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    The EU Clinical Trials Register currently displays   44241   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-005526-17
    Sponsor's Protocol Code Number:417-201-00012
    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:2022-12-13
    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 number2021-005526-17
    A.3Full title of the trial
    A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects
    with Immunoglobulin A Nephropathy
    Ensayo en fase 2/3, multicéntrico, abierto para evaluar la seguridad, la tolerabilidad y la eficacia a largo plazo del sibeprenlimab administrado por vía subcutánea a sujetos con nefropatía por inmunoglobulina A
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy
    Ensayo abierto de fase II/III con sibeprenlimab en el tratamiento de la nefropatía por inmunoglobulina A
    A.4.1Sponsor's protocol code number417-201-00012
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05248659
    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 SponsorOtsuka Pharmaceutical Development and Commercialization, 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 supportOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.5.2Functional name of contact pointOtsuka Call Center
    B.5.3 Address:
    B.5.3.1Street Address2440 Research Blvd
    B.5.3.2Town/ cityRockville, MD
    B.5.3.3Post code20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18446878522
    B.5.6E-mailvisionary@otsuka-us.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 nameSibeprenlimab
    D.3.2Product code VIS649
    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 INNSibeprenlimab
    D.3.9.2Current sponsor codeVIS649
    D.3.9.4EV Substance CodeSUB201705
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    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
    Immunoglobulin A Nephropathy
    Nefropatía por inmunoglobulina A
    E.1.1.1Medical condition in easily understood language
    A kidney disease that occurs when antibody deposits build up in the kidneys
    Una enfermedad renal que ocurre cuando se acumulan depósitos de anticuerpos en los riñones
    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 PT
    E.1.2Classification code 10021263
    E.1.2Term IgA nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety and tolerability:
    - To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN.
    Seguridad y tolerabilidad:
    • Evaluar la seguridad y tolerabilidad a largo plazo de sibeprenlimab en pacientes con NIgA.
    E.2.2Secondary objectives of the trial
    Efficacy:
    - To evaluate the long-term efficacy of sibeprenlimab in subjects with IgAN.
    Pharmacodynamics:
    - To evaluate Ig response in subjects with IgAN.
    Other:
    - To evaluate immunogenicity in subjects with IgAN.
    Eficacia:
    • Evaluar la eficacia a largo plazo de sibeprenlimab en pacientes con NIgA.
    Farmacodinámica:
    • Evaluar la respuesta de Ig en pacientes con NIgA.
    Otros:
    • Evaluar la inmunogenia en pacientes con NIgA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects who completed Trial 417-201-00007 (at least 20 of the 26 doses and the end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN.

    2) Subject has eGFR ≥ 20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

    3) Ability to provide written, informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
    1) Sujetos que completaron el Ensayo 417-201-00007 (al menos 20 de las 26 dosis y la visita de final del ensayo) o el Ensayo VIS649-201 (al menos 9 de las 12 dosis y la visita de final del ensayo) sin problemas de seguridad y que, en opinión del investigador, podrían beneficiarse potencialmente del tratamiento con sibeprenlimab para la NIgA.

    2) El sujeto tiene una FGe ≥20 ml/min/1,73 m2., calculada mediante la fórmula de la Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).

    3) Capacidad para proporcionar consentimiento informado por escrito antes del inicio de cualquier procedimiento específico del ensayo y capacidad, en opinión del investigador principal, para cumplir con todos los requisitos del ensayo.
    E.4Principal exclusion criteria
    1) Subjects who have not completed participation in Trials 417-201-00007 or VIS649-201.

    2) Subjects with treatment-limiting adverse events (AEs) during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement that would preclude rollover into this trial.

    3) Noncompliance, due to subject’s repeated failure to follow trial procedures during the course of their participation in Trials 417-201-00007 and VIS649-201 (eg, subjects deemed to be noncompliant with the visit schedule, trial assessments, or treatment regimen). The medical monitor should be contacted if the investigator is unsure of a subject’s eligibility.

    4) Subjects who have a positive pregnancy test result prior to receiving IMP.

    5) Heterosexually biological active males or subjects of childbearing potential, or their partners, who do not agree to adhere to contraceptive requirements from the time of consent through the end of the subject’s participation in the trial and an additional 90 days (biological male subjects) or 30 days (biological female subjects) thereafter.

    6) Subjects must also agree not to donate sperm from the time of consent through the end of the subject’s participation in the trial and an additional 90 days thereafter.

    7) Subject has nephrotic syndrome, defined for this purpose as 24-hour urine protein > 3.5 g with concurrent hypoalbuminemia (serum albumin < 2.5 g/dL),
    hyperlipidemia (total cholesterol > 350 mg/dL), and edema. Subjects with isolated nephrotic range proteinuria (> 3.5 g/day) will be eligible.

    8) Subject has a history or current evidence of a serious and/or unstable
    cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune,
    rheumatologic, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or ongoing malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.

    9) History of a previous severe allergic reaction with generalized urticaria;
    angioedema or anaphylaxis.

    10) Subject has a body mass index < 16 kg/m2.

    11) Subject has received an organ transplant (ie, solid or a bone marrow or
    hematologic stem cell transplantation).

    12) Subject is currently receiving, or has received within 16 weeks prior to
    enrollment, systemic immunosuppression (note: topical, ophthalmic, rectal,
    intra-articular, inhaled corticosteroids, and short courses of oral/intravenous
    steroids [≤ 14 days] are allowed).

    13) Subject has participated in another interventional clinical trial (other than
    Trials 417-201-00007 and VIS649-201) and received another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last
    investigational drug administration, whichever is longer.

    14) Subject has any chronic infectious disease (eg, chronic urinary tract infection; chronic sinusitis; bronchiectasis; active pulmonary or systemic tuberculosis; chronic viral hepatitis, such as hepatitis C or hepatitis B [defined as positive for hepatitis B surface antigen]; or human immunodeficiency virus [HIV] infection).

    15) Subject has acute infectious disease at the time of screening.

    16) Subject has Type 1 diabetes.

    17) Subject has uncontrolled Type 2 diabetes, as evidenced by a screening
    hemoglobin A1c (HbA1c) value > 8%.

    18) Subject has uncontrolled hypertension (defined as systolic blood pressure
    > 140 mmHg or diastolic blood pressure > 90 mmHg).

    19) Subject who has a history of alcohol or drug/chemical abuse based on the
    investigator’s clinical judgement.

    20) Subject is judged by the investigator or the medical monitor to be inappropriate for the trial.
    1) Sujetos que no hayan completado su participación en los Ensayos 417-201-00007 o VIS649-201.
    2) Sujetos con eventos adversos (EA) que limitarón el tratamiento durante los Ensayos 417-201-00007 o VIS649-201 y relacionados con IMP según el criterio del investigador que impediría la transferencia a este ensayo.
    3) Incumplimiento, debido a que el sujeto no cumplió repetidamente con los procedimientos del ensayo durante el curso de su participación en los Ensayos 417-201-00007 y VIS649-201 (p. ej., sujetos que se consideró que no cumplieron con el programa de visitas, las evaluaciones del ensayo o el régimen de tratamiento). Se debe contactar al monitor médico si el investigador no está seguro de la elegibilidad de un sujeto.
    4) Sujetos que tengan un resultado positivo en la prueba de embarazo antes de recibir IMP.

    5) Varones heterosexuales biológicamente activos o sujetos en edad fértil, o sus parejas, que no acepten cumplir con los requisitos anticonceptivos desde el momento del consentimiento hasta el final de la participación del sujeto en el ensayo y 90 días adicionales (sujetos biológicos masculinos) o 30 días (sujetos biológicos femeninos) a partir de entonces.

    *** Por favor, consultar el protocolo para mas información ***
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability: Incidence of TEAEs graded by severity and as assessed by clinical laboratory tests, vital sign measurements, physical examinations, and injection site reactions.
    Seguridad y tolerabilidad: Incidencia de AADT clasificada por intensidad y evaluada mediante análisis clínicos, mediciones de constantes vitales, exploraciones físicas y reacciones en el lugar de la inyección.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to end-of-trial visit in Week 112
    Desde el inicio hasta la visita al final del ensayo en la semana 112
    E.5.2Secondary end point(s)
    1) The slope of eGFR over the course of approximately 12 and 24 months.

    2) Relative change from baseline in terms of uPCR at 12 and 24 months, based on 24-hour urine collection.

    3) Overall rate of clinical remission, based on 24-hour urine collection, and defined as the proportion of subjects with total protein < 1.0 g/day at 12 and 24 months.

    4) Progression of chronic kidney disease measured as the time to a doubling of serum creatinine, 40% reduction in eGFR, eGFR < 15 mL/min/1.73m2, or requiring renal replacement therapy (for ≥ 3 months).

    5) Progression of chronic kidney disease measured as the proportion of subjects with a doubling of serum creatinine, 40% reduction in eGFR, eGFR < 15 mL/min/1.73m2, or requiring renal replacement therapy (for ≥ 3 months) over the course of 24 months.

    6) Change from baseline in total serum IgA, IgG, and IgM concentrations.

    7) Evaluation of serum ADA levels.
    1) La pendiente de la FGe a lo largo de aproximadamente 12 y 24 meses.
    2) Cambio respecto al valor inicial en cuanto a la RPCO a los 12 y 24 meses, basada en la recogida de orina de 24 horas.
    3) Tasa global de remisión clínica, basada en la recogida de orina de 24 horas, y definida como la proporción de pacientes que alcanzan una proteína total en orina <1,0 g/día a los 12 y 24 meses.

    *** Por favor, consultar el protocolo para mas información ***
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Over 12 and 24 months
    2) At 12 and 24 months
    3) At 12 and 24 months
    4) Over 24 months
    5) Over 24 months
    6) From baseline to end-of-trial visit in Week 112
    7) From baseline to end-of-trial visit in Week 112
    1) Mayores de 12 y 24 meses
    2) A los 12 y 24 meses
    3) A los 12 y 24 meses
    4) Más de 24 meses
    5) Más de 24 meses
    6) Desde el inicio hasta la visita de finalización del ensayo en la semana 112
    7) Desde el inicio hasta la visita al final del ensayo en la semana 112
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Australia
    Brazil
    Canada
    China
    Hong Kong
    India
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Philippines
    Singapore
    Sri Lanka
    Taiwan
    Thailand
    United States
    Viet Nam
    France
    Poland
    Netherlands
    Spain
    Czechia
    Germany
    Greece
    Italy
    Belgium
    Croatia
    Hungary
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months9
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 600
    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 Decision2022-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-01
    P. End of Trial
    P.End of Trial StatusOngoing
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