A Study to Assess the Safety of TPM502 in Adults With Celiac Disease
Celiac Disease
About this trial
This is an interventional treatment trial for Celiac Disease focused on measuring celiac disease, tolerance
Eligibility 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
Sites / Locations
- Wesley Research InstituteRecruiting
- CRST OyRecruiting
- Charite' HospitalRecruiting
- Centre for Human Drug ResearchRecruiting
- Oslo University Hospital HF - RikshospitaletRecruiting
- University Hospital of North-NorwayRecruiting
- Clinical Trial Consultants, Uppsala UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
TPM502
placebo