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

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 toleratedif TPM502 can induce modifications in parameters indicating that it may induce tolerance to glutenParticipants 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

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 screeningSerum IL-2 levels (AUC1-6h) above a pre-defined threshold following the GC at screeningPatients must have been on GFD for ≥ 6 monthsPatients 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 assessmentHLA-DQ2.5 positiveExclusion Criteria:Known or suspected refractory CeD (refractory CeD type I or II)Known intolerable symptoms following previous GCs, as per investigator's assessmentHLA DQ8 positiveAny 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 CeDKnown history of or active Crohn's disease, ulcerative colitis, or ulcerative jejunitisKnown wheat allergyKnown hypersensitivity to i.v. iron preparations or any other excipients present in the reconstituted TPM502 or placebo