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    Summary
    EudraCT Number:2017-004352-33
    Sponsor's Protocol Code Number:ALLN-177-301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-04-09
    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 number2017-004352-33
    A.3Full title of the trial
    Evaluate the Safety and Efficacy of ALLN-177 in Patients with Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study
    Estudio de fase III, randomizado y controlado con placebo para evaluar la seguridad y la eficacia de ALLN-177 en pacientes con hiperoxaluria entérica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluate the Safety and Efficacy of ALLN-177 in Patients with Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study
    Estudio de fase III, randomizado y controlado con placebo para evaluar la seguridad y la eficacia de ALLN-177 en pacientes con hiperoxaluria entérica
    A.4.1Sponsor's protocol code numberALLN-177-301
    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 SponsorAllena 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 supportAllena Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Spain S.L.
    B.5.2Functional name of contact pointMónica Bermejo
    B.5.3 Address:
    B.5.3.1Street AddressAgustín de Foxa 29. 8ª Planta
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28036
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491790056525854
    B.5.5Fax number+34900981853
    B.5.6E-mailspain.regulatory@medpace.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 nameALLN-177 (Oxalate decarboxylase)
    D.3.4Pharmaceutical form Capsule
    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 INNNot established yet
    D.3.9.1CAS number 9024-97-9
    D.3.9.2Current sponsor codeALLN-177
    D.3.9.3Other descriptive nameOXDc
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 placeboCapsule
    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
    Enteric Hyperoxaluria
    Hiperoxaluria Entérica
    E.1.1.1Medical condition in easily understood language
    excessive urinary oxalate excretion
    Eliminación urinaria excesiva de oxalato
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the efficacy of ALLN-177 in reducing UOx excretion in subjects with enteric HOx

    Evaluate the safety of ALLN-177 in subjects with enteric HOx
    Determinar la eficacia de ALLN-177 para reducir la eliminación urinaria de oxalato en pacientes con hiperoxaluria entérica.
    Evaluar la seguridad de ALLN-177 en pacientes con hiperoxaluria entérica.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplican
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form (ICF) before undergoing any Screening procedure
    2. Is ≥ 18 years of age at Screening
    3. Has a history of HOx (confirmed by documented UOx excretion ≥ 50 mg/24 hr in the most recent 24-hour urine collection obtained within 6 months prior to Screening) that is secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn’s disease, short bowel syndrome, or other malabsorption syndrome)
    - Note: Subjects with known or suspected HOx (e.g., history of kidney stones or oxalate nephropathy) without a 24-hour urine collection to determine UOx excretion within ≤ 6 months of Screening may perform a pre-screening 24-hour urine collection after providing appropriate consent. This 24-hour urine collection can also be used to satisfy Inclusion Criterion No. 4, if obtained within 6 weeks prior to Screening
    4. Has adequate (i.e., appropriate ratio of creatinine [mg]/body weight [kg] for gender) 24-hour urine collection at Screening, with resulting UOx excretion ≥ 50 mg/24 hr
    5. Has provided 2 adequate 24-hour urine collections at Baseline, with average urinary oxalate ≥ 50 mg/24 hr (and neither is < 40 mg/24 hr).
    6. For subjects taking concomitant medication for management of kidney stone risk factors (e.g., pyridoxine, thiazides, citrate supplements, allopurinol): has been on a stable dose regimen for >8 weeks prior to and during Screening, with no changes in dosing (dose level or dosing frequency) anticipated during the remainder of the study.
    7. For female subjects: Is either medically incapable of pregnancy (e.g., has undergone hysterectomy or tubal ligation or has experienced prolonged [≥ 1year prior to Screening] amenorrhea) or, if a woman of childbearing potential, has a negative Screening serum pregnancy test, is not pregnant or nursing at Screening, and agrees to use an effective (approved by the Investigator) method of birth control for the duration of the study
    1.Documento de consentimiento informado autorizado por el Comité Ético de Investigación con medicamentos (CEIm), firmado y fechado antes de someterse a cualquier procedimiento del screening.
    2.Ser mayor de edad en el screening.
    3.Antecedentes de hiperoxaluria (confirmada mediante la eliminación urinaria de oxalato ≥ 50 mg/24 h en la muestra más reciente de orina de 24 horas en el plazo de los seis meses anteriores al screening) que sea secundaria a un trastorno entérico subyacente conocido asociado a malabsorción (por ej., cirugía bariátrica, enfermedad de Crohn, síndrome del intestino corto u otro síndrome de malabsorción).
    -Nota: A los pacientes con hiperoxaluria conocida o sospecha de esta (por ej., antecedentes de cálculos renales o nefropatía por oxalato) sin una muestra de orina de 24 horas para determinar la eliminación urinaria de oxalato en el plazo de ≤ 6 meses antes del screening se les puede realizar la obtención de una muestra de orina de 24 horas antes del screening tras otorgar el correspondiente consentimiento. Esta muestra de orina de 24 horas se puede utilizar también para cumplir el criterio n.º 4 de inclusión, si se obtiene en las 6 semanas anteriores al screening.
    4.Presentar una obtención de muestras de orina de 24 horas suficiente (es decir, un cociente adecuado de creatinina [mg]/peso corporal [kg] para su sexo) en el screening, con una eliminación urinaria de oxalato resultante de ≥ 50 mg/24 h.
    5.Haber proporcionado dos obtenciones de muestras de orina de 24 horas suficientes en el periodo basal, con un promedio de oxaluria ≥ 50 mg/24 h (y sin que ninguna sea < 40 mg/24 h).
    6.Para pacientes que tomen medicación concomitante para el tratamiento de los factores de riesgo de cálculos renales (por ej., piridoxina, tiazidas, suplementos de citrato, alopurinol): haber estado con una pauta posológica estable durante más de 8 semanas antes y durante el screening, sin cambios en la medicación (concentración de dosis o frecuencia de la dosis) previstas durante el resto del estudio.
    7.Para las mujeres: mujeres que no sean potencialmente fértiles por motivos médicos (por ej., que se hayan sometido a histerectomía o ligadura tubárica o que presenten una amenorrea prolongada [≥ 1 año antes del screening]) o si se trata de una mujer potencialmente fértil, presentar una prueba de embarazo en suero negativa en el screening, no estar embarazada o en periodo de lactancia en el screening y comprometerse a utilizar un método anticonceptivo eficaz (autorizado por el investigador) durante todo el estudio.
    E.4Principal exclusion criteria
    1. Has > 30% variability in the ratio of creatinine (mg)/body weight (kg) among the three 24-hour urine samples collected prior to randomization (1 at Screening, 2 at Baseline)
    2. Is in acute renal failure or has an estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m2 at Screening
    3. Has HOx with a known cause other than underlying enteric disorder associated with malabsorption (e.g., primary HOx)
    4. Is unable or unwilling to discontinue Vitamin C supplementation at Screening and for the duration of the study
    5. Any clinically significant findings during Screening, any ongoing clinically significant illness requiring changes in management within 4 weeks prior to or during Screening (e.g., flare of inflammatory bowel disease), or any planned surgical/invasive procedure during the study
    6. Malignancy or treatment for malignancy within 12 months prior to screening with the exception of localized basal cell or squamous cell skin cancer or any cancer in situ
    ‒ Note: Subjects whose malignancy is in remission and who are on a stable dose of chronic suppressive or maintenance therapy are not excluded
    7. Has an active autoimmune disorder or other condition requiring therapy with high doses of systemic steroids (i.e., >10 mg/day prednisone or equivalent) or intensification of other immunosuppressant therapy within 4 weeks prior to or during Screening
    ‒ Note: Stable subjects on low chronic or maintenance doses of steroids or other immunosuppressant drugs, including transplant recipients, are not excluded
    8. Has received study drug (ALLN-177 or placebo) in any other ALLN-177 clinical study, or participation in another drug or device clinical trial within 30 days prior to or during Screening
    9. Is not, per Investigator judgment, an ideal clinical trial candidate due to a personal issue (e.g., unwillingness/inability to comply with protocol) or medical condition (e.g., mental illness, laboratory abnormalities) that is likely to impede successful study completion
    1.Presentar una variabilidad > 30 % en la proporción de creatinina (mg)/peso corporal (kg) entre las tres muestras de orina de 24 horas obtenidas antes de la randomización (1 en el screening, 2 en el periodo basal).
    2.Tener insuficiencia renal aguda o una tasa de filtración glomerular estimada (TFGe) < 30 ml/minuto/1,73 m2 en el screening.
    3.Presentar hiperoxaluria debida a una causa conocida distinta a un trastorno entérico subyacente relacionado con la malabsorción (por ej., hiperoxaluria primaria).
    4.No poder o no estar dispuesto a interrumpir el suplemento de vitamina C en el momento del screening y mientras dure el estudio.
    5.Resultados significativos desde el punto de vista clínico durante el screening, enfermedad clínicamente significativa actual que exija cambios en el tratamiento en el plazo de las 4 semanas anteriores o durante el screening (por ej., brote de enfermedad inflamatoria intestinal) o un procedimiento invasivo/quirúrgico programado durante el estudio.
    6.Neoplasias malignas o tratamiento para neoplasias malignas en el plazo de los 12 meses anteriores al screening con la excepción de carcinoma basocelular o epidermoide de piel o carcinoma in situ.
    -Nota: Los pacientes cuya neoplasia maligna se encuentre en remisión y que están con una dosis estable de tratamiento inmunosupresor crónico o de mantenimiento no quedan excluidos.
    7.Pacientes con un trastorno autoinmunitario activo u otra dolencia que necesite tratamiento con dosis elevadas de corticosteroides sistémicos (por ej., >10 mg/día prednisona o equivalente) o la intensificación de otro tratamiento inmunosupresor en las 4 semanas anteriores o durante el screening.
    -Nota: Los pacientes estables con dosis de corticosteroides crónicas bajas o de mantenimiento u otros fármacos inmunosupresores, entre otros los receptores de trasplantes, no quedan excluidos.
    8.Haber recibido el fármaco del estudio (ALLN-177 o placebo) en cualquier otro estudio clínico de ALLN-177 o haber participado en un ensayo clínico con otro fármaco o producto en los 30 días anteriores al screening o durante este.
    9.Paciente que, a juicio del investigador, no es un candidato ideal para el ensayo clínico debido a un problema personal (por ej., no está dispuesto/o no es capaz de cumplir el protocolo) o por una dolencia médica (por ej., enfermedad mental, alteraciones en los análisis) que es probable que le impida finalizar el estudio de forma satisfactoria.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints
    • Percent change from baseline in 24-hour UOx excretion during Weeks 1-4
    Criterio principal de valoración de la eficacia:
    •La variación porcentual con respecto al valor basal de la eliminación urinaria de oxalato durante 24 horas en las semanas 1 a 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    weeks 1-4
    Semanas 1-4
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints
    • Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour UOx excretion during Weeks 1-4 (alternate primary efficacy endpoint for ex-US submission)
    • Ordered categorical analysis of the percentage change from Baseline in 24-hour UOx excretion during Weeks 1-4
    • Analysis of efficacy parameters by bariatric surgery vs. other enteric condition subgroup

    Exploratory Endpoints
    • Change from Baseline to Week 4 in urine supersaturation of calcium oxalate
    Criterios secundarios de valoración de la eficacia:
    •La proporción de pacientes con una reducción ≥ 20 % con respecto al valor basal de la eliminación urinaria de oxalato durante 24 horas en las semanas 1 a 4 (criterio de valoración principal de la eficacia alterno para la presentación fuera de los EE UU).
    •Análisis de datos categóricos ordenados del cambio porcentual con respecto al valor basal de la eliminación urinaria de oxalato durante 24 horas en las semanas 1 a 4.
    •Análisis de los parámetros de la eficacia por subgrupo de cirugía bariátrica en comparación con otras afecciones entéricas.

    Criterio de valoración exploratorio
    •Variación de la supersaturación urinaria de oxalato cálcico entre el momento basal y la semana 4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    weeks 1-4
    Semanas 1-4
    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 No
    E.6.7Pharmacodynamic No
    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) 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Última Visita del Ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 36
    F.4.2.2In the whole clinical trial 124
    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
    Ninguno
    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 Decision2018-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-28
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