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)

Topas Therapeutics GmbH0 个研究点目标入组 42 人开始时间: 2023年1月31日最近更新: 2024年1月15日

研究概览

暂无简介。

•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
•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

•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

发起方