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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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:2021-002727-38
    Sponsor's Protocol Code Number:OMS721-HCT-002
    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:2022-11-15
    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 number2021-002727-38
    A.3Full title of the trial
    A Phase 2 Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Narsoplimab in Paediatric Patients (28 Days to 18 Y.O.) with High Risk Haematopoietic Stem Cell Transplant Thrombotic Microangiopathy
    Estudio de fase 2 para evaluar la eficacia, seguridad, farmacocinética y farmacodinámica del narsoplimab en pacientes pediátricos (de 28 días a 18 años de edad) con microangiopatía trombótica asociada a trasplante de células madre hematopoyéticas de alto riesgo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study on Narsoplimab in Paediatric Patients with High Risk Haematopoietic Stem Cell Transplant Thrombotic Microangiopathy
    Estudio de fase 2 pdel narsoplimab en pacientes pediátricos con microangiopatía trombótica asociada a trasplante de células madre hematopoyéticas de alto riesgo
    A.4.1Sponsor's protocol code numberOMS721-HCT-002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/400/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOmeros Corporation
    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 supportOmeros Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOmeros Corporation
    B.5.2Functional name of contact pointSamantha Magazu
    B.5.3 Address:
    B.5.3.1Street Address201 Elliott Ave W
    B.5.3.2Town/ citySeattle
    B.5.3.3Post code98119
    B.5.3.4CountryUnited States
    B.5.4Telephone number0012062987817
    B.5.6E-mailsmagazu@omeros.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/3/18/1984
    D.3 Description of the IMP
    D.3.1Product nameNarsoplimab
    D.3.2Product code OMS721
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNarsoplimab
    D.3.9.1CAS number 2108782-45-0
    D.3.9.2Current sponsor codeOMS721
    D.3.9.3Other descriptive nameMASP-2 Antibody, OMS00620646, OMS620646
    D.3.9.4EV Substance CodeSUB194964
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number185
    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
    Thrombotic microangiopathies following haematopoietic stem cell transplant
    Microangiopatías trombóticas tras un trasplante de células madre hematopoyéticas
    E.1.1.1Medical condition in easily understood language
    Thrombotic microangiopathies following haematopoietic stem cell transplant
    Microangiopatías trombóticas tras un trasplante de células madre hematopoyéticas
    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 HLGT
    E.1.2Classification code 10064477
    E.1.2Term Coagulopathies and bleeding diatheses (excl thrombocytopenic)
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10043645
    E.1.2Term Thrombotic microangiopathy
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10053567
    E.1.2Term Coagulopathies
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Describe the 100-day survival rate following high risk HSCT-TMA diagnosis.
    Describir la tasa de supervivencia a los 100 días tras el diagnóstico de HSCT-TMA de alto riesgo.
    E.2.2Secondary objectives of the trial
    - Evaluate the safety and tolerability of intravenous (IV) administration of narsoplimab.
    - Describe the efficacy of narsoplimab by responder rate; survival at 52 weeks; and mean, median, and overall survival rates.
    - Evaluate peak and trough PK of IV narsoplimab.
    - Immunogenicity will be evaluated.
    - Anti-drug antibody (ADA) responses will be summarized by treatment group and will be evaluated.
    - Evaluar la seguridad y tolerabilidad de la administración intravenosa (intravenous, IV) de narsoplimab.
    - Describir la eficacia de narsoplimab mediante la tasa de respondedores; la supervivencia a las 52 semanas; y las tasas de supervivencia media, mediana y global.
    - Evaluar la PK máxima y mínima de narsoplimab IV.
    - Evaluar la inmunogenicidad.
    - Resumir y evaluar las respuestas de producción de anticuerpos antimedicamento (anti-drug antibody, ADA) por grupo de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age at least 28 days and less than 18 years prior to informed consent (Visit 0).
    2. Have informed consent from at least one parent or legal guardian as required by local law and regulation. Patient informed consent will be required if the patient has reached the local legal age of majority.
    3. Assent from patients as required by local law and regulation.
    4. Have received an allogeneic haematopoietic stem cell transplant for the treatment of non-malignant or malignant disease. All donor cell sources are allowed (i.e., matched, mismatched, and haploidentical; related and unrelated; bone marrow, peripheral blood stem cells, and umbilical cord blood).
    5. Have a diagnosis of HSCT-TMA defined as having both of the following:
    -Platelet count < 50,000/µL or a decrease in platelet count > 50% from the highest value obtained following transplant.
    -Evidence of microangiopathic hemolysis (presence of schistocytes, serum lactate dehydrogenase [LDH] > upper limit of normal ([ULN], or haptoglobin < lower limit of normal [LLN])
    6. Have at least one of the following HSCT-TMA high-risk criteria:
    - HSCT-TMA persistence > 2 weeks following modification of calcineurin inhibitors or sirolimus
    OR
    - Have evidence of high-risk HSCT-TMA defined as at least one of the following:
    - Spot protein/creatinine ratio > 2 mg/mg
    - Serum creatinine > 1.5 x the creatinine level prior to TMA development
    - Biopsy-proven gastrointestinal TMA
    - TMA-related neurological abnormality (e.g., confusion, stroke, transient ischemic attack [TIA] or seizures)
    - Pericardial or pleural effusion without alternative explanation
    - Pulmonary hypertension without alternative explanation
    - Have Grade III or Grade IV graft-versus-host disease (GVHD) or, in the opinion of the Investigator, risk for development of Grade III or Grade IV GVHD if immunosuppression were to be modified
    - Have elevated serum C5b-9 (> 244 ng/mL)
    7. If sexually active and of childbearing potential, must agree to practice a highly effective method of birth control throughout the study drug treatment and for at least 12 weeks after the last dose of study drug, such method of birth control defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence (abstinence is acceptable when it is in line with the patient’s preferred and usual lifestyle and is defined as complete abstinence of sexual intercourse, not periodic abstinence or withdrawal), or vasectomized partner.
    8. Male patients must be willing to avoid fathering children for at least 12 weeks following the last dose of study medication.
    1. Edad mínima de 28 días y menor de 18 años antes del consentimiento informado (visita 0).
    2. Contar con el consentimiento informado de al menos uno de los padres o tutores legales, tal y como exijan las leyes y normativas locales. Se requerirá el consentimiento informado del paciente si este ha alcanzado la mayoría de edad legal local.
    3. Asentimiento de los pacientes, tal como exijan las leyes y reglamentos locales.
    4. Haber recibido un trasplante alogénico de células madre hematopoyéticas para el tratamiento de una enfermedad no maligna o maligna. Se permiten todas las fuentes de células de donantes (es decir, compatibles, no compatibles y haploidénticas; emparentadas y no emparentadas; médula ósea, células madre de sangre periférica y sangre del cordón umbilical).
    5. Tener un diagnóstico de HSCT-TMA, definido por los dos hechos siguientes:
    - Recuento de plaquetas <50.000/uL o una disminución del recuento de plaquetas >50% respecto al valor más alto obtenido tras el trasplante.
    - Evidencia de hemólisis microangiopática (presencia de esquistocitos, lactato deshidrogenasa [LDH] sérica >límite superior de la normalidad ([upper limit of normal, ULN] o haptoglobina <límite inferior de la normalidad [lower limit of normal, LLN])
    6. Tener al menos uno de los siguientes criterios de alto riesgo de HSCT-TMA:
    - Persistencia de HSCT-TMA >/=2 semanas después de la modificación de los inhibidores de la calcineurina o del sirólimus O BIEN
    - Tener evidencia de HSCT-TMA de alto riesgo definida como al menos uno de los siguientes hechos:
    Relación proteína/creatinina en muestra de orina puntual >/= 2 mg/mg
    Creatinina sérica >1,5 veces el nivel de creatinina previo al desarrollo de la TMA
    TMA gastrointestinal demostrada por biopsia
    Anomalía neurológica relacionada con la TMA (por ejemplo, confusión, accidente cerebrovascular, accidente isquémico transitorio [transient ischemic attack, AIT] o convulsiones)
    Derrame pericárdico o pleural sin explicación alternativa
    Hipertensión pulmonar sin explicación alternativa
    Enfermedad de injerto contra huésped (graft-versus-host disease, GVHD) de grado III o IV o, en opinión del investigador, riesgo de desarrollar una GVHD de grado III o IV si se modifica la inmunosupresión
    C5b-9 sérica elevada (>244 ng/mL)
    7. Si es sexualmente activo y tiene capacidad para tener hijos, debe aceptar practicar un método anticonceptivo altamente eficaz durante todo el tratamiento con el fármaco del estudio y durante al menos 12 semanas después de la última dosis del fármaco del estudio; dicho método anticonceptivo se define como aquel cuya tasa de fracaso es baja (es decir, menos del 1% al año) cuando se utiliza de forma sistemática y correcta, como los implantes, los inyectables, los anticonceptivos orales combinados, algunos dispositivos intrauterinos, la abstinencia sexual (la abstinencia es aceptable cuando está en consonancia con el estilo de vida preferido y habitual del paciente y se define como la abstinencia completa de las relaciones sexuales, no la abstinencia periódica o el coito interrumpido), o la pareja vasectomizada.
    8. Los pacientes varones deben estar dispuestos a no engendrar hijos durante al menos 12 semanas después de la última dosis de la medicación del estudio.
    E.4Principal exclusion criteria
    1. All treatments for HSCT-TMA are allowed except eculizumab, ravulizumab, and defibrotide within 3 months prior to informed consent, unless failure of therapy can be documented.
    a. Patients may not be on eculizumab, ravulizumab, or defibrotide for any indication at screening.
    2. Have Shiga toxin-producing Escherichia coli haemolytic uraemic syndrome (STEC-HUS). Test results obtained within 28 days prior to informed consent may be used.
    3. Have ADAMTS13 activity < 10%. Test results obtained within 28 days prior to informed consent may be used.
    4. Have a severe, uncontrolled systemic bacterial or fungal infection requiring antimicrobial therapy (prophylactic antimicrobial therapy administered as standard of care is allowed).
    5. Have malignant hypertension (blood pressure [BP] > 99th percentile plus 5 mmHg with bilateral hemorrhages or “cotton-wool” exudates on fundoscopic examination).
    6. Due to conditions other than HSCT-TMA, have a poor prognosis with a life expectancy of less than 3 months in the opinion of the Investigator.
    7. If pregnant or lactating
    8. Have received treatment with an investigational drug or device within 4 weeks of entering study.
    9. Have abnormal liver function tests defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times ULN within 28 days prior to informed consent through prior to the first dose.
    10. Have a positive test by antigen, antibody, or polymerase chain reaction (PCR) for human immunodeficiency virus (HIV); if negative within 28 days prior to informed consent, the test does not need to be repeated.
    11. Patients or their parents or legal guardians are an employee of Omeros, Clinical Research Organization (CRO), an Investigator, a study staff member, or an immediate family member.
    12. Have a known hypersensitivity to any constituent of the product.
    13. Presence of any condition that the Investigator believes would put the patient at risk.
    1. Se permiten todos los tratamientos para HSCT-TMA, excepto eculizumab, ravulizumab y defibrotida, en los 3 meses anteriores al consentimiento informado, a menos que se pueda documentar el fracaso del tratamiento.
    a.En la selección, los pacientes no podrán estar recibiendo eculizumab, ravulizumab o defibrotida por ninguna indicación.
    2. Tener síndrome urémico hemolítico por Escherichia coli productora de la toxina de Shiga (Shiga toxin-producing Escherichia coli haemolytic uraemic syndrome, STEC-HUS). Podrán utilizarse los resultados de pruebas efectuadas en el plazo de los 28 días anteriores al consentimiento informado.
    3. Tener actividad de ADAMTS13 <10%. Podrán utilizarse los resultados de pruebas efectuadas en el plazo de los 28 días anteriores al consentimiento informado
    4. Tener una infección bacteriana o fúngica sistémica grave y no controlada que requiera tratamiento antimicrobiano (se permite el tratamiento antimicrobiano profiláctico administrado como tratamiento habitual).
    5. Tener hipertensión maligna (presión arterial [blood pressure, BP] > percentil del 99% más 5 mm Hg con hemorragias bilaterales o exudados “algodonosos” en el examen fundoscópico).
    6. Debido a enfermedades distintas a la HSCT-TMA, tener un mal pronóstico con una esperanza de vida inferior a 3 meses en opinión del investigador.
    7. Estar embarazada o en período de lactancia.
    8. Haber recibido tratamiento con un fármaco o dispositivo en investigación en las 4 semanas anteriores a la entrada en el estudio.
    9. Tener pruebas de función hepática anormales, definidas como alanina aminotransferasa (alanine aminotransferase, ALT) o aspartato aminotransferasa (aspartate aminotransferase, AST) >5 veces el ULN, en el plazo de los 28 días anteriores al consentimiento informado o antes de la primera dosis.
    10. Tener una prueba positiva por antígeno, anticuerpo o reacción en cadena de la polimerasa (polymerase chain reaction, PCR) para el virus de la inmunodeficiencia humana (human immunodeficiency virus, VIH); no será necesario repetirla en caso de negatividad en el plazo de los 28 días anteriores al consentimiento informado.
    11. Ser (el paciente o sus padres o tutores legales) empleado de Omeros, Organización de Investigación Clínica (Clinical Research Organization, CRO), un investigador, un miembro del personal del estudio o un familiar directo.
    12. Tener hipersensibilidad conocida a cualquier componente del producto.
    13. Presencia de cualquier enfermedad que el investigador considere que podría poner en riesgo al paciente.
    E.5 End points
    E.5.1Primary end point(s)
    100-day survival rate from date of HSCT-TMA diagnosis
    Tasa de supervivencia a 100 días desde la fecha del diagnóstico de HSCT-TMA
    E.5.1.1Timepoint(s) of evaluation of this end point
    100 days
    100 días
    E.5.2Secondary end point(s)
    - Survival at 52 weeks and median, mean, and overall survival from date of TMA diagnosis
    - Narsoplimab peak and trough PK and concomitant lectin pathway activation measured by ex vivo assay
    - Safety will be evaluated by adverse events (AEs) and laboratory measures
    - Anti-drug antibody response
    - Responder rate based on clinical response criteria
    - Supervivencia a las 52 semanas y supervivencia mediana, media y global desde la fecha del diagnóstico de TMA
    - PK máxima y mínima de narsoplimab y activación concomitante de la vía de la lectina medida mediante un ensayo ex vivo
    - Seguridad evaluada mediante los acontecimientos adversos (adverse events, AE) y las determinaciones de laboratorio
    - Respuesta de producción de anticuerpos antimedicamento
    - Tasa de respondedores basada en criterios de respuesta clínica
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semanas
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Israel
    United States
    Poland
    Netherlands
    Spain
    Germany
    Italy
    Hungary
    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
    Última visita del último paciente (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 18
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 6
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 6
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Paediatric patients
    Pacientes pediátricos
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9
    F.4.2.2In the whole clinical trial 18
    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)
    Patient has option if needed to go into Compassionate Use study
    El paciente tiene la opción, si fuera necesario, de entrar en el Estudio de Uso Compasivo
    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 Decision2023-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-14
    P. End of Trial
    P.End of Trial StatusOngoing
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