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    Summary
    EudraCT Number:2018-002716-27
    Sponsor's Protocol Code Number:ALN-CC5-005
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-04-12
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-002716-27
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy
    Estudio de fase 2, aleatorizado, doble ciego y controlado con placebo de cemdisirán en pacientes adultos con nefropatía por IgA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy
    estudio de fase 2 de Cemdisiran en pacientes adultos con nefropatía por IgA
    A.3.2Name or abbreviated title of the trial where available
    A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy
    estudio de fase 2 de Cemdisiran en pacientes adultos con nefropatía por IgA
    A.4.1Sponsor's protocol code numberALN-CC5-005
    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 SponsorAlnylam Pharmaceuticals Inc
    B.1.3.4CountryUnited States
    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 supportAlnylam Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlnylam Pharmaceuticals Inc
    B.5.2Functional name of contact pointClinical Trials Hotline
    B.5.3 Address:
    B.5.3.1Street Address300 Third Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018663300326
    B.5.6E-mailclinicaltrials@alnylam.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 namecemdisiran
    D.3.2Product code ALN-CC5
    D.3.4Pharmaceutical form Solution for injection
    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 INNcemdisiran
    D.3.9.2Current sponsor codeALN-62643
    D.3.9.3Other descriptive nameCEMDISIRAN
    D.3.9.4EV Substance CodeSUB194793
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 placeboSolution for injection
    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
    Immunoglobulin A nephropathy (IgAN)
    nefropatía por inmunoglobulina A (NIgA)
    E.1.1.1Medical condition in easily understood language
    IgA nephropathy, also known as Berger’s disease, is a kidney disease that occurs when IgA deposits build up in the kidneys, causing inflammation that damages kidney tissues.
    Nefropatía por IgA,conocida como enfermedad de Berger, es una enfermedad renal que ocurre cuando los depósitos de IgA se acumulan en los riñones,causando una inflamación que daña los tejidos renales
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of cemdisiran on proteinuria in adult patients with immunoglobulin A nephropathy (IgAN)
    Evaluar el efecto de cemdisirán sobre la proteinuria en pacientes adultos con nefropatía por inmunoglobulina A (NIgA)
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of cemdisiran on remission of proteinuria in adult patients with IgAN
    2. To evaluate the effect of cemdisiran on hematuria in adult patients with IgAN
    3. To evaluate the safety and tolerability of cemdisiran
    1. Evaluar el efecto de cemdisirán sobre la remisión de la proteinuria en pacientes adultos con NIgA
    2. Evaluar el efecto de cemdisirán sobre la hematuria en pacientes adultos con NIgA
    3. Evaluar la seguridad y la tolerabilidad de cemdisirán
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥18 years and ≤65 years of age at the time of informed consent
    2. Clinical diagnosis of primary IgAN as demonstrated by historical biopsy collected within 60 months of screening
    3. Treated for IgAN with stable, optimal pharmacological therapy. In general, stable and optimal treatment will include maximum allowed or tolerated ACE inhibitor or an ARB for at least 3 months prior to start of run-in period
    4. Urine protein ≥1g/24-hour at screening and mean urine protein ≥1g/24-hour from two valid 24-hour urine collections at the end of the run-in period, prior to randomization
    5. Hematuria as defined by ≥10 RBCs per high powered field (RBC/hpf) at screening and either ≥10 RBC/hpf or a positive urinary dipstick (1+ and above) at the end of the run-in period, prior to randomization (local result accepted for assessment of eligibility at the end of the run-in period)
    6. Females of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception 14 days before first dose, throughout study participation, and for 90 days after last dose administration
    7. Previously vaccinated with meningococcal group ACWY conjugate vaccine and meningococcal group B vaccine or willingness to receive these vaccinations as well as prophylactic antibiotic treatment if required by local standard of care
    8. Previously vaccinated or willingness to receive vaccinations for Hib and Streptococcus pneumoniae according to current national/local vaccination guidelines for vaccination use
    9. Patient is willing and able to provide written informed consent and to comply with the study requirements
    1.Sujetos de ambos sexos entre 18 y 65 años de edad en el momento del consentimiento informado.

    2.Diagnóstico clínico de NIgA primaria demostrado mediante una biopsia histórica obtenida en los 60 meses previos a la selección.
    3.Tratamiento farmacológico estable y óptimo contra la NIgA. En general, el tratamiento estable y óptimo consistirá en un IECA o un ARA en la dosis máxima permitida o tolerada durante al menos tres meses antes del comienzo del período de preinclusión.
    4.Proteinuria ≥ 1 g/24 horas en la fase de selección y proteinuria media ≥ 1 g/24 horas a partir de dos recogidas válidas de orina de 24 horas al final del período de preinclusión, antes de la aleatorización.
    5.Hematuria, definida por ≥ 10 eritrocitos por campo de gran aumento (eritrocitos/CGA) en la fase de selección y ≥ 10 eritrocitos/CGA o positividad (1+ o superior) en la tira reactiva de orina al final del período de preinclusión, antes de la aleatorización (para la evaluación de la elegibilidad al final del período de preinclusión se acepta el resultado del laboratorio local).
    6.Las mujeres en edad fértil deberán obtener un resultado negativo en la prueba de embarazo, no podrán estar amamantando y tendrán que estar dispuestas a utilizar un método anticonceptivo muy eficaz desde 14 días antes de la primera dosis, durante todo el tiempo que participen en el estudio y hasta 90 días después de la administración de la última dosis.
    7.Vacunación previa con las vacunas antimeningocócica conjugada contra los grupos ACWY y antimeningocócica contra el grupo B o disposición para recibir estas vacunas, así como tratamiento antibiótico profiláctico si así lo exigen las normas asistenciales locales.
    8.Vacunación previa con las vacunas contra Hib y Streptococcus pneumoniae o disposición para recibir estas vacunas conforme a las directrices de vacunación nacionales o locales vigentes.

    9.Disposición y capacidad para dar el consentimiento informado por escrito y para cumplir todos los requisitos del estudio.
    E.4Principal exclusion criteria
    1. Concomitant significant renal disease other than IgAN
    2. A diagnosis of rapidly progressive glomerulonephritis as measured by eGFR loss >30% over the duration of the run-in phase
    3. Secondary etiologies of IgAN (eg, inflammatory bowel disease, celiac disease)
    4. Diagnosis of Henoch-Schonlein Purpura (IgA Vasculitis)
    5. eGFR <30 mL/min/1.73 m2 2 weeks prior to randomization (local results will be used for assessment of eligibility)
    6. Has any of the following laboratory parameter assessments:
    a. Alanine transaminase (ALT) >1.5×upper limit of normal (ULN), International Normalized Ratio (INR) >2 (or >3.5 if on anticoagulants), or total bilirubin >1.5×ULN (unless bilirubin elevation is due to Gilbert’s syndrome)
    7. Confirmed positive IgG/IgM/IgA ADAs to cemdisiran at Screening
    8. Clinical laboratory test results considered clinically relevant and unacceptable in the opinion of the Investigator
    9. Known human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection or hepatitis B virus (HBV) infection
    10. Treatment with systemic steroids at dosages exceeding 20 mg prednisone-equivalent for more than 7 days or other immunosuppressant agents in the 12 months prior to randomization
    11. Received an investigational agent within the last 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug, or are in follow-up of another clinical study prior to study enrollment
    12. Malignancy (except for non-melanoma skin cancers, cervical in situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate cancer) within the last 5 years
    13. Active psychiatric disorder, including, but not limited to schizophrenia, bipolar disorder, or severe depression despite current pharmacological intervention
    14. Known medical history or evidence of chronic liver disease or cirrhosis
    15. Has other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation
    16. History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc
    17. History of intolerance to SC injection(s) or significant abdominal scarring that could potentially hinder study drug administration or evaluation of local tolerability
    18. Known contraindication to meningococcal vaccines (group ACWY conjugate and group B vaccines) required for this study. Refer to the most recent local product information for each vaccine for the current list of contraindications
    19. Unable to take antibiotics for meninigococcal prophylaxis, if required by local standard of care
    20. Sustained blood pressure >140/90 mmHg as defined by 2 or more readings during the run-in period, measured in supine position after 10 minutes of rest
    21. Receipt of an organ transplant (including hematologic transplant)
    22. History of meningococcal infection within 12 months before Screening
    23. Patients with systemic bacterial or fungal infections, that require systemic treatment with antibiotics or antifungals
    24. Patients with functional or anatomic asplenia
    25. Patients who consume more than 14 units of alcohol a week (unit 1 glass of wine [125 mL] = 1 measure of spirits [approximately 1 fluid ounce] = ½ pint of beer [approximately 284 mL])
    1.Nefropatía concomitante importante distinta de NIgA.
    2.Diagnóstico de glomerulonefritis rápidamente progresiva, determinado por una disminución de la FGe > 30% durante la fase de preinclusión.
    3.Etiologías secundarias de la NIgA (por ejemplo, enfermedad inflamatoria intestinal o enfermedad celíaca).
    4.Diagnóstico de púrpura de Henoch-Schonlein (vasculitis por IgA).
    5.FGe < 30 ml/min/1,73 m2 dos semanas antes de la aleatorización (para evaluar la elegibilidad se utilizarán los resultados del laboratorio local).
    Evaluaciones analíticas
    6.Presencia de alguno de los valores analíticos siguientes:
    a.Alanina transaminasa (ALT) > 1,5 veces el límite superior de la normalidad (LSN), cociente internacional normalizado (INR) > 2 (o > 3,5 si recibe anticoagulantes) o bilirrubina total > 1,5 veces el LSN (salvo que la hiperbilirrubinemia se deba a un síndrome de Gilbert).
    7.Positividad confirmada para anticuerpos IgG/IgM/IgA contra cemdisiran durante la fase de selección.
    8.Resultados de las evaluaciones analíticas que el investigador considere clínicamente relevantes e inaceptables.
    9.Infección confirmada por el virus de la inmunodeficiencia humana (VIH), el virus de la hepatitis C (VHC) o el virus de la hepatitis B (VHB).
    10.Tratamiento con corticoides sistémicos en dosis superiores a 20 mg de prednisona o equivalente durante más de siete días o con otros inmunodepresores en los 12 meses previos a la aleatorización.
    11.Haber recibido un fármaco en investigación en los últimos 30 días o cinco semividas antes de la primera dosis del fármaco del estudio, lo que suponga más tiempo, o estar en seguimiento en otro estudio clínico antes de la inclusión en el estudio.

    12.Neoplasia maligna (excepto cáncer de piel distinto del melanoma, carcinoma cervicouterino in situ, carcinoma ductal de mama in situ o cáncer de próstata en estadio 1) en los últimos cinco años.
    13.Trastorno psiquiátrico activo, como esquizofrenia, trastorno bipolar o depresión intensa a pesar de una intervención farmacológica en curso.
    14.Antecedentes médicos conocidos o signos de hepatopatía crónica o cirrosis.
    15.Otras afecciones médicas o enfermedades que, en opinión del investigador, podrían interferir con el cumplimiento del estudio o la interpretación de los datos.
    16.Antecedentes de alergias múltiples a fármacos o antecedentes de reacción alérgica a un oligonucleótido o a GalNAc.
    17.Antecedentes de intolerancia a inyecciones SC o fibrosis abdominal importante que pudiera dificultar la administración del fármaco del estudio o la evaluación de la tolerabilidad local.
    18.Contraindicación conocida a las vacunas antimeningocócicas (vacuna conjugada contra los grupos ACWY y vacuna contra el grupo B) necesarias para el estudio. Véase la lista actual de contraindicaciones en la ficha técnica local vigente de cada vacuna.
    19.Incapacidad para tomar antibióticos para la profilaxis antimeningocócica cuando la exijan las normas asistenciales locales.
    20.Presión arterial mantenida > 140/90 mm Hg, definida por dos o más lecturas durante el período de preinclusión obtenidas en decúbito supino después de 10 minutos de reposo.
    21.Haber recibido un trasplante de órgano (incluido un trasplante hematológico).
    22.Antecedentes de infección meningocócica en los 12 meses previos a la selección.
    23.Infecciones bacterianas o micosis sistémicas que requieren tratamiento sistémico con antibióticos o antifúngicos.
    24.Asplenia funcional o anatómica

    25.Consumo de más de 14 unidades de alcohol a la semana (unidad: un vaso de vino [125 ml] = una medida de licor [aproximadamente 30 ml] = media pinta de cerveza [aproximadamente 284 ml])
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from baseline in 24 hour proteinuria (g/24-hours)
    Variación porcentual de la proteinuria de 24 horas (g/24 horas)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 32
    semana 32
    E.5.2Secondary end point(s)
    1. Percent of patients with partial clinical remission (urine protein [UP] <1.0 g/24-hours)
    2. Percent of patients with >50% reduction in 24-hour proteinuria
    3. Change from baseline in urine protein/creatinine ratio (UPCR; in g/g) as measured in 24-hour urine 4. Change from baseline in UPCR as measured in a spot urine
    5. Change from baseline in hematuria (red blood cells per high powered field [RBC/hpf])
    6. Frequency of adverse events (AEs)
    1. Porcentaje de pacientes con remisión clínica parcial (proteinuria < 1,0 g/24 horas) en la semana 32
    2. Porcentaje de pacientes con una reducción > 50 % de la proteinuria de 24 horas en la semana 32
    3. Variación del cociente proteínas/creatinina en orina (CPCO; en g/g), medido en orina de 24 horas, entre el momento basal y la semana 32
    4. Variación del CPCO, medido en una muestra de orina puntual, entre el momento basal y la semana 32
    5. Variación de la hematuria (eritrocitos por campo de gran aumento [eritrocitos/CGA]) entre el momento basal y la semana 32
    6. Frecuencia de acontecimientos adversos (AA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 32
    Semana 32
    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 No
    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 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 No
    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 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 EEA15
    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
    Australia
    Canada
    France
    Germany
    Korea, Republic of
    Malaysia
    Philippines
    Singapore
    Spain
    Sweden
    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
    LVLS
    UPUV
    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 months0
    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 months0
    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: 30
    F.1.3Elderly (>=65 years) No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 30
    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 36 patients have the option to participate in the open label extension period for 52 weeks.
    Después de la semana 36, los pacientes tienen la opción de participar en el período de extensión de etiqueta abierta durante 52 semanas.
    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 Decision2019-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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