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    Summary
    EudraCT Number:2020-004529-22
    Sponsor's Protocol Code Number:D3465C00001
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-07-23
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2020-004529-22
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus
    A.3.2Name or abbreviated title of the trial where available
    Tulip SC
    A.4.1Sponsor's protocol code numberD3465C00001
    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
    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
    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 AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    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 Yes
    D.2.1.1.1Trade name SAPHNELO
    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 MEDI-546
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    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 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 Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate-to-severe Systemic Lupus Erythematosus (SLE)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus is a disease in which the body's own immune system attacks its own cells and tissues, leading to inflammation and damage.
    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 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 compare efficacy of anifrolumab with placebo on overall disease activity in patients with SLE.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of anifrolumab with placebo on the onset of a sustained reduction in disease activity.
    To compare the efficacy of anifrolumab with placebo on improvement in overall disease activity and low (or reduced) OCS use.
    To compare the efficacy of anifrolumab with placebo on the onset of first flare.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients who have a diagnosis of paediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF
    2.To be eligible a patient must have SLEDAI-2K ≥ 6 points and “Clinical” SLEDAI-2K score ≥4 points coming from clinical components ("Clinical" SLEDAI-2K") at screening. In addition, the following criteria must be met:
    Clinical SLEDAI of at least ≥ 4 points at Day 1 (randomization).
    Note: The "Clinical" SLEDAI-2K is the SLEDAI-2K assessment score without the inclusion of points attributable to any urine or laboratory results including immunologic measures: Includes points from the following clinical components: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, or vasculitis. Excludes points attributed to a fever, an SLE headache, and organic brain syndrome. Clinical SLEDAI-2K points at screening cannot only be due to alopecia and mucosal ulcers.
    3.At Screening, BILAG2004 with at least 1 of the following as confirmed by Disease Activity Central Team Review:
    a.BILAG2004 level A disease in ≥ 1 organ system
    b.BILAG2004 level B disease in ≥ 2 organ systems
    4.Physician’s Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening
    5.Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,
    6.Must be on stable background standard therapy with therapy with antimalarials and/or immunosuppressants and glucocorticoids alone or in combination
    7.Contraception Requirements
    Male patients:
    All fertile males who are sexually active must use condom from Day 1 until at least 16 weeks after receipt of the final dose of study intervention. It is strongly recommended that the female partner of a male patient also use an effective method of contraception from Table 9 throughout this period.
    Male patients must not donate sperm during the course of the study and for 16 weeks after the last dose of the study intervention.
    Female patients:
    Negative serum β-human chorionic gonadotropin (β-hCG) test at screening (females of childbearing potential only).
    Women of childbearing potential must have a negative urine pregnancy test at randomisation (Day 1), prior to administration of study intervention.
    Woman of non-childbearing potential must be postmenopausal or have been surgically sterilised (for example: bilateral oophorectomy, or complete hysterectomy), which should be documented in the patient's medical records.
    Age-specific requirements may apply for a postmenopausal state. Females of childbearing potential must use 1 highly effective method of contraception plus a male condom, from Screening until 16 weeks after the final dose of study intervention, unless the patient is surgically sterile (eg, bilateral oophorectomy, tubal ligation or complete hysterectomy), has a sterile male/non-fertile male partner, is at least 12 months postmenopausal, or practices sustained abstinence consistent with the patient’s customary lifestyle.
    Malignancy:
    Females who have been or are sexually active with an intact cervix must have ocumentation of a cervical cancer screening (Pap smear or human papilloma virus [HPV] tests as per local guidelines) with a normal test result within 2 years prior to randomisation. Any abnormal cervical cancer screening result documented within 2 years prior to randomisation must be repeated to confirm patient eligibility.
    Females aged < 25 years, who have never been sexually active or have well-documented HPV vaccination records may not require a cervical cancer screening test.
    E.4Principal exclusion criteria
    1.Active severe or unstable neuropsychiatric SLE
    2.Active severe SLE-driven renal disease
    3.Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.
    4.Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),
    5.Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.
    6.History of cancer, apart from:
    a. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1)
    b. Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1)
    7.Any history of severe COVID-19 infection eg. prolonged hospitalisation [hospitalisation for observational purposes is not exclusionary] or any prior COVID-19 infection with documented long COVID and/or clinically significant unresolved sequelae
    Any mild/asymptomatic COVID-19 infection (lab confirmed or suspected based on clinical symptoms) within the last 6 weeks prior to first dosing
    8.Lactating, breastfeeding or pregnant females or females who intend to become pregnant or begin
    breastfeeding anytime from initiation of Screening until the end of the 16-week safety follow-up period following last dose of study intervention.
    E.5 End points
    E.5.1Primary end point(s)
    BICLA a composite binary response defined by meeting all of the following criteria:
    -Reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no
    BILAG-2004 worsening in other organ systems, as defined by ≥ 1 new
    BILAG-2004 A or ≥ 2 new BILAG-2004 B
    -No worsening from baseline in SLEDAI-2K, where worsening is defined as an increase from baseline of > 0 points in SLEDAI-2K
    -No worsening from baseline in patients' lupus disease activity, where worsening is defined by an increase ≥ 0.30 points on a 3 point PGA VAS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    1.Proportion of patients who are BICLA responders at Week 52, and have maintained low (or reduced) OCS use through Week 52
    •Maintained low (or reduced) OCS use is defined as follows:
    -If baseline OCS ≥ 10mg/day an OCS dose of ≤ 7.5mg/day prednisone or equivalent must be achieved by Week 40 and an OCS dose ≤ 7.5mg/day prednisone or equivalent must be maintained form Week 40 to Week 52
    -If baseline OCS < 10mg/day, OCS dose at Week 40 must be less than or equal to OCS dose at baseline, with no increase from Week 40 OCS dose between Week 40 and Week 52.
    2.The time from first dose of study intervention during the Double-Blind Study Period to first BICLA response sustained through week 52
    3.Time to flare through Week 52 where flare is defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG 2004 B items compared to the previous visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. at week 52
    2. through week 52
    2. through 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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Imunogenicity
    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
    an OLE Period; A Follow-up Period;
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Chile
    Colombia
    Peru
    Philippines
    Ukraine
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Thailand
    United Kingdom
    United States
    Bulgaria
    Germany
    Hungary
    Poland
    Spain
    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 is defined as the date of the last scheduled procedure shown in the SoA for the last patient in the study globally.
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    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: 324
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    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)
    Patients are to be treated with standard therapy after they have concluded study treatment. There are no provisions for administration of study intervention following End of Treatment (EOT) visit (Week 52 for patients not participating in the OLE Period, and Week 104 for patients participating in the OLE Period).
    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 Decision2021-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-10
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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