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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7258   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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

    Summary
    EudraCT Number:2020-002637-15
    Sponsor's Protocol Code Number:APL2-C3G-204
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002637-15
    A.3Full title of the trial
    An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrenceof C3G or IC-MPGN
    Studio randomizzato, controllato, in aperto, di fase 2 per valutare la sicurezza e l'efficacia di pegcetacoplan nel trattamento della recidiva post-trapianto di C3G o IC-MPGN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN
    Studio randomizzato, controllato, in aperto, di fase 2, progettato per valutare la sicurezza e l'efficacia di APL-2 in pazienti che hanno recidive post-trapianto di C3G o IC-MPGN
    A.3.2Name or abbreviated title of the trial where available
    NOBLE
    NOBLE
    A.4.1Sponsor's protocol code numberAPL2-C3G-204
    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 SponsorAPELLIS PHARMACEUTCIALS, INC.
    B.1.3.4CountryUnited States
    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 supportApellis Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationApellis Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClin. Development and Med. Affairs
    B.5.3 Address:
    B.5.3.1Street Address100 5th Avenue, 3rd Floor
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.6E-mailfederico@apellis.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.3.1Product namePegcetacoplan
    D.3.2Product code [APL-2]
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPegcetacoplan
    D.3.9.1CAS number 2019171-69-6
    D.3.9.2Current sponsor codeAPL-2
    D.3.9.4EV Substance CodeSUB195466
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1080
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Prevenar 13 suspension for injection
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namePrevenar 13 suspension for injection
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive namePneumococcal polysaccharide serotype 11 2.2 µg Pneumococcal polysaccharide serotype 31 2.2 µg Pneumococcal polysaccharide serotype 41 2.2 µg Pneumococcal polysaccharide serotype 51 2.2 µg Pneumococcal polysaccharide serotype 6A1 2.2 µg Pneumococcal polysaccharide serotype 6B1 4.4 µg Pneumococcal polysaccharide serotype 7F1 2.2 µg Pneumococcal polysaccharide serotype 9V1 2.2 µg Pneumococcal polysaccharide serotype 141 2.2 µg Pneumococcal polysaccharide serotype 18C1 2.2 µg Pneumococcal polysaccha
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number31
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Pneumococcal polysaccharide vaccine
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    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 namePneumococcal polysaccharide vaccine solution for injection in a vial
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPneumococcal Polysaccharide Vaccine
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameThe 0.5 mL dose of vaccine contains 25 micrograms of each of the following 23 pneumococcal polysaccharide serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F.
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Bexsero
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline UK
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameBexsero Meningococcal Group B vaccine for injection in pre-filled syringe
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant Neisseria meningitidis group B NHBA fusion protein
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeAS14
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant Neisseria meningitidis group B NadA protein
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeAS15
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant Neisseria meningitidis group B fHbp fusion protein
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeAS16
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    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.IMP: 5
    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 Yes
    D.2.1.1.1Trade name Ciprofloxacin 500mg Film-Coated Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameCiprofloxacin 500mg Film-Coated Tablets
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNciprofloxacin hydrochloride
    D.3.9.1CAS number 0085721-33-1
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB07470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 6
    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 Yes
    D.2.1.1.1Trade name Hiberix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline (Ireland) Limited
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameHiberix
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Powder and suspension for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHaemophilus influenza coupled to tetanus toxoid
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameEach 0.5 ml dose of the vaccine contains 10 micrograms of purified capsular polysaccharide of Haemophilus type b covalently bound to approximately 25 micrograms tetanus toxoid
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    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.IMP: 7
    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 Yes
    D.2.1.1.1Trade name Phenoxymethylpenicillin potassium
    D.2.1.1.2Name of the Marketing Authorisation holderMedreich Plc
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namePhenoxymethylpenicillin potassium TABLETS BP 250 mg
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPHENOXYMETHYLPENICILLIN POTASSIUM
    D.3.9.1CAS number 132-98-9
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB03766MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 8
    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 Yes
    D.2.1.1.1Trade name Nimenrix
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameNimenrix powder and solvent for solution for injection in pre-filled syringe
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group A polysaccharide
    D.3.9.2Current sponsor codena
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group C polysaccharide
    D.3.9.2Current sponsor codena
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group W-135 polysaccharide
    D.3.9.2Current sponsor codena
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group Y polysaccharide
    D.3.9.2Current sponsor codena
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    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
    complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
    glomerulopatia da complemento 3 (C3G) / glomerulonefrite membranoproliferativa a depositi di immunocomplessi (IC-MPGN)
    E.1.1.1Medical condition in easily understood language
    Rare kidney disease which can reoccur after a kidney transplant.
    Malattia renale rara che può ripresentarsi dopo un trapianto renale.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10063210
    E.1.2Term Transplant glomerulopathy
    E.1.2System Organ Class 100000004870
    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 efficacy of pegcetacoplan in improving the underlying pathophysiology of complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) after 12 weeks of treatment.
    Valutare l'efficacia di pegcetacoplan sul miglioramento della fisiopatologia sottesa della glomerulopatia da complemento 3 (C3G) o della glomerulonefrite membranoproliferativa a depositi di immunocomplessi (IC-MPGN) dopo 12 settimane di trattamento.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of pegcetacoplan for up to 52 weeks in patients with recurrent C3G/IC-MPGN in a renal allograft.
    To evaluate the effect of pegcetacoplan on key clinical manifestations of the disease after 52 weeks of treatment.
    Valutare le sicurezza di pegcetacoplan per un periodo fino a 52 settimane in pazienti che presentano recidiva di C3G/IC-MPGN in un allotrapianto di rene.
    Valutare l'effetto di pegcetacoplan sulle manifestazioni cliniche fondamentali dopo 52 settimane di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Individuals must meet all of the following criteria at screening visits to be included in the study:
    1. Patients of at least 18 years of age at screening
    2. Patients must have clinical and pathologic evidence of recurrent C3G or IC-MPGN, as evidenced by all of the following:a. A diagnosis of C3G or IC-MPGN, with at least 2+ staining for C3c in therenal allograft, confirmed by a central pathologist, based on the screening renal allograft biopsyb. Clinical evidence of C3G or IC-MPGN recurrence in the form of at least 1 g/day of proteinuria in a 24-hour urine collection that is attributable todisease recurrence in the opinion of the investigatorc. C3G or IC-MPGN must be primary and not secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, autoimmunity, chronic antibody-mediated rejection, chronic thrombotic microangiopathy, or a medication)
    3. Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan
    4. eGFR =30 mL/min/1.73 m2, calculated by the Chronic Kidney Disease–Epidemiology Collaboration (CKD-EPI) creatinine equation for adults
    5. No more than 50% glomerulosclerosis or interstitial fibrosis on the screening renal biopsy
    6. Stable regimen for recurrent C3G/IC-MPGN for at least 4 weeks prior to the screening renal allograft biopsy and from the time of the screening renal allograft biopsy until randomization
    7. Willing to receive required vaccinations against N. meningitides, S. pneumoniae, and H. influenzae if applicable vaccination records are not available
    8. Women of childbearing potential (WOCBP) must have a negative bloodpregnancy test at screening (and negative urine pregnancy at Visit 4) and must agree to use protocoldefined methods of contraception from screening through 12 weeks after receiving last dose of pegcetacoplan
    9. Men must agree to use protocol-defined methods of contraception andagree to refrain from donating semen from screening through 12 weeks after receiving last dose of pegcetacoplan
    10. Willing and able to provide written informed consent
    11. Able to understand and willing to comply with all scheduled procedures and other requirements of the study in the opinion of the investigator
    12. Willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration
    Per essere ammessi allo studio, alle visite di screening i soggetti devono soddisfare tutti i criteri elencati di seguito.
    1. Pazienti di almeno 18 anni di età allo screening
    2. I pazienti devono presentare evidenza clinica e patologica di recidiva di C3G o IC-MPGN, confermata da:
    a. diagnosi di C3G o IC-MPGN, con almeno 2+ colorazioni per C3c nell'allotrapianto renale, confermata da un patologo centrale, sulla base della biopsia di screening dell'allotrapianto renale
    b. evidenza clinica di recidiva di C3G o IC-MPGN sotto forma di almeno 1 g/giorno di proteinuria nella raccolta delle urine delle 24 ore
    c. la C3G o l'IC-MPGN deve essere una patologia primaria e non secondaria a un'altra patologia (per. es., infezione, neoplasia maligna, gammopatia monoclonale, autoimmunità, rigetto cronico anticorpo-mediato, microangiopatia trombotica cronica o da un farmaco)
    3. Malattia stabile (che non migliora) o in peggioramento, secondo l'opinione dello sperimentatore, nei 2 mesi precedenti alla somministrazione della prima dose di pegcetacoplan
    4. eGFR = 30 mL/min/1,73 m2, calcolata mediante l'equazione CKD-EPI (Chronic Kidney Disease–Epidemiology Collaboration) per la creatinina negli adulti
    5. Non oltre il 50% di glomerulosclerosi o fibrosi interstiziale sul campione bioptico di screening dell'allotrapianto renale
    6. Regime stabile per recidiva di C3G/IC-MPGN perlomeno nelle 4 settimane precedenti alla biopsia di screening dell'allotrapianto renale e a partire dal momento di tale biopsia di screening fino alla randomizzazione
    7. Disponibilità a essere vaccinati contro Neisseria meningitidis, Streptococcus pneumoniae e Haemophilus influenzae se il tesserino personale delle vaccinazioni applicabili non fosse disponibile
    8. Le donne in età fertile devono risultare negative al test di gravidanza nel sangue allo screening (e al test di gravidanza nelle urine alla Visita 4); devono inoltre accettare di far uso di metodi contraccettivi definiti dal protocollo dal momento dello screening fino al 12 settimane dopo la somministrazione dell'ultima dose di pegcetacoplan
    9. Gli uomini devono accettare di far uso di metodi contraccettivi definiti dal protocollo e di astenersi dalla donazione di sperma a partire dallo screening fino al 12 settimane dopo la somministrazione dell'ultima dose di pegcetacoplan
    10. Pazienti disposti e in grado di accordare il consenso informato scritto.
    11. Pazienti in grado di comprendere e disposti ad aderire alle indagini programmate dello studio e agli altri requisiti dello studio, secondo l'opinione dello sperimentatore
    12. Pazienti disposti e capaci di autosomministrarsi pegcetacoplan o assistiti da un caregiver identificato che possa eseguire la somministrazione
    E.4Principal exclusion criteria
    Individuals meeting any of the following criteria at screening or baselineare ineligible to participate in this study:
    1. Absolute neutrophil count <1000 cells/mm3 during screening (not including Day 1)
    2. Previous treatment with pegcetacoplan
    3. Evidence of rejection on the screening renal allograft biopsy that requires treatment
    4. Diagnosis or history of HIV, hepatitis B, or hepatitis C infection or positive serology at screening indicative of infection
    5. Malignancy, except for the following:a. Cured basal or squamous cell skin cancerb. Curatively treated in situ diseasec. Malignancy free and off treatment for =5 years
    6. Significant renal disease in the renal allograft secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, rejection,or a medication) that would confound interpretation of the study results
    7. Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or 5 half-lives from the last dose of the investigational agent (whichever is longer) prior to screening period
    8. Women who are currently breastfeeding
    9. Inability to cooperate or any condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study
    10. Evidence of drug or alcohol abuse or dependence, in the opinion of the investigator
    Non saranno eleggibili a partecipare al questo studio i pazienti che soddisfano allo screening o al basale uno qualsiasi dei criteri elencati di seguito.
    1. Conta assoluta dei neutrofili < 1.000 cellule/mm3 durante lo screening (Giorno 1 escluso)
    2. Precedente trattamento con pegcetacoplan
    3. Evidenza di rigetto sul campione bioptico di screening dell'allotrapianto renale necessitante di trattamento
    4. Diagnosi o anamnesi di infezione da HIV, epatite B o C o sieropositività allo screening indicativa d'infezione
    5. Neoplasia maligna, fatta eccezione per:
    a. carcinoma cutaneo basocellulare o squamocellulare curato
    b. patologia in situ trattata con intento curativo
    c. paziente libero da tumore maligno e non in terapia da = 5 anni
    6. Importante patologia renale nell'allotrapianto renale secondaria a un'altra patologia (per es., infezione, neoplasia maligna, gammopatia monoclonale, rigetto o da farmaco) che confonderebbe l'interpretazione dei risultati dello studio
    7. Partecipazione ad altre sperimentazioni con un farmaco sperimentale o esposizione ad altro agente, dispositivo o intervento sperimentale nei 30 giorni o 5 emivite dalla somministrazione dell'ultima dose dell'agente sperimentale (a seconda di quale periodo sia il più lungo) prima dello screening
    8. Donne che allattano con latte materno
    9. Incapacità di collaborazione o qualsiasi patologia che, a giudizio dello sperimentatore, potrebbe aumentare il rischio per il paziente se partecipasse allo studio oppure confondere l'esito dello studio
    10. Evidenza di abuso o dipendenza da sostanze o alcol, a giudizio dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of patients with reduction in C3c staining on renal biopsy after 12 weeks of treatment with pegcetacoplan.
    L'endpoint primario di efficacia è la percentuale di pazienti che presenta una riduzione della colorazione per C3c su campione bioptico renale dopo 12 settimane di trattamento con pegcetacoplan.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 Biopsy
    Settimana 12 Biopsia
    E.5.2Secondary end point(s)
    The secondary endpoints are as follows:
    • The number and incidence of treatment-related AEs
    • The proportion of patients with reduction in C3c staining on renal biopsy after 52 weeks of treatment
    • The proportion of patients achieving at least a 50% reduction in proteinuria over time
    • The proportion of patients achieving complete clinical remission of proteinuria, defined as normalization of proteinuria
    • The proportion of patients with stabilization or improvement in estimated glomerular filtration rate (eGFR) over time
    Gli endpoint secondari sono:
    • Numero e incidenza degli eventi avversi (AE) correlati al trattamento
    • Percentuale di pazienti con riduzione della colorazione per C3c su campione bioptico renale dopo 52 settimane di trattamento
    • Percentuale di pazienti che raggiunge una riduzione pari ad almeno il 50% della proteinuria nel tempo
    • Percentuale di pazienti che raggiunge la remissione clinica completa della proteinuria, definita come la normalizzazione della proteinuria
    • Percentuale di pazienti che presenta stabilizzazione o miglioramento della velocità di filtrazione glomerulare stimata (eGFR) nel tempo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52 Biopsy
    Settimana 52 Biopsia
    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 Yes
    E.6.4Safety No
    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) 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Variazione del programma di trattamento: il gruppo 2 non riceverà pegcetacoplan durante la porzione
    Variation in treatment schedule: Group2 will not receive pegcetacoplan during the Controlled Portion
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    United States
    Austria
    France
    Italy
    Netherlands
    Spain
    Switzerland
    United Kingdom
    Argentina
    E.8.7Trial has a data monitoring committee No
    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
    The end of the study will be the last patient's last visit (LVLS) or the last patient's scheduled visit/assessment as indicated in the Schedule of Events OR as requested by the sponsor.
    La fine dello studio avverrà all'ultima visita del paziente (LVLS) o all'ultima visita/valutazione programmata del paziente come indicato nel Calendario degli eventi OPPURE come richiesto dallo sponsor.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 12
    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)
    All patients who complete study treatment and don't enter Part B, the long-term extension, will return to the site for follow-up visits for 24 weeks, where assessments will be performed per the SoE in Protocol, and where the visit window allowances are also provided. Patients who discontinue treatment early and don't elect to continue their participation in the study will complete a follow-up visit 6 weeks after discontinuation of treatment and also the exit visit, 6 weeks thereafter.
    Tutti i pazienti che completano il trattamento in studio e non partecipano alla Parte B(estensione a lungo termine)torneranno al centro per le visite di follow-up per 24 settimane, per eseguire le valutazioni previste dal protocollo e verranno anche fornite le finestre di visita. I pazienti che interrompono il trattamento in anticipo e non scelgono di continuare lo studio completeranno una visita di follow-up 6 settimane dopo l'interruzione del trattamento e la visita di uscita, 6 settimane dopo
    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 Decision2021-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA