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    Summary
    EudraCT Number:2021-006271-42
    Sponsor's Protocol Code Number:HZNP-HZN-825-302
    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:2023-01-10
    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 number2021-006271-42
    A.3Full title of the trial
    A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis
    Ensayo de extensión abierto multicéntrico para evaluar la eficacia, seguridad y tolerabilidad de HZN-825 en pacientes con esclerosis sistémica cutánea difusa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Open-label Study to Evaluate the Efficacy, Safety, Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis
    Ensayo abierto para evaluar la eficacia, seguridad y tolerabilidad de HZN-825 en pacientes con esclerosis sistémica cutánea difusa
    A.4.1Sponsor's protocol code numberHZNP-HZN-825-302
    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 SponsorHorizon Therapeutics Ireland DAC
    B.1.3.4CountryIreland
    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 supportHorizon Therapeutics USA, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHorizon Therapeutics U.S.A., Inc.
    B.5.2Functional name of contact pointFarah Ali
    B.5.3 Address:
    B.5.3.1Street Address1 Horizon Way
    B.5.3.2Town/ cityDeerfield, IL
    B.5.3.3Post code60015
    B.5.3.4CountryUnited States
    B.5.4Telephone number0034900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1108
    D.3 Description of the IMP
    D.3.2Product code HZN-825
    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 INNHZN-825
    D.3.9.2Current sponsor codeHZN-825
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Diffuse Cutaneous Systemic Sclerosis
    Esclerosis sistémica cutánea difusa
    E.1.1.1Medical condition in easily understood language
    Disease characterized by skin hardening (fibrosis) and problems in many organs of the body.
    Enfermedad caracterizada por un engrosamiento de la piel (fibrosis) y problemas en muchos órganos del cuerpo
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10042953
    E.1.2Term Systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall objective is to investigate the efficacy, safety and tolerability of HZN-825, a selective antagonist of LPAR1, administered BID to subjects with diffuse cutaneous SSc in a 52-week open-label extension following completion of the randomized, double-blind, 52-week clinical trial (HZNP-HZN-825-301).
    The primary efficacy objective is to assess the efficacy of 52 weeks of
    open-label treatment with HZN-825 in subjects with diffuse cutaneous SSc, as measured by change from both Baselines in FVC % predicted.
    The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN 825, inclusive of, but not limited to, AEs, SAEs and the AESI, from Day 1 to 4 weeks after last dose.
    El objetivo general es estudiar la eficacia, seguridad y tolerabilidad de HZN-825, un antagonista sreceptor del ácido lisofosfatídico 1 (LPAR1), administrado dos veces al día a sujetos con esclerosicutánea difusa (EScd) en una fase de extensión sin enmascaramiento de 52 semanas después de la finalización del ensayo clínico aleatorizado, doble ciego, de 52 semanas (HZNP-HZN-825-301).
    El objetivo principal de eficacia es evaluar la eficacia de 52 semanas de tratamiento sin enmascaramiento con HZN-825 en sujetos con EScd, calculada en base a los cambios respecto a ambos valores basales del porcentaje de capacidad vital forzada (CVF) previsto.
    El objetivo principal de seguridad es examinar la seguridad y tolerabilidad de 52 semanas de tratamiento sin enmascaramiento con HZN-825, incluidos, entre otros, los acontecimientos adversos (AA), los AA graves y los acontecimientos adversos de especial interés (AAEI), desde el día 1 hasta 4 semanas después de la última dosis.
    E.2.2Secondary objectives of the trial
    The exploratory objectives are to evaluate the following after 52 weeks of open-label treatment with HZN-825:
    • Change from both Baselines in HAQ-DI; Physician Global Assessment (MDGA); Patient Global Assessment (PTGA); the Physical Effects and Physical Limitations subscales of the scleroderma skin patient-reported outcome (SSPRO-18); the mRSS; American College of Rheumatology-Composite Response Index in Systemic Sclerosis (ACR-CRISS), among others as indicated in protocol section 8.2.
    • The PK of HZN-825 and metabolite(s)
    Los objetivos exploratorios son evaluar lo siguiente después de 52 semanas de -tratamiento sin enmascaramiento con HZN-825:
    • Cambio respecto a ambos valores basales del índice de discapacidad del cuestionario de - evaluación de la salud (HAQ-DI); valoración global del médico (VGM); valoración global del paciente (VGP); subescalas de efectos físicos y limitaciones físicas de los resultados cutáneos percibidos por el paciente con esclerodermia (SSPRO-18); puntuación de la escala modificada de Rodnan (mRSS); índice de respuesta combinada en esclerosis sistémica del Colegio Estadounidense de Reumatología (ACR-CRISS), entre otros como se indica en la sección 8.2 del protocolo.
    • La farmacocinética (FC) de HZN-825 y su(s) metabolito(s).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent.
    2. Completed the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301; subjects prematurely discontinued from trial drug in Trial HZNP-HZN-825-301 for reasons other than safety or toxicity can be included at the discretion of the Investigator after completing Trial HZNP-HZN-825-301 scheduled visits, including Week 52 assessments.
    3. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
    1. Consentimiento informado por escrito.
    2. Completó el período de tratamiento doble ciego (semana 52) en el ensayo HZNP-HZN-825-301; los sujetos que suspendieron prematuramente el tratamiento con el fármaco del estudio en el ensayo HZNP-HZN-825-301 por razones ajenas a la seguridad o la toxicidad se pueden incluir a discreción del investigador después de que completen las visitas programadas del ensayo HZNP-HZN-825-301, incluidas las evaluaciones de la semana 52.
    3. Sujeto capaz y dispuesto a cumplir con el protocolo de tratamiento prescrito y las evaluaciones durante todo el ensayo.
    E.4Principal exclusion criteria
    1. Anticipated use of another investigational agent for any condition during the course of the trial.
    2. New diagnosis of malignant condition after enrolling in Trial HZNP-HZN-825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
    3. Women of childbearing potential (WOCBP) or male subjects not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug. Male subjects must refrain from sperm donation and females from egg/ova donation for this same time period. Women are considered of childbearing potential if they are not postmenopausal and not surgically sterile (documented bilateral salpingectomy, bilateral oophorectomy or hysterectomy). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Fertile male subjects must use a condom throughout the trial and for 4 weeks after the last dose of trial drug. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
    4. Pregnant or lactating women.
    5. Any new development with the subject’s disease or condition or any significant laboratory test abnormality during the course of Trial HZNP-HZN-825-301 that, in the opinion of the Investigator, would potentially put the subject at unacceptable risk.
    6. Subjects will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the trial protocol or have a concomitant disease or condition that could interfere with the conduct of the trial.
    1. Uso previsto de otro fármaco en investigación para tratar cualquier enfermedad durante el desarrollo del ensayo.
    2. Nuevo diagnóstico de neoplasia maligna después de inscribirse en el ensayo HZNP-HZN-825-301 (excepto carcinoma de células basales/escamosas de la piel o cáncer de cuello de útero localizado tratado de manera satisfactoria).
    3. Mujeres en edad fértil (MEF) o varones que no están de acuerdo en usar métodos anticonceptivos altamente efectivos durante todo el ensayo y durante 4 semanas después de la última dosis del fármaco del ensayo. Los varones deben abstenerse de donar esperma, y las mujeres de donar óvulos, durante este mismo período de tiempo. Se considera que una mujer está en edad fértil si no ha alcanzado la posmenopausia y no se ha sometido a una esterilización quirúrgica (p. ej., salpingectomía bilateral, ooforectomía bilateral o histerectomía documentadas). Un estado posmenopáusico se define como la ausencia de menstruación durante 12 meses sin una causa médica alternativa. Una cantidad elevada de hormona foliculoestimulante (FSH), en el intervalo posmenopáusico, puede servir para confirmar un estado posmenopáusico en mujeres que no usan anticonceptivos hormonales o terapia de reposición hormonal. Sin embargo, en ausencia de 12 meses de amenorrea, una sola medición de la FSH es insuficiente. Los varones fértiles deben utilizar preservativo durante todo el ensayo y durante 4 semanas después de la última dosis del fármaco del ensayo. Un varón se considera fértil después de la pubertad a menos que sea permanentemente estéril por orquiectomía bilateral.
    4. Mujeres embarazadas o en período de lactancia.
    5. Cualquier evolución de la enfermedad o del estado del sujeto o cualquier anomalía analítica relevante en el transcurso del ensayo HZNP-HZN-825-301 que, en opinión del investigador, podría poner al sujeto en un riesgo inaceptable.
    6. Los sujetos no serán elegibles si, en opinión del investigador, es poco probable que cumplan con el protocolo del ensayo o tienen una enfermedad o afección concomitante que pueda interferir con el desarrollo del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Change from both Baselines in FVC % predicted at Week 52
    Variación del porcentaje de CVF previsto entre ambos valores basales y la semana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 52
    Desde el momento basal a la semana 52
    E.5.2Secondary end point(s)
    Exploratory Efficacy Endpoints
    1. Change from both Baselines in HAQ-DI at Week 52.
    2. Change from both Baselines in MDGA at Week 52.
    3. Change from both Baselines in PTGA at Week 52.
    4. Change from both Baselines in the Physical Effects subscale of the SSPRO-18 at Week 52.
    5. Change from both Baselines in the Physical Limitations subscale of the SSPRO-18 at Week 52.
    6. Proportion of subjects with an mRSS decrease of ≥5 points and 25% from both Baselines at Week 52.
    7. Responder rate (defined as ACR-CRISS [predicted probability] of at least 0.6) at Week 52.
    8. Proportion of subjects with an improvement in ≥3 of 5 core measures from both Baselines: ≥20% in mRSS, ≥20% in HAQ-DI, ≥20% in PTGA, ≥20% in MDGA and ≥5% in FVC % predicted at Week 52 (ACR-CRISS-20).
    9. Change from both Baselines in the SSPRO-18 at Week 52.
    10. Change from both Baselines in each scale of the UCLA SCTC GIT 2.0 and the total GIT score at Week 52.
    11. Change from both Baselines in Raynaud’s phenomenon using the Raynaud’s Assessment at Week 52.
    12. Change from both Baselines in the SHAQ at Week 52.
    13. Change from both Baselines in SScQoL scores at Week 52.
    14. Change from both Baselines in SF-12 scores at Week 52.
    15. Change from both Baselines in pain and pain component scale scores at Week 52.
    16. Change from both Baselines in the FACIT-F score at Week 52.
    17. Change from both Baselines in the mRSS at Week 52.
    18. Change from both Baselines in lung fibrosis based on HRCT at Week 52.
    19. Change from both Baselines in DLCO at Week 52.
    20. Change from both Baselines in serum and plasma biomarkers associated with LPAR1 pathway, inflammation and/or fibrosis at Week 52.
    21. Change from both Baselines in swollen and tender joint count, digital ulcer assessment and joint contracture assessment at Week 52.
    1. Variación en el HAQ-DI entre ambos valores basales y la semana 52.
    2. Variación en el VGM entre ambos valores basales y la semana 52.
    3. Variación en el VGP entre ambos valores basales y la semana 52.
    4. Variación en la subescala de efectos físicos de la SSPRO 18 entre ambos valores basales y la semana 52.
    5. Variación en la subescala de limitaciones físicas de la SSPRO 18 entre ambos valores basales y la semana 52.
    6. Proporción de sujetos con una reducción de ≥5 puntos y un 25 % en mRSS entre ambos valores basales y la semana 52.
    7. Tasa de respuesta (definida como ACR-CRISS [probabilidad prevista] de al menos 0,6) en la semana 52.
    8. Proporción de sujetos con una mejoría en 3 o más de 5 parámetros principales con respecto a los valores basales: ≥20 % en mRSS, ≥20 % en HAQ DI, ≥20 % en VGP, ≥20 % en VGM y ≥5 % en el porcentaje de CVF previsto en la semana 52 (ACR CRISS 20).
    9. Variación en la SSPRO-18 entre ambos valores basales y la semana 52.
    10. Variación en cada escala del UCLA SCTC GIT 2.0 y la puntuación total del cuestionario GIT entre ambos valores basales y la semana 52.
    11. Variación en el fenómeno de Raynaud según la evaluación de Raynaud entre ambos valores basales y la semana 52.
    12. Variación en el SHAQ entre ambos valores basales y la semana 52.
    13. Variación en las puntuaciones de SScQoL entre ambos valores basales y la semana 52.
    14. Variación en la puntuación de SF-12 entre ambos valores basales y la semana 52.
    15. Variación en las puntuaciones de la escala de dolor y componentes de dolor entre ambos valores basales y la semana 52.
    16. Variación en la puntuación FACIT-F entre ambos valores basales y la semana 52.
    17. Variación en la mRSS entre ambos valores basales y la semana 52.
    18. Variación en la fibrosis pulmonar según la TCAR entre ambos valores basales y la semana 52.
    19. Variación en la DLCO entre ambos valores basales y la semana 52.
    20. Variación en los biomarcadores séricos y plasmáticos asociados con la vía del LPAR1, la inflamación o la fibrosis entre ambos valores basales y la semana 52.
    21. Variación en el número de articulaciones inflamadas y dolorosas a la palpación, la evaluación de las úlceras dactilares y la evaluación de las contracturas articulares entre ambos valores basales y la semana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 52
    Desde el momento basal a la semana 52
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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 Yes
    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 trial1
    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 EEA61
    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
    Argentina
    Israel
    Japan
    Korea, Republic of
    Mexico
    United States
    Austria
    France
    Poland
    Netherlands
    Romania
    Spain
    Switzerland
    Germany
    Greece
    Italy
    Belgium
    Portugal
    United Kingdom
    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
    Ultima visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 96
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 157
    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)
    Subjects will return to the clinic 4 weeks after the last dose of HZN-825 for a Safety Follow-up Visit.
    Los sujetos volverán al hospital 4 semanas después de la última dosis de HZN-825 para una visita de seguimiento de seguridad
    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 Decision2023-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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