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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05660109
Registration number
NCT05660109
Ethics application status
Date submitted
5/12/2022
Date registered
21/12/2022
Date last updated
28/05/2024
Titles & IDs
Public title
A Study to Assess the Safety of TPM502 in Adults With Celiac Disease
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Scientific 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
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Secondary ID [1]
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TCeD21
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Celiac Disease
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TPM502
Other interventions - Placebo
Experimental: TPM502 -
Placebo Comparator: placebo -
Treatment: Drugs: TPM502
TPM502 contains 3 peptides each consisting of two overlapping T cell epitopes that encompass the major gluten epitopes for HLA-DQ2.5
Other interventions: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence, severity, causality, and outcomes of treatment-emergent adverse events
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Assessment method [1]
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Timepoint [1]
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throughout the study, on average 43 days
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/05/2024
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Actual
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Sample size
Target
42
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Wesley Research Institute - Brisbane
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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4066 - Brisbane
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Recruitment outside Australia
Country [1]
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Finland
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State/province [1]
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Turku
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Country [2]
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Germany
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State/province [2]
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Berlin
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Country [3]
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Netherlands
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State/province [3]
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Leiden
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Country [4]
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Norway
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State/province [4]
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Oslo
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Country [5]
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Norway
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State/province [5]
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Tromsø
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Country [6]
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Sweden
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State/province [6]
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Uppsala
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Topas Therapeutics GmbH
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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:
- 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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05660109
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Knut Lundin, MD
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Address
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Oslo University Hospital
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Veronica Asnaghi, MD
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Address
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Country
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Phone
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+41 (0)79 5722414
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05660109
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