A placebo-controlled study to evaluate the safety, tolerability, biochemical and physiologic effects of two infusions of escalating doses of TPM502 in adults diagnosed with celiac disease

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 (CeD)

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001656-41-SE

Enrollment

Registered

2022-11-16

Start date

2023-04-24

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coeliac disease

Interventions

Product Code: TPM502 Pharmaceutical Form: Dispersion for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Availability of a documented biopsy-confirmed diagnosis of CeD OR documented tissue transglutaminase >10x upper limit of normal (ULN) and documented positive immunoglobulin A (IgA) anti-endomysial antibody (EMA) at time of CeD diagnosis (as per local guidelines) 2. Serum anti-tissue transglutaminase 2 immunoglobin A antibodies within normal range at screening 3. Serum IL-2 levels (AUC1-6h) > 2x AUC1-6h at the lower level of quantification (LLOQ) (i.e., 8x LLOQ) following the GC at screening 4. Patients must have been on gluten-free diet (GFD) for = 6 months 5. 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 6. Human leukocyte antigen (HLA)-DQ2.5 positive (homozygous and heterozygous) but HLA-DQ8 and HLA-DQ2.2 negative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Known or suspected refractory CeD (refractory CeD type I or II) 2. Known intolerable symptoms following previous GCs, as per investigator`s assessment 3. Treatment with systemic immunosuppressants (e.g., glucocorticoids), ongoing or administered in the 12 weeks preceding the first investigational medicinal product (IMP) administration

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and tolerability of two i.v. infusions of escalating doses of TPM502 in CeD patients.;Secondary Objective: • To identify PD effects consistent with the induction of antigen-specific immune tolerance following the administration of TPM502 • To describe the severity of gastrointestinal (GI) symptoms following the administration of TPM502 and a GC • To determine TPM502 PK Exploratory objectives: • To assess ex vivo gluten-specific T cell responses following TPM502 administration • To assess changes in T cell phenotypes upon TPM502 treatment • To further investigate the mechanism of action of TPM502. ;Primary end point(s): Incidence, severity, causality and outcomes of TEAEs (serious and non-serious), including hypersensitivity reactions, CRS, hepatotoxicity and other AEs suggestive of these conditions.;Timepoint(s) of evaluation of this end point: Continuous monitoring, all time points.	—

Measure

Time frame

Main Objective: To evaluate the safety and tolerability of two i.v. infusions of escalating doses of TPM502 in CeD patients.;Secondary Objective: • To identify PD effects consistent with the induction of antigen-specific immune tolerance following the administration of TPM502 • To describe the severity of gastrointestinal (GI) symptoms following the administration of TPM502 and a GC • To determine TPM502 PK Exploratory objectives: • To assess ex vivo gluten-specific T cell responses following TPM502 administration • To assess changes in T cell phenotypes upon TPM502 treatment • To further investigate the mechanism of action of TPM502. ;Primary end point(s): Incidence, severity, causality and outcomes of TEAEs (serious and non-serious), including hypersensitivity reactions, CRS, hepatotoxicity and other AEs suggestive of these conditions.;Timepoint(s) of evaluation of this end point: Continuous monitoring, all time points.

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Secondary

Measure	Time frame
Secondary end point(s): • Ratio “Interleukin 2 (IL-2) after GC post-TPM502 treatment/IL-2 after GC at screening” compared to the placebo group • Modified Celiac disease patient-reported outcome (CeD PRO®) and GloSS (Global Symptom Survey) 1 hour before and then hourly up to 6 hours post GC/ TPM502 compared to placebo • Maximum observed plasma concentration after dosing (Cmax), area under the plasma concentration-time curve from time zero to the time of the last quantifiable sample (area under the curve (AUC) 0-last ;Timepoint(s) of evaluation of this end point: Continuous monitoring, all time points.	—

Measure

Time frame

Secondary end point(s): • Ratio “Interleukin 2 (IL-2) after GC post-TPM502 treatment/IL-2 after GC at screening” compared to the placebo group • Modified Celiac disease patient-reported outcome (CeD PRO®) and GloSS (Global Symptom Survey) 1 hour before and then hourly up to 6 hours post GC/ TPM502 compared to placebo • Maximum observed plasma concentration after dosing (Cmax), area under the plasma concentration-time curve from time zero to the time of the last quantifiable sample (area under the curve (AUC) 0-last ;Timepoint(s) of evaluation of this end point: Continuous monitoring, all time points.

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Countries

Finland, Germany, Netherlands, Norway, Sweden

Contacts

Public ContactHead of Clinical Operations

Topas Therapeutics GmbH

clinicaltrials@topas-therapeutics.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026