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    EudraCT Number:2016-004186-83
    Sponsor's Protocol Code Number:RZ358-606
    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:2020-01-09
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-004186-83
    A.3Full title of the trial
    An Open-Label Multiple-Dose Study of RZ358 in Patients with Congenital Hyperinsulinism
    Estudio abierto de dosis múltiples de RZ358 en pacientes con hiperinsulinismo congénito
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A non-blinded study of multiple doses of RZ358, in patients with low blood sugars due to genetic dysfunction resulting in over-secretion of insulin
    Estudio no ciego de múltiples dosis de RZ358 en pacientes con bajos niveles de glucosa debido a un mal funcionamiento congénito que resulta en la producción de insulina en exceso.
    A.4.1Sponsor's protocol code numberRZ358-606
    A.5.4Other Identifiers
    Name:IND NumberNumber:119319
    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 SponsorRezolute, 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 supportRezolute, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRezolute, Inc
    B.5.2Functional name of contact pointClinical Trials Info
    B.5.3 Address:
    B.5.3.1Street Address201 Redwood Shores Parkway, Suite 315
    B.5.3.2Town/ cityRedwood City
    B.5.3.3Post codeCA 94065
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650206-4507
    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 numberEMA/OD/040/16
    D.3 Description of the IMP
    D.3.2Product code RZ358
    D.3.4Pharmaceutical form Concentrate for 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 INNNot Available
    D.3.9.2Current sponsor codeRZ358
    D.3.9.3Other descriptive namefully human IgG2 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Hypoglycemia associated with congenital hyperinsulinism
    Hipoglucemia asociada a hiperinsulinismo congénito
    E.1.1.1Medical condition in easily understood language
    Low blood glucose levels associated with abnormally high level of insulin due to a specific birth defect
    Bajos niveles de glucosa debido a niveles altos de insulina causados por un defecto de nacimiento.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10077227
    E.1.2Term Hyperinsulinemic hypoglycemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020644
    E.1.2Term Hyperinsulinism NOS
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061211
    E.1.2Term Hyperinsulinism
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10022484
    E.1.2Term Insulin hypoglycaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and glycemic efficacy of multiple ascending doses of RZ358 administered for 8 weeks in patients with hyperinsulinemic hypoglycemia due to congenital hyperinsulinism (CHI).
    Los objetivos de este estudio son evaluar la seguridad, tolerabilidad, farmacocinética (FC), farmacodinámica (FD) y eficacia glucémica de dosis múltiples ascendentes de RZ358 administradas durante 8 semanas en pacientes con hipoglucemia hiperinsulínica debido al hiperinsulinismo congénito (HIC).
    E.2.2Secondary objectives of the trial
    not applicable
    no aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent and, as applicable, assent, before any study specific procedures are performed
    2. At Screening, aged ≥ 2 years and ≤ 45 years
    3. An established clinical diagnosis, with or without a genetic diagnosis, of congenital hyperinsulinism
    4. Patient is currently receiving SOC medications (i.e corticosteroids, diazoxide, lanreotide, sirolimus, and octreotide) and/or nutritional supplementation for CHI, with at least 2 months of stable treatment; OR is not on treatment, at the time of Screening.
    5. Glucose values <70 mg/dL (3.9 mmol/L) for ≥ 8% of the overall monitored time and for ≥ 60 min per day on at least 5 of the 10 days of a 10-day Screening CGM evaluation
    6. Hepatic ultrasound at Screening without clinically significant findings, gallstones or evidence of peliosis hepatitis
    7. For female patients of childbearing potential, a negative serum or urine pregnancy test within 7 days before dosing Females of childbearing potential are defined as fertile following menarche and until becoming postmenopausal or permanently sterile. Note: Postmenopausal is defined as absence of vaginal bleeding or spotting for at least 1 year. Permanently sterile is defined as having had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
    8. For female patients of childbearing potential, a willingness to use highly effective* contraceptive measures adequate to prevent a new pregnancy for the duration of the study, including for at least 105 days after receiving the last dose of study drug. For women with reproductive potential who use a hormonal method of contraception, concurrent use of a second (barrier) method is recommended. (*Highly effective methods of birth control are defined as those that result in a low failure rate [ie, less than 1% per year] when used consistently and correctly [eg, implants, injectables, oral contraceptives, some intrauterine devices, bilateral tubal occlusion, true sexual abstinence in line with the preferred and usual lifestyle of the patient, or vasectomized partner.])
    9. For sexually active males, a willingness to use highly effective* contraceptive measures, e.g. a condom, for the duration of the study, including for at least 105 days after receiving the last dose of study drug. In addition, males must agree not to donate sperm over the same study period.
    1. Proporcionar el consentimiento informado por escrito y, según corresponda, el asentimiento, antes de realizar cualquier procedimiento específico del estudio.
    2. En la selección, tener ≥ 2 años y ≤ 45 años.
    3. Un diagnóstico clínico establecido, con o sin diagnóstico genético, de hiperinsulinismo congénito.
    4. El paciente está recibiendo actualmente medicamentos de la SOC (p. ej., diazóxido, lanreótida, sirolimus, pasireotida u octreótida) y/o suplementos nutricionales para HIC, con al menos 2 meses de tratamiento estable; O no está en tratamiento, en el momento de la selección.
    5. Valores de glucosa < 70 mg/dl (3,9 mmol/l) durante ≥ 8 % del tiempo total monitorizado y durante ≥ 60 min al día durante al menos 5 de los 10 días de una evaluación de la MCG para la selección.
    6. Ecografía hepática en la selección sin hallazgos clínicamente significativos, cálculos biliares o evidencia de peliosis o hepatitis.
    7. Para las pacientes en edad fértil, una prueba de embarazo en suero u orina negativa en los 7 días anteriores a la dosis:
     Las mujeres en edad fértil se definen como fértiles después de la menarquia y hasta que se vuelvan posmenopáusicas o estériles permanentemente. (La posmenopausia se define como ausencia de hemorragia vaginal o manchas durante al menos 1 año. La esterilidad permanente se define como haber tenido una histerectomía, salpingectomía bilateral u ovariectomía bilateral).
    8. En el caso de las pacientes en edad fértil, la voluntad de utilizar medidas anticonceptivas altamente eficaces* adecuadas para evitar un nuevo embarazo durante el estudio, incluidos al menos 105 días después de recibir la última dosis del fármaco del estudio. Para las mujeres con potencial reproductivo que utilizan un método anticonceptivo hormonal, se recomienda el uso simultáneo de un segundo método (de barrera).
    9. Para hombres sexualmente activos, la voluntad de utilizar medidas anticonceptivas altamente eficaces*, por ejemplo, preservativo, durante el estudio, incluidos al menos 105 días después de recibir la última dosis del fármaco del estudio. Además, los hombres deben aceptar no donar esperma durante el mismo periodo del estudio.
    *Los métodos anticonceptivos altamente eficaces se definen como aquellos que tienen una tasa baja de fracaso (es decir, menos del 1 % al año) cuando se utilizan de forma uniforme y correcta (p. ej., implantes, inyectables, anticonceptivos orales, algunos dispositivos intrauterinos, oclusión tubárica bilateral, abstinencia sexual real en consonancia con el estilo de vida preferido y habitual del paciente o pareja vasectomizada).
    E.4Principal exclusion criteria
    1. Any out-of-range laboratory value at Screening that has not been reviewed, approved, and documented as not clinically significant by the Investigator, with the exception of liver function tests for total bilirubin, ALT, AST, and ALP, which must be within 1.5X the upper limit of normal (ULN) for the reference range
    2. Body mass index ≥ 35 kg/m2 for patients aged 18 years and above and, for patients aged less than 18 years, BMI ≥ 95% percentile for age
    3. History of malignancy within 3 years before Screening other than carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell carcinoma of the skin
    4. History of seropositivity for HIV antibody, hepatitis B, or hepatitis C antibody
    5. Major general surgery within 3 months before Screening or anticipated during the study period
    6. Use of systemic corticosteroids within 30 days before Screening
    7. Known allergy or sensitivity to RZ358 or any component of the study drug
    8. Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug before Day 1 of Week 1, whichever is longer. Participation in registries and purely diagnostic studies is allowed.
    9. Female patients who are pregnant, planning to become pregnant during the course of the study, have recently delivered (within 3 months before Screening), or are breastfeeding
    10. Male patients who are planning a pregnancy with a female partner during the course of the study or within 105 days after administration of study drug
    11. Any organ condition, concomitant disease (eg, psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which, could interfere with the conduct of the study (eg, may affect absorption, distribution, metabolism, or elimination of the study drug) or that, in the opinion of the Investigator and/or Sponsor´s medical monitor, would pose an unacceptable risk to the patient in the study.
    1. Cualquier valor analítico fuera de intervalo en la selección que no haya sido revisado, aprobado y documentado como no clínicamente significativo por el investigador, con la excepción de las pruebas de función hepática para la bilirrubina total, alanina transaminasa (ALT), aspartato transaminasa (AST) y fosfatasa alcalina (ALP), que debe estar dentro de 1,5 veces el límite superior de la normalidad (LSN) para el intervalo de referencia.
    2. Índice de masa corporal (IMC) ≥ 35 kg/m2 para pacientes de 18 años o mayores y para pacientes de menos de 18 años, IMC ≥ 95 % percentil para la edad.
    3. Antecedentes de neoplasia maligna en los 3 años anteriores a la selección, excepto carcinoma in situ del cuello uterino o carcinoma de células basales no metastásico o carcinoma basocelular de la piel tratados adecuadamente.
    4. Antecedentes de seropositividad para anticuerpos contra el VIH, el virus de la hepatitis B o de la hepatitis C.
    5. Cirugía general importante en los 3 meses anteriores a la selección o prevista durante el periodo del estudio.
    6. Uso de corticoesteroides sistémicos en los 30 días anteriores a la selección.
    7. Alergia o sensibilidad conocidas a RZ358 o a cualquier componente del fármaco.
    8. Tratamiento con un fármaco o dispositivo en investigación en un plazo de 30 días o 5 semividas del fármaco en investigación antes del día 1 de la semana 1, lo que sea más largo. Se permite participar en registros y estudios puramente diagnósticos.
    9. Las pacientes que estén embarazadas, que planeen quedarse embarazadas durante el transcurso del estudio, hayan dado a luz recientemente (en los 3 meses anteriores a la selección) o estén en periodo de lactancia.
    10. Pacientes varones que estén planeando un embarazo con una pareja femenina durante el transcurso del estudio o en los 105 días posteriores a la administración del fármaco del estudio.
    11. Cualquier afección orgánica, enfermedad concomitante (p. ej., enfermedad psiquiátrica, alcoholismo grave o abuso de drogas, enfermedad cardíaca, hepática o renal) u otra anomalía que pueda interferir en la realización del estudio (p. ej., puede afectar a la absorción, distribución, metabolismo o eliminación del fármaco del estudio) o que, en opinión del investigador y/o del supervisor médico del promotor, supondría un riesgo inaceptable para el paciente en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    • Glycemic efficacy of RZ358 as evaluated by the average daily percent time within a glucose target range of 70-180 mg/dL (3.9-10 mmol/L) by continuous glucose monitoring (CGM);
    • Repeat-dose safety and tolerability of RZ358 administered for a total of 8 weeks;
    • Repeat-dose pharmacokinetics of RZ358.
    • Eficacia glucémica de RZ358 evaluada por el porcentaje medio diario de tiempo dentro de un intervalo objetivo de glucosa de 70-180 mg/dl (3,9-10 mmol/l) mediante monitorización continua de la glucosa (MCG);
    • Seguridad y tolerabilidad de dosis repetidas de RZ358 administradas durante un total de 8 semanas;
    • Farmacocinética de dosis repetidas de RZ358.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured at various timepoints (see schedule of events)
    Medidos en distintos momentos (ver el esquema de visitas y procedimientos)
    E.5.2Secondary end point(s)
    • Average daily duration and percent time with hypoglycemia at thresholds of:
    < 70 mg/dL (3.9 mmol/L)
    < 60 mg/dL (3.3 mmol/L)
    < 50 mg/dL (2.8 mmol/L)
    by CGM

    • Average daily hypoglycemia incidence (event rate) at each of the specified glucose thresholds by CGM;
    • Average 8h overnight percent time in glucose target range of 70-180 mg/dL (3.9-10 mmol/L) by CGM;
    • Occurrence of hypoglycemia during a 12h overnight fasting challenge
    • Duración media diaria (min) y porcentaje de tiempo con hipoglucemia a umbrales de < 70, < 60 y < 50 mg/dl (3,9, 3,3 y 2,8 mmol/l, respectivamente) según MCG;
    • incidencia media diaria de hipoglucemia (tasa de acontecimientos) en cada uno de los umbrales de glucosa especificados por MCG;
    • media de porcentaje de tiempo de 8 horas de la noche en el intervalo objetivo de glucosa de 70-180 mg/dl (3,9-10 mmol/l) según MCG;
    • aparición de hipoglucemia durante un estímulo nocturno de ayuno de 12 horas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measured at various timepoints (see schedule of events)
    Medidos en distintos momentos (ver el esquema de visitas y procedimientos)
    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 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. 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    United Kingdom
    United States
    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
    Ultima visita del ultimo paciente
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 30
    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) Yes
    F. of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2
    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 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 Yes
    F. of subjects incapable of giving consent
    Minors will be included in this study. They will be given age appropriate information sheets and assent will be collected alongside parental/legal guardian consent where appropriate.
    Menores serán incluidos en este estudio. Se les proporcionará apropiada información y el asentimiento será recogido con el consentimiento de los padres o representante legal cuando sea apropiado.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 32
    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 completion of the study, the Investigator is responsible for ensuring that consideration has been given to the patient´s post-study care. At the conclusion of the study, patients should be treated with SOC, as appropriate.
    Después de completar el estudio, el Investigador es responsable de asegurar que se ha evaluado el tratamiento del paciente después del estudio. En el momento de término del estudio, los pacientes deberían ser tratados según práctica habitual, como fuese apropiado.
    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 Decision2019-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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