Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   43216   clinical trials with a EudraCT protocol, of which   7153   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2019-001727-12
    Sponsor's Protocol Code Number:TPV11
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-12
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2019-001727-12
    A.3Full title of the trial
    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
    Multizentrische, offene Phase-1-Studie, Teil A mit Einzeldosen in aufsteigenden Konzentrationen, Teil B mit Mehrfachdosen, zur Bewertung der Sicherheit, Verträglichkeit und Pharmakokinetik und zur Untersuchung früher Anzeichen der Wirksamkeit bei der Induktion der antigenspezifischen Immuntoleranz durch TPM203 bei PV-Patienten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.
    Erste Anwendung der Prüfsubstanz TPM203 in verschiedenen Dosen bei Patienten mit Pemphigus vulgaris, um die Sicherheit, Verträglichkeit und das Verhalten der Substanz im Körper zu testen und ggf. erste Wirksamkeitsanzeichen zu sehen.
    A.4.1Sponsor's protocol code numberTPV11
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTopas Therapeutics GmbH
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTopas Therapeutics GmbH
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKoordinierungszentrum für Klinische Studien Marburg (KKS)
    B.5.2Functional name of contact pointSusanne Harnisch
    B.5.3 Address:
    B.5.3.1Street AddressKarl-von-Frisch-Straße 4
    B.5.3.2Town/ cityMarburg
    B.5.3.3Post code35043
    B.5.4Telephone number+49064212866553
    B.5.5Fax number+49064212866517
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTPM203
    D.3.4Pharmaceutical form Dispersion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D. medicinal product typeNon-biological complex drug (NBCD) TPM203 is a mixture of four Topas Particle Conjugates (TPC0002, TPC0003,TPC0005 and TPC0012)
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pemphigus vulgaris
    Pemphigus vulgaris
    E.1.1.1Medical condition in easily understood language
    Pemphigus vulgaris is a blistering skin disorder in which antibodies target the body's own tissues.
    Pemphigus vulgaris ist eine blasenbildende Hauterkrankung, bei der sich Antikörper gegen körpereigenes Gewebe richten.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052802
    E.1.2Term Pemphigus vulgaris
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of the intravenous infusion of TPM203 in pemphigus vulgaris (PV) patients.
    Untersuchung der Sicherheit und Verträglichkeit der intravenösen Infusion von TPM203 bei Patienten mit Pemphigus vulgaris (PV).
    E.2.2Secondary objectives of the trial
    Secondary: Pharmacokinetics of TPM203 in PV patients
    Sekundär: Pharmakokinetik von TPM203 bei PV-Patienten
    E.2.3Trial contains a sub-study No
    E.3Principal 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.

    1. Schriftliche Einverständniserklärung zur Teilnahme an der Studie
    2. Alter des Patienten (männlich oder weiblich) zwischen ≥ 18 Jahre und ≤ 70 Jahre
    3. Körpergewicht ≥ 50 kg und Body-Mass-Index ≥ 18,5 und ≤ 32 kg / m2
    4. Dokumentierte Diagnose von PV und beim Screening vollständige klinische Remission oder geringe bis mäßige klinische Krankheitsaktivität (d. H. ABSIS ≤17 und PDAI ≤15)
    5. Beim Screening Anwesenheit von Anti-Dsg3-IgG (Immunglobulin G) -Antikörpern und CD4 + -T-Zellen in peripherem Blut, die für mindestens eines der in TPM203 verwendeten Dsg3-Peptide spezifisch sind
    E.4Principal exclusion criteria
    1. Immunosuppressive or immunomodulatory treatment during the study other than prednisolone ≤10 mg/d (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.
    1. Andere immunsuppressive oder immunmodulatorische Behandlung während der Studie als Prednisolon ≤ 10 mg / d (oder äquipotente Dosen anderer Steroide)
    2. Erkrankungen einschließlich früherer oder begleitender Medikamente, die ein Risiko für den Patienten darstellen und / oder die Erreichung der Ziele der Studie behindern könnten.
    E.5 End points
    E.5.1Primary 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.
    Primäre Endpunkte: Sicherheit und Verträglichkeit von TPM203, bestimmt anhand der Häufigkeit und Schwere von Nebenwirkungen (TEAEs) und einer Verschlechterung der PV während und innerhalb von 28 Tagen nach der Applikation des Prüfpräparates.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation during and within 28 days after first administration of TPM203
    Erfassung während und innerhalb von 28 Tagen nach der Applikation von TPM203
    E.5.2Secondary end point(s)
    • Pharmacokinetics
    • Pharmakokinetik
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A only from pre-dose (day 1) up to 23 hours after start of IMP administration

    Nur in Part A im Zeitraum von pre-dose (Tag 1) bis zu 23 Stunden nach dem Start der IMP-Gabe
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Data base closure
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not different from the expected normal treatment of that condition
    Nicht anders als die normale Behandlung von PV
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice