CompletedPhase 2
A Study to Assess the Safety of TPM502 in Adults With Celiac Disease
Key facts
- Who runs it
- Topas Therapeutics GmbH
- Where
- Australia, Finland, Germany, Netherlands, Norway, and Sweden8 sites in 6 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 28 people enrolled
- Started
- 12 Dec 2022
- Ended
- 8 Aug 2024
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- TPM502
- Placebo
- Record updated
- 3 December 2025
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Known intolerable symptoms following previous GCs, as per investigator's assessment
- 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
- Known or suspected refractory CeD (refractory CeD type I or II)
- HLA DQ8 positive
This trial has no sites in United States.
It has sites in 6 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
The goal of this clinical trial is to learn about the safety and the pharmacodynamic (PD) effects of TPM502 in adults with celiac disease. The main questions it aims to answer are:
Read full original descriptionShow less
* if TPM502 is safe and well tolerated * if TPM502 can induce modifications in parameters indicating that it may induce tolerance to gluten
Participants will:
* undergo 1-day gluten challenge during screening and after administration of TPM502 or placebo. * receive 2 infusions of TPM502 or placebo, 2 weeks apart
The 2 groups in the trial
- TPM502Treatment being tested
- placeboPlacebo, for comparison
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 3 December 2025