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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
Royal Adelaide Hospital
Adelaide, Australia
Wesley Research Institute
Brisbane, Australia
CRST Oy
Turku, Finland
Charite' Hospital
Berlin, Germany
Incidence, severity, causality, and outcomes of treatment-emergent adverse events
Time frame: throughout the study, on average 43 days
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Centre for Human Drug Research
Leiden, Netherlands
Oslo University Hospital HF - Rikshospitalet
Oslo, Norway
University Hospital of North-Norway
Tromsø, Norway
Clinical Trial Consultants, Uppsala University
Uppsala, Sweden