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    Summary
    EudraCT Number:2022-000748-32
    Sponsor's Protocol Code Number:SPI-62-CL-2002
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-10-22
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2022-000748-32
    A.3Full title of the trial
    SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
    A.4.1Sponsor's protocol code numberSPI-62-CL-2002
    A.5.4Other Identifiers
    Name:IND NumberNumber:155268
    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 SponsorSparrow Pharmaceuticals, 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 supportSparrow Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSparrow Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointFrank Czerwiec
    B.5.3 Address:
    B.5.3.1Street Address920 SW 6th Avenue, Suite 1200
    B.5.3.2Town/ cityPortland, Oregon
    B.5.3.3Post code97204
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1301-580-5954
    B.5.6E-mailinfo@sparrowpharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSPI-62
    D.3.2Product code SPI-62
    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 INNNot applicable
    D.3.9.1CAS number 1204178-50-6
    D.3.9.2Current sponsor codeSPI-62
    D.3.9.3Other descriptive nameSPI-62
    D.3.9.4EV Substance CodeSUB263389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    D.3.11.13.1Other medicinal product typeSPI-62 is a novel, potent, and selective inhibitor of 11β-hydroxysteroid dehydrogenase type 1 (HSD-1), an intracellular enzyme that converts inactive cortisone to active cortisol.
    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
    Hypercortisolism Related to a Benign Adrenal Tumor
    E.1.1.1Medical condition in easily understood language
    Hypercortisolism Related to a Benign Adrenal Tumor
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10020611
    E.1.2Term Hypercortisolism
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is:
    • to study the benefit-risk of SPI-62 in participants with complications due to endogenous hypercortisolism related to autonomous cortisol secretion (ACS) in participants under current ‘standard of care’.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • to study the efficacy of SPI-62 in reducing morbidity and mortality related to hypercortisolism.
    • short-term progression, persistence, improvement, or resolution of clinical signs, markers, and symptom of hypercortisolism including: hyperglycemia, dyslipidemia, osteopenia, hypertension, and other features associated with endogenous hypercortisolism.
    • long-term safety as it relates to serious morbidity and mortality.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following are the main inclusion criteria:
    1. Adults able to provide informed consent and willing to adhere to necessary reproductive precautions:
    •Reasonably effective contraception or abstinence
    •This excludes those below the local age of majority and those who are incarcerated or otherwise unable to freely provide consent
    2. Participants with benign adrenal lesion(s) with proven ACS:
    •Clinical evidence of ACS confirmed by positive diagnostic tests per current guidelines1, 2
    •This minimally includes a non-suppressed morning serum cortisol > 50 nmol/L (1.8 mcg/dL) after a 1 mg (or greater) overnight dexamethasone suppression test (ONDST) within the last 3 years attributable to otherwise benign ACS. ONDST results between 1.8 and 5 mcg/dL (139 nmol/L) should be repeated at screening to confirm non-suppression unless other testing (see point iii below) supports the diagnosis of ACS.
    •Testing should be confirmed by concurrent dexamethasone level adequate to provide suppression. Individuals using estrogen should meet further criteria accounting for potential increased corticosteroid binding globulin (CBG), e.g., free cortisol ≥ 2.2 nM (80 ng/dL), total serum cortisol ≥ 5 mcg/dL (138 nmol/L), or correction based on CBG measurement.
    •The dates and results of other tests used in confirmation of the diagnosis of ACS (e.g., non-suppressed repeat ONDST, elevated 24-hour UFC or LNSC, low DHEA-S or basal ACTH) must be recorded.
    •These benign adrenal nodule(s) may be either unilateral or bilateral (e.g., including primary macronodular adrenal hyperplasia), and should have characteristics inconsistent with malignancy. Such characteristics may include having an individual diameter ≤ 4 cm, homogenous texture, non-contrast computerized tomography ≤ 20 HU attenuation or washout (or comparable MRI iso-intensity or chemical shift), slow rate of growth, known benign etiology, or other evidence of a non malignant disease process.
    •Participants should have a documentation of a clinical need for intervention for consequences of glucocorticoid toxicity:
    •This includes treatment for, or evidence of ongoing metabolic consequences of ACS e.g., hyperglycemia, hypertension, hyperlipidemia, osteopenia, or other features of hypercortisolism. Such abnormalities should not be considered clinically relevant consequences of hypercortisolism if their onset was demonstrably present > 5 years prior to the evidence for hypercortisolism, or diagnosis of ACS and they do not meet any of the criteria noted in “b” below.
    •Presence of at least one of the following features in comorbidities potentially attributable to hypercortisolism:
    progressive,
    difficult to treat,
    associated with disproportionate end organ damage for age,
    unusual for age or discrepant from family history, or
    multiple comorbidities.
    •Surgery as first-line therapy should be discussed with participants having ACS, particularly those with a unilateral mass, and evidence of more severe glucocorticoid toxicity. The decision to pursue surgery or medical treatment should be based on patient preference and consensus of a multidisciplinary group of surgical, radiology, and endocrinology experts.

    3. Participants should have a documentation of a clinical need for intervention for consequences of glucocorticoid toxicity:
    •This includes treatment for, or evidence of ongoing metabolic consequences of ACS e.g., hyperglycemia, hypertension, hyperlipidemia, osteopenia, or other features of hypercortisolism. Such abnormalities should not be considered clinically relevant consequences of hypercortisolism if their onset was demonstrably present > 5 years prior to the evidence for hypercortisolism, or diagnosis of ACS and they do not meet any of the criteria noted in “b” below.
    •Presence of at least one of the following features in comorbidities potentially attributable to hypercortisolism:
    progressive,
    difficult to treat,
    associated with disproportionate end organ damage for age,
    unusual for age or discrepant from family history, or
    multiple comorbidities.
    •Surgery as first-line therapy should be discussed with participants having ACS, particularly those with a unilateral mass, and evidence of more severe glucocorticoid toxicity. The decision to pursue surgery or medical treatment should be based on patient preference and consensus of a multidisciplinary group of surgical, radiology, and endocrinology experts.
    E.4Principal exclusion criteria
    Participants will be excluded from the study if they satisfy any of the following criteria during screening unless otherwise stated:
    1. Participants with adrenal Cushing’s syndrome (aCs), i.e., autonomous cortisol secretion having clear stigmata of Cushing’s syndrome, are excluded.
    2. History of adrenalectomy or planned adrenalectomy within 4 months after enrollment (history of unilateral or incomplete bilateral adrenalectomy occurring before 4 months prior to enrollment is not exclusionary).
    3. Hypercortisolism which is exogenous (iatrogenic or factitious), ACTH-dependent (Cushing’s disease or ectopic), cyclical, intermittent, or physiological (a.k.a. “pseudo-Cushing’s syndrome). Generally, a basal morning ACTH > 20 pg/mL is consistent with ACTH-dependent Cushing’s or pseudo-Cushing’s.
    4. Participants who plan to undergo curative adrenal surgery within the next 3 years.
    5. History of idiopathic thrombocytopenia.
    6. History of cancer within 3 years likely to require further testing or intervention during the trial period or associated with a poor prognosis (e.g., other than treatable skin, thyroid, or early-stage prostate cancer, please consult with Medical Monitor for others).
    7. Any major surgery, or significant post-operative sequelae, within 1 month prior to informed consent or planned during the trial.
    8. Pregnant or lactating.
    9. Other medical contraindications to SPI-62 therapy or other current or prior medical condition (including those listed in Section 4.3.2) or medication (as listed in Section 6.1 “Concomitant Therapy”) expected to interfere with the conduct of the trial or the evaluation of its results.
    a. Serious hypersensitivity to SPI-62 or its excipients
    b. Moderately or severely impaired renal function (estimated glomerular filtration rate < 60 mL/min/1.73m2)
    c. Uncontrolled, clinically significant hypo- or hyperthyroidism (abnormal TSH values are acceptable as long as the free T4 values are within 0.75-fold of the lower to 1.25-fold of the upper limits of the normal range)
    d. Hepatic disease including moderate or severe hepatic impairment (e.g., Child Pugh Class B or C; baseline elevations of liver transaminases [alanine aminotransferase and/or aspartate aminotransferase)] > 3 x ULN; or baseline elevations of total bilirubin > 1.5 x ULN [except in benign conditions, e.g., Gilbert’s syndrome])
    e. Participants without hepatic impairment, but evidence of inadequately treated hepatitis B (HBsAg positive) or C (hepatitis C antibody positive unless viral load adequately suppressed).
    f. Baseline prolonged QT interval (defined as QTc > 500 msec or uncorrected QT > 600 msec), poorly controlled hypertension (resting supine blood pressure ≥ 180 mmHg systolic or ≥ 120 mmHg diastolic), or persistent or recurrent atrial fibrillation poorly managed on anticoagulant therapy.
    g. Positive test for SARS-CoV-2 active, transmissible infection within 4 weeks, or hospitalization for SARS-CoV-2 within 6 months, prior to randomization
    10. Participation in any clinical trial within 3 months prior to the first dose of study drug, or longer depending on half-life of the investigational therapy.
    11. Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a sanitary or social institution for purposes other than research and major persons subject to a legal protection measure.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is:
    an evaluation of the benefit-risk profile of SPI-62 consisting of laboratory data, incidence of treatment emergent adverse events (TEAEs), progression, or regression, of underlying disease or its complications
    E.5.1.1Timepoint(s) of evaluation of this end point
    There is no formal statistics planned for this study
    E.5.2Secondary end point(s)
    Efficacy: 1. Dyslipidemia 2. Hyper- and hypo-tension 3. Osteopenia 4. Diabetes or glucose intolerance
    E.5.2.1Timepoint(s) of evaluation of this end point
    There is no formal statistics planned for this study
    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 No
    E.6.7Pharmacodynamic No
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Romania
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of the study is defined as the date of the last visit of the last subject in the study.
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 10
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 30
    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)
    Standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-05
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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