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    Summary
    EudraCT Number:2020-001429-30
    Sponsor's Protocol Code Number:WA42294
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001429-30
    A.3Full title of the trial
    A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF)
    STUDIO DI ESTENSIONE DI FASE III IN APERTO, TESO A VALUTARE LA SICUREZZA E L'EFFICACIA A LUNGO TERMINE DI PRM-151 IN PAZIENTI AFFETTI DA FIBROSI POLMONARE IDIOPATICA (IPF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis
    Studio teso a valutare la sicurezza e l'efficacia a lungo termine di Pentraxin-2 ricombinante umana (rhPTX-2; PRM-151) in pazienti affetti da fibrosi polmonare idiopatica
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberWA42294
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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/3/12/1020
    D.3 Description of the IMP
    D.3.1Product nameRecombinant human Pentraxin-2 (PRM-151)
    D.3.2Product code [RO7490677]
    D.3.4Pharmaceutical form 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 INNRecombinant human Pentraxin-2
    D.3.9.2Current sponsor codePRM-151
    D.3.9.3Other descriptive namePRM-151
    D.3.9.4EV Substance CodeSUB182526
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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
    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
    Idiopathic pulmonary fibrosis (IPF)
    Fibrosi polmonare idiopatica (Idiopathic Pulmonary Fibrosis, IPF)
    E.1.1.1Medical condition in easily understood language
    IPF is a chronic and irreversible lung disease. Because of the progressive nature of the disease, lung function deteriorates over time ultimately leading to death.
    L'IPF è una malattia polmonare cronica ed irreversibile. A causa della natura progressiva della malattia, la funzionalità polmonare si deteriora nel tempo portando infine alla morte.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 confirm long-term safety and tolerability of 10 mg/kg PRM-151 administered every 4 weeks (Q4W) via intravenous infusion plus standard of care (SOC) treatment
    Confermare la sicurezza e la tollerabilità a lungo termine di 10 mg/kg di PRM-151 somministrato ogni 4 settimane (Q4W) per infusione endovenosa (EV) più il trattamento standard di cura (Standard of Care, SOC)
    E.2.2Secondary objectives of the trial
    - To assess the long-term efficacy of 10 mg/kg PRM-151 plus SOC administered Q4W via IV infusion
    - To characterize pharmacokinetics of PRM-151 in patients with IPF
    - To evaluate the immune response to PRM-151
    - Valutare l'efficacia a lungo termine di 10 mg/kg di PRM-151 più SOC somministrato Q4W per infusione EV
    - Caratterizzare la farmacocinetica di PRM-151 in pazienti con IPF
    - Valutare la risposta immunologica a PRM-151
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Taken part in a previous study of PRM-151, as follows:
    o Participated in Study PRM-151-202, and tolerated the study drug in the opinion of the investigator OR
    o Completed study treatment in Study WA42293 OR
    o Participated in Study WA42293 but have discontinued from study treatment
    • For women of childbearing potential: agreement to remain abstinent or use contraception, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 8 weeks after the final dose of PRM-151
    • For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 8 weeks after the final dose of PRM-151 to avoid exposing the embryo. Men must refrain from donating sperm during this same period
    • Partecipazione a uno studio precedente su PRM-151 come segue:
    o Aver partecipato allo studio PRM-151-202 e aver tollerato il farmaco in studio secondo il giudizio dello sperimentatore OPPURE
    o Aver completato il trattamento in studio nello studio WA42293 OPPURE
    o Aver partecipato allo studio WA42293 ma aver interrotto il trattamento in studio
    • Per le donne in grado di procreare: consenso all'astinenza o all'uso di metodi contraccettivi, le donne devono osservare l'astinenza dai rapporti sessuali oppure utilizzare metodi contraccettivi con un tasso di insuccesso <1% all'anno durante il periodo di trattamento e per almeno 8 settimane dopo la dose finale di PRM-151
    • Per gli uomini: consenso all'astinenza o all'uso del preservativo e impegno a non donare sperma, gli uomini con partner femminile in grado di procreare o gestante devono osservare l'astinenza o utilizzare un preservativo durante il periodo di trattamento e per 8 settimane dopo la dose finale di PRM-151 per evitare l'esposizione dell'embrione. Durante lo stesso periodo gli uomini devono impegnarsi a non donare sperma
    E.4Principal exclusion criteria
    • Received any experimental treatment other than PRM-151 within 4 weeks or five half-lives of the experimental drug, whichever is longer, prior to the first dose in the OLE study
    • Receiving strong inhibitor or inducer of CYP1A2 in patients taking pirfenidone
    • Receiving potent inhibitor or inducer of P-gp in patients taking nintedanib
    • Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202)
    • History of smoking within 3 months prior to the first visit in the OLE
    • History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance use disorder
    • History of severe allergic reaction or anaphylactic reaction to PRM-151
    • Clinically significant abnormality on ECG during eligibility assessment including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula; or laboratory tests (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the patient
    • Aver ricevuto qualsiasi trattamento sperimentale diverso da PRM-151 nelle 4 settimane o nelle cinque emivite del farmaco sperimentale, qualunque periodo sia più lungo, prima della prima dose dello studio OLE
    • Trattamento in corso con un inibitore o induttore forte di CYP1A2 per pazienti che assumono pirfenidone
    • Trattamento in corso con un inibitore o induttore potente di P-gp per pazienti che assumono nintedanib
    • Infezione respiratoria acuta o sistemica di origine batterica, virale o fungina alla prima visita dello studio OLE o nelle 2 settimane che precedono la prima visita per i pazienti della coorte A (provenienti dallo studio PRM-151-202)
    • Storia di tabagismo nei 3 mesi che precedono la prima visita dello studio OLE
    • Storia di disturbo da uso di alcol o sostanze stupefacenti nei 2 anni che precedono la prima visita dello studio OLE o noto o sospetto disturbo attivo da uso di alcol o sostanze stupefacenti
    • Anamnesi di reazione allergica grave o reazione anafilattica a PRM-151
    • Anomalia clinicamente significativa dell'ECG durante la valutazione dell’idoneità, incluso prolungamento dell’intervallo QT corretto >450 ms (per gli uomini) o >470 ms (per le donne) in base alla formula di correzione di Fridericia, o delle analisi di laboratorio (ematologia, chimica del siero e analisi delle urine) se, secondo il giudizio dello sperimentatore, potrebbe comportare un ulteriore rischio nella somministrazione del farmaco in studio al paziente
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence and severity of adverse events (AE), with severity determined according to the 5-point severity scale (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE, v.5.0])
    2. Incidence and severity of IRRs and other AEs of special interest
    3. Proportion of patients permanently discontinuing study treatment due to AEs
    4. Change from baseline in targeted clinical laboratory test results
    1. Incidenza e gravità di tutti gli eventi avversi (Adverse Event, AE), dove la gravità sarà determinata in base alla scala della gravità a 5 punti dei criteri terminologici comuni per gli eventi avversi del National Cancer Institute, versione 5.0 (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, NCI CTCAE, v.5.0)
    2. Incidenza e gravità delle reazioni correlate all'infusione (Infusion Related Reaction, IRR) e altri AE di interesse specifico
    3. Percentuale di pazienti che interrompono definitivamente il trattamento in studio per AE
    4. Variazione rispetto al basale dei risultati di analisi cliniche di laboratorio mirate
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-3. Approximately 8 weeks after the last dose of study drug
    4. From baseline (Day 1) to 8 weeks after the last dose of study drug
    1-3. Circa 8 settimane dopo l'ultima dose del farmaco in studio
    4. Dal basale (Giorno 1) a 8 settimane dopo l'ultima dose del farmaco in studio
    E.5.2Secondary end point(s)
    1. Annual rate of decline in forced vital capacity (FVC) (mL)
    2. Annual rate of change in 6-minute walk distance
    3. Annual rate of decline in FVC% predicted
    4. Progression-free survival
    5. Change from baseline in University of California, San Diego-Shortness of Breath Questionnaire
    6. Change from baseline in St. George Respiratory Questionnaire Total Score
    7. Change from baseline in carbon monoxide diffusing capacity
    8. Survival
    9. Plasma concentrations of PRM-151 at specified timepoints for a subset of patients
    10. Prevalence of anti-drug antibodies (ADAs) to PRM-151 at baseline and incidence of ADAs during the study
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. End of study
    2. End of study.
    3. End of study
    4. Time to first occurrence of >= 10% absolute decline in % predicted FVC, >= 15% relative decline in 6MWD, or death
    5-7. Day 1, Week 24 and then every 24 weeks thereafter and at treatment discontinuation
    8. Every 6 months and at study completion or discontinuation
    9. Day 1, 3, 5. Week 4, 12, 24 and at unscheduled visit
    10. Baseline (Day 1), Week 4, 12, 24 and at unscheduled visit
    -
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Biomarker, Health Status Utility
    -
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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
    STUDIO DI ESTENSIONE IN APERTO
    Open-Label Extension
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned28
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA160
    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
    Canada
    China
    Hong Kong
    Israel
    Korea, Republic of
    Mexico
    New Zealand
    Peru
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    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
    The end of this study is defined as the date when the last patient last visit (LPLV) occurs or safety follow-up is received from the last patient whichever occurs later.
    -
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state76
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 700
    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)
    The sponsor will terminate the trial once PRM-151 becomes commercially available. Currently, the Sponsor does not have any plans to provide PRM-151 to patients who have completed the study. The Sponsor may evaluate whether to continue providing PRM-151 in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following website: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    -
    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 Decision2020-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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