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

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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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

Conditions
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Celiac Disease

Intervention / Treatment
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* Drug: TPM502
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPM502<br> | Drug: TPM502<br>* TPM502 contains 3 peptides each consisting of two overlapping T cell epitopes that encompass the major gluten epitopes for HLA-DQ2.5<br>|
| Placebo Comparator: placebo<br> | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, severity, causality, and outcomes of treatment-emergent adverse events |  | throughout the study, on average 43 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tolerance, celiac disease