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    Summary
    EudraCT Number:2020-000419-56
    Sponsor's Protocol Code Number:TCD601B101
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-07
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-000419-56
    A.3Full title of the trial
    A 12-month, randomized, controlled, open-label, dose escalation study evaluating safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an anti-CD2 monoclonal antibody, TCD601 (siplizumab), compared to anti-thymocyte globulin (rATG), as induction therapy in de novo renal transplant recipients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-Month Clinical Research Study to evaluate a new investigational medication (siplizumab) compared to another medication (anti-thymocyte globulin) for the prevention of rejection in patients who have received a kidney transplant.
    A.4.1Sponsor's protocol code numberTCD601B101
    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 SponsorITB-MED AB
    B.1.3.4CountrySweden
    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 supportITB-MED AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationITB-MED LLC
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address110 E. 59th Street, FL 28
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10022
    B.5.3.4CountryUnited States
    B.5.6E-mailKTX@itb-med.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1931
    D.3 Description of the IMP
    D.3.1Product namesiplizumab
    D.3.2Product code TCD601
    D.3.4Pharmaceutical form Concentrate for solution 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 INNSIPLIZUMAB
    D.3.9.1CAS number 288392-69-8
    D.3.9.2Current sponsor codeTCD601
    D.3.9.3Other descriptive nameSIPLIZUMAB
    D.3.9.4EV Substance CodeSUB33504
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Thymoglobuline
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Powder for solution 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 INNrATG
    D.3.9.3Other descriptive nameRABBIT ANTI-HUMAN THYMOCYTE IMMUNOGLOBULIN
    D.3.9.4EV Substance CodeSUB30326
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    renal transplantation
    E.1.1.1Medical condition in easily understood language
    kidney transplantation
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10050436
    E.1.2Term Prophylaxis against renal transplant rejection
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety, tolerability, PK and PD of siplizumab compared to rATG, in de novo renal transplant recipients at 12 months post-transplant.
    E.2.2Secondary objectives of the trial
    • To measure changes in peripheral lymphocyte immunophenotype
    • To the time-course and duration of siplizumab induced lymphocyte depletion and time to recovery
    • To measure peripheral CD2-receptor occupancy following siplizumab administration over time
    • To assess the incidence of treated biopsy proven acute rejection (tBPAR) at 12 months
    • To assess the incidence of treatment emergent de novo, donor specific antibodies (DSA) at 12 months
    • To assess the incidence of antibody meditated rejection at 12 months
    • To assess renal function via eGFR using MDRD equation at Months 3, 6, 12 or EOS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to understand the study requirements and provide written informed consent before any study assessment is performed.
    2. Male or female patients ≥ 18 to 70 years of age.
    3. Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated or non-HLA identical living related donor.
    4. Recipients of a kidney with a cold ischemia time (CIT) < 30 hours; hypothermic machine perfusion within the same timeframe is acceptable.
    E.4Principal exclusion criteria
    • Transplant recipients sero-negative for Epstein-Barr virus (EBV).
    • Multi-organ transplant recipients.
    • Subjects who have received a kidney allograft previously; e.g. re-transplant.
    • Recipient of a kidney from an HLA identical living related donor.
    • Recipient of a kidney from a donor after cardiac death.
    • Subjects at high immunological risk for rejection as determined by local practice [(e.g., presence of pre-existing DSA, recipient of high Kidney Donor Profile Index ≥ 85 kidney (where assessed)].
    • Subjects with donor specific anti-HLA antibody as measured by complement-dependent cytotoxicity assay (CDC), enzyme-linked immunosorbent assay (ELISA), or flow cytometry within 90 days prior to transplant or as performed per the center’s local practice.
    • Complement-dependent cytotoxicity (CDC) crossmatch positive transplant (isolated positive B cell crossmatches are not an exclusion criterion).
    • ABO incompatible recipient.
    • History of malignancy of any organ system, except for localized excised non-melanomatous skin lesions or carcinoma in situ of the cervix.
    • Subjects with clinically significant laboratory abnormality that would preclude participation in the study (e.g., >2.5 x Upper Limit of Normal (ULN) values for (a) liver function chemistries (ALT, AST, alkaline phosphatase (ALP)), (b) bilirubin, (c) coagulation studies (INR/PT, aPTT).
    • Patient with any of the following: hemoglobin (Hbg) < 8 mg/dL, WBC count ≤ 2,000/mm3 or platelet count ≤ 75,000/mm3.
    • Sero-positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Surface Antigen (HBsAg). Subjects who are sero-positive for Hepatitis C virus (HCV) are excluded without proof of sustained viral response (SVR) after anti-HCV treatment.
    • Recipient of a kidney from a donor who tests positive for HIV, HBsAg/HBc positive or HCV.
    • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g., siplizumab, ATG, TAC, MMF, CS).
    • Any additional contraindication to the use of TAC or MMF according to the national labeling information of these products (refer to the local product label).
    • Evidence of TB infection (after anti-TB treatment, patients with history of latent TB may become eligible according to national guidelines).
    • Patient with severe systemic infections, current or within the two weeks prior to randomization.
    • Subjects with any other clinically significant medical condition, active infection or laboratory abnormality that would, in the judgment of the investigator, interfere with the subject’s ability to participate in the study.
    • Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.
    • Use of other investigational products or enrollment in another investigational drug study within 30 days of screening or 5 half-lives of the medication, whichever is longer.
    • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
    • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 24 weeks after the study medications have been stopped.
    E.5 End points
    E.5.1Primary end point(s)
    • Adverse events
    • Serious adverse events
    • Clinically significant changes in clinical chemistry, hematology, vital signs, serology
    • siplizumab PK
    • Immunophenotyping
    • CD2 RO
    • eGFR via MDRD
    E.5.1.1Timepoint(s) of evaluation of this end point
    12-months post-transplant
    E.5.2Secondary end point(s)
    • Immunophenotyping via FACS
    • Lymphocyte counts
    • CD2 RO
    • Anti-siplizumab Ab
    • Incidence of BPAR
    • de novo-DSA / anti-HLA ab measurement
    • incidence of AMR
    E.5.2.1Timepoint(s) of evaluation of this end point
    12-months post-transplant
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.1.1First administration to humans No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 32
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    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)
    None
    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 Decision2021-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-23
    P. End of Trial
    P.End of Trial StatusOngoing
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