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    Summary
    EudraCT Number:2021-002862-42
    Sponsor's Protocol Code Number:D3466C00001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-10-25
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-002862-42
    A.3Full title of the trial
    A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis
    A.4.1Sponsor's protocol code numberD3466C00001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/239/2020
    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 AB
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@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 Anifrolumab
    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.3.9.1CAS number 1326232-46
    D.3.9.2Current sponsor codeMEDI-546
    D.3.9.3Other descriptive nameANIFROLUMAB
    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
    Active Proliferative Lupus Nephritis
    E.1.1.1Medical condition in easily understood language
    Lupus Nephritis, an autoimmune disease
    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 compared with placebo as added to SOC in active proliferative LN (Lupus Nephritis) on the proportion of participants achieving CRR (Complete renal response).
    E.2.2Secondary objectives of the trial
    To evaluate the effect of anifrolumab as compared with placebo as added to SOC on:
    -sustained OCS reduction
    -onset of sustained CRR (Complete renal response)
    -proteinuria
    -early onset of CRR
    -onset of renal-related event or death through Week 52
    -onset of renal-related event or death through Week 76
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 through 70 years at the time of Screening.
    2. Fulfills updated 2019 SLE criteria.
    3. Positive ANA, anti-dsDNA, or anti-Sm test result in sample obtained during Screening.
    4. Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol) (mean of 2 spot UPCR [FMV] samples obtained during Screening).
    5. Active proliferative LN Class III or IV either with or without the presence of Class V (excluding pure Class III[C], IV-S[C], or IV-G[C]) according to the 2003 ISN/RPS classification based on a renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
    6. eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
    7. Adequate peripheral venous access.
    8. Chest radiograph (obtained during Screening or within 12 weeks prior to signing of the informed consent) or a CT scan of the chest (within 12 weeks of signing the informed consent) that meets all of the following criteria: No evidence of current active infection (eg, pneumonia, TB) or previous TB; No evidence of malignancy; No CS abnormalities (unless due to SLE).
    9. Meets all of the following TB criteria: No signs or symptoms of active TB prior to or during any Screening visit; No medical history or past physical examinations suggestive of active TB; A chest radiograph during the Screening Period or within 12 weeks prior to signing the ICF with no evidence of active or signs of prior TB infection; No recent contact with a person with active TB OR if there has been such contact, referral to a physician specializing in TB to undergo additional evaluation prior to Week 0 (Day 1) (documented comprehensively in source) and, if warranted, receipt of appropriate treatment for latent TB at or before the first administration of study intervention; No history of latent TB prior to signing the ICF, with the exception of latent TB with documented completion of appropriate treatment.The participant must undergo an IGRA (eg, QFT-G test) test for TB obtained from the study central laboratory at Screening with results in line with protocol specified rules.
    10. Negative SARS-Cov-2 RT-PCR test result at Screening and no known or suspected COVID-19 infection or exposure between signing the ICF and Week 0 (Day 1). There must be a minimum of 2 weeks between the 2 tests at Screening and Week 0 (Day 1).
    11. Body weight ≥ 40.0 kg.
    12. Females with an intact cervix must have documentation of a Pap smear with no documented malignancy (eg, CIN III, carcinoma in situ, or adenocarcinoma in situ) within 2 years prior to Week 0 (Day 1)
    13. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies (as described in protocol).
    E.4Principal exclusion criteria
    1.A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening
    2.History of dialysis within 12 months prior to the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6-month period after enrollment
    3.History of, or current renal diseases (other than LN) that, in the opinion of the Investigator, could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy)
    4.History of recurrent infection requiring hospitalization and/or IV antibiotics (eg, 2 or more of the same type of infection over the previous 52 weeks).
    5.Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1)
    6.At Screening, confirmed positive test for hepatitis B serology, as confirmed by central lab, for: HBsAg or HBcAb and HBV DNA detected above the LLOQ by reflex testing by the central lab at Screening. Participants who are HBcAb positive at Screening will be tested every 3 months for HBV DNA. To remain eligible for the study, the participant’s HBV DNA levels must remain below the LLOQ as per the central lab
    7.Positive test for hepatitis C antibody as confirmed by the central lab
    8.Any severe case, as defined by study guidelines, of HZ infection at any time prior to Week 0 (Day 1)
    9.Any clinical CMV or EBV infection that has not completely resolved within 12 weeks prior to the ICF
    10.Opportunistic infection (see Section 8.3.8.2 of protocol) requiring hospitalization or IV antimicrobial treatment within 3 years prior to the ICF
    11.Clinically significant chronic infection within 8 weeks prior to signingnthe ICF (chronic nail infections are allowed) or any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to the ICF
    12.Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Week 0 (Day 1)
    13.History of cancer, apart from: Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥3 months
    prior to Week 0 (Day 1); Cervical cancer in situ treated with apparent success with curative therapy ≥1 year prior to Week 0 (Day 1)
    14.Any history of severe COVID-19 infection or any prior COVID-19 infection with documented long COVID and/or clinically significant unresolved sequelae. Any mild/asymptomatic COVID-19 infection within the last 6 weeks prior to first dosing
    15.Failure to comply with all required Screening procedures due to circumstances related to pandemic or public health emergency
    16.Prior receipt of anifrolumab
    17.Previous receipt of >2 investigational treatments for LN since time of diagnosis of LN and through signing the ICF
    18.Known intolerance to ≤1.0 g/day of MMF
    19.Receipt of any commercially available biologic agent within 5 halflives prior to signing of the ICF
    20.Receipt of any of the following prior to signing the ICF: Receipt of B cell-depleting therapy ≤26 weeks prior to signing the ICF or if therapy was administered >26 weeks ago, if absolute B cell count is <50 cells/microliter
    21.A known history of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma
    globulin therapy, human proteins, or monoclonal antibodies
    22.Receipt of any of the following:
    -Any live or attenuated vaccine within 8 weeks prior to signing the ICF
    (killed vaccines are acceptable)
    -Any prohibited medication listed in Appendix O not discontinued according to the prescribed timeframe prior to signing of ICF
    -Blood transfusion or receipt of blood products, except human albumin, within 4 weeks prior to signing the ICF
    -Any of the following for current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide >2 pulses of high-dose (≥0.5 g/m2) or >4 doses of low dose (500 mg every 2 weeks) or Average MMF >2.5 g/day (or >1800 mg/day of enteric coated mycophenolate sodium) for > 8 weeks or Tacrolimus >4 mg/day for more than 8 weeks or 4 weeks prior to signing the ICF; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior to signing the ICF
    23.Receipt of any commercially available Janus kinase (JAK) inhibitor ≤12 weeks or Bruton's tyrosine kinase (BTK) inhibitor ≤24 weeks prior to the ICF
    24.Any new medicinal cannabinoid should not be started during the course of the study.
    25.Participation in another clinical study with another intervention (besides anifrolumab) administered within 4 weeks prior to ICF signing or within 5 half-lives of the study intervention used in that study, whichever is longer
    26.Within 4 weeks of Week 0 (Day 1),any of the following:
    -AST >2.5 × ULN
    -ALT >2.5 × ULN
    -TBL >ULN (unless due to Gilbert's syndrome)
    -Glycosylated hemoglobin > 8% (or >0.08) at Screening (diabetic participants only)
    -Neutrophil count <1 × 10^3/μL (or <1.0 × 109/L)
    -Platelet count <25 × 10^3/μL (or <25 × 109/L) -Hemoglobin <8 g/dL (or <80 g/L)
    E.5 End points
    E.5.1Primary end point(s)
    CRR at Week 52, ie, meeting all of the following:
    - UPCR ≤ 0.5 mg/mg
    - eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20%
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    1. Sustained OCS reduction, ie, meeting all of the following:
    - OCS dose of ≤ 7.5 mg/day prednisone or equivalent by Week 24
    - Sustained OCS dose of ≤ 7.5 mg/day prednisone or equivalent from Week 24 through Week 52
    2. Time to sustained CRR, ie, meeting all of the following:
    - UPCR ≤ 0.5 mg/mg
    - eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20% (ie, time from first study intervention dose to achieving CRR that is sustained from that time point through Week 52)
    3. Cumulative UPCR as determined by the standardized AUC from baseline up to and including Week 52.
    4. CRR at Week 24 (see definition above)
    5. Time to renal event as defined as any of the following: 1) ESKD, 2) doubling of serum creatinine, 3) renal worsening as evidenced by increased proteinuria and/or renal function impairment, or 4) renal disease treatment failure, or 5) death - through Week 52.
    6. Time to renal-related event or death (see definition above) through Week 76
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 52
    2. Week 52
    3. Week 52
    4. Week 24
    5. Week 52
    6. Week 76
    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 No
    E.6.12Pharmacoeconomic Yes
    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) 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 Yes
    E.8.1.7.1Other trial design description
    After completion of the double-blind period, the 52-week open label portion of the study commences.
    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 trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Peru
    Taiwan
    China
    India
    Japan
    Mexico
    Thailand
    United States
    Viet Nam
    Belgium
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Türkiye
    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
    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 years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 360
    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)
    None
    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 Decision2021-12-04
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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