First use of TPM203 in various doses in patients with pemphigus vulgaris to to evaluate the safety, tolerability, and metabolism and to explore early signs of effectiveness.

A multi-centre, open-label, phase 1 study, Part A single ascending dose and Part B multiple dose, to evaluate the safety, tolerability and pharmacokinetics, and to explore early signs of effectiveness of induction of antigen-specific immune tolerance with TPM203 in pemphigus vulgaris patients

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001727-12-DE

Enrollment

Registered

2019-06-12

Start date

2019-10-24

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pemphigus vulgaris MedDRA version: 20.0 Level: LLT Classification code 10052802 Term: Pemphigus vulgaris System Organ Class: 100000004858

Interventions

Product Name: TPM203 Pharmaceutical Form: Dispersion for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent to take part in the study 2.Patient (male or female) age =18 years and =70 years 3.Body weight of =50 kg and a body mass index =18.5 and =32 kg/m2 4.Diagnosis with PV (documented) and at screening complete clinical remission or low to moderate clinical disease activity (i.e. ABSIS =17 and PDAI =15) 5.Presence of anti-Dsg3 IgG (immunoglobulin G) antibodies and peripheral blood CD4+ T cells specific for at least one of the Dsg3 peptides employed in TPM203 in blood samples at screening or presence of human leucocyte antigen (HLA)-DRB1*04:02 and/or HLA-DQB1*05:03. 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: 1.Immunosuppressive or immunomodulatory treatment during the study other than prednisolone =10 mg/d for patients with body weight <70 kg or =12.5 mg/d for patients with body weight = 70 kg (or equipotent doses of other steroids) 2.Conditions including previous or concomitant medication that might present a risk to the patient and/or impede the attainment of the study's objectives.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and tolerability of the intravenous infusion of TPM203 in pemphigus vulgaris (PV) patients.;Secondary Objective: Secondary: Pharmacokinetics of TPM203 in PV patients ;Primary end point(s): Primary endpoints: safety and tolerability of TPM203 measured by frequency and severity of treatment-emergent adverse events (TEAEs) and worsening of PV during IMP administration and within 28 days after study treatment.;Timepoint(s) of evaluation of this end point: Evaluation during and within 28 days after first administration of TPM203	—

Measure

Time frame

Main Objective: To evaluate the safety and tolerability of the intravenous infusion of TPM203 in pemphigus vulgaris (PV) patients.;Secondary Objective: Secondary: Pharmacokinetics of TPM203 in PV patients ;Primary end point(s): Primary endpoints: safety and tolerability of TPM203 measured by frequency and severity of treatment-emergent adverse events (TEAEs) and worsening of PV during IMP administration and within 28 days after study treatment.;Timepoint(s) of evaluation of this end point: Evaluation during and within 28 days after first administration of TPM203

—

Secondary

Measure	Time frame
Secondary end point(s): Pharmacokinetics ;Timepoint(s) of evaluation of this end point: Part A only from pre-dose (day 1) up to 23 hours after start of IMP administration	—

Countries

Germany, Israel, Italy, United Kingdom

Contacts

Public ContactSusanne Harnisch

Koordinierungszentrum für Klinische Studien Marburg (KKS)

susanne.harnisch@kks.uni-marburg.de+49064212866553

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026