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    Summary
    EudraCT Number:2020-001049-38
    Sponsor's Protocol Code Number:CLNP023A2301
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-06-02
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2020-001049-38
    A.3Full title of the trial
    A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients
    Multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana raziskava faze III z vzporednima skupinama za ovrednotenje učinkovitosti in varnosti učinkovine LNP023 pri pacientih s primarno IgA nefropatijo (APPLAUSE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of LNP023 in primary IgA nephropathy patients
    A.4.1Sponsor's protocol code numberCLNP023A2301
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma Services Inc., Podružnica v Sloveniji
    B.5.2Functional name of contact pointMedical Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressVerovškova 57
    B.5.3.2Town/ cityLjubljana
    B.5.3.3Post codeSI-1000
    B.5.3.4CountrySlovenia
    B.5.4Telephone number+38 613007550
    B.5.5Fax number+38 613007595
    B.5.6E-mailmedinfo.slo@novartis.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2336
    D.3 Description of the IMP
    D.3.1Product nameiptacopan
    D.3.2Product code LNP023
    D.3.4Pharmaceutical form Capsule, hard
    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 INNIptacopan
    D.3.9.2Current sponsor codeLNP023
    D.3.9.3Other descriptive nameIptacopan hydrochloride
    D.3.9.4EV Substance CodeSUB216376
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    IgA Nephropathy
    E.1.1.1Medical condition in easily understood language
    Kidney disorder
    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 27.0
    E.1.2Level PT
    E.1.2Classification code 10021263
    E.1.2Term IgA nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main Objective for Interim Analysis:
    •To demonstrate superiority of LNP023 vs. placebo in the reduction of proteinuria at 9 months by measuring UPCR sampled from a 24h urine collection.

    Main Objective for Final Analysis:
    •To demonstrate superiority of LNP023 vs. placebo in slowing
    IgAN progression measured by the annualized total slope of eGFR decline over 24 months.
    E.2.2Secondary objectives of the trial
    For Interim Analysis:
    To evaluate the effect of LNP023 vs placebo on slowing eGFR decrease as measured by the change from baseline in eGFR; To assess the effect of LNP023 vs placebo on the proportion of study participants reaching proteinuria below 1g/g of UPCR; To evaluate the effect of LNP023 vs placebo on slowing IgAN progression measured by the annualized total slope of eGFR decline over 1 year; To assess the effect of LNP023 vs placebo on the change from baseline to 9 months in fatigue scale measured by the FACIT-Fatigue questionnaire

    For Final Analysis:
    To demonstrate the superiority of LNP023 vs placebo on delaying the time to first occurrence of a composite kidney failure endpoint; in the reduction of proteinuria at 9 months by measuring UPCR sampled from a 24h urine collection; on the proportion of study participants reaching proteinuria below 1g/g of UPCR at 9 months; on the change from baseline to 9 months in the fatigue scale measured by FACIT-Fatigue questionnaire
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    optional genetic research component
    E.3Principal inclusion criteria
    •Male and female patients ≥ 18 years of age with an eGFR level and biopsy-confirmed IgA nephropathy as follows:
    •For patients eGFR* ≥ 45ml/min/1.73m2, a qualifying biopsy performed within the last 5 years is required
    •For patients with eGFR* 30 to <45ml/min/1.73m2, a qualifying biopsy performed within 2 years with < 50% tubulointerstitial fibrosis is required.
    • For patients with eGFR* 20 to <30ml/min/1.73m2, a qualifying biopsy performed at any time.
    In all cases, if a historical biopsy is not available, one may be performed during screening. *eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)
    •Proteinuria due to primary diagnosis of IgA nephropathy as assessed at screening by UPCR ≥1 g/g (113 mg/mmol) sampled from FMV or 24h urine collection, as well as at the completion of the run-in period by UPCR ≥1 g/g (113 mg/mmol) calculated as the (geometric) mean of two 24h urine collections obtained within 14 days of each other at baseline
    •Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection is required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.
    •If not previously vaccinated, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.
    •All patients must have been on supportive care including stable dose regimen of ACEi or ARB at either the locally approved maximal daily dose or the maximally tolerated dose (per investigators’ judgment) for approximately 90 days before first study drug administration. In addition, if patients are taking diuretics or other antihypertensive medication or other background medication for IgAN, the doses should also be stabilized for approximately -90 days prior to the first dosing of study treatment.

    Other protocol-defined inclusion criteria may apply.
    E.4Principal exclusion criteria
    •Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease, familial mediterranean fever, etc.
    •Sitting office SBP >140 mmHg or DBP >90 mmHg at the randomization visit
    • Patients previously treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, hydroxychloroquine, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 90 days (or 180 days for rituximab) prior to first study drug administration. Participants previously or currently treated with oral budesonide. Participants treated with endothelin (receptor) antagonists within 90 days prior to first study drug administration
    •Prior use of LNP023 or prior enrollment in any other LNP023 clinical trial where study drug was taken, including matching placebo
    •History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.
    •Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration.

    Other protocol-defined exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint for Interim Analysis:
    •Log-transformed ratio to baseline in UPCR (sampled from 24h urine collection) at 9 months

    Primary Endpoint for Final Analysis:
    •Annualized total eGFR slope estimated over 24 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For Interim Analysis:
    baseline and 9 months

    For Final Analysis:
    baseline and 24 months
    E.5.2Secondary end point(s)
    Secondary Endpoint for Interim Analysis:
    •Change from baseline in eGFR at 9 months
    •Proportion of participants reaching UPCR (sampled from 24h urine collection) <1g/g at 9 months, without receiving CS/IS or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating Kidney Replacement Therapy (KRT).
    •Annualized total eGFR slope estimated over 12 months
    •Change from baseline to 9 months in the fatigue scale measured by the FACIT-Fatigue questionnaire
    •Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to 9 months.


    Secondary Endpoints for Final Analysis:
    •Time from randomization to first occurrence of composite kidney failure event, defined as reaching either sustained ≥30% decline in eGFR relative to baseline, or sustained eGFR <15 mL/min/1.73m², or maintenance dialysis, or receipt of kidney transplant, or death from kidney failure
    •Log-transformed ratio to baseline in UPCR (sampled from 24h urine collection) at 9 months
    •Proportion of participants reaching UPCR (sampled from 24h urine collection) <1g/g at 9 months without receiving CS/IS, or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating KRT
    •Change from baseline to 9 months in the fatigue scale measured by the FACIT-Fatigue questionnaire.
    •Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to the End of Study (EOS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    For Interim Analysis:
    baseline and 9 months
    baseline and 9 months
    baseline and 12 months
    baseline and 9 months
    baseline and 9 months

    For Final Analysis:
    up to 24 months
    9 months
    baseline and 9 months
    baseline and 9 months
    baseline and EOS
    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
    Tolerability
    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 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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA56
    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
    Malaysia
    Singapore
    Taiwan
    Australia
    Brazil
    Canada
    China
    India
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    South Africa
    Thailand
    United Kingdom
    United States
    Viet Nam
    Belgium
    Czechia
    Denmark
    Finland
    France
    Germany
    Hungary
    Italy
    Netherlands
    Norway
    Slovakia
    Slovenia
    Spain
    Sweden
    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
    LVLS
    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 months10
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days5
    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: 456
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 470
    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)
    Participants can receive post-trial access by joining the roll-over extension program to allow participants' access to LNP023 and in order to enable long-term safety monitoring.
    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 Decision2022-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-18
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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