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    Summary
    EudraCT Number:2020-001189-13
    Sponsor's Protocol Code Number:C4181005
    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:2021-06-15
    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 number2020-001189-13
    A.3Full title of the trial
    A PHASE 2 MULTIPLE DOSE, RANDOMIZED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA
    STUDIO RANDOMIZZATO DI FASE 2 A DOSI MULTIPLE, VOLTO A VALUTARE LA SICUREZZA, LA TOLLERABILITÀ, LA FARMACOCINETICA E L’EFFICACIA DI RECIFERCEPT NEI BAMBINI CON ACONDROPLASIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 study of safety, tolerability, PK and efficacy of recifercept in achondroplasia
    Studio di fase 2 su sicurezza, tollerabilità, farmacocinetica (PK) ed efficacia di recifercept nell’acondroplasia
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberC4181005
    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 codeNY10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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/3/17/1843
    D.3 Description of the IMP
    D.3.1Product nameRecifercept
    D.3.2Product code [PF-07256472]
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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 INNRecifercept
    D.3.9.2Current sponsor codePF-07256472
    D.3.9.4EV Substance CodeSUB190544
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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) 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
    Achondroplasia
    Acondroplasia
    E.1.1.1Medical condition in easily understood language
    Short stature
    Bassa statura
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000452
    E.1.2Term Achondroplasia
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000452
    E.1.2Term Achondroplasia
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Evaluate the safety and tolerability of recifercept doses and dosing regimes in participants aged >2 to <11 years with achondroplasia.
    - To assess efficacy of recifercept to increase height growth in children with achondroplasia.
    - Valutare la sicurezza e la tollerabilità delle dosi e dei regimi di dosaggio di recifercept nei partecipanti di età compresa tra =2 e <11 anni con acondroplasia.
    - Valutare l’efficacia di recifercept nel far aumentare l’altezza dei bambini con acondroplasia.
    E.2.2Secondary objectives of the trial
    - To evaluate the pharmacokinetics (PK) of recifercept in children aged >2 to <11 years old with achondroplasia.
    - To assess efficacy of recifercept to improve achodroplasia-related complications
    - Assess change in individual safety parameters
    - Valutare la PK di recifercept in bambini di età compresa tra =2 e <11 anni di età con acondroplasia.
    - Valutare l’efficacia di recifercept per migliorare le complicazioni correlate all’acodroplasia.
    - Valutare la variazione dei parametri di sicurezza personali.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age and Sex
    1.Main cohort: Aged >= 2 years to <11 years (up to the day before 11th birthday inclusive) at time of enrollment; or exploratory cohort: aged >=3 months to <2years (up to the day before 2nd birthday inclusive) at time of enrollment.
    Type of Participant and Disease Characteristics
    2. Documented, confirmed genetic diagnosis of achondroplasia from historical medical records prior to entry into this trial (test must have been performed at a laboratory fully accredited for genetic testing under
    local regulations).
    3. Completed the C4181001 natural history study with at least 2 valid height/length measurements (at least 3 months apart) prior to enrollment in this study. One of these measurement timepoints must be within the 3 months prior to enrollment in C4181005.
    4. Tanner stage 1 based on investigator assessment during physical examination (must include assessment of breast development for females, testicular stage for males).
    5. Able to stand independently for height measurements (if >2 years of age at enrollment).
    6. If aged <2 years at enrollment, has a documented historical MRI brain/cervical spine performed in the previous 12 months.
    7. Capable of giving signed informed consent/assent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
    8. Following receipt of oral and written information about the trial, the child (depending on local institutional review board/independent ethics committee requirements) must provide assent, and one or both
    (according to local regulations) parents or guardians of the child must provide signed informed consent before any trial-related activity is carried out.
    Età e sesso:
    1. Coorte principale: età >=2 anni e <11 anni (fino al giorno precedente l’11° compleanno) al momento dell’arruolamento; o coorte esplorativa: età >= 3 mesi e < 2 anni (fino al giorno precedente il 2° compleanno) al momento dell'arruolamento.
    Caratteristiche principali della malattia:
    2. Diagnosi genetica confermata e documentata di acondroplasia con cartelle cliniche precedenti l’ingresso nella sperimentazione (ed esami effettuati presso laboratori totalmente accreditati per i test genetici in base alle normative locali).
    3. Completamento dello studio di anamnesi naturale C4181001 con almeno 2 misurazioni di altezza/lunghezza valide (a distanza di non meno di 3 mesi l’una dall’altra) prima dell’arruolamento nel presente studio. Uno di questi punti temporali di misurazione deve ricadere nei 3 mesi precedenti l’arruolamento in C4181005.
    4. Stadio di Tanner 1 in base alla valutazione dello sperimentatore nel corso dell’esame obiettivo (con valutazione di sviluppo del seno per i soggetti di sesso femminile e dello stadio testicolare per quelli di sesso maschile).
    5. Capacità di stare in piedi autonomamente per misurare l’altezza (se =2 anni di età all’arruolamento).
    6. RMI cerebrale/alla colonna cervicale effettuata nei 12 mesi precedenti per i soggetti con <2 anni di età all’arruolamento.
    7. Capacità di fornire il consenso/assenso informato firmato secondo quanto descritto nell’Appendice 1 del protocollo, che include la conformità ai requisiti e alle restrizioni elencati nel documento di consenso informato (ICD) e nel presente protocollo.
    8. Assenso del bambino (in base ai requisiti del Consiglio di revisione istituzionale/Comitato etico indipendente locale) e firma del consenso informato da parte di uno o entrambi i genitori/tutori (in base alle normative locali) forniti in seguito alla ricezione di informazioni orali e scritte sulla sperimentazione e prima di avviare qualsiasi attività correlata.
    E.4Principal exclusion criteria
    1. Presence of co-morbid conditions or circumstances that, in the opinion of the investigator, would affect interpretation of growth data or ability to complete the trial procedures.
    2. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
    3. Presence of severe obesity (BMI >95th percentile on Hoover-Fong BMI charts)
    4. Known closure of long bone growth plates (cessation of height growth).
    5. Body weight <7 kg or >30 kg.
    6. Severe renal impairment (eGFR <60 ml/min/1,73m2) or hepatic impairment (AST/ALT >1,5 ULN).
    7. History of hypersensitivity to study intervention or any excipients.
    8. History of any prior treatment with human growth hormone or related products (including insulin-like growth factor 1 [IGF-1]).
    9. History of receipt of any treatment that are known to potentially affect growth (including oral steroids >5 days in the last 6 months, high dose inhaled corticosteroids (>800 mcg/day beclametasone equivalent) and
    medication for attention deficit hyperactivity disorder).
    10. History of limb lengthening surgery (defined as distraction osteogenesis/Ilizarov/callostasis technique following submetaphyseal osteotomy to extend bone length).
    11. Any limb lengthening/corrective orthopaedic surgery planned at any point during the trial period.
    12. Less than 6 months since fracture or surgical procedure of any bone determined from the screening visit date.
    13. Presence of any internal guided growth plates/devices.
    14. History of removal of internal guided growth plates/devices within less than 6 months.
    15. History of receipt of any investigational product for achondroplasia or that may affect growth/interpretation of growth parameters.
    16. History of receipt of an investigational product (not for achondroplasia/growth affecting) within the last 30 days or 5 half-lives (whichever is longer).
    17. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
    1. Presenza di condizioni di comorbilità o circostanze che, secondo il parere dello sperimentatore, potrebbero influenzare l’interpretazione dei dati sulla crescita o la capacità di completare le procedure della sperimentazione.
    2. Altra condizione medica o psichiatrica, compresa l’ideazione o la condotta suicidaria recente (nell’anno precedente) o attiva, oppure un’anomalia di laboratorio che potrebbe aumentare il rischio associato alla partecipazione allo studio o che, a giudizio dello sperimentatore, renderebbe il soggetto inadatto allo studio.
    3. Presenza di obesità grave (IMC >95° percentile nei grafici per IMC di Hoover-Fong) [Hoover-Fong et al, 2008].
    4. Nota chiusura delle piastre di crescita delle ossa lunghe (cessazione della crescita in altezza).
    5. Peso corporeo <7 kg o >30 kg.
    6. Grave compromissione renale (eGFR <60 ml/min/1,73m2) o compromissione epatica (AST/ALT >1,5 ULN).
    7. Anamnesi di ipersensibilità all’intervento dello studio o agli eccipienti.
    8. Anamnesi di qualsiasi trattamento precedente con ormone della crescita umano o prodotti correlati (compreso il fattore di crescita insulino-simile 1 [IGF-1]).
    9. Anamnesi di assunzione di qualsiasi trattamento noto per possibili effetti sulla crescita (ad es. steroidi per via orale >5 giorni nei 6 mesi precedenti, corticosteroidi per via inalatoria a dosi elevate [>800 mcg/die beclametasone equivalente] e farmaci per il disturbo da deficit di attenzione e iperattività).
    10. Anamnesi di intervento chirurgico di allungamento degli arti (quale osteogenesi per distrazione/tecnica di Ilizarov/callotasi a seguito di osteotomia submetafisaria per l’estensione della lunghezza ossea).
    11. Previsione di qualsiasi intervento chirurgico ortopedico correttivo o per l’allungamento degli arti in qualsiasi momento nel periodo della sperimentazione.
    12. Frattura o procedura chirurgica di qualsiasi osso verificatasi nei 6 mesi precedenti alla data della visita di screening.
    13. Presenza di piastre/dispositivi interni per la crescita guidata.
    14. Anamnesi di rimozione di piastre/dispositivi interni per la crescita guidata nei 6 mesi precedenti.
    15. Anamnesi di assunzione di qualsiasi IP per l’acondroplasia o IP che potrebbe influire sulla crescita o sull’interpretazione dei parametri di crescita.
    16. Anamnesi di assunzione di IP (non per l’acondroplasia e che non influisce sulla crescita) nei 30 giorni precedenti o entro 5 emivite (a seconda di quale periodo è più lungo).
    17. Il personale del centro dello sperimentatore e i dipendenti di Pfizer direttamente coinvolti nella conduzione dello studio, il personale del centro altrimenti supervisionato dallo sperimentatore e i rispettivi familiari.
    E.5 End points
    E.5.1Primary end point(s)
    - Safety and tolerability of recifercept as assessed through frequency and severity of AEs/SAEs.
    - Increase in height growth above expected in reference population [Merker et al,2018]
    - Sicurezza e tollerabilità di recifercept valutate in base alla frequenza e alla gravità di eventi avversi (EA)/eventi avversi gravi (EAG).
    - Aumento dell’altezza al di sopra dei livelli attesi nella popolazione di riferimento [Merker et al, 2018].
    E.5.1.1Timepoint(s) of evaluation of this end point
    At screening, D1, D4, D8, D15, D29, D61, D91, D121, D152, D183, D274, D2, D365
    Allo screening, G1, G4, G8, G15, G29, G61, G91, G121, G152, G183, G274, G2, G365
    E.5.2Secondary end point(s)
    - Population PK characterization in children aged >2 to <11 years old with achondroplasia. Clearance (CL/F) and other PK parameters of recifercept to assess exposures in different age group.
    - Sitting height/standing height ratio.
    - Arm span to height/length difference.
    - Knee height:lower segment ratio.
    - Occipito-frontal circumference.
    - Ratio of occipito-frontal distance to occipito-mid-face measurements.
    - z-score of the above proportionality and skull morphology where achondroplasia reference datasets exist (occipito-frontal circumference, arm span, sitting height).
    - Fixed flexion angles at elbow.
    - Polysomnography parameters in those with pre-existing sleepdisordered breathing at the time of enrollment.
    - Body mass index (BMI).
    - Waist:chest circumference ratio.
    - Change from baseline in CHAQ component and index scores, QoLISSY Brief total score.
    - Change from baseline in safety labs, vital signs, physical examination.
    - Rate of anti-drug antibodies.
    - Caratterizzazione della PK di popolazione nei bambini di età compresa tra =2 e <11 anni di età
    con acondroplasia. Clearance (CL/F) e altri parametri PK di recifercept per valutare l’esposizione in diversi gruppi di età.
    - Rapporto altezza da seduti/altezza in posizione eretta.
    - Differenza tra apertura del braccio e altezza/lunghezza.
    - Rapporto altezza del ginocchio/segmento inferiore.
    - Circonferenza occipitofrontale.
    - Rapporto fra la distanza occipitofrontale e le misure occipito-mediofacciale.
    - Punteggio z della proporzionalità superiore e della morfologia del cranio laddove esistano dati di riferimento per l’acondroplasia (circonferenza occipitofrontale, apertura del braccio, altezza da
    seduti).
    - Angoli di flessione fissi a livello del gomito.
    - Parametri della polisonnografia nei pazienti con preesistenti disturbi respiratori nel sonno al
    momento dell’arruolamento.
    - Indice di massa corporea (IMC).
    - Rapporto circonferenza vita/torace.
    - Variazione rispetto al basale del componente Questionario di valutazione dello stato di salute dei bambini (CHAQ) e dei punteggi indicizzati, punteggio totale dello strumento Qualità della vita nei giovani di bassa statura (QoLISSY) breve.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At screening, D1, D4, D8, D15, D29, D61, D91, D121, D152, D183, D274, D2, D365
    Allo screening, G1, G4, G8, G15, G29, G61, G91, G121, G152, G183, G274, G2, G365
    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 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Stesso farmaco, dose diversa
    Same product, different dose
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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 EEA6
    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
    Belgium
    Denmark
    Italy
    Japan
    Portugal
    Spain
    United Kingdom
    United States
    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
    LVLS
    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 years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 9
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 54
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    - 54 children with achondroplasia aged 2-10 years
    - one exploratory cohort of approximately 9 children with achondroplasia, ages 0-2 years
    - 54 bambini affetti da acondroplasia di età 2-10 anni
    - una corte esplorativa di circa 9 bambini affetti da acondroplasia, di età 0-2 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 63
    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 participants who complete the study and in the opinion of the investigator, continue to have a positive risk:benefit profile, will be offered to enroll into an open-label extension (OLE) study. Participants will continue to receive recifercept at the dose previously received in this phase 2 study or at the therapeutic dose once this is identified.
    Tutti i partecipanti che completano lo studio e secondo il parere del investigatore, continuerà ad avere un rischio positivo: il profilo di beneficio, sarà offerto di iscriversi a uno studio di estensione in aperto (OLE). Partecipanti continuerà a ricevere recifercept alla dose precedentemente ricevuta in questo studio di fase 2 o alla dose terapeutica una volta identificato.
    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 Decision2021-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-19
    P. End of Trial
    P.End of Trial StatusOngoing
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