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    Summary
    EudraCT Number:2021-005611-31
    Sponsor's Protocol Code Number:CORT113176-652
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-07
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-005611-31
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients with Amyotrophic Lateral Sclerosis (DAZALS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the safety and efficacy of CORT113176 in Patients with Amyotrophic Lateral Sclerosis
    A.3.2Name or abbreviated title of the trial where available
    DAZALS
    A.4.1Sponsor's protocol code numberCORT113176-652
    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 SponsorCorcept Therapeutics Incorporated
    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 supportCorcept Therapeutics Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCorcept Therapeutics Incorporated
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address149 Commonwealth drive
    B.5.3.2Town/ cityMenlo Park, California
    B.5.3.3Post code94025
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16503273270
    B.5.6E-mailstudy652@corcept.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 nameDazucorilant
    D.3.2Product code CORT113176
    D.3.4Pharmaceutical form Capsule, soft
    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 INNDazucorilant
    D.3.9.1CAS number 1496508-34-9
    D.3.9.2Current sponsor codeCORT113176
    D.3.9.4EV Substance CodeSUB224041
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Amyotrophic Lateral Sclerosis
    E.1.1.1Medical condition in easily understood language
    Amyotrophic Lateral Sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.2System Organ Class 10029205 - Nervous 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
    • To assess the efficacy of dazucorilant in patients with ALS.
    • To assess the safety of dazucorilant in patients with ALS.
    E.2.2Secondary objectives of the trial
    To assess the effect of the dazucorilant on:
    • Muscle strength.
    • Scales assessing Quality of Life and function.
    • Time to event for patients experiencing:
    − Hospitalization due to ALS-related event or condition
    − Full time or nearly full-time respiratory support
    − Undergoing a tracheostomy procedure
    − Death.
    • Combined Assessment of Function and Survival (CAFS).
    • To assess the PK of dazucorilant in patients with ALS.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There will be an optional PK sub-study, included in the main protocol.
    Plasma samples for pharmacokinetic (PK) analysis will be obtained in a dedicated PK substudy in a subset (~20%) of patients at the Week 3 visit. The AUC and Cmax will be reported.
    E.3Principal inclusion criteria
    1. Male and female patients ≥18 years of age with ALS as defined by Gold Coast Criteria.
    2. Patients with sporadic or familial ALS with a risk of ALS progression characterized by an ENCALS risk profile score ≥ -6 and ≤ -3.
    3. Regulatory-authority-approved therapies for the treatment of ALS are permitted. If taking riluzole and/or edaravone, and/or sodium phenylbutryte and taurursodial, must have been on a stable dose of riluzole for ≥30 days and/or edaravone for ≥60 days and/or sodium phenylbutyrate and taurursodial maintenance dosage ≥30 days prior to Screening.
    4. Medically able to undergo the study procedures and to adhere to the visit schedule at the time of study entry, as determined by the Investigator.
    5. Able to understand the purpose and risks of the study; willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study evaluations and procedures.
    6. Provide written informed consent for participation in the study.
    7. Male patients and female patients of childbearing potential must agree to use a protocol-specified method of contraception from screening and during the study until 28 days after last dose of study drug.
    E.4Principal exclusion criteria
    1. History of a clinically significant non-ALS neurologic disorder, including, but not limited to, muscular dystrophy, spinal stenosis, peripheral neuropathy, inherited neuropathies, Alzheimer’s disease, cervical spondylosis, Parkinson’s disease, Lewy body dementia, vascular dementia, Huntington’s disease, epilepsy, stroke, multiple sclerosis, multifocal motor neuropathy, diabetic neuropathy, brain tumor, or brain infection/abscess.
    2. Inability to swallow capsules.
    3. Blood platelet count <150,000/mm3.
    4. Renal impairment indicated by eGFR ≤30 mL/min/1.73m2.
    5. Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus including patients with chronic or active hepatitis B as diagnosed by serologic tests.
    6. Women who are pregnant, planning to become pregnant, or are breastfeeding. Women of childbearing potential who are unwilling or unable to use highly effective method of contraception from screening through the duration of treatment and up to 28 days after last dose of study drug.
    7. Known liver impairment (Child-Pugh Class A, B, or C).
    8. History of Class III/IV heart failure (per New York Heart Association).
    9. At the time of Screening, any use of non-invasive ventilation (NIV), e.g., continuous positive airway pressure [CPAP], noninvasive bi-level positive airway pressure [NPPV] or noninvasive volume ventilation [NVV] for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.
    10. Any form of cancer within the 5 years before first dose in this study (with the exception of basal cell and/or squamous cell cancer of the skin that has been treated completely and is without evidence of local recurrence or metastasis).
    11. History of any other clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal (GI), bleeding, autoimmune, neurological, psychiatric disorder, or unstable medical condition (other than ALS), as judged by the Investigator.
    12. History and/or symptoms of adrenal insufficiency.
    13. Abnormal liver function defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 × upper limit of normal (ULN).
    14. QTcF interval based on the mean of 2 ECGs of >450 ms, for men and >470 ms for women.
    15. History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long-QT syndrome).
    16. Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -1 or within 8 weeks prior to Screening.
    17. Ongoing use of any strong CYP3A4 inhibitor/inducer or any medication with a narrow therapeutic index that is predominantly metabolized by CYP2C8.
    18. Taking, or have taken, any strong CYP3A inducer within 30 days (or 5 half-lives if longer) before Screening, or any strong CYP3A inhibitor within 14 days before Screening.
    19. Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system (DPS) during the study period.
    20. Received any live or attenuated vaccine within 30 days, before the first dose of study drug. Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and the Corcept Medical Monitor.
    21. Currently using glucocorticoids or have a history of regular systemic glucocorticoid use at any dose within the last 12 months or 3 months for inhaled products before first dose of study drug. (Patients who have stopped glucocorticoid use should have an alternative option if their condition deteriorates during the study.)
    22. Participation in a clinical trial for ALS involving small molecules within 30 days of the Screening, or treatment with another investigational drug (including through compassionate use programs), biological agent, or device within 30 days or 5 half-lives of study agent, whichever is longer. No prior treatment with small interfering RNA, stem cell therapy, or gene therapy is allowed at any time in the patient’s history.
    23. Unstable or poorly controlled comorbid disease process of any organ system currently requiring active treatment or likely to require treatment adjustment during the study.
    24. Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.
    25. History of hypersensitivity or severe reaction to the study drug’s excipients.
    26. In the Investigator’s opinion, should not participate in the study or may not be capable of providing informed consent or following the study schedule. This includes, but is not limited to, presence of unstable psychiatric disease, cognitive impairment, dementia, or substance abuse within 2 years prior to Screening.
    27. Is a family member of one of the Sponsor’s employees, the Investigator, or the site staff working directly on the study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    • Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.
    Primary Safety Endpoint
    • Incidence of AEs, SAEs, treatment-related AEs, AEs by severity, and deaths due to AEs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    Secondary Endpoints
    • Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer).
    • Change from Baseline to Week 24 in:
    − Percent Slow Vital Capacity
    − EQ-5D-5L.
    • Time to death.
    • Time to hospitalization due to ALS-related event or condition.
    • Time to tracheostomy (for respiratory failure or saliva management or both).
    • Time to respiratory support >22 hours per day for 7 days.
    • Combined Assessment of Function and Survival (CAFS).
    • Plasma samples for pharmacokinetic (PK) analysis will be obtained in a dedicated PK substudy in a subset (~20%) of patients at the Week 3 visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    PK end point: Week 3 visit
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA24
    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
    Ireland
    Belgium
    Canada
    France
    Germany
    Israel
    Netherlands
    Poland
    Spain
    United Kingdom
    United States
    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 study is defined as the date of protocol-specified last contact (i.e., visit, telephone, e-mail) with the last patient in the study.

    Justification where it is not last visit:
    • Discovery of an unexpected risk to the patients enrolled in the study that is serious and/or unacceptable.
    • Decision on the part of the Sponsor to suspend or discontinue testing, evaluation, or development of the product
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 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: 133
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 198
    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)
    Once a subject has completed all periods of the study including the long-term follow-up assessments after the double-blind treatment period or the OLE, their doctor will discuss their treatment options with them.
    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 Decision2022-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-07
    P. End of Trial
    P.End of Trial StatusOngoing
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