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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05660109
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Topas Therapeutics GmbH
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Knut Lundin, MD
Principal Investigator Affiliation	Oslo University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Finland, Germany, Netherlands, Norway, Sweden
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease

Additional Details

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).

Arms & Interventions

Arms

Experimental: TPM502

Placebo Comparator: placebo

Interventions

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

Contact a Trial Team

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