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Trial record 1 of 1 for:    TPM502 | Celiac Disease
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A Study to Assess the Safety of TPM502 in Adults With Celiac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05660109
Recruitment Status : Recruiting
First Posted : December 21, 2022
Last Update Posted : June 6, 2023
Sponsor:
Information provided by (Responsible Party):
Topas Therapeutics GmbH

Study Description
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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

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: TPM502 Other: Placebo Phase 2

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 12, 2022
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : May 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: TPM502 Drug: TPM502
TPM502 contains 3 peptides each consisting of two overlapping T cell epitopes that encompass the major gluten epitopes for HLA-DQ2.5
Placebo Comparator: placebo Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Incidence, severity, causality, and outcomes of treatment-emergent adverse events [ Time Frame: throughout the study, on average 43 days ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05660109


Contacts
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Contact: Veronica Asnaghi, MD +41 (0)79 5722414 Asnaghi@topas-therapeutics.com

Locations
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Finland
CRST Oy Recruiting
Turku, Finland, FI-20520
Contact: Mika Scheinin, MD       mika.scheinin@crst.fi   
Netherlands
Centre for Human Drug Research Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Naomi Klarenbeek, MD       nklarenbeek@chdr.nl   
Norway
Oslo University Hospital HF - Rikshospitalet Recruiting
Oslo, Norway, 0372
Contact: Knut Lundin, MD       knut.lundin@medisin.uio.no   
University Hospital of North-Norway Recruiting
Tromsø, Norway, 9038
Contact: Rasmus Goll, MD       rasmus.goll@unn.no   
Sweden
Clinical Trial Consultants, Uppsala University Recruiting
Uppsala, Sweden, 752 37
Contact: Per M Hellström, MD       per.hellstrom@medsci.uu.se   
Sponsors and Collaborators
Topas Therapeutics GmbH
Investigators
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Principal Investigator: Knut Lundin, MD Oslo University Hospital
More Information
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Responsible Party: Topas Therapeutics GmbH
ClinicalTrials.gov Identifier: NCT05660109    
Other Study ID Numbers: TCeD21
First Posted: December 21, 2022    Key Record Dates
Last Update Posted: June 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Topas Therapeutics GmbH:
celiac disease
tolerance
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases