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    Summary
    EudraCT Number:2021-004849-20
    Sponsor's Protocol Code Number:283PD201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-21
    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 number2021-004849-20
    A.3Full title of the trial
    A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson’s Disease
    Estudio de fase IIb, multicéntrico, aleatorizado, doble ciego y controlado con placebo para determinar la eficacia y la seguridad de BIIB122 en participantes con enfermedad de Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Safety of BIIB122 Tablets and if it can Slow the Worsening of Early-Stage Parkinson’s Disease in Participants Between the Ages of 30 and 80
    Un estudio para evaluar la seguridad de las tabletas BIIB122 y si puede retrasar el empeoramiento de la enfermedad de Parkinson en etapa temprana en participantes de entre 30 y 80 años
    A.4.1Sponsor's protocol code number283PD201
    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 SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointN/A
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34913107110
    B.5.6E-mailclinicaltrials@biogen.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 nameBIIB122
    D.3.2Product code DNL151, DN0001575, DN1575
    D.3.4Pharmaceutical form Tablet
    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 INNNA
    D.3.9.1CAS number 2170179-24-3
    D.3.9.2Current sponsor codeBIIB122
    D.3.9.3Other descriptive nameDNL151, DN0001575, DN1575
    D.3.9.4EV Substance CodeSUB221129
    D.3.10 Strength
    D.3.10.1Concentration unit mg/h milligram(s)/hour
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 placeboTablet
    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
    Parkinson's Disease
    Enfermedad de Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's Disease
    Enfermedad de Parkinson
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system 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 evaluate the efficacy of BIIB122 225 mg compared with placebo.
    Evaluar la eficacia de 225 mg de BIIB122 en comparación con placebo.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy, safety and tolerability and of BIIB122 225 mg compared with placebo
    Evaluar la eficacia, la seguridad y la tolerabilidad de 225 mg de BIIB122 en comparación con placebo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A biofluid sub-study may be conducted to evaluate exploratory biofluid in a subset of participants.

    The objective of biofluid sub-study is to evaluate change in central and peripheral biomarkers over time. Collection will include repeat LPs for CSF collection and blood sampling for PBMC. All biofluid sub-study participants are planned to participate in CSF portion of the sub-study. A subset of participants are planned to participate in the PBMC portion of the sub-study. Samples will be evaluated for measures of LRRK2 pathway, lysosomal function, and exploratory measures relevant to PD.
    Un subestudio de líquidos corporales puede ser realizado para evaluar biomarcadores exploratorios de líquidos corporales en un subconjunto de participantes.

    El objetivo del subestudio de líquidos corporales es evaluar el cambio en los biomarcadores centrales y periféricos a lo largo del tiempo. La recogida incluirá la repetición de las PL para la recogida de líquido cefalorraquídeo (LCR) y la obtención de muestras de sangre para CMSP. Está previsto que todos los participantes del subestudio de líquidos corporales participen en la parte de LCR del subestudio. Está previsto que un subconjunto de participantes participe en la parte de CMSP del subestudio. Las muestras se evaluarán para determinar las medidas de la vía de LRRK2, la función lisosómica y las medidas exploratorias relevantes para la EP.
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    - Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 2 years of the screening visit, inclusive, and at least 30 years of age at the time of diagnosis
    - Modified Hoehn and Yahr scale, stages 1 to 2 (in OFF state), inclusive
    - MDS-UPDRS Parts II and III (in OFF state) combined score less than or equal to (<=)40 at screening
    - Screening genetic test results verifying the absence of a pathogenic leucine-rich repeat kinase 2 (LRRK2) variant (i.e., G2019S, N1437H, R1441G, R1441C, R1441H, Y1699C, or I2020T). Participants with additional LRRK2 variants may be excluded if data emerge to convincingly support an association of the variants with LRRK2-PD pathogenicity. Confirmation of this eligibility requirement may come from an accredited genetic test that includes all exclusionary LRRK2 genetic variants.

    NOTE: Other protocol defined Inclusion criteria may apply. See Protocol section 6.1
    Criterios de inclusión principales:
    - Diagnóstico clínico de EP que cumpla los criterios de diagnóstico clínico de la Sociedad de Trastornos del Movimiento en los 2 años anteriores a la visita de selección, inclusive, y tener al menos 30 años de edad en el momento del diagnóstico.
    - Estadios 1 a 2 de la escala modificada de Hoehn y Yahr (en AUSENCIA de respuesta), ambos inclusive.
    -( Puntuación combinada de las partes II y III de la escala unificada para la evaluación de la enfermedad de Parkinson de la Sociedad de trastornos del movimiento (MDS-UPDRS) (en AUSENCIA de respuesta) inferior o igual a (<=)40 en la selección.
    - Resultados de las pruebas genéticas de la selección que verifiquen la ausencia de una variante patógena de cinasa rica en repeticiones de leucina 2 (LRRK2) (es decir, G2019S, N1437H, R1441G, R1441C, R1441H, Y1699C, o I2020T). Se puede excluir a los participantes con variantes adicionales de LRRK2 si surgen datos que respalden de forma convincente una asociación de las variantes con patogenia de LRRK2-EP. La confirmación de este requisito de elegibilidad puede venir de un test genético acreditado que incluye todos los LRRK2 excluyentes variantes genéticas.

    NOTA: Podrán aplicarse otros criterios de inclusión definidos en el protocolo. Véase la sección 6.1 del protocolo.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    - Clinically significant neurological disorder other than PD, including but not limited to stroke, dementia, or seizure, within 5 years of screening visit, in the opinion of the Investigator
    - Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.
    - Montreal Cognitive Assessment (MoCA) score <24 at the screening visit

    NOTE: Other protocol defined Exclusion criteria may apply. See Protocol section 6.2
    Criterios de exclusión principales:
    - Trastorno neurológico clínicamente significativo distinto de la EP, incluidos, entre otros, accidente cerebrovascular, demencia o convulsiones, en los 5 años anteriores a la visita de selección, en opinión del investigador.
    - Indicios clínicos de parkinsonismo atípico (p. ej., atrofia multisistémica o parálisis supranuclear progresiva) o indicios de parkinsonismo inducido por fármacos.
    - Puntuación de la evaluación cognitiva de Montreal (MoCA) <24 en la visita de selección.

    NOTA: Podrán aplicarse otros criterios de exclusión definidos en el protocolo. Véase la sección 6.2 del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Time to confirmed worsening in Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III combined score over the treatment period.
    Tiempo hasta el empeoramiento confirmado en la puntuación combinada de las partes II y III de la escala unificada para la evaluación de la enfermedad de Parkinson de la Sociedad de trastornos del movimiento (MDS-UPDRS) a lo largo del periodo de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Minimum 48 weeks, maximum 144 weeks.
    48 semanas como mínimo, 144 semanas como máximo.
    E.5.2Secondary end point(s)
    1. Incidence of AEs and SAEs during the treatment period
    2. Time to confirmed worsening in MDS-UPDRS Part II score over the treatment period
    3. Change in MDS-UPDRS Parts II and III combined score
    4. Time to confirmed worsening in Schwab and England Activities of Daily Living Scale (SEADL) over the treatment period
    5. Change in MDS-UPDRS Parts I, II, and III combined score
    1. Incidencia de acontecimientos adversos (AA) y AA graves (AAG) durante el periodo de tratamiento.
    2. Tiempo hasta el empeoramiento confirmado de la puntuación de la parte II de la MDS-UPDRS a lo largo del periodo de tratamiento.
    3. Cambio en la puntuación combinada de las partes II y III de la MDS-UPDRS.
    4. Tiempo hasta el empeoramiento confirmado en la escala de actividades de la vida diaria de Schwab y England (SEADL) a lo largo del periodo de tratamiento.
    5. Cambio en la puntuación combinada de las partes I, II y III de la MDS-UPDRS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Minimum 48 weeks, maximum 144 weeks
    2. Up to Week 144
    3. From Baseline to Week 48
    4. Up to Week 144
    5. From Baseline to Week 48
    1. 48 semanas como mínimo, 144 semanas como máximo.
    2. Hasta la semana 144.
    3. Desde el inicio hasta la semana 48.
    4. Hasta la semana 144.
    5. Desde el inicio hasta la semana 48.
    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 Yes
    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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    Canada
    China
    Israel
    Japan
    United States
    Austria
    France
    Poland
    Netherlands
    Spain
    Germany
    Italy
    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
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days20
    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: 416
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 224
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 325
    F.4.2.2In the whole clinical trial 640
    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
    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 Decision2022-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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