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    Summary
    EudraCT Number:2016-004472-21
    Sponsor's Protocol Code Number:PCS_03_16
    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:2017-06-12
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-004472-21
    A.3Full title of the trial
    Phase IIa study to evaluate the safety, pharmacokinetics, and pharmacodynamics of repeated administrations over 4 weeks of the hepcidin antagonist PRS-080#022-DP in anemic chronic kidney disease patients undergoing hemodialysis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIa study to evaluate the safety, blood concentration and effect on the body of repeated administrations of PRS-080#022-DP to patients with chronic kidney disease undergoing dialysis and suffering from decreased amount of red blood cells
    A.4.1Sponsor's protocol code numberPCS_03_16
    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 SponsorPieris Pharmaceuticals 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 supportPieris Pharmaceuticals GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPieris Pharmaceuticals GmbH
    B.5.2Functional name of contact pointProject leader
    B.5.3 Address:
    B.5.3.1Street Address255 State Street 9th Floor
    B.5.3.2Town/ cityBoston
    B.5.3.3Post codeMA 02109
    B.5.3.4CountryUnited States
    B.5.4Telephone number+13479520110
    B.5.6E-mailbruns@pieris.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 namePRS-080#022-DP
    D.3.2Product code PRS-080#022-DP
    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 INNAnticalin
    D.3.9.2Current sponsor codePRS-080#022-DP
    D.3.9.4EV Substance CodeSUB127618
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8.1
    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 Yes
    D.3.11.13.1Other medicinal product typeThe PRS-080#022 is a recombinant protein derived from natural Neutrophil gelatinase-associated lipocalin (NGAL), from E. coli fermentation and which is covalently linked to PEG30 moiety.
    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
    Anemia of chronic disease
    E.1.1.1Medical condition in easily understood language
    Decrease in the total amount of red blood cells in the blood in patients with a persisting disease
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10054310
    E.1.2Term Anemia of chronic disease
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine the safety and tolerability of 5 repeated intravenous administrations of PRS-080#022-DP at 4 and 8 mg/kg BW in anemic stage 5 CKD patients requiring hemodialysis.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    - to determine the pharmacokinetics of PRS-080#022-DP associated with 5 repeated administrations
    - to evaluate the effect of 5 repeated PRS-080#022-DP administrations on plasma Hb concentrations
    - to evaluate the effect of 5 repeated PRS-080#022-DP administrations on pharmacodynamic parameters including serum iron, ferritin, transferrin saturation
    (TSAT), reticulocyte hemoglobin (RetHb), and reticulocyte count (Ret)
    - to evaluate the effect of 5 repeated PRS-080#022-DP administrations on hepcidin plasma levels
    - to collect data on immunogenicity associated with 5 repeated PRS-080#022-DP administrations
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with stage 5 CKD having been on hemodialysis for at least 90 days;
    2. Male and post-menopausal (no menses for at least 12 months without an alternative medical cause) female patients with an age of ≥18 years and with a maximum BW of 85 kg;
    3. Patients being on stable erythropoiesis-stimulating agent (ESA) dose with the beginning of Screening;
    4. Patients being on stable oral or intravenous iron doses with the beginning of Screening. Iron will be kept stable for a minimum of 2 weeks during the screening period before it will be discontinued one week before the first treatment;
    5. Mean of 3 Hb values during the screening period, each obtained at least 7 days apart must be ≤10.5 g/dL, with a difference of ≤1.0 g/dL between the lowest and highest value;
    6. Serum ferritin concentration ≥200 ng/mL;
    7. TSAT ≤30%;
    8. Plasma hepcidin concentration at least 5 nmol/L;
    9. Male patients with a female partner of childbearing potential agree to use a medically acceptable method of contraception (e.g., condoms, sexual abstinence, vasectomy), not including the rhythm method for 30 days after administration of the study medication.
    10. The patient is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study’s provisions, and has duly signed the informed consent form (ICF). Patient agrees to comply with the protocol-mandated procedures and visits.
    E.4Principal exclusion criteria
    1. Anemia due to causes other than CKD, including hemoglobinopathies, hemolytic anemias, myelodysplasia or malignancy;
    2. Blood transfusion within 2 months before administration of study medication;
    3. Previous enrollment in this study;
    4. Patients treated with PRS-080#022-DP in a former clinical study;
    5. Current or previous (within 60 days or 5 half-lives before study medication administration) treatment with another investigational drug and/or medical device or participation in another clinical study;
    6. Employees of the sponsor or patients who are employees or relatives of the investigator;
    7. Known allergy to any component of the PRS-080#022-DP formulation;
    8. Positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibody (anti-HCV Ab), or HIV; serology test results not older than 3 months are accepted;
    9. Planned surgery during the study period;
    10. Known or suspected active infection;
    11. Active or chronic gastrointestinal bleeding, or known coagulation disorder;
    12. Unwilling or unable to comply with the protocol, in the judgment of the investigator;
    13. Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, apoplexy (sudden circulatory disturbances of an organ or specific region of the body) or coronary artery bypass grafting <3 months prior to Screening;
    14. Congestive heart failure: New York Heart Association Class III or IV;
    15. Peripheral arterial disease with necrosis, stage IV (Fontaine) or grade III (category 5 and 6, Rutherford);
    16. Screening serum folate and vitamin B12 clinically significant below lower limit of normal judged by the investigator;
    17. History of malignancy
    18. Any medical condition that in the judgment of the investigator might interfere with study participation or jeopardize patient’s safety during the study (e.g., active infection).
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events: Pre-treatment emergent event, treatment-emergent adverse events, serious adverse events, adverse drug reactions, unexpected adverse drug reactions, SUSARs
    Biochemistry: sodium, potassium, calcium, phosphate, iron, aspartate-amino-transferase, alanine-amino-transferase, alkaline phosphatase, gamma-glutamyl-transferase, creatine-phosphokinase, cholesterol, blood urea, creatinine, total bilirubin, albumin, high sensitivity c-reactive protein, Vitamin B12, folate.
    Coagulation: prothrombin time, activated partial thromboplastin-time test.
    Body temperature, physical findings, electrocardiogram, and other observations related to safety
    Vital signs: systolic blood pressure, diastolic blood pressure and heart rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoints will be monitored during the entire study period
    E.5.2Secondary end point(s)
    Immunogenicity: anti-drug antibodies

    Pharmacokinetics (from total and free PRS-080#22-DP): Cmax (measured maximum concentration), Ctrough (plasma concentration immediately before the drug infusion), tmax (time of observed maximum concentration), lambda z (terminal rate constant) after the very last administration, t½ (terminal half-life, from lambda z after the very last administration

    Pharmacodynamics: iron, transferrin saturation, and ferritin in blood serum; reticulocyte hemoglobin, reticulocyte count in whole blood; hepcidin concentration in blood plasma; hemoglobin concentration

    Hematology: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, white blood cell count, platelet blood count
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be monitored during the entire study period
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 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 EEA6
    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
    Last visit of the last subject undergoing the trial
    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 months6
    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 months6
    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: 3
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 13
    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. Treatment after the subject has ended the participation in the trial follows standard treatment of the patients' condition.
    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 Decision2017-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-20
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