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    Summary
    EudraCT Number:2015-003783-36
    Sponsor's Protocol Code Number:R475-PN-1523
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-28
    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 number2015-003783-36
    A.3Full title of the trial
    A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients with Pain Due to Osteoarthritis of the Knee or Hip
    Studio di Fase 3 randomizzato, in doppio cieco, multidose, controllato con placebo, per valutare la sicurezza e l¿efficacia a lungo termine di fasinumab in pazienti con dolore da osteoartrite del ginocchio o dell¿anca
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine the long-term safety and the efficacy of fasinumab for treatment of adults with pain from osteoarthritis of the knee or hip
    Studio per determinare la sicurezza e l'efficacia a lungo termine di fasinumab in pazienti con dolore da osteoartrite del ginocchio o dell¿anca
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberR475-PN-1523
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    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 SponsorREGENERON PHARMACEUTICALS, 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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number0
    B.5.5Fax number0
    B.5.6E-mailclinicaltrials@regeneron.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 nameFasinumab
    D.3.2Product code REGN475
    D.3.4Pharmaceutical form Solution for injection
    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 INNFasinumab
    D.3.9.1CAS number 1190239-42-9
    D.3.9.2Current sponsor codeREGN475
    D.3.9.4EV Substance CodeSUB128096
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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.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 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 nameFasinumab
    D.3.2Product code REGN475
    D.3.4Pharmaceutical form Solution for injection
    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 INNFasinumab
    D.3.9.1CAS number 1190239-42-9
    D.3.9.2Current sponsor codeREGN475
    D.3.9.4EV Substance CodeSUB128096
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain due to osteoarthritis of the knee or hip
    Dolore da osteoartrite del ginocchio o dell'anca
    E.1.1.1Medical condition in easily understood language
    Pain of the knee or hip due to a joint disease that results from breakdown of joint cartilage and underlying bone
    Dolore al ginocchio o anca dovuto a malattia delle giunture con conseguente rottura delle cartilagini e osso sottostante
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10020108
    E.1.2Term Hips osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed osteoarthritis (OA) of the knee or hip
    between baseline and week 16 (treatment period 1).
    Descrivere la sicurezza e la tollerabilit¿ di fasinumab, inclusi gli eventi avversi di speciale interesse (EASI), in pazienti con dolore da osteoartrite (OA) del ginocchio o dell¿anca confermata radiologicamente, tra il basale e la Settimana 16 (periodo 1 di trattamento).
    E.2.2Secondary objectives of the trial
    To describe the safety and tolerability of fasinumab, including AESIs, in patients with pain due to radiographically-confirmed OA of the knee or
    hip between:
    - week 16 and week 52 (treatment period 2).
    - baseline and week 52 (overall study period).
    Descrivere la sicurezza e la tollerabilit¿ di fasinumab, inclusi gli EASI, in pazienti con dolore da OA del ginocchio o dell¿anca confermata radiologicamente, tra:
    -settimana 16 e la Settimana 52 (periodo 2 di trattamento).
    - basale e la Settimana 52 (periodo complessivo dello studio).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Onset of Pain Relief Sub-Study
    Primary objectives of the Sub-Study:
    To evaluate the efficacy of fasinumab vs placebo as measured by:
    - Change from baseline at week 16 in the WOMAC pain subscale score
    - Change from baseline at week 16 in the WOMAC physical function subscale score
    - Change from baseline at week 16 in the Patient Global Assessment of OA score
    Secondary objectives of the Sub-Study:
    To evaluate the efficacy of fasinumab vs placebo as measured by:
    - Change from baseline at weeks 1, 2, 4, 8, and 12 in the WOMAC pain subscale score & physical function subscale score and in the Patient
    Global Assessment of OA score
    - Change from baseline at weeks 1, 2, 4, 8, 12, and 16 using the Average Daily Walking Index Joint Pain Numeric Rating Scale and in the WOMAC total score & WOMAC stiffness subscale score
    - Change from baseline to week 16 in the % of patients who are responders based on WOMAC pain and physical function subscale scores and Patient Global Assessment scale scores defined by 30% reduction and 50% reduction
    -For further information please refer to the protocol

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio sull'inizio dell'attenuazione del dolore
    Obiettivi primari del sottostudio:
    valutare l'efficacia di fasinumab vs placebo misurata tramite:
    - variazione rispetto al valore basale alla set. 16 del punteggio nella sottoscala WOMAC per il dolore
    - variazione rispetto al valore basale alla set. 16 del punteggio nella sottoscala WOMAC per la funzionalit¿ fisica
    - variazione rispetto al valore basale alla set. 16 del punteggio della valutazione globale dell'OA da parte del paziente
    Obiettivi secondari del sottostudio:
    valutare l'efficacia di fasinumab vs placebo misurata tramite:
    - variazione rispetto al valore basale alle set. 1, 2, 4, 8 e 12 del punteggio nella sottoscala WOMAC per il dolore, per la funzionalit¿ fisica e della valutazione globale dell'OA da parte del paziente
    - variazione rispetto al valore basale alle set. 1, 2, 4, 8, 12 e 16 usando la scala di valutazione numerica Average Daily Walking Index Joint Pain (Indice medio giornaliero del dolore articolare durante le camminate), il punteggio WOMAC totale e il punteggio nella sottoscala WOMAC per la rigidit¿
    - variazione rispetto al valore basale alla set. 16 della % di pazienti che vengono intervistati in base ai punteggi delle sottoscale WOMAC per il dolore e per la funzionalit¿ fisica e ai punteggi della scala di valutazione globale da parte del paziente, definiti sulla base di una riduzione del 30% e di una riduzione del 50%
    Per altri dati riferirsi al protocollo
    E.3Principal inclusion criteria
    1) Male or female > 18 years of age at the screening visit
    2) Clinical diagnosis of OA of knee or hip based on ACR criteria with radiologic evidence of OA and moderate to severe pain in an eligible joint
    defined by WOMAC pain subscore
    3) Willing to discontinue current pain medication
    4) History of inadequate pain relief or intolerance to analgesics used for OA
    5) History of regular use of analgesic medications for OA
    1) Maschio o femmina > 18 anni di età al momento della visita di screening
    2) Diagnosi clinica di OA del ginocchio o dell'anca basata sui criteri ACR, con evidenza radiologica di OA e dolore da moderato a grave in un'articolazione eleggibile definito in base al punteggio nella sottoscala WOMAC per il dolore
    3) Disponibilità a interrompere l'attuale farmaco antidolorifico
    4) Anamnesi di sollievo inadeguato dal dolore o intolleranza agli analgesici usati per l'OA
    5) Anamnesi di uso regolare di farmaci analgesici per l'OA
    E.4Principal exclusion criteria
    1) Joint diseases or other underlying conditions that can confound with the study parameters
    2) Recent use of systemic or intra-articular corticosteroids
    3) Evidence of destructive arthropathy
    4) Evidence of autonomic or other neuropathy
    5) Scheduled for joint replacement surgery during the trial
    6) Other medical conditions that may interfere with participation or accurate assessments during the trial
    7) Pregnant or breastfeeding women
    1) Patologie articolari o altre condizioni primarie che possono interferire con i parametri dello studio
    2) Recente utilizzo di corticosteroidi sistemici o intrarticolari
    3) Segni di artropatia distruttiva
    4) Segni di neuropatia autonomica o di altro genere
    5) Intervento di sostituzione articolare pianificato nel corso della sperimentazione
    6) Altre condizioni mediche che possono interferire con la partecipazione o le valutazioni accurate nel corso della sperimentazione
    7) Donne in gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Safety monitoring including adverse event (AE) incidence, serious adverse event (SAE) incidence, AESI incidence, changes in safety laboratory analyses, and incidence of anti-fasinumab antibody formation between baseline and week 16 (treatment period 1).
    Monitoraggio della sicurezza, inclusa l’incidenza di eventi avversi (EA), l’incidenza di eventi avversi gravi (EAG), l’incidenza di EASI, le variazioni nelle analisi di laboratorio per la sicurezza e l’incidenza di formazione di anticorpi anti-fasinumab tra il basale e la Settimana 16 (periodo di trattamento 1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 16
    Alla settimana 16
    E.5.2Secondary end point(s)
    - Safety monitoring through all adverse events incidences
    - Incidence of anti-fasinumab antibody formation
    -Monitoraggio della sicurezza, inclusa l¿incidenza di EA
    -L¿incidenza di formazione di anticorpi anti-fasinumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 52
    Alla settimana 52
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Efficacy only for the Onset of Pain Relief Sub-study
    Tollerabilit¿
    Efficacia solo per il sotto-studio sul sollievo dal dolore
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    Argentina
    Brazil
    Canada
    Chile
    Colombia
    Hong Kong
    Mexico
    Peru
    Russian Federation
    South Africa
    Bulgaria
    Czechia
    Denmark
    Estonia
    France
    Germany
    Italy
    Lithuania
    Poland
    Romania
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS - study ends after 24 weeks of follow up
    LVLS - lo studio terminer¿ dopo 24 settimane di follow-up
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 3500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6500
    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 state87
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4500
    F.4.2.2In the whole clinical trial 10000
    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)
    Treatment after trial completion will be dependent on
    recommendations from the patient's personal physician.
    Il trattamento dopo il completamento della sperimentazione dipender¿ dalle raccomandazioni del medico di famiglia
    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 Decision2016-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
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    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.

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