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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05660109




Registration number
NCT05660109
Ethics application status
Date submitted
5/12/2022
Date registered
21/12/2022
Date last updated
27/09/2024

Titles & IDs
Public title
A Study to Assess the Safety of TPM502 in Adults With Celiac Disease
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
Secondary ID [1] 0 0
TCeD21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Celiac Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence, severity, causality, and outcomes of treatment-emergent adverse events
Timepoint [1] 0 0
throughout the study, on average 43 days

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/07/2024
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Wesley Research Institute - Brisbane
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4066 - Brisbane
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Turku
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Netherlands
State/province [3] 0 0
Leiden
Country [4] 0 0
Norway
State/province [4] 0 0
Oslo
Country [5] 0 0
Norway
State/province [5] 0 0
Tromsø
Country [6] 0 0
Sweden
State/province [6] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Topas Therapeutics GmbH
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT05660109
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Knut Lundin, MD
Address 0 0
Oslo University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Veronica Asnaghi, MD
Address 0 0
Country 0 0
Phone 0 0
+41 (0)79 5722414
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05660109