Coeliac disease
Conditions
Interventions
Product Code: TPM502
Pharmaceutical Form: Dispersion for infusion
INN or Proposed INN: TPC0203S
Current Sponsor code: TPC0203S
Other descriptive name: TPC0203S
Concentration unit: mmol/l millimole(s)/
Sponsors
Topas Therapeutics GmbH
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. | — |
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. | — |
Countries
Finland, Germany, Netherlands, Norway
Contacts
Public ContactHead of Clinical Operations
Topas Therapeutics GmbH
Outcome results
None listed