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A Study to Assess the Safety of TPM502 in Adults With Celiac Disease

Primary Purpose

Celiac Disease

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TPM502
Placebo
Sponsored by
Topas Therapeutics GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring celiac disease, tolerance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

TPM502

placebo

Arm Description

Outcomes

Primary Outcome Measures

Incidence, severity, causality, and outcomes of treatment-emergent adverse events

Secondary Outcome Measures

Full Information

First Posted
December 5, 2022
Last Updated
October 18, 2023
Sponsor
Topas Therapeutics GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05660109
Brief Title
A Study to Assess the Safety of TPM502 in Adults With Celiac Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Topas Therapeutics GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
This is a multi center, double-blind, randomized, placebo-controlled Phase 2a study to evaluate the safety, tolerability, and PD effects of two infusions of TPM502 in adult patients diagnosed with CeD. The patient´s participation in the study comprises 3 phases: screening period, treatment period and follow-up period. Patients fulfilling the eligibility criteria will be randomized to receive two infusions of TMP502 (or placebo) at the same dose level. Patients will undergo a second GC one week after the second infusion of TPM502. The study includes 4 cohorts of patients, each cohort will receive escalating doses of TPM502 (or placebo).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
celiac disease, tolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TPM502
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TPM502
Intervention Description
TPM502 contains 3 peptides each consisting of two overlapping T cell epitopes that encompass the major gluten epitopes for HLA-DQ2.5
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Incidence, severity, causality, and outcomes of treatment-emergent adverse events
Time Frame
throughout the study, on average 43 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica Asnaghi, MD
Phone
+41 (0)79 5722414
Email
Asnaghi@topas-therapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut Lundin, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wesley Research Institute
City
Brisbane
ZIP/Postal Code
4066
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Daveson, MD
Email
james.daveson@endosq.com
Facility Name
CRST Oy
City
Turku
ZIP/Postal Code
FI-20520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mika Scheinin, MD
Email
mika.scheinin@crst.fi
Facility Name
Charite' Hospital
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federica Branchi, MD
Email
federica.branchi@charite.de
Facility Name
Centre for Human Drug Research
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naomi Klarenbeek, MD
Email
nklarenbeek@chdr.nl
Facility Name
Oslo University Hospital HF - Rikshospitalet
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Knut Lundin, MD
Email
knut.lundin@medisin.uio.no
Facility Name
University Hospital of North-Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasmus Goll, MD
Email
rasmus.goll@unn.no
Facility Name
Clinical Trial Consultants, Uppsala University
City
Uppsala
ZIP/Postal Code
752 37
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per M Hellström, MD
Email
per.hellstrom@medsci.uu.se

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Assess the Safety of TPM502 in Adults With Celiac Disease

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