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    Summary
    EudraCT Number:2021-004320-16
    Sponsor's Protocol Code Number:77242113PSO2002
    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:2022-04-21
    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 number2021-004320-16
    A.3Full title of the trial
    A Phase 2b Multicenter, Long-Term Extension, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
    Estudio en fase IIb, multicéntrico, de ampliación a largo plazo y de determinación de la dosis para evaluar la eficacia y la seguridad de JNJ-77242113 para el tratamiento de la psoriasis en placas de moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long-Term Extension Study of JNJ-77242113 in Participants with Moderate-to-Severe Plaque Psoriasis
    Estudio de ampliación a largo plazo de JNJ-77242113 en pacientes con psoriasis en placas de moderada a grave
    A.3.2Name or abbreviated title of the trial where available
    FRONTIER 2: Efficacy and Safety of JNJ-77242113 in Moderate to Severe Plaque Psoriasis
    FRONTIER 2: Eficacia y seguridad de JNJ-77242113 en psoriasis en placas de moderada a grave
    A.4.1Sponsor's protocol code number77242113PSO2002
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research and Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag, S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34672 60 18 55
    B.5.6E-mailerodr169@ITS.JNJ.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 nameJNJ-77242113
    D.3.4Pharmaceutical form Film-coated 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 INNNot available
    D.3.9.1CAS number Not assigned
    D.3.9.2Current sponsor codeJNJ-77242113
    D.3.9.3Other descriptive nameJNJ-77242113-AAC
    D.3.9.4EV Substance CodeSUB235599
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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 nameJNJ-77242113
    D.3.4Pharmaceutical form Film-coated 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 INNNot available
    D.3.9.1CAS number Not assigned
    D.3.9.2Current sponsor codeJNJ-77242113
    D.3.9.3Other descriptive nameJNJ-77242113-AAC
    D.3.9.4EV Substance CodeSUB235599
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboFilm-coated tablet
    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
    Plaque Psoriasis
    Psoriasis en placas
    E.1.1.1Medical condition in easily understood language
    Plaque Psoriasis
    Psoriasis en placas
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    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 long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis
    Evaluar la respuesta clínica a largo plazo del tratamiento con JNJ-77242113 en pacientes con psoriasis en placas de moderada a grave
    E.2.2Secondary objectives of the trial
    - To evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis
    - To evaluate the effect of JNJ-77242113 treatment on patient-reported psoriasis severity in participants with moderate-to-severe plaque psoriasis
    - To assess the safety and tolerability of JNJ-77242113 in participants with moderate-to-severe plaque psoriasis
    - Evaluar la respuesta clínica a largo plazo del tratamiento con JNJ-77242113 en pacientes con psoriasis en placas de moderada a grave
    - Evaluar el efecto del tratamiento con JNJ-77242113 sobre la gravedad de la psoriasis notificada por el paciente en pacientes con psoriasis en placas de moderada a grave
    - Evaluar la seguridad y la tolerabilidad de JNJ-77242113 en pacientes con psoriasis en placas de moderada a grave
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must have completed the Week 16 visit in Protocol 77242113PSO2001.
    2. In the opinion of the investigator, may benefit from inclusion in this LTE study.
    3. Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
    4. Must agree to discontinue all topical therapies that could affect psoriasis or the PASI or IGA evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention.
    5. A woman of childbearing potential must have a negative urine pregnancy test at Week 0 prior to dispensing study intervention.
    1. Haber completado la visita de la semana 16 en el protocolo 77242113PSO2001.
    2. En opinión del investigador, poder beneficiarse de la inclusión en este estudio de ampliación a largo plazo (ALP).
    3. Debe aceptar evitar la exposición prolongada al sol y evitar el uso de cabinas de bronceado u otras fuentes de luz ultravioleta durante el estudio.
    4. Debe comprometerse a discontinuar todos los tratamientos tópicos que puedan afectar a la psoriasis o a la evaluación del PASI o IGA, que no sean emolientes sin medicación y champús con ácido salicílico, antes de la primera administración del tratamiento del estudio.
    5. Una mujer en edad fértil debe haber dado negativo en una prueba de embarazo en orina en la semana 0 antes de la administración del tratamiento del estudio.
    Por favor, refiérase a la sección 5.1 del protocolo para consultar todos los criterios de inclusión.
    E.4Principal exclusion criteria
    1. Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason.
    2. Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001.
    3. Has received any phototherapy or systemic treatment, with the exception of systemic corticosteroids taken <2 weeks in duration, that could impact the assessment of psoriasis (PASI/IGA) since completion of the originating study, 77242113PSO2001, and within 4 weeks of the first administration of study intervention.
    4. Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention. For exclusions related to the bacille Calmette-Guerin (BCG) vaccine, see Exclusion 5.
    5. Has received the BCG vaccine within 12 months of the first administration of study intervention.
    1. Hayan discontinuado de forma permanente el tratamiento del estudio en el protocolo 77242113PSO2001 por cualquier motivo.
    2. Hayan recibido algún tratamiento biológico o experimental desde la finalización del estudio original, 77242113PSO2001.
    3. Hayan recibido fototerapia o un tratamiento sistémico, a excepción de corticosteroides sistémicos que se hayan tomado <2 semanas de duración, lo que podría afectar la evaluación de la psoriasis (PASI/IGA) desde la finalización del estudio original, 77242113PSO2001, y en las 4 semanas anteriores a la primera administración del tratamiento del estudio.
    4. Hayan recibido una vacuna elaborada con bacterias o virus vivos en las 12 semanas anteriores a la primera administración del tratamiento del estudio. Para las exclusiones relacionadas con la vacuna del bacilo de Calmette Guerin (BCG), véase el criterio de exclusión 5.
    5. Hayan recibido la vacuna de BCG en los 12 meses anteriores a la primera administración del tratamiento del estudio.
    Por favor, refiérase a la sección 5.2 del protocolo para consultar todos los criterios de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants achieving PASI 75 (≥75% improvement in PASI from baseline of the originating study 77242113PSO2001)
    Proporción de pacientes que logran un índice de extensión y gravedad de la psoriasis (PASI) 75 (≥75 % de mejora en el PASI desde la visita basal del estudio original 77242113PSO2001)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 36
    Semana 36
    E.5.2Secondary end point(s)
    - Proportion of participants achieving PASI 90 (≥90% improvement in PASI from baseline of the originating study)
    - Proportion of participants achieving PASI 100 (100% improvement in PASI from baseline of the originating study)
    - Change from baseline of the originating study in PASI total score
    - Proportion of participants achieving an IGA score of cleared (0) or minimal (1)
    - Change from baseline of the originating study in Psoriasis Symptoms and Signs Diary (PSSD) symptoms score
    - Change from baseline of originating study in PSSD signs score
    - Proportion of participants achieving PSSD symptoms score=0 at among participants with a baseline (in the originating study) symptoms score ≥1
    - Proportion of participants achieving PSSD signs score=0 among participants with a baseline (in the originating study) signs score ≥1
    - Frequency and type of AEs and SAEs
    - Proporción de pacientes que logran un PASI 90 (≥90 % de mejora en el PASI respecto a la visita basal del estudio original)
    - Proporción de pacientes que logran un PASI 100 (100 % de mejora en el PASI respecto a la visita basal del estudio original)
    - Cambio respecto a la visita basal del estudio original en la puntuación total del PASI
    - Proporción de pacientes que logran una puntuación en la evaluación global realizada por el investigador (IGA) de aclarada (0) o mínima (1)
    - Cambio respecto a la visita basal del estudio original en la puntuación de los síntomas del diario de signos y síntomas de psoriasis (PSSD)
    - Cambio respecto a la visita basal del estudio original en la puntuación de los signos del PSSD
    - Proporción de pacientes que logran una puntuación de los síntomas del PSSD = 0 entre los pacientes con una puntuación de los síntomas en la visita basal (en el estudio original) ≥1
    - Proporción de pacientes que logran una puntuación de los signos del PSSD = 0 entre los pacientes con una puntuación de los signos en la visita basal (en el estudio original) ≥1
    - Frecuencia y tipo de acontecimientos adversos (AA) y acontecimientos adversos graves (AAG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 36
    Semana 36
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Biomarkers
    Inmunogenicidad
    Biomarcadores
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 EEA32
    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
    Japan
    Korea, Republic of
    Taiwan
    United States
    Czechia
    France
    Germany
    Poland
    United Kingdom
    Spain
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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: 216
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 119
    F.4.2.2In the whole clinical trial 240
    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 Decision2022-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-29
    P. End of Trial
    P.End of Trial StatusOngoing
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