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    Summary
    EudraCT Number:2021-002476-39
    Sponsor's Protocol Code Number:RLX0121
    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:2021-08-30
    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 number2021-002476-39
    A.3Full title of the trial
    Prospective study to evaluate the effects of Raloxifene therapy on SARS-CoV-2 immunity after COVID-19 vaccination
    Prospective study to evaluate the effects of Raloxifene therapy on SARS-CoV-2 immunity after COVID-19 vaccination
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective study to evaluate the effects of Raloxifene therapy on SARS-CoV-2 immunity after COVID-19 vaccination
    Studio prospettico per valutare gli effetti della terapia con Raloxifene sull'immunità SARS-CoV-2 dopo la vaccinazione per COVID-19
    A.3.2Name or abbreviated title of the trial where available
    RALOXIVAXI
    RALOXIVAXI
    A.4.1Sponsor's protocol code numberRLX0121
    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 SponsorDOMPé FARMACEUTICI S.P.A.
    B.1.3.4CountryItaly
    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 supportDompé farmaceutici S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDompé farmaceutici S.p.A.
    B.5.2Functional name of contact pointFlavio Mantelli
    B.5.3 Address:
    B.5.3.1Street AddressVia Santa Lucia, 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number02583831
    B.5.5Fax number0258383324
    B.5.6E-mailFlavio.Mantelli@dompe.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 Yes
    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 nameRaloxifene
    D.3.2Product code [Raloxifene]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRALOXIFENE CLORIDRATO
    D.3.9.1CAS number 84449-90-1
    D.3.9.2Current sponsor coderaloxifene cloridrato
    D.3.9.4EV Substance CodeSUB12568MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    The study will be conducted in non-oncological female patients older than 50 years who have received the first dose of a COVID vaccination, or who have received the full vaccination within 8 weeks prior to the first planned blood collection.
    Lo studio sarà condotto su pazienti non oncologici di sesso femminile di età superiore ai 50 anni che hanno ricevuto la prima dose di una vaccinazione COVID-19 o soggetti che hanno ricevuto la vaccinazione completa entro 8 settimane prima del primo prelievo di sangue pianificato
    E.1.1.1Medical condition in easily understood language
    The study will be conducted in non-oncological female patients older than 50 years who have received COVID vaccination.
    Lo studio sarà condotto su pazienti non oncologici di sesso femminile di età superiore ai 50 anni che hanno ricevuto vaccinazione COVID.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084457
    E.1.2Term COVID-19 immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 is to verify if Raloxifene treatment is able to stimulate the immunization against Sars-CoV-2 compared to other osteoporosis treatments/prevention strategies.
    L'obiettivo principale dello studio è verificare se il trattamento con Raloxifene è in grado di stimolare l'immunizzazione contro Sars-CoV-2 rispetto ad altri trattamenti / strategie di prevenzione dell'osteoporosi.
    E.2.2Secondary objectives of the trial
    The Secondary objective is to evaluate if Raloxifene is able to boost COVID-19 vaccine’s efficacy by comparing the number of Sars-CoV-2 cases in the different groups after vaccination.
    L'obiettivo secondario è valutare se il Raloxifene è in grado di aumentare l'efficacia del vaccino anti-SARS-CoV-2 confrontando il numero di casi di infezione nei diversi gruppi dopo la vaccinazione.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Females Age > 50 years old
    • Patients who are under Raloxifene therapy as a prevention strategy or treatment of osteoporosis OR
    • Subjects who are taking alendronate as a prevention strategy for osteoporosis OR
    • Subjects who are taking Vit. D and Calcium as a prevention approach for osteoporosis OR
    • Subjects who are not receiving any osteoporosis preventive treatment or treatment
    • AND
    Who have received the first dose of a COVID vaccination, or who have received the full vaccination within 8 weeks prior to the first planned blood collection. All approved COVID vaccines are accepted.
    • Donne di età> 50 anni
    • Pazienti sottoposti a terapia con Raloxifene come strategia di prevenzione o trattamento dell'osteoporosi O
    • Soggetti che assumono alendronato come strategia di prevenzione per l'osteoporosi O
    • Soggetti che assumono Vit. D e Calcio come approccio di prevenzione per l'osteoporosi O
    • Soggetti che non ricevono alcun trattamento come strategia di prevenzione o trattamento per l'osteoporosi
    E
    • che hanno ricevuto la prima dose di una vaccinazione COVID o che hanno ricevuto la vaccinazione completa entro 8 settimane prima del primo prelievo di sangue pianificato. Tutti i vaccini COVID approvati sono accettati.
    E.4Principal exclusion criteria
    • Subjects who are SARS-CoV-2 positive
    • Subjects who have received the complete COVID vaccination more than 8 weeks prior to the first planned blood collection
    • Immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection, asplenia, and recurrent severe infections
    • Subjects who have received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the first planned blood collection (for corticosteroids =20 milligrams (mg)/day of prednisone equivalent)
    • Subjects who have received systemic immunoglobulins or blood products within 3 months prior to the first planned blood collection
    • Subjects who have received chemotherapy, radiation therapy or have undergone surgical intervention for cancer in the last 5 years
    • Soggetti che sono SARS-CoV-2 positivi
    • Soggetti che hanno ricevuto la vaccinazione COVID completa più di 8 settimane prima del primo prelievo di sangue pianificato
    • Stato immunosoppressivo o immunodeficiente, inclusa l'infezione da virus dell'immunodeficienza umana (HIV), asplenia e infezioni gravi ricorrenti
    • Soggetti che hanno ricevuto immunosoppressori sistemici o farmaci immunomodificanti per > 14 giorni in totale entro 6 mesi prima del primo prelievo di sangue pianificato (per corticosteroidi =20 milligrammi (mg) / giorno di prednisone equivalente)
    • Soggetti che hanno ricevuto immunoglobuline sistemiche o emoderivati entro 3 mesi prima del primo prelievo di sangue pianificato
    • Soggetti che hanno ricevuto chemioterapia, radioterapia o hanno subito un intervento chirurgico per cancro negli ultimi 5 anni.
    E.5 End points
    E.5.1Primary end point(s)
    Quantification of SARS-CoV-2 Specific Neutralizing Antibody (nAb) and S protein-specific Binding Antibody (bAb) levels in patients’ blood serum and measurement of GMTs (geometric mean titers) and GMFRs (geometric mean fold rises) in SARS-CoV-2 Specific Neutralizing Antibody (nAb) and S protein-specific Binding Antibody (bAb) at the different timepoints
    Quantificazione dei livelli di anticorpi neutralizzanti specifico per SARS-CoV-2 (nAb) e anticorpi specifici legante la proteina S (bAb) nel siero del paziente e misurazione delle GMT (media geometrica dei titoli) e GMFR (aumento della piega media geometrica) nei diversi punti temporali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Settimana 16
    E.5.2Secondary end point(s)
    Proportion of participants tested positive for Sars-CoV-2 in the period from complete COVID vaccination to the end of the study (week 16 after complete vaccination) in the different groups
    Percentuale di partecipanti che risultata positiva per Sars-CoV-2 nel periodo dalla vaccinazione COVID completa alla fine dello studio (settimana 16 dopo la vaccinazione completa) nei diversi gruppi
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prospettico
    Prospective
    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
    Soggetti che non ricevono alcun trattamento terapeutico o preventivo per l'osteoporosi.
    Subjects who are not receiving any osteoporosis preventive treatment or treatment
    E.8.2.4Number of treatment arms in the trial4
    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 No
    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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    NA
    NA
    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 Decision2021-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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