory CeD (refractory CeD type I or II)

• Known intolerable symptoms following previous GCs, as per investigator's assessment

• HLA DQ8 positive

• Any active gastrointestinal disease such as gastroesophageal reflux disease, esophagitis or peptic ulcer, microscopic colitis, or irritable bowel syndrome, which in the opinion of the investigator might interfere with the assessment of the symptoms related to CeD

• Known history of or active Crohn's disease, ulcerative colitis, or ulcerative jejunitis

• Known wheat allergy

• Known hypersensitivity to i.v. iron preparations or any other excipients present in the reconstituted TPM502 or placebo

Related Conditions & MeSH terms

• Celiac Disease

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Wesley Research Institute	Brisbane
Finland	CRST Oy	Turku
Germany	Charite' Hospital	Berlin
Netherlands	Centre for Human Drug Research	Leiden
Norway	Oslo University Hospital HF - Rikshospitalet	Oslo
Norway	University Hospital of North-Norway	Tromsø
Sweden	Clinical Trial Consultants, Uppsala University	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Topas Therapeutics GmbH

Countries where clinical trial is conducted

Australia,  Finland,  Germany,  Netherlands,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, severity, causality, and outcomes of treatment-emergent adverse events		throughout the study, on average 43 days