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    Summary
    EudraCT Number:2022-001656-41
    Sponsor's Protocol Code Number:TCeD21
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2023-01-31
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2022-001656-41
    A.3Full title of the trial
    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)
    Eine doppelblinde, randomisierte, Placebo-kontrollierte Phase-2a-Studie zur Bewertung der Sicherheit, Verträglichkeit und pharmakodynamischen (PD) Wirkung nach Dosiseskalation von zwei Infusionen von TPM502 bei Erwachsenen mit Zöliakie (CeD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    Eine Studie zur Untersuchung von Sicherheit, Verträglichkeit und der biochemischen sowie physiologischen Effekte des Prüfpräparats TPM502 im Vergleich zu einem Placebo anhand einer steigenden Dosierung nach zwei Injektionen in Erwachsenen mit Glutenunverträglichkeit.
    A.4.1Sponsor's protocol code numberTCeD21
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTopas Therapeutics GmbH
    B.1.3.4CountryGermany
    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.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTopas Therapeutics GmbH
    B.5.2Functional name of contact pointHead of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressFalkenried 88
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20251
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@topas-therapeutics.com
    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.3.2Product code TPM502
    D.3.4Pharmaceutical form Dispersion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTPC0203S
    D.3.9.2Current sponsor codeTPC0203S
    D.3.9.3Other descriptive nameTPC0203S
    D.3.9.4EV Substance CodeSUB293356
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.55
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTPC0205S
    D.3.9.2Current sponsor codeTPC0205S
    D.3.9.3Other descriptive nameTPC0205S
    D.3.9.4EV Substance CodeSUB293355
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.55
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTPC0206S
    D.3.9.2Current sponsor codeTPC0206S
    D.3.9.3Other descriptive nameTPC0206S
    D.3.9.4EV Substance CodeSUB293357
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.55
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Coeliac disease
    E.1.1.1Medical condition in easily understood language
    Coeliac disease
    Glutenunverträglichkeit
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of two i.v. infusions of escalating doses of TPM502 in CeD patients.
    E.2.2Secondary objectives of the trial
    • To identify PD effects consistent with the induction of antigen-specific immune tolerance following the administration of TPM502
    • To describe the severity of gastrointestinal (GI) symptoms following the administration of TPM502 and a GC
    • To determine TPM502 PK

    Exploratory objectives:
    • To assess ex vivo gluten-specific T cell responses following TPM502 administration
    • To assess changes in T cell phenotypes upon TPM502 treatment
    • To further investigate the mechanism of action of TPM502.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    Incidence, severity, causality and outcomes of TEAEs (serious and non-serious), including hypersensitivity reactions, CRS, hepatotoxicity and other AEs suggestive of these conditions.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuous monitoring, all time points.
    E.5.2Secondary end point(s)
    • Ratio “Interleukin 2 (IL-2) after GC post-TPM502 treatment/IL-2 after GC at screening” compared to the placebo group
    • Modified Celiac disease patient‐reported outcome (CeD PRO®) and GloSS (Global Symptom Survey) 1 hour before and then hourly up to 6 hours post GC/ TPM502 compared to placebo
    • Maximum observed plasma concentration after dosing (Cmax), area under the plasma concentration-time curve from time zero to the time of the last quantifiable sample (area under the curve (AUC) 0-last
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuous monitoring, all time points.
    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 No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    LVLS
    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 months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months13
    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: 42
    F.1.3Elderly (>=65 years) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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)
    After the end of the study, the patients will return to their normal course of observation and treatment, as required, under the direction of their own physician. No further study treatment will be offered.
    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 Decision2023-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-08-08
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