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

Last updated: September 26, 2024
Sponsor: Topas Therapeutics GmbH
Overall Status: Completed

Phase

2

Condition

Celiac Disease

Treatment

TPM502

Placebo

Clinical Study ID

NCT05660109
TCeD21
  • Ages 18-70
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Availability of a documented biopsy-confirmed diagnosis of CeD OR documented tissuetransglutaminase >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 atscreening

  • Patients must have been on GFD for ≥ 6 months

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

  • HLA-DQ2.5 positive

Exclusion

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, whichin the opinion of the investigator might interfere with the assessment of thesymptoms related to CeD

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

  • Known wheat allergy

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

Study Design

Total Participants: 38
Treatment Group(s): 2
Primary Treatment: TPM502
Phase: 2
Study Start date:
December 12, 2022
Estimated Completion Date:
July 04, 2024

Study 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.

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide, 5000
    Australia

    Site Not Available

  • Wesley Research Institute

    Brisbane, 4066
    Australia

    Site Not Available

  • CRST Oy

    Turku, FI-20520
    Finland

    Site Not Available

  • Charite' Hospital

    Berlin, 12200
    Germany

    Site Not Available

  • Centre for Human Drug Research

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Oslo University Hospital HF - Rikshospitalet

    Oslo, 0372
    Norway

    Site Not Available

  • University Hospital of North-Norway

    Tromsø, 9038
    Norway

    Site Not Available

  • Clinical Trial Consultants, Uppsala University

    Uppsala, 752 37
    Sweden

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.