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    Summary
    EudraCT Number:2021-005217-14
    Sponsor's Protocol Code Number:DCR-A1AT-202
    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:2022-03-15
    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 number2021-005217-14
    A.3Full title of the trial
    A Phase 2 Open-Label Extension Study to Evaluate the Safety and Pharmacodynamics of Belcesiran in Patients with PiZZ Alpha-1 Antitrypsin Deficiency Associated Liver Disease
    Estudio de prolongación en fase II y sin enmascaramiento para evaluar la seguridad y la farmacodinámica de belcesirán en pacientes homocigotos PiZZ con hepatopatía asociada al déficit de α1-antitripsina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An extension study to evaluate Safety and Pharmacodynamics of Belcesiran in patients with PiZZ Alpha-1 Antitrypsin Deficiency.
    Un estudio de extensión para evaluar la seguridad y farmacodinamia de Belcesiran en pacientes con deficiencia de PiZZ alfa-1 antitripsina.
    A.3.2Name or abbreviated title of the trial where available
    STARLIGHT
    A.4.1Sponsor's protocol code numberDCR-A1AT-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05146882
    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 SponsorDicerna 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 supportDicerna Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDicerna Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street Address75 Hayden Avenue
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@dicerna.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 nameBelcesiran
    D.3.2Product code DCR-A1AT
    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 INNBelcesiran
    D.3.9.1CAS number 2375562-01-7
    D.3.9.2Current sponsor codeDCR-A1AT
    D.3.9.3Other descriptive nameSynthetic double-stranded siRNA oligonucleotide directed against SERPINA1 mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues
    D.3.9.4EV Substance CodeSUB199253
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    PiZZAlpha-1 Antitrypsin Deficiency Associated Liver Disease
    Enfermedad hepática asociada a la deficiencia de piZZAlpha-1 antitripsina
    E.1.1.1Medical condition in easily understood language
    PiZZ A1ATD-associated liver disease is a progressive Alpha1 Antitrypsin-Deficiency Associated Liver Disease condition resulting in liver fibrosis, cirrhosis, and hepatocellular carcinoma.
    La enfermedad hepática asociada a PiZZ A1ATD es una enfermedad hepática progresiva asociada a deficiencia de antitripsina alfa1 que produce fibrosis hepática, cirrosis y carcinoma hepatocelular.
    E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10001806
    E.1.2Term Alpha-1 anti-trypsin deficiency
    E.1.2System Organ Class 100000004850
    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 long-term safety of belcesiran in patients with AATLD
    Evaluar la seguridad a largo plazo de belcesiran en pacientes con AATLD.
    E.2.2Secondary objectives of the trial
    To further characterize the PD of belcesiran in patients with AATLD
    Caracterizar aún más la EP de belcesiran en pacientes con AATLD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age
    1. Must be 18 to 75 years of age inclusive, at the time of signing the Informed Consent.

    Type of Participant and Disease Characteristics – Cohort A
    2. Documented diagnosis of PiZZ-type AATD
    3. Completed the assigned 24- or 48-week treatment period in DCR-A1AT-201
    a. All test results (except for liver biopsy results) from DCR-A1AT-201 must have been received prior to Day 1
    b. DCR-A1AT-201 EOT liver biopsy must have been performed prior to Day 1
    4. Pre- and post-bronchodilator FEV1 > 60% of predicted at EOT Visit in DCR-A1AT-201
    5. Post-bronchodilator DLCO ≥ 50% of predicted at EOT Visit in DCR-A1AT-201
    6. Estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2 at EOT Visit in DCR-A1AT-201
    7. No more than 56 days may have elapsed from EOT Visit in DCR-A1AT-201 to first dose (Day 1) in DCR-A1AT-202

    Type of Participant and Disease Characteristics – Cohort B
    8. Documented diagnosis of PiZZ-type AATD
    9. Offered the opportunity to enter DCR-A1AT-202 after completing the assigned treatment period in DCR-A1AT-201 but declined to participate at that time
    10. Completed 48 weeks of CFU in DCR-A1AT-201
    11. Serum AAT protein concentration did not return to ≥ 80% of baseline at EOS Visit in DCR-A1AT-201
    12. No more than 28 days may have elapsed from EOS in DCR-A1AT-201 to Day 1 in DCR-A1AT-202

    Sex
    13. Male participants: A male participant with a partner of childbearing potential must agree to use contraception, as detailed in Section 10.4, during the treatment period (Cohort A only) and for at least 12 weeks after the last dose of study intervention and refrain from donating sperm during this period. Contraceptive use should be regulations regarding the methods of contraception for those participating in clinical studies.
    Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and not a WOCBP, as defined in Section 10.4.1 of the Protocol

    Informed Consent
    14. Capable of giving signed informed consent as described in Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICF and in this Protocol. consistent with local
    Edad
    1. Debe tener entre 18 y 75 años inclusive, al momento de firmar el Consentimiento informado.

    Tipo de participante y características de la enfermedad - Cohorte A
    2. Diagnóstico documentado de AATD tipo PiZZ
    3. Completó el período de tratamiento asignado de 24 o 48 semanas en DCR-A1AT-201
    una. Todos los resultados de la prueba (excepto los resultados de la biopsia hepática) de DCR-A1AT-201 deben haberse recibido antes del Día 1
    B. La biopsia de hígado DCR-A1AT-201 EOT debe haberse realizado antes del día 1
    4. FEV1 antes y después del broncodilatador> 60% del previsto en la visita EOT en DCR-A1AT-201
    5. DLCO posbroncodilatador ≥ 50% de lo previsto en la visita EOT en DCR-A1AT-201
    6. Tasa de filtración glomerular estimada ≥ 60 ml / min / 1,73 m2 en la visita EOT en DCR-A1AT-201
    7. No pueden haber transcurrido más de 56 días desde la visita de EOT en DCR-A1AT-201 hasta la primera dosis (día 1) en DCR-A1AT-202

    Tipo de participante y características de la enfermedad - Cohorte B
    8. Diagnóstico documentado de AATD tipo PiZZ
    9. Se le ofreció la oportunidad de ingresar a DCR-A1AT-202 después de completar el período de tratamiento asignado en DCR-A1AT-201, pero se negó a participar en ese momento.
    10. Completó 48 semanas de CFU en DCR-A1AT-201
    11. La concentración de proteína AAT en suero no volvió a ≥ 80% del valor inicial en la visita EOS en DCR-A1AT-201
    12. No pueden haber transcurrido más de 28 días desde EOS en DCR-A1AT-201 hasta el Día 1 en DCR-A1AT-202

    Sexo
    13. Participantes masculinos: un participante masculino con una pareja en edad fértil debe aceptar el uso de métodos anticonceptivos, como se detalla en la Sección 10.4, durante el período de tratamiento (solo Cohorte A) y durante al menos 12 semanas después de la última dosis de la intervención del estudio y abstenerse de la donación de esperma durante este período. El uso de anticonceptivos debe ser una reglamentación con respecto a los métodos anticonceptivos para quienes participan en estudios clínicos.
    Participantes femeninas: Una participante es elegible para participar si no está embarazada, no amamanta ni es WOCBP, como se define en la Sección 10.4.1 del Protocolo.

    Consentimiento informado
    14. Capaz de otorgar consentimiento informado firmado como se describe en la Sección 10.1.3, que incluye el cumplimiento de los requisitos y restricciones enumerados en el ICF y en este Protocolo. coherente con el local
    E.4Principal exclusion criteria
    Prior/Concomitant Therapy
    1. Routine use of acetaminophen/paracetamol during the Treatment Period (Cohort A only) NOTE: Occasional use of up to 1000 mg/day is acceptable
    2. Use of systemically acting steroids throughout the Treatment Period (Cohort A only). Occasional use is acceptable if needed for participant safety, e.g., in the case of an exacerbation of underlying pre-existing conditions.
    3. Routine use of NSAIDs during the Treatment Period or use within 3 days of dosing (Cohort A only)

    Diagnostic Assessments (Cohort A only)
    Diagnostic assessments from the EOT Visit in DCR-A1AT-201 may be used for screening/determination of eligibility. Should more than 28 days elapse between the DCR-A1AT-201 EOT visit and Day 1 of DCR-A1AT-202, all diagnostic assessments must be repeated.
    4. AST and ALT > 5 × ULN
    5. ALP 2 × ULN
    6. Serum AFP > 100 ng/mL
    NOTE: If AFP at screening is above the ULN but < 100 ng/mL, the participant is still eligible if an appropriate hepatic imaging study reveals no lesions
    7. HbA1c > 8%
    NOTE: HbA1c is not assessed at the DCR-A1AT-201 EOT Visit. Testing is only required if more than 28 days elapse between the DCR-A1AT-201 EOT visit and Day 1 of DCR-A1AT-202.
    8. Fasting triglycerides > 400 mg/dL or total cholesterol > 400 mg/dL
    9. Platelets < 50,000/mm³
    10. White blood cells < 2000/mm³
    11. Neutrophils < 1000/mm³
    12. INR > 1.6 × ULN
    13. Blood pressure parameters, defined as Systolic BP > 150 mmHg and diastolic BP > 90 mmHg after 5 minutes rest in the sitting position at Screening.
    NOTE: Repeat measures are allowed.
    14. Positive SARS-CoV-2 virus test at Screening, via a confirmatory test, for example RT-PCR or Nucleic Acid Amplification Test (NAAT)
    15. Any other safety laboratory test result considered clinically significant and unacceptable by the Investigator

    Other Exclusions
    16. Inability or unwillingness to comply with the specified study procedures, including lifestyle considerations
    17. Any condition that, in the opinion of the Investigator, would make the participant unsuitable for enrollment or could interfere with participation in or completion of the study
    Terapia previa / concomitante
    1. Uso de rutina de acetaminofén / paracetamol durante el período de tratamiento (solo cohorte A) NOTA: El uso ocasional de hasta 1000 mg / día es aceptable
    2. Uso de esteroides de acción sistémica durante el período de tratamiento (solo cohorte A). El uso ocasional es aceptable si es necesario para la seguridad del participante, por ejemplo, en el caso de una exacerbación de condiciones preexistentes subyacentes.
    3. Uso rutinario de AINE durante el Período de tratamiento o uso dentro de los 3 días posteriores a la dosificación (solo cohorte A)

    Evaluaciones de diagnóstico (solo cohorte A)
    Las evaluaciones de diagnóstico de la visita EOT en DCR-A1AT-201 pueden usarse para la detección / determinación de elegibilidad. Si transcurren más de 28 días entre la visita de DCR-A1AT-201 EOT y el Día 1 de DCR-A1AT-202, se deben repetir todas las evaluaciones de diagnóstico.
    4. AST y ALT> 5 × ULN
    5. ALP 2 × ULN
    6. AFP sérico> 100 ng / ml
    NOTA: Si la AFP en la detección está por encima del LSN pero <100 ng / mL, el participante aún es elegible si un estudio de imágenes hepáticas apropiado no revela lesiones.
    7. HbA1c> 8%
    NOTA: La HbA1c no se evalúa en la visita EOT DCR-A1AT-201. La prueba solo es necesaria si transcurren más de 28 días entre la visita al EOT del DCR-A1AT-201 y el Día 1 del DCR-A1AT-202.
    8. Triglicéridos en ayunas> 400 mg / dL o colesterol total> 400 mg / dL
    9. Plaquetas <50.000 / mm³
    10. Glóbulos blancos <2000 / mm³
    11. Neutrófilos <1000 / mm³
    12. INR> 1,6 × ULN
    13. Parámetros de presión arterial, definidos como PA sistólica> 150 mmHg y PA diastólica> 90 mmHg después de 5 minutos de descanso en la posición sentada en la Selección.
    NOTA: Se permiten medidas repetidas.
    14. Prueba positiva del virus del SARS-CoV-2 en la selección, mediante una prueba de confirmación, por ejemplo, RT-PCR o prueba de amplificación de ácidos nucleicos (NAAT)
    15. Cualquier otro resultado de prueba de laboratorio de seguridad considerado clínicamente significativo e inaceptable por el investigador.

    Otras exclusiones
    16. Incapacidad o falta de voluntad para cumplir con los procedimientos especificados del estudio, incluidas las consideraciones sobre el estilo de vida.
    17. Cualquier condición que, en opinión del investigador, haría que el participante no fuera apto para la inscripción o pudiera interferir con la participación o la finalización del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The incidence and nature of treatment-emergent adverse events (TEAEs), and the change from baseline in PFTs, 12-lead ECGs, physical examination findings, vital signs, and clinical laboratory tests
    La incidencia y la naturaleza de los eventos adversos emergentes del tratamiento (TEAE) y el cambio con respecto al valor inicial en las PFP, los ECG de 12 derivaciones, los hallazgos del examen físico, los signos vitales y las pruebas de laboratorio clínico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    A lo largo de todo el estudio
    E.5.2Secondary end point(s)
    Changes in serum AAT protein concentrations over time
    Cambios en las concentraciones séricas de proteína AAT a lo largo del tiempo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    A lo largo de todo el estudio
    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 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No tratamiento
    No treatment
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    New Zealand
    United States
    Austria
    Belgium
    France
    Germany
    Ireland
    Netherlands
    Portugal
    Spain
    Sweden
    United Kingdom
    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 completion of the database lock.
    El final del estudio se define como la finalización del bloqueo de la base de datos.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months110
    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 months11
    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: 49
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 54
    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)
    The subjects will follow the treatment regime set out by their local physician
    Los sujetos seguirán el régimen de tratamiento establecido por su médico.
    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 Decision2022-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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