A placebo-controlled study to evaluate the safety, tolerability, biochemical and physiologic effects of two infusions of escalating doses of TPM502 in adults diagnosed with celiac disease

Phase 1

• Conditions: Coeliac disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2022-001656-41-FI
• Lead Sponsor: Topas Therapeutics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-26
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Availability of a documented biopsy-confirmed diagnosis of CeD OR documented tissue transglutaminase >10x upper limit of normal (ULN) and documented positive immunoglobulin A (IgA) anti-endomysial antibody (EMA) at time of CeD diagnosis (as per local guidelines)
2. Serum anti-tissue transglutaminase 2 immunoglobin A antibodies within normal range at screening
3. Serum IL-2 levels (AUC1-6h) > 2x AUC1-6h at the lower level of quantification (LLOQ) (i.e., 8x LLOQ) following the GC at screening
4. Patients must have been on gluten-free diet (GFD) for = 6 months
5. 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
6. Human leukocyte antigen (HLA)-DQ2.5 positive (homozygous and heterozygous) but HLA-DQ8 and HLA-DQ2.2 negative
7. Full SARS-Cov2 vaccination, as defined by specific national guidance.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known or suspected refractory CeD (refractory CeD type I or II)
2. Known intolerable symptoms following previous GCs, as per investigator`s assessment
3. Treatment with systemic immunosuppressants (e.g., glucocorticoids), ongoing or administered in the 12 weeks preceding the first investigational medicinal product (IMP) administration

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified