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    Summary
    EudraCT Number:2017-004878-34
    Sponsor's Protocol Code Number:ATR-101-202
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-04-24
    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 ConcernedFrance - ANSM
    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
    Une étude ouverte multicentrique avec titrage de la posologie du chlorhydrate de nevanimibe dans le traitement de l’hyperplasie congénitale des surrénales classique
    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
    Une étude ouverte multicentrique avec titrage de la posologie du chlorhydrate de nevanimibe dans le traitement de l’hyperplasie congénitale des surrénales classique
    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, 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 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1000-2000
    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
    L’hyperplasie congénitale des surrénales classique
    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.

    L'hyperplasie congénitale des glandes surrénales est un trouble extrêmement rare de la glande surrénale, dans laquelle la production de cortisone et de Mineralkortikoide est perturbée.
    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
    Évaluer l'innocuité et l’efficacité du chlorhydrate de nevanimibe administré par voie orale dans le traitement de l'hyperplasie congénitale des surrénales classique
    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)
    • Évaluer les variations des corticostéroïdes surrénaux et des intermédiaires stéroïdiens
    • Déterminer les paramètres pharmacocinétiques (PK) du nevanimibe et de son principal/ses principaux métabolite(s)
    • Évaluer les relations entre la pharmacocinétique (PK) et la pharmacodynamique (PD) du nevanimibe et de son principal/ses principaux métabolite(s)
    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
    1. Premenopausal women in the follicular phase of the menstrual cycle must have serum 17 OHP ≥ 4x follicular phase ULN
    2. 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
    • Hommes et femmes âgés de 18 à 80 ans (inclus) au moment du consentement éclairé
    • Diagnostic historique documenté d’HCS classique due à un déficit en 21-hydroxylase, basé sur un ou deux des critères suivants :
    1. Mutation génétique documentée de l’enzyme CYP21A2, compatible avec un diagnostic d’HCS classique
    2. Observation historique documentée de 17-OHP élevée (par exemple, dans l’enfance ou suite à un test de cosyntropine/ACTH)
    • 17-OHP sérique ≥ 4 x LSN au cours de la période de référence
    1. Durant la phase folliculaire du cycle menstruel, les femmes pré-ménopausées doivent avoir une 17-OHP sérique ≥ 4 x à la phase folliculaire LSN
    2. Durant la phase lutéale du cycle menstruel, les femmes pré-ménopausées doivent avoir une 17-OHP sérique ≥ (4 x phase folliculaire LSN + (phase lutéale LSN – phase folliculaire LSN))
    • Thérapie de substitution glucocorticoïde chronique pendant au moins 6 mois consécutifs avant la sélection
    • Prise de glucocorticoïdes et minéralocorticoïdes stable pendant au moins 4 semaines avant les visites de sélection (S1), de référence (B1) et de recrutement (T1)
    • Pour les sujets qui subissent un ajustement de la dose d’entretien de glucocorticoïdes entre la sélection et le recrutement, des taux sériques stables de 17-OHP (ajustés selon les besoins à la phase du cycle menstruel) avant le recrutement, définis comme les 2 valeurs les plus récentes ayant un écart de 30 % (calculé comme 100 × (1 - (valeur la plus petite/valeur la plus grande)))
    • Les sujets féminins en âge de procréer doivent consentir à utiliser deux méthodes de contraception médicalement acceptables, à l’exclusion de la médroxyprogestérone, pendant toute la durée de l’étude et pendant 30 jours suivant la dernière dose du traitement de l’étude au cours des rapports sexuels avec un partenaire masculin fertile
    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)
    • Forme non classique d’HCS
    • Autres causes d’insuffisance surrénalienne telles que la maladie d’Addison, une surrénalectomie ou une HSC classique avec sérum 17-OHP < 4x LSN et dose d’entretien quotidien de glucocorticoïdes dans l’ordre de grandeur d´une insuffisance surrénale (p.ex. 8-10 mg de hydrocortisone/m2 superficie du corps par jour).
    • Une intervention chirurgicale au cours des trois mois précédents la sélection ou une intervention chirurgicale prévue pendant la participation à l’étude. Les interventions mineures sont autorisées (par exemple, l’ablation d’acrochordons ou d’autres procédures dermatologiques mineures)
    • Des antécédents de cancer actif ayant nécessité un traitement médical ou chirurgical au cours des 6 derniers mois (à l’exception de carcinomes basocellulaire ou épidermoïde de la peau ou carcinome in situ du col de l’utérus, non métastatiques et traités avec succès)
    • Les sujets féminins ne doivent pas être en cours de grossesse ou allaiter ou avoir conçu ou avoir donné naissance dans les 3 mois suivant la sélection
    • Examens de laboratoire anormaux lors de la sélection :
    1. ALAT ou ASAT > 2 x LSN
    2. Bilirubine > 1,5 x LSN
    3. Créatinine sérique > 1,5 x LSN
    • Dépistage positif du VIH, de l'antigène de surface de l'hépatite B ou de l’anticorps de l'hépatite C, lors de la sélection
    • Une valeur moyenne de QTcF > 470 msec lors de la sélection
    • L'utilisation actuelle ou continue de tout médicament concomitant interdit (article 5.8)
    • Antécédents de toxicomanie au cours des 12 mois précédents le consentement éclairé
    • Test de dépistage toxicologique positif pour des substances donnant lieu à des abus, autres que la marijuana
    • Allergie connue au HCl de nevanimibe (anciennement connu sous le nom ATR-101)
    • La participation à toute étude d'un médicament expérimental dans les 30 jours (ou 5 demi-vies du médicament expérimental, selon la période la plus longue) avant la sélection
    • Toute autre affection médicale ou psychiatrique qui, de l'avis de l'investigateur, est susceptible de fausser l'interprétation des résultats de l'étude ou d’empêcher le sujet de comprendre les exigences de l’étude ou de la mener à bien (par exemple, infarctus du myocarde (IM) ou accident vasculaire cérébral / accident ischémique transitoire (AVC / AIT) au cours des 6 derniers mois)
    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))
    Le critère d’évaluation primaire d'efficacité est le taux de réponse global au sein de chaque cohorte, défini comme le pourcentage de sujets ayant atteint les cibles de 17-OHP sérique comme suit :

    • Hommes et femmes ménopausées : 17-OHP : ≤ 2 x LSN
    • Les femmes pré-ménopausées :
    - Phase folliculaire 17-OHP : ≤ 2 x phase folliculaire LSN
    - Phase lutéale 17-OHP : ≤ (2 x phase folliculaire LSN + (phase lutéale LSN – phase folliculaire LSN))
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation of the primary end Point: T2, T3, T4
    Lorsque le point de terminaison principal est évalué: T2, T3, T4
    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.
    Critères de sécurité:
    Les critères d’évaluation d’innocuité comprennent l'incidence des événements indésirables (EI) et les effets indésirables graves (EIG), liés au traitement, ainsi que les valeurs et les écarts par rapport aux valeurs de référence des examens de laboratoire cliniques, des signes vitaux, des examens physiques et des paramètres d'électrocardiogramme (ECG).

    Critères d’évaluation pharmacocinétiques :
    Les critères d'évaluation pharmacocinétiques et pharmacodynamiques sont les suivants : (des critères d'évaluation pharmacocinétiques et pharmacodynamiques supplémentaires peuvent être décrits dans le plan d’analyse statistique).

    • Les Cmax, Tmax , l'ASC0-4 et les autres paramètres pharmacocinétiques du nevanimibe et de son/ses principal/principaux métabolites (selon le cas et selon les données)
    • La relation entre la Cmax et l'ASC0-4 de nevanimibe et son/ses principal/principaux métabolite(s) par rapport à la variation des niveaux de 17-OHP (selon le cas et selon les données)
    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
    Moment de l'évaluation du point de terminaison de sécurité: toutes les 4 semaines pendant la participation à l'étude.

    Temps d'évaluation des points de terminaison SPK et DP: T1, T2, T3, T4
    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 Yes
    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 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
    Dernière visite du patient = Octobre 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 state18
    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
    Pas
    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 Decision2018-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-18
    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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