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

NCT05660109 | Completed Phase 2 DMC

• 1 other identifier: TCeD21
• Study Type: interventional
• Target: 28
• Locations: 6 countries
• Sites: 8

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

Conditions

Celiac Disease

Keywords

celiac disease; tolerance

Outcome Measures

Primary Outcomes (1)

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

  throughout the study, on average 43 days

Study Arms (2)

TPM502

EXPERIMENTAL

Drug: TPM502

placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

TPM502 DRUG

TPM502 contains 3 peptides each consisting of two overlapping T cell epitopes that encompass the major gluten epitopes for HLA-DQ2.5

TPM502

Placebo OTHER

Placebo

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Topas Therapeutics GmbH: lead

Study Sites (8)

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Wesley Research Institute

Brisbane, 4066, Australia

Location

CRST Oy

Turku, FI-20520, Finland

Location

Charite' Hospital

Berlin, 12200, Germany

Location

Centre for Human Drug Research

Leiden, 2333 ZA, Netherlands

Location

Oslo University Hospital HF - Rikshospitalet

Oslo, 0372, Norway

Location

University Hospital of North-Norway

Tromsø, 9038, Norway

Location

Clinical Trial Consultants, Uppsala University

Uppsala, 752 37, Sweden

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Knut Lundin, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 21, 2022
• Study Start: December 12, 2022
• Primary Completion: July 4, 2024
• Study Completion: August 8, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); SE (1); FI (1); AU (2); NO (2); DE (1)