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    Summary
    EudraCT Number:2022-000855-35
    Sponsor's Protocol Code Number:HZNP-DAX-204
    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:2022-07-19
    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 number2022-000855-35
    A.3Full title of the trial
    An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Daxdilimab (HZN-7734) in Subjects with Systemic Lupus Erythematosus
    Estudio de extensión abierto para evaluar la seguridad y la tolerabilidad a largo plazo de daxdilimab (HZN-7734) en sujetos con lupus eritematoso sistémico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Daxdilimab (HZN-7734) in Subjects with Systemic Lupus Erythematosus
    Estudio de extensión abierto para evaluar la seguridad y la tolerabilidad a largo plazo de daxdilimab (HZN-7734) en sujetos con lupus eritematoso sistémico
    A.3.2Name or abbreviated title of the trial where available
    RECAST SLE OLE
    RECAST SLE OLE
    A.4.1Sponsor's protocol code numberHZNP-DAX-204
    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 Ireland DAC
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointCourtney Sauer
    B.5.3 Address:
    B.5.3.1Street Address929 N Front St
    B.5.3.2Town/ cityWilmington, NC
    B.5.3.3Post code28401
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDaxdilimab
    D.3.2Product code HZN-7734, VIB7734
    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 INNDaxdilimab
    D.3.9.1CAS number 2245966-28-1
    D.3.9.2Current sponsor codeHZN-7734
    D.3.9.3Other descriptive nameHZN-7734, VIB7734, MEDI7734
    D.3.9.4EV Substance CodeSUB195573
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 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
    Systemic Lupus Erythematosus (SLE)
    Lupus Eritematoso Sistémico (LES)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus
    Lupus Eritematoso Sistémico
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 long-term safety and tolerability of 200mg Q12W daxdilimab
    Evaluar la seguridad y la tolerabilidad a largo plazo de daxdilimab 200 mg C12S
    E.2.2Secondary objectives of the trial
    To characterize the PK, PD, and immunogenicity of daxdilimab
    Caracterizar la FC, la FD y la inmunogenicidad de daxdilimab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to understand and provide written informed consent prior to any study-related procedures and to comply with all study requirements and complete study assessments.
    2. Must have qualified for and received IP (daxdilimab or placebo) and complete the treatment period (through Day 337) in the RECAST SLE study. Subjects who discontinued early from IP in RECAST SLE are not eligible for this study.
    3. Women of childbearing potential must have a negative urine pregnancy test on Day 1. Women of childbearing potential are defined as those who are not surgically sterile (ie, surgical sterilization includes bilateral salpingectomy, bilateral oophorectomy, or hysterectomy) or those who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause and a follicle-stimulating hormone [FSH] within the postmenopausal range as established by the central laboratory during the screening period of the RECAST SLE study, unless on postmenopausal hormone replacement therapy).If a female subject becomes postmenopausal during the study (ie, 12months with no menses without an alternative medical cause, unless on postmenopausal hormone replacement therapy), a FSH test will be performed at the central laboratory. If the FSH level is within the postmenopausal range, the female subject will not be required to use contraception after that. Women of childbearing potential who are sexually active with a nonsterilized male partner must agree to use a highly effective method of contraception from signing of the ICF and must agree to continue using such precautions through the end of the study follow-up or 3months (approximately 5 half-lives) following the last dose of IP in the case of early withdrawal from the study, and refrain from egg retrieval/egg donation during this period. After this point, a decision about contraception should be made by the subject and her regular healthcare providers. Female subjects who participate in the SLE OLE are expected to maintain the same form of contraception they used during the RECAST SLE study. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Note that because mycophenolate affects the metabolism of hormonal contraceptives and may reduce their effectiveness in women receiving MMF or mycophenolic acid (MPA) who are using hormonal contraceptives for birth control, the subject must employ an additional contraceptive method (eg, barrier method).
    4. Nonsterilized male subjects who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Day 1 and until 3 months (approximately 5 half-lives) after receipt of the last dose. Because a male condom with spermicide is not a highly effective contraception method, it is strongly recommended that male subjects advise their women partners of childbearing potential to use a highly effective method of contraception throughout this period.
    1. Disposición y capacidad para comprender y otorgar el consentimiento informado por escrito antes de realizar ningún procedimiento relacionado con el estudio y para cumplir todos los requisitos del estudio y completar las evaluaciones del estudio.
    2. Deben haber cumplido los requisitos y haber recibido el PEI (daxdilimab o placebo) y completar el período de tratamiento (hasta el día 337) en el estudio RECAST SLE. Los sujetos que hayan abandonado prematuramente el PEI en el estudio RECAST SLE no podrán participar en este estudio.
    3. Las mujeres en edad fértil deben tener una prueba de embarazo negativa en orina el día 1. Las mujeres en edad fértil se definen como las que no están esterilizadas quirúrgicamente (la esterilización quirúrgica comprende salpingectomía bilateral, ovariectomía bilateral o histerectomía) o las que no son posmenopáusicas (definido como 12 meses sin menstruación sin una causa médica alternativa y una concentración de folitropina [FSH] dentro del intervalo posmenopáusico establecido por el laboratorio central durante el período de selección del estudio RECAST SLE, salvo en caso de tratamiento hormonal sustitutivo posmenopáusico).
    Si una mujer pasa a ser posmenopáusica durante el estudio (es decir, 12 meses sin menstruación sin una causa médica alternativa, a menos que reciba tratamiento hormonal sustitutivo posmenopáusico), se realizará un análisis de FSH en el laboratorio central. Si la concentración de FSH está dentro del intervalo posmenopáusico, no será necesario que la mujer utilice métodos anticonceptivos a partir de ese momento.
    Las mujeres en edad fértil que mantengan relaciones sexuales con una pareja masculina no esterilizada deberán comprometerse a utilizar un método anticonceptivo muy eficaz desde la firma del DCI y a seguir adoptando tales precauciones hasta el final del seguimiento del estudio o hasta 3 meses (aproximadamente 5 semividas) después de la última dosis del PEI en caso de retirada prematura del estudio y abstenerse de la extracción/donación de óvulos durante este periodo. Después de este momento, la paciente y sus profesionales sanitarios habituales tomarán una decisión sobre el uso de anticonceptivos. Se espera que las mujeres que participen en la EA del estudio del LES continúen con el mismo método anticonceptivo que usaron durante el estudio RECAST SLE.
    La abstinencia mantenida es una práctica aceptable; sin embargo, la abstinencia periódica, el método de Ogino y el coito interrumpido no son métodos anticonceptivos aceptables.
    Hay que señalar que, dado que el micofenolato afecta al metabolismo de los anticonceptivos hormonales y podría reducir su eficacia en las mujeres tratadas con MMF o ácido micofenólico (AMF) que utilicen anticonceptivos hormonales, la paciente deberá utilizar un método anticonceptivo adicional (por ejemplo, un método de barrera).
    4. Los pacientes varones no esterilizados que mantengan relaciones sexuales con una pareja femenina en edad fértil deberán comprometerse a utilizar preservativo con espermicida desde el día 1 hasta 3 meses (aproximadamente 5 semividas) después de recibir la última dosis. Dado que el preservativo masculino con espermicida no es un método anticonceptivo muy eficaz, se recomienda que los pacientes varones indiquen a sus parejas mujeres en edad fértil que utilicen un método anticonceptivo muy eficaz durante todo este período.
    E.4Principal exclusion criteria
    1. Any condition or change during the RECAST SLE study that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety or alter the risk-benefit associated with IP administration.
    2. Participation in another clinical study with an IP during the RECAST SLE study period.
    3. Planned elective surgeries that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety.
    4. Any herpes zoster, cytomegalovirus, or Epstein-Barr virus infection that was not completely resolved prior to Visit 1.
    5. Clinically significant active infection at Visit1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication (chronic nail infections are allowed).
    6. Pregnant or lactating females.
    7. Receipt of any prohibited medication during the RECAST SLE study period. Receipt of any restricted medications during the RECAST SLE study period must be discussed with the Sponsor’s Medical Monitor and agreed upon prior to enrollment into this study.
    1. Cualquier trastorno o cambio durante el estudio RECAST SLE que, en opinión del investigador o del promotor, podría interferir en la evaluación e interpretación de la seguridad del sujeto o alterar la relación riesgo-beneficio asociada a la administración del PEI.
    2. Participación en otro estudio clínico con un PEI durante el período del estudio RECAST SLE.
    3. Intervenciones quirúrgicas programadas que, en opinión del investigador o el promotor, podrían interferir en la evaluación e interpretación de la seguridad de los sujetos.
    4. Cualquier infección por herpes zóster, citomegalovirus o virus de Epstein-Barr que no se haya resuelto por completo antes de la visita 1.
    5. Infección activa de importancia clínica en la visita 1 en opinión del investigador, incluida infección en curso y crónica con necesidad de antibióticos o antivirales (se permiten las infecciones ungueales crónicas).
    6. Mujeres embarazadas o en período de lactancia.
    7. Tratamiento con cualquier medicamento prohibido durante el período del estudio RECAST SLE. El tratamiento con cualquier medicamento restringido durante el período del estudio RECAST SLE deberá comentarse con el monitor médico del promotor y acordarse antes de la inclusión en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of AEs, SAEs, and AESIs
    Incidencia de AA, AAG y AAIE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56
    Semana 0, Semana 4, Semana 8, Semana 12, Semana 16, Semana 20, Semana 24, Semana 28, Semana 32, Semana 36, Semana 40, Semana 44, Semana 48, Semana 52 y Semana 56.
    E.5.2Secondary end point(s)
    Daxdilimab concentrations, change in pDCs, and ADA rate
    Concentraciones de daxdilimab, variación de las CDp y tasa de ACF
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 0, Week 12, Week 24, Week 36, Week 48, Week 56
    Semana 0, Semana 12, Semana 24, Semana 36, Semana 48 y Semana 56.
    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 No
    E.6.6Pharmacokinetic Yes
    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 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.8.3 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 EEA22
    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
    India
    Mexico
    Taiwan
    United States
    Poland
    Spain
    Greece
    Serbia
    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 date of the last protocol-specified visit/assessment for the last subject in the study.
    La fecha de la última visita/evaluación especificada por el protocolo para el último sujeto del estudio.
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 148
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-07-19. Yes
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 156
    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)
    After the end of the study, each subject will be treated according to standard clinical practice and local practice, at the discretion of the Investigator.
    Después del final del estudio, cada sujeto será tratado de acuerdo con la práctica clínica estándar y la práctica local, a discreción del investigador.
    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 Decision2022-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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