EUCTR2022-001656-41-FI
Active, not recruiting
Phase 1
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)
DrugsFerinject
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Topas Therapeutics GmbH
- Enrollment
- 42
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •7\. Full SARS\-Cov2 vaccination, as defined by specific national guidance.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
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
Outcomes
Primary Outcomes
Not specified
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