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    Summary
    EudraCT Number:2015-001442-29
    Sponsor's Protocol Code Number:D3461C00007
    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:2021-02-09
    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 number2015-001442-29
    A.3Full title of the trial
    A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Proliferative Lupus Nephritis
    Studio di fase 2, multicentrico, randomizzato, in doppio cieco, controllato verso placebo per la valutazione dell’efficacia e della sicurezza di anifrolumab in soggetti adulti con nefrite lupica proliferativa in fase attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects with Active Proliferative Lupus Nephritis
    Sicurezza ed efficacia di due dosi di anifrolumab contro placebo in soggetti adulti con nefrite lupica proliferativa in fase attiva
    A.3.2Name or abbreviated title of the trial where available
    TULIP-LN1
    TULIP-LN1
    A.4.1Sponsor's protocol code numberD3461C00007
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressUSA
    B.5.3.2Town/ cityUSA
    B.5.3.3Post codeUSA
    B.5.3.4CountryUnited States
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailinformation.centre@astrazeneca.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 nameAnifrolumab
    D.3.2Product code [-]
    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 INNANIFROLUMAB
    D.3.9.2Current sponsor codeMedi-546
    D.3.9.4EV Substance CodeSUB128931
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboConcentrate for solution 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
    Lupus Nephritis
    Nefrite lupica
    E.1.1.1Medical condition in easily understood language
    Lupus Nephritis
    Nefrite lupica
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of anifrolumab plus standard of care (SOC) compared to placebo plus SOC in subjects with active proliferative lupus nephritis measured by the relative difference in change from baseline to Week 52 in 24-hour urine protein to creatinine ratio (UPCR)
    Valutare l’efficacia di anifrolumab + la terapia standard (SOC) rispetto a placebo + SOC in soggetti con nefrite lupica proliferativa in fase attiva misurata in base alla differenza relativa nella variazione dal basale alla Settimana 52 del rapporto urinario proteine-creatinina (UPCR) delle 24 ore
    E.2.2Secondary objectives of the trial
    To evaluate the effect of anifrolumab plus SOC compared to placebo plus SOC on:
    - Proportion of subjects achieving Complete Renal Response (CRR) at Week 52
    - Proportion of subjects achieving alternative CRR (aCRR) at Week 52.
    The difference between the CRR and the aCRR is the addition of a criterion regarding "inactive urine sediment"
    Valutare l’effetto di anifrolumab + SOC vs. placebo + SOC sui seguenti parametri:
    • Percentuale di soggetti che ottengono una risposta renale completa (CRR) alla Settimana 52
    • Percentuale di soggetti che ottengono una CRR alternativa (aCRR) alla Settimana 52.
    La differenza tra CRR e aCRR risiede nell’aggiunta di un criterio relativo al “sedimento urinario inattivo”
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 through 70 years at the time of screening
    2. Fulfils at least 4 of the 11 criteria of the revised 1982 ACR classification criteria for SLE, at least one of which must be:
    a. Positive antinuclear antibody (ANA) test (1:40 or higher) or
    b. Elevated anti-dsDNA antibodies at screening (reported as equivocal or positive results), as per the central laboratory or
    c Anti-Smith antibody at screening elevated to above normal (ie, positive or equivocal results) as per the central laboratory
    3.Class III (±class V) or class IV (±class V) LN according to the World Health Organisation (WHO) or 2003 ISN/RPS classification based on a renal biopsy obtained within 12 weeks prior to signing the ICF or during the screening period
    4. Urine protein to creatinine ratio >1 mg/mg (113.17 mg/mmol), obtained on a 24-hour urine collection at both:
    - The start of screening and
    - Within 14 days prior to the expected date of randomisation. Without the results of the second (stratification) sample, subjects cannot be randomised.
    5. Estimated glomerular filtration rate =35 mL/min/1.73 m2
    6. Must not have active or untreated latent TB on either chest radiograph or by Quantiferon gold test
    7. Women of childbearing potential must have a negative serum betahCG test at screening and negative urine pregnancy test prior to administration of investigational product and prior to the first dose of sponsor-provided MMF
    1. soggetti adulti di età compresa tra 18 e 70 anni al momento dello screening
    2. soddisfare almeno 4 degli 11 criteri per la classificazione di SLE secondo i criteri rivisti dell’ACR 1982, di cui almeno uno deve essere:
    a) positività all’analisi degli anticorpi antinucleo (ANA) (1:40 o superiore) oppure
    b) Elevati anticorpi anti-dsDNA allo screening (indicati come risultati equivoci o positivi), determinati tramite laboratorio centralizzato
    c) Anticorpi anti-Smith elevati più del normale allo screening (cioè risultati equivoci o positivi), determinati tramite laboratorio centralizzato
    3. Nefrite lupica di classe III (±classe V) o classe IV (±classe V) secondo l’Organizzazione Mondiale della Sanità o la classificazione 2003 ISN/RPS sulla base di una biopsia renale ottenuta entro le 12 settimane precedenti la firma del consenso informato o durante il periodo di screening.
    4. Rapporto urinario proteine-creatinina > 1 mg/mg (113.17 mg/mmol), ottenute sulla raccolta delle urine delle 24 ore:
    - sia al momento dello screening
    - sia entro 14 giorni prima della data prevista di randomizzazione. Senza i risultati del secondo campione (stratificazione), i soggetti non possono essere randomizzati.
    5. Tasso stimato di filtrazione glomerulare =35 mL/min/1.73 m2
    6. Assenza di tubercolosi in stadio attivo o latente non trattata su entrambe le radiografie toraciche o tramite test Quantiferon Gold
    7. Donne fertili devono avere un test beta-hCG sierico negativo allo screening e un test di gravidanza negativo sulle urine prima della somministrazione del farmaco sperimentale e prima della prima dose di MMF fornito dal Promotore.
    E.4Principal exclusion criteria
    1. Receipt of any investigational product (small molecule or biologic) or commercially available biologic agent within four weeks or 5 half lives prior to signing of the ICF, whichever is greater
    2. Pure Class V membranous LN on a renal biopsy obtained within 12 weeks prior to signing ICF or during the screening period
    3. Known intolerance to =1.0 gm/day of MMF
    4. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant)
    within a 6 month period after enrolment
    5. Subjects, who at the time of signing the ICF, received any of the following immunosuppressive therapies after their qualifying biopsy
    (a) Oral corticosteroids >0.5 mg/kg/day for more than 8 weeks or
    (b) Oral or IV pulse methylprednisolone >3.0 gm (cumulative dose) or
    (c) IV cyclophosphamide >2 pulses of high dose
    (=0.5 gm/m2) or >4 doses of low-dose (500 mg every 2 weeks) or
    (d) Average MMF >2.5 gm/day (or >1800 mg/day of enteric-coated mycophenolate sodium) for more than 8 weeks or
    (e) Tacrolimus >4 mg/day for more than 8 weeks
    6. Major surgery within 8 weeks before signing the ICF or major surgery planned during the study period
    7. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF
    8. Confirmed positive test for hepatitis B or hepatitis C
    9. Any severe herpes infection at any time prior to randomization
    10.Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years prior to randomization
    11. History of cancer, apart from:
    a. Squamous or basal cell carcinoma of the skin
    that has been successfully treated
    b. High-grade squamous intraepithelial lesion (CIN III, CIS) treated with apparent success with curative therapy =1 year prior to randomisation
    1. Somministrazione di qualsiasi prodotto sperimentale (molecole di piccole dimensioni o biologiche) o di farmaci biologici commercialmente disponibili entro 4 settimane o 5 emivite (qualunque sia il più grande) dalla firma del consenso informato
    2. Nefrite lupica membranosa pura di classe V su biopsia renale ottenuta entro 12 settimane prima della firma del consenso informato o durante il periodo di screening.
    3. Nota intolleranza a =1.0 gm/die di MMF
    4. Storia di dialisi entro 12 mesi prima della firma del consenso informato, o previsto bisogno di una terapia sostitutiva renale (dialisi o trapianto renale) entro un periodo di 6 mesi successivo all’arruolamento
    5. Soggetti che al momento della firma del consenso informato hanno ricevuto qualsiasi delle seguenti terapie immunosoppressive, dopo biopsia qualificante:
    a) Corticosteroidi orali >0.5 mg/kg/die per più di 8 settimane oppure
    b) Metilprednisolone >3.0 g orale o intravenoso (dose cumulativa) oppure
    c) Ciclofosfamide intravenoso >2 impulsi ad alta dose (=0.5 g/m2) o >4 dosi a basso dosaggio (500 mg ogni 2 settimane) oppure
    d) MMF media >2.5 g/die (oppure >1800 mg/die di micofenolato sodico gastroresistente) per più di 8 settimane oppure
    e) Tacrolimus >4 mg/die per più di 8 settimane
    6. Chirurgia maggiore entro 8 settimane prima della firma del consenso informato o chirurgia maggiore pianificata durante il periodo dello studio
    7. Storia di qualsiasi patologia non-SLE che abbia richiesto un trattamento con corticosteroidi orali o parenterali per più di 2 settimane totali entro le ultime 24 settimane prima della firma del consenso informato
    8. Test positivo confermato per epatite B o epatite C
    9. Qualsiasi infezione grave da herpes in qualsiasi momento prima della randomizzazione
    10. Infezioni opportunistiche che richiedano ospedalizzazione o trattamenti antimicrobici per via parenterale entro 3 anni prima della randomizzazione
    11. Storia di cancro, con l’esclusione di:
    a) Carcinoma della pelle a cellule squamose o basali, trattato con successo
    b) Lesione intraepiteliale squamosa di alto grado (CIN III, CIS) trattata con successo evidente con terapie curative =1 anno prima della randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint used to evaluate the effect of anifrolumab compared to placebo on LN disease activity is the relative difference in change from baseline to Week 52 in the 24-hour
    UPCR.
    L’endpoint primario utilizzato per valutare l’effetto di anifrolumab rispetto a placebo nell’attività della nefrite lupica è la differenza relativa nella variazione dal basale alla Settimana 52 del rapporto urinario proteine-creatinina (UPCR) delle 24 ore
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 52
    dal basale alla Settimana 52
    E.5.2Secondary end point(s)
    Complete renal response
    To evaluate the effect of anifrolumab compared to placebo on renal
    response in LN subjects,
    the proportion of subjects achieving CRR at Week 52 will be used. A
    subject achieves CRR if
    all of the following criteria are met:
    • Estimated glomerular filtration rate (eGFR):
    - =80 mL/min/1.73 m2, if baseline eGFR =90 mL/min/1.73 m2 or
    - >85% of baseline eGFR, if baseline eGFR <90 mL/min/1.73 m2
    • 24-hour UPCR <0.5 mg/mg
    • No discontinuation of investigational product or use of restricted
    medication beyond
    the protocol-allowed threshold before assessment.
    Alternative Complete renal response
    To evaluate the effect of anifrolumab compared to placebo on renal
    response in LN subjects
    when urine sediment is considered in the definition, the proportion of
    subjects achieving
    aCRR at Week 52 will be used. A subject achieves aCRR if all of the
    following criteria are
    met:
    • Estimated glomerular filtration rate (eGFR):
    - =80 mL/min/1.73 m2, if baseline eGFR =90 mL/min/1.73 m2 or
    - >85% of baseline eGFR, if baseline eGFR <90 mL/min/1.73 m2
    • 24-hour UPCR <0.5 mg/mg
    • Inactive urine sediment (defined as <10 RBC/hpf)
    Risposta renale completa Per valutare l’effetto di anifrolumab rispetto a placebo nella risposta renale di pazienti con nefrite lupica, sarà utilizzata la percentuale di soggetti che ottengono una risposta renale completa alla Settimana 52. La CRR si considera raggiunta quando vengono soddisfatti tutti i parametri seguenti: • velocità di filtrazione glomerulare stimata (eGFR): - =80 mL/min/1,73 m2 con eGFR basale =90 mL/min/1,73 m2 oppure - >85%della eGFR basale con eGFR basale <90 mL/min/1,73 m2 • UPCR delle 24 ore <0,5 mg/mg • nessuna interruzione del prodotto sperimentale né uso di farmaci soggetti a restrizione oltre la soglia stabilita dal protocollo prima della valutazione Risposta renale completa alternativa Per valutare l’effetto di anifrolumab rispetto a placebo nella risposta renale di pazienti con nefrite lupica quando il sedimento urinario è considerato nella definizione, sarà utilizzata la percentuale di soggetti che ottengono una risposta renale completa alternativa alla Settimana 52. La aCRR si considera raggiunta quando vengono soddisfatti tutti i parametri seguenti: • velocità di filtrazione glomerulare stimata (eGFR): - =80 mL/min/1,73 m2 con eGFR basale =90 mL/min/1,73 m2 oppure - >85%della eGFR basale con eGFR basale <90 mL/min/1,73 m2 • UPCR delle 24 ore <0,5 mg/mg • sedimento urinario inattivo (definito come <10 RBC/hpf)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Australia
    Korea, Republic of
    Mexico
    Peru
    Russian Federation
    Serbia
    South Africa
    Taiwan
    United States
    Belgium
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    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
    An individual subject will be considered to have completed the study if the subject was followed up until the end of the study (Week 60), regardless of the number of doses of investigational product that were received. The end of the study ("study completion") is defined as the date of the last protocol-specified visit/assessment for the last subject in the study.
    Si considera che un soggetto avrà completato lo studio se il soggetto ha eseguito il follow-up fino alla fine dello studio (settimana 60), indipendentemente dal numero di dosi di farmaco sperimentale ricevuto. La fine dello studio ("completamento dello studio") è definita come data dell'ultima visita/valutazione specificata nel protocollo per l'ultimo paziente dello studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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: 145
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 150
    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)
    After Week 52, eligible participants will be offered the opportunity to continue treatment for another 12 months in a long-term extension study.
    Dopo la settimana 52, ai pazienti idonei sarà data l'opportunità di continuare il trattamento per altri 12 mesi, con uno studio di estensione a lungo termine.
    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 Decision2016-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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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