Phase
Condition
Celiac Disease
Treatment
TPM502
Placebo
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Availability of a documented biopsy-confirmed diagnosis of CeD OR documented tissuetransglutaminase >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 atscreening
Patients must have been on GFD for ≥ 6 months
Patients must have well-controlled CeD, defined as mild or with no ongoing signs orsymptoms felt to be related to active CeD, as per investigator's assessment
HLA-DQ2.5 positive
Exclusion
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, whichin the opinion of the investigator might interfere with the assessment of thesymptoms related to CeD
Known history of or active Crohn's disease, ulcerative colitis, or ulcerativejejunitis
Known wheat allergy
Known hypersensitivity to i.v. iron preparations or any other excipients present inthe reconstituted TPM502 or placebo
Study Design
Study Description
Connect with a study center
Royal Adelaide Hospital
Adelaide, 5000
AustraliaSite Not Available
Wesley Research Institute
Brisbane, 4066
AustraliaSite Not Available
CRST Oy
Turku, FI-20520
FinlandSite Not Available
Charite' Hospital
Berlin, 12200
GermanySite Not Available
Centre for Human Drug Research
Leiden, 2333 ZA
NetherlandsSite Not Available
Oslo University Hospital HF - Rikshospitalet
Oslo, 0372
NorwaySite Not Available
University Hospital of North-Norway
Tromsø, 9038
NorwaySite Not Available
Clinical Trial Consultants, Uppsala University
Uppsala, 752 37
SwedenSite Not Available
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