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    Summary
    EudraCT Number:2019-003607-35
    Sponsor's Protocol Code Number:C0221002
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-26
    Trial results View 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 ConcernedCzechia - SUKL
    A.2EudraCT number2019-003607-35
    A.3Full title of the trial
    A PHASE 2, 12-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
    12TÝDENNÍ, ADAPTIVNÍ, OTEVŘENÉ KLINICKÉ HODNOCENÍ FÁZE 2 SE SEKVENČNÍM USPOŘÁDÁNÍM KOHORT HODNOTÍCÍ ÚČINNOST, BEZPEČNOST, SNÁŠENLIVOST A FARMAKOKINETIKU PŘÍPRAVKU PF-06730512 PO PODÁNÍ NĚKOLIKA DÁVEK U DOSPĚLÝCH SUBJEKTŮ S FOKÁLNĚ SEGMENTÁLNÍ GLOMERULOSKLERÓZOU (FSGS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)
    A.4.1Sponsor's protocol code numberC0221002
    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 SponsorPfizer 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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    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 namePF-06730512
    D.3.2Product code PF-06730512
    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 INNPF-06730512
    D.3.9.2Current sponsor codePF-06730512
    D.3.9.3Other descriptive namePF-06730512
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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.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
    Focal Segmental Glomerulosclerosis (FSGS)
    E.1.1.1Medical condition in easily understood language
    Kidney disease
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067757
    E.1.2Term Focal segmental glomerulosclerosis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    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 PF-06730512 compared to baseline in the reduction of proteinuria following 12 weeks of treatment in patients with FSGS.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of PF-06730512 following 12 weeks of treatment in subjects with FSGS.
    - To evaluate the effects of PF-06730512 on proteinuria time course.
    - To summarize complete and partial remission rates following administration of PF-06730512.
    - To evaluate the effect of PF-06730512 on renal function.
    - To evaluate the serum exposure of PF-06730512 in FSGS patients.
    - To evaluate the immunogenicity profile of PF-06730512.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

    - Male or female subject age ≥18 years must have a confirmed diagnosis of FSGS defined as a minimum of 1 glomerulus demonstrating segmental sclerosis on light microscopy within the past 5 years.

    - Estimated glomerular filtration rate (eGFR) ≥45 ml/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, with repeat measurements permitted, as appropriate.
     - If eGFR is 30-45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to Screening) must demonstrate <50% tubulo-interstitial fibrosis. The Investigator and the subject may decide to perform a biopsy which might fulfill this eligibility criterion.

    - UPCR >1.5 g protein/g creatinine at Screening.

    - Based on all previous treatment received for FSGS, subject is eligible if:
    a. Subject has been treated with at least 1, and up to 3 classes of Immunosuppressants* either alone or in combination;
    OR
    b. Subject has a contraindication to any class of Immunosuppressant (may include steroids) or is considered to be intolerant to any class of Immunosuppressant (may include steroids) per Investigator judgment.

    - For inclusion into the Lead-in Period, subjects on ongoing corticosteroid treatment must have discontinued steroid treatment or tapered down to a stable prednisone dose ≤7.5 mg per day (or 15 mg q.o.d.) or other steroid equivalent at least one week prior to the Lead-in Period. Treatment with CNIs OR MMF (but not both) may be continued upon entry into the Lead-in Period at the discretion of the Principal Investigator. Treatment with the agent (CNIs or MMF) must have been ongoing for at least 6 months prior to Lead-in, and the dose (or level) of the agent must have been stable for at least 1 month prior to the Lead-in Period.

    - Female subjects of non-childbearing potential will meet at least 1 of the following criteria (all other female subjects, including female subjects with tubal ligations, are considered to be of childbearing potential):
    a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with/and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
    b. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    c. Have medically confirmed ovarian failure.
    E.4Principal exclusion criteria
    1. Diagnosis of collapsing FSGS.

    2. Advanced chronic changes on renal biopsy as evidenced by >50% tubulo-interstitial fibrosis.

    3. Evidence or history of clinically significant hematological, endocrine (including Type 1 diabetes mellitus), pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or hepatic disease, like cirrhosis or chronic active liver disease.

    4. Organ transplantation.

    5. History of any malignancy except for subjects who had a basal or squamous cell skin cancer which has been treated and fully resolved for a minimum of 5 years.

    7. Treatment with rituximab within 6 months prior to start of the Lead-in Period. If Rituximab treatment is longer than 6 months (prior to start of the Lead-in Period), subject is still excluded if no peripheral CD19+ B-cells are identified in the local laboratory prior to first study drug dosing.

    8.- Any immunosuppressant medication (besides corticosteroids, MMF, or CNIs) within the past 28 days prior to start of the Lead-in Period.

    20. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this
    study.

    21. Subjects with a history of hypersensitivity to the components of the study drug (For Japan, EU member states which participate in the VHP Process, and any additional countries selected for study participation in the future).
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change from baseline to Week 13 in Urinary Protein to Creatinine Ratio (UPCR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 13
    E.5.2Secondary end point(s)
    - Adverse Events, Laboratory Safety Tests (Hematology, Clinical Chemistry, Urinalysis), Body Weight, Blood Pressure, Pulse Rate, oral temperature and Electrocardiogram (ECG).
    - Percentage change from baseline to Weeks 3, 5 and 9 in UPCR.
    - Partial and complete remission of proteinuria at Week 13.
    - Percentage change from baseline to Weeks 3, 5, 9 and 13 in estimated glomerular filtration rate (eGFR).
    - Serum concentration of PF-06730512.
    - Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 3, 5, 9 and 13 (see above)
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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 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 Yes
    E.8.1.7.1Other trial design description
    Sequential study
    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
    Same compound, different dose
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Japan
    Thailand
    United States
    France
    Germany
    Italy
    Poland
    Romania
    Spain
    United Kingdom
    Czechia
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 44
    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 Decision2020-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-14
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