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    Summary
    EudraCT Number:2015-001442-29
    Sponsor's Protocol Code Number:D3461C00007
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-27
    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 ConcernedFrance - ANSM
    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
    Étude de phase 2, multicentrique, randomisée, en double aveugle, contre placebo, évaluant l'efficacité et la tolérance de l'anifrolumab chez des patients adultes atteints de glomérulonéphrite lupique proliférative active
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Two Doses of Anirfrolumab Compared to Placebo in Adult Subjects with Active Proliferative Lupus Nephritis
    Étude évaluant l'efficacité et la tolérance de l'anifrolumab, contre placebo, chez des patients adultes atteints de glomérulonéphrite lupique proliférative active
    A.3.2Name or abbreviated title of the trial where available
    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.5.6E-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.3.4Pharmaceutical 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.3.9.3Other descriptive nameANIFROLUMAB
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    E.1.1.1Medical condition in easily understood language
    Lupus Nephritis
    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 19.0
    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)
    Évaluer l'efficacité de l'anifrolumab plus un traitement standard, comparativement au placebo plus un traitement standard chez des patients présentant une glomérulonéphrite lupique proliférative active, mesurée par la différence relative des modifications observées entre l'inclusion et la Semaine 52 concernant le rapport protéine/créatinine urinaire (RPCU) de 24 heures
    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”
    Évaluer l'effet de l'anifrolumab plus traitement standard comparativement au placebo plus traitement standard sur les paramètres suivants :
    - Proportion de patients parvenant à une réponse rénale complète (RRC) à la Semaine 52
    - Proportion de patients atteignant la RRC alternative (RRCa) à la Semaine 52. La différence entre la RRC et la RRCa est l'addition d'un critère concernant le « sédiment urinaire inactif »
    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 or anti-Sm antibody at screening as determined by 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 gm/gm, obtained on a 24-hour urine collection at screening
    5. Estimated glomerular filtration rate ≥35 mL/min/1.73 m2
    6. Must not have active or latent TB on either chest radiograph or by Quantiferon gold test
    7. Women of childbearing potential must have a negative serum beta-hCG test at screening and negative urine pregnancy test prior to administration of investigational product
    1. Hommes et femmes âgés de 18 à 70 ans au moment de la sélection
    2. Présence d'au moins 4 des 11 critères de classification de l'ACR (voir Annexe D) dont un doit être :
    (a) Test positif pour les anticorps antinucléaires (AAN) (au moins 1:40) lors de la sélection selon l'analyse par immunofluorescence effectuée au laboratoire central ou
    (b) Taux élevés des anticorps anti-ADNdb ou anti-Sm lors de la sélection, selon les analyses effectuées par le laboratoire central
    3. Diagnostic de GNL proliférative fondé sur une biopsie rénale effectuée dans les 12 semaines précédant la signature du formulaire de consentement éclairé ou pendant la période de sélection : GNL de classe III (± classe V) ou de classe IV (± classe V) d'après la classification de l'Organisation Mondiale de la Santé (OMS) ou la classification 2003 ISN/RPS (reposant sur l'évaluation locale de la biopsie rénale)
    4. Rapport protéine/créatinine urinaire > 1 g/g, obtenu sur un recueil d'urines de 24 heures aux début de la sélection et
    entre le Jour -14 et le Jour -7 de la date attendue de la randomisation
    5. Taux de filtration glomérulaire estimé ≥ 35 ml/min/1,73 m²
    6. Absence de signes ou symptômes évoquant une TB active dans les antécédents médicaux ou l'examen clinique
    7. Les femmes en âge de procréer doivent avoir un test urinaire de grossesse négatif avant l'administration du médicament à l'étude et dépistage négatif de la gonadotrophine chorionique humaine β (β-hCG) à la sélection.
    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 ≤1.5 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
    (b) Oral corticosteroids >0.5 mg/kg/day for more than 8 weeks or
    (c) IV methylprednisolone >2.5 gm or
    (d) IV cyclophosphamide >2 pulses of high dose
    (≥0.5 gm/m2) or >4 doses of low dose (500 mg every 2 weeks) or
    (e) MMF >2.5 gm/day (average) for more than 8
    weeks or
    (f) 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. Cervical cancer in situ that has been successfully treated
    1. Réception d'un agent expérimental (petite molécule ou agent biologique) ou d'un agent biologique déjà commercialisé, dans les quatre semaines ou 5 demi-vies, selon la période la plus longue (voir l'Annexe G) avant la signature du formulaire de consentement éclairé
    2. Diagnostic de GNL membraneuse pure de classe V. Ce diagnostic sera fondé sur une biopsie rénale effectuée dans les 12 semaines précédant la signature du formulaire de consentement éclairé ou pendant la période de sélection
    3. Intolérance connue à ≤ 1,5 g/jour de MMF
    4. Antécédents de dialyse dans les 12 mois précédant la signature du formulaire de consentement éclairé ou besoin attendu de traitement substitutif rénal (dialyse ou transplantation rénale) dans les 6 mois suivant le recrutement
    5. Au moment de la signature du formulaire de consentement éclairé, administration d'un des traitements immunosuppresseurs suivants après la biopsie qualifiante
    (a) Corticothérapie orale > 0,5 mg/kg/jour pendant plus de 8 semaines ou
    (b) Méthylprednisolone IV >2,5 g ou
    (c) Cyclophosphamide IV > 2 cures courtes à hautes doses (≥ 0,5 g/m²) ou > 4 administrations à faibles doses (500 mg toutes les 2 semaines) ou
    (d) MMF > 2,5 g/jour (moyenne) pendant plus de 8 semaines ou
    (e) Tacrolimus > 4 mg/jour pendant plus de 8 semaines
    6. Chirurgie majeure dans les 8 semaines précédant la signature du formulaire de consentement éclairé ou chirurgie majeure prévue pendant la période d'étude
    7. Antécédents de pathologie non liée au LED ayant nécessité un traitement par corticoïdes oraux ou parentéraux pendant un total de plus de 2 semaines au cours des 24 semaines avant la signature du formulaire de consentement éclairé
    8. Résultat positif pour la recherche anticorps dirigés contre le virus de l'hépatite C ou B
    9. Infection récidivante à herpès zoster (définie comme 2 épisodes en 2 ans) dans les 5 ans précédant le Jour 1
    10. Antécédents d'infection opportuniste systémique ayant nécessité une hospitalisation ou un traitement anti-infectieux parentéral dans les 3 ans précédant le Jour 1
    11. Antécédents de cancer hormis :
    (a) Épithélioma malpighien spinocellulaire ou cancer basocellulaire de la peau traité avec un traitement curatif ≥ 12 semaines avant le Jour 1 (visite de la Semaine 0), dont la réussite est documentée
    (b) Carcinome cervical in situ (néoplasie intraépithéliale cervicale de grade III [CIN III], carcinome in situ [CIS]) traité par traitement curatif ≥ 1 an avant le Jour 1 (visite de la Semaine 0), avec réussite apparente du traitement
    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.
    Évaluer l'efficacité de l'anifrolumab plus un traitement standard, comparativement au placebo plus un traitement standard chez des patients présentant une glomérulonéphrite lupique proliférative active, mesurée par la différence relative des modifications observées entre l'inclusion et la Semaine 52 concernant le rapport protéine/créatinine urinaire (RPCU) de 24 heures
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 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 gm/gm
    • 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 gm/gm
    • Inactive urine sediment (defined as <10 RBC/hpf)
    Évaluer l'effet de l'anifrolumab plus traitement standard comparativement au placebo plus traitement standard sur les paramètres suivants :
    Proportion de patients parvenant à une réponse rénale complète (RRC) à la Semaine 52:
    - La RRC est définie comme réunissant tous les critères suivants :
     Le taux de filtration glomérulaire estimé (TFGe) est
     ≥ 80 ml/min/1,73 m², si le TFGe initial était ≥ 90 ml/min/1,73 m² ou
     > 85 % du TFGe initial, si le TFGe initial était < 90 ml/min/1,73 m²
    - RPCU de 24 heures < 0,5 g/ga
    - Aucun arrêt du produit à l'étude ou d'utilisation de médicaments à usage restreintb au-delà du seuil autorisé par le protocole avant l'évaluation

    Proportion de patients atteignant la RRC alternative (RRCa) à la Semaine 52:
    - La RRCa est définie comme réunissant tous les critères suivants :
     Le TFGe est
     ≥ 80 ml/min/1,73 m², si le TFGe initial était ≥ 90 ml/min/1,73 m² ou
     > 85 % du TFGe initial, si le TFGe initial était < 90 ml/min/1,73 m²
    - RPCU de 24 heures < 0,5 g/ga
    - Sédiment urinaire inactif (défini comme < 10 hématies/champ à fort grossissement)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Week 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 concerned6
    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 No
    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
    Belgium
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Mexico
    Peru
    Poland
    Russian Federation
    Serbia
    South Africa
    Spain
    Taiwan
    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
    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.
    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 months3
    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 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.
    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 Opinion2016-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-18
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