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 (CeD)

Recruiting

Conditions: Coeliac disease
Gluten intolerance
10017943

Registration Number: NL-OMON53376

Lead Sponsor: Topas Therapeutics GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

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

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence, severity, causality and outcomes of TEAEs (serious and nonserious),<br /><br>including hypersensitivity reactions, CRS, hepatotoxicity and other AEs<br /><br>suggestive of these conditions.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Ratio Interleukin 2 (IL-2) after GC post-TPM502 treatment/IL-2 after GC at<br /><br>screening compared to the placebo group<br /><br>• Modified Celiac disease patient*reported outcome (CeD PRO®) and GloSS (Global<br /><br>Symptom Survey) 1 hour before and then hourly up to 6 hours post GC/ TPM502<br /><br>compared to placebo<br /><br>• Maximum observed plasma concentration after dosing (Cmax), area under the<br /><br>plasma concentration-time curve from time zero to the time of the last<br /><br>quantifiable sample (AUC0-last).</p><br>