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    Summary
    EudraCT Number:2017-004878-34
    Sponsor's Protocol Code Number:ATR-101-202
    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:2018-05-21
    Trial results View 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 number2017-004878-34
    A.3Full title of the trial
    A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal Hyperplasia
    Ensayo multicéntrico sin enmascaramiento de ajuste de la dosis de hidrocloruro de nevanimibe para el tratamiento de la hiperplasia suprarrenal congénita clásica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal Hyperplasia
    Ensayo multicéntrico sin enmascaramiento de ajuste de la dosis de hidrocloruro de nevanimibe para el tratamiento de la hiperplasia suprarrenal congénita clásica
    A.4.1Sponsor's protocol code numberATR-101-202
    A.5.4Other Identifiers
    Name:US IND NumberNumber:122745
    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 SponsorMillendo Therapeutics US, 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 supportMillendo Therapeutics US, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGCP-Service International Ltd. & Co. KG
    B.5.2Functional name of contact pointDr. Andreas Grund
    B.5.3 Address:
    B.5.3.1Street AddressAnne-Conway-Str. 2
    B.5.3.2Town/ cityBremen
    B.5.3.3Post code28359
    B.5.3.4CountryGermany
    B.5.4Telephone number004942189676611
    B.5.5Fax number00494214348659
    B.5.6E-mailagrund@gcp-service.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/3/13/1128
    D.3 Description of the IMP
    D.3.1Product nameNevanimibe Hydrochloride
    D.3.2Product code ATR-101
    D.3.4Pharmaceutical form 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 INNNevanimibe hydrochloride
    D.3.9.1CAS number 133825-81-7
    D.3.9.2Current sponsor codeATR-101
    D.3.9.3Other descriptive nameCI-984, 17AA70, PD 132301-2
    D.3.9.4EV Substance CodeSUB185323
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500 to 2000
    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
    Classic Congenital Adrenal Hyperplasia
    Hiperplasia suprarrenal congénita clásica
    E.1.1.1Medical condition in easily understood language
    Classic Congenital Adrenal Hyperplasia is a rare disease of the adrenal glands which have the inabiltiy to produce cortisol and mineralocorticoids.
    La hiperplasia suprarrenal congénita clásica es una enfermedad rara de las glándulas suprarrenales que tienen la incapacidad de producir cortisol y mineralocorticoides.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10010323
    E.1.2Term Congenital adrenal hyperplasia
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of orally administered nevanimibe HCl for the treatment of classic CAH
    Evaluar la eficacia y seguridad del hidrocloruro de nevanimibe para el tratamiento de la hiperplasia suprarrenal congénita clásica
    E.2.2Secondary objectives of the trial
    • To assess the changes in adrenal cortical steroids and steroid intermediates
    • To determine the pharmacokinetic (PK) parameters of nevanimibe and its major metabolite(s)
    • To assess the PK/pharmacodynamic (PD) relationships of nevanimibe and its major metabolite(s)
    • Evaluar los cambios en los esteroides suprarrenocorticales y los intermediarios esteroides
    • Determinar los parámetros farmacocinéticos (PK) de nevanimibe y sus metabolitos principales
    • Evaluar las relaciones PK/farmacodinámicas (PD) de nevanimibe y sus metabolitos principales
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women 18 to 80 years of age (inclusive) at the time of informed consent.
    • Documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency based on either or both of the following criteria:
    1.Documented genetic mutation in the CYP21A2 enzyme consistent with a diagnosis of classic CAH
    2.Historical documentation of elevated 17-OHP (e.g., in infancy or following a cosyntropin/ACTH stimulation test)
    • Serum 17-OHP ≥ 4x ULN during the Baseline Period
    - Premenopausal women in the follicular phase of the menstrual cycle must have serum 17 OHP ≥ 4x follicular phase ULN
    - Premenopausal women in the luteal phase of the menstrual cycle must have serum 17 OHP ≥ (4x follicular phase ULN + (luteal phase ULN – follicular phase ULN))
    • Chronic glucocorticoid replacement therapy for at least 6 consecutive months prior to Screening
    • Stable glucocorticoid and mineralocorticoid regimen for at least 4 weeks prior to the Screening (S1), Baseline (B1), and Enrollment (T1) Visits
    • For subjects who undergo maintenance glucocorticoid dose adjustment between Screening and Enrollment, stable serum 17-OHP levels (adjusted as needed for menstrual cycle phase) prior to Enrollment, defined as the most recent 2 values being within 30% of each other (calculated as 100 × (1 – (smaller value/larger value)))
    • Female subjects of childbearing potential must consent to use two medically acceptable methods of contraception, excluding depot progesterone, throughout the study period and for 30 days after the last dose of study treatment during any sexual intercourse with a fertile male partner
    1. Entregar un consentimiento informado firmado antes de iniciar cualquier procedimiento relacionado con el ensayo
    2. Hombres y mujeres mayores entre 18 y 80 años de edad (incluidos) en el momento del consentimiento informado
    3. Diagnóstico histórico documentado de HSC clásica debida a deficiencia de 21-hidroxilasa basada en uno o los criterios siguientes:
    • Mutación genética documentada en la enzima CYP21A2 que consista en un diagnóstico de HSC clásica
    • Documentación histórica de niveles elevados de 17-OHP (ej. en la infancia o después de una prueba de estimulación de la tetracosactida/ACTH)
    4. Nivel de 17-OHP ≤ 4x LSN durante el periodo basal
    • Las mujeres premenopáusicas en fase folicular del ciclo menstrual deben tener un nivel de 17-OHP ≤ 4x en fase folicular LSN
    • Las mujeres premenopáusicas en fase luteínica del ciclo menstrual deben tener un nivel de 17-OHP ≤
    (4x fase folicular LSN + (fase luteínica LSN – fase folicular LSN))
    5. Tratamiento crónico de sustitución de glucocorticoides durante al menos 6 meses consecutivos antes de la Selección
    6. Tratamiento con glucocorticoides y mineralocorticoides durante al menos 4 semanas antes de las visitas de selección (S1), basal (B1) y de inclusión (T1)
    7. Para sujetos a los que se les ajuste la dosis de mantenimiento de glucocorticoides entre la selección y la inclusión, niveles estables de 17-OHP en suero (ajustados según necesidad para la fase de ciclo menstrual) antes de la inclusión, definidos como los dos valores más recientes que estén dentro del 30 % entre sí (calculados como 100
    × (1 – (valor menor/valor mayor)))
    8. Las mujeres en edad fértil deben dar su consentimiento para usar dos métodos anticonceptivos médicamente aceptables, que excluyen la progesterona de liberación lenta, a lo largo del periodo del ensayo y durante 30 días después de la última dosis de tratamiento del ensayo durante cualquier relación sexual con una pareja masculina fértil
    E.4Principal exclusion criteria
    • Nonclassic CAH
    • Other causes of adrenal insufficiency such as Addison’s disease or adrenalectomy, or classic CAH with serum 17-OHP < 4x ULN and daily maintenance glucocorticoid dose in the adrenal insufficiency range (e.g., ≤ 8-10 mg hydrocortisone/m2 body surface area per day)
    • Surgery within the previous three months prior to screening or planned surgery during study participation. Minor procedures are permitted (e.g., removal of skin tags or other minor dermatological procedures)
    • History of active cancer requiring medical or surgical therapy within the past 6 months (with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix)
    • Female subjects must not be currently pregnant or breastfeeding or have conceived or given birth within 3 months of Screening
    • Abnormal laboratory tests at Screening:
    1. ALT or AST > 2x ULN
    2. Bilirubin > 1.5x ULN
    3. Serum creatinine > 1.5x ULN
    • Positive screen for HIV, hepatitis B surface antigen or hepatitis C antibody at Screening
    • An average QTcF value of > 470 msec at Screening
    • Current or ongoing use of any prohibited concomitant medications (Section 5.8)
    • History of substance abuse within the past 1 year prior to informed consent
    • Positive toxicology screening test for substances of abuse, other than marijuana
    • Known allergy to nevanimibe HCl (formerly known as ATR-101)
    • Participation in any study of an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening
    • Any other medical or psychiatric condition that, in the opinion of the Investigator, is likely to confound the interpretation of the study results or prevent the subject from understanding the requirements of or successfully completing the study (e.g., myocardial infarction (MI) or cerebrovascular accident/transient ischemic attack (CVA/TIA) within the past 6 months)
    1. HSC no clásica
    2. Otras causas de insuficiencia suprarrenal como la enfermedad de Addison;.o adrenalectomía; o CAH clásico con un valor serico de 17-OHP <4x ULN y mantenimiento diario de
    dosis de glucocorticoides en el rango de insuficiencia suprarrenal (p. ej.,< 8-10 mg de hidrocortisona / m2 área de superficie coporal por día)
    3. Cirugía en los tres meses anteriores a la selección o cirugía programada durante la participación en el estudio. Se permiten intervenciones menores (ej. extirpación de papilomas cutáneos u otras intervenciones dermatológicas menores)
    4. Historial de cáncer activo que haya requerido terapia médica o quirúrgica en los últimos 6 meses (con la excepción de carcinoma no metastásico de células basales o células escamosas o carcinoma cervical in situ tratados con éxito)
    5. Las mujeres no deben estar embarazadas ni en periodo de lactancia ni haberse quedado embarazadas o dado a luz en los 3 meses anteriores a la selección
    6. Análisis anormales en el momento de la selección:
    • ALT o AST > 2x LSN
    • Bilirrubina > 1.5x LSN
    • Creatinina en suero > 1.5x LSN
    7. Positivo en HIV, antígeno de superficie de la hepatitis B o anticuerpos de hepatitis C en el momento de la selección
    8. Un valor medio QTcF de > 470 milisegundos en el momento de la selección
    9. Consumo actual o continuado de cualquier medicación concomitante prohibida (Sección 5.8)
    10. Historial de abuso de sustancias en el último año antes del consentimiento informado
    11. Positivo en análisis toxicológico para sustancias de abuso que no sean marihuana
    12. Alergia conocida al HCl de nevanimibe (antes conocido como ATR-101)
    13. Participación en cualquier ensayo de fármaco en pruebas en los 30 días (o 5 medias vidas del fármaco del ensayo, lo que sea más largo) antes de la selección
    14. Cualquier otro trastorno médico o psiquiátrico que, en opinión del investigador, pueda interferir en la interpretación de los resultados del ensayo o impida que el sujeto entienda los requisitos del ensayo o que pueda finalizarlo con éxito (ej. infarto de miocardio (IM) o
    accidente cerebrovascular/accidente isquémico transitorio (ACV/AIT) en los últimos 6 meses)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the overall response rate within each cohort, defined as the percentage of subjects achieving serum 17-OHP targets as follows:
    • Men and postmenopausal women: 17-OHP ≤ 2x ULN
    • Premenopausal women:
    - Follicular phase: 17-OHP ≤ 2x follicular phase ULN
    - Luteal phase: 17-OHP ≤ (2x follicular phase ULN + (luteal phase ULN – follicular phase ULN))
    El criterio principal de valoración de la eficacia es el índice de respuesta global dentro de cada cohorte, definido como el porcentaje de sujetos que alcanzan los objetivos de 17-OHP en suero de la siguiente manera:
    • Hombres y mujeres postmenopáusicas: 17-OHP ≤ 2x LSN
    • Mujeres premenopáusicas:
    - Fase folicular: 17-OHP ≤ 2x fase folicular LSN
    - Fase luteínica: 17-OHP ≤ (2x fase folicular LSN + (fase luteínica LSN – fase folicular LSN))
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation of the primary end Point: T2, T3, T4, T5
    Punto de tiempo de evaluación del extremo primario Punto: T2, T3, T4, T5
    E.5.2Secondary end point(s)
    Safety Endpoints: Safety endpoints include the incidence of treatment-emergent AEs and SAEs, as well as the values and changes from baseline in clinical laboratory tests, vital signs, PEs and ECG parameters. There are no prespecified targets for the safety endpoints.

    The PK and PD endpoints include the following:
    •The Cmax, Tmax, AUC0-4 and other PK parameters of nevanimibe and its major metabolite(s) (as appropriate and as the data allow)
    •The relationship between the Cmax and AUC0-4 of nevanimibe and its major metabolite(s) in relation to the change in 17-OHP levels (as appropriate and as the data allow)
    Additional PK and PD endpoints may be described in the SAP.
    Criterios de valoración de seguridad: Los criterios de valoración de seguridad incluyen la aparición de acontecimientos adversos (AA) durante el tratamiento y acontecimientos adversos serios (AAS), además de valores y cambios en los valores basales en datos de análisis clínico, signos vitales, exploraciones físicas y parámetros de electrocardiograma (ECG).
    Criterios de valoración farmacocinéticos:
    Entre los criterios de valoración PK y PD se encuentran los siguientes; pueden describirse más criterios de valoración PK y PD en el PAE.
    • El Cmax, Tmax, AUC0-4, y otros parámetros PK de nevanimibe y su principal metabolito (de forma adecuada y tal como permiten los datos)
    • La relación entre el Cmax y AUC0-4 de nevanimibe y su principal metabolito en relación con el cambio en niveles de 17-OHP (de forma adecuada y tal como permiten los datos)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation of the safety end Point: every 4 weeks during study participation

    Timepoint of evaluation of the PK and PD end Point: T1, T2, T3, T4, T5
    Tiempo de evaluación del punto extremo de seguridad: cada 4 semanas durante la participación en el estudio

    Punto de tiempo de evaluación del punto extremo PK y PD: T1, T2, T3, T4, T5
    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 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.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 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
    Brazil
    Israel
    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
    Last Patient last visit = October 2019
    Ultima visita del último paciente = Octubre 2019
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 24
    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
    Ninguno
    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 Decision2018-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-06-23
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