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    Summary
    EudraCT Number:2019-002193-31
    Sponsor's Protocol Code Number:CRN00808-05
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-17
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2019-002193-31
    A.3Full title of the trial
    AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CRN00808 IN SUBJECTS WITH ACROMEGALY (ACROBAT ADVANCE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CRN00808 IN SUBJECTS WITH ACROMEGALY (ACROBAT ADVANCE)
    A.4.1Sponsor's protocol code numberCRN00808-05
    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 SponsorCrinetics 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 supportCrinetics Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCrinetics Pharmaceuticals Inc
    B.5.2Functional name of contact pointCrinetics Cinical Trials
    B.5.3 Address:
    B.5.3.1Street Address10222 Barnes Canyon Road, Building #2
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@crinetics.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 nameCRN00808
    D.3.2Product code CRN00808
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeCRN00808
    D.3.9.3Other descriptive nameCRN00808
    D.3.9.4EV Substance CodeSUB194845
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Acromegaly is typically caused by a growth hormone (GH) secreting tumor in the pituitary. Excess GH secretion results in excess secretion of insulin-like growth factor-1 (IGF-1) from the liver, which causes bone overgrowth, organ enlargement, and changes in glucose and lipid metabolism. The symptoms of acromegaly include abnormal growth of hands and feet and changes in shape of the bones that result in alteration of facial features.
    E.1.1.1Medical condition in easily understood language
    Acromegaly is a chronic metabolic disorder in which there is too much growth hormone and the body tissues gradually enlarge.
    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 PT
    E.1.2Classification code 10000599
    E.1.2Term Acromegaly
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study is designed ito evaluate the long-term safety and tolerability of CRN00808 in acromegaly subjects; to evaluate the efficacy of CRN00808 in acromegaly patients.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who have completed Crinetics Phase 2 studies CRN00808-02 or CRN00808-03 within
    12 months prior to Screening or subjects with uncontrolled acromegaly who are not being treated
    with acromegaly medications:
    a. Group 1: Subjects who are not currently enrolled in CRN00808-02 or CRN00808-03, but
    have completed CRN00808-02 or CRN00808-03 within 12 months and now have
    resumed standard acromegaly medications;
    b. Group 2a: Subjects who are completing studies CRN00808-02 or CRN00808-03 and
    have not resumed standard acromegaly medication;
    Group 2b: Subjects who are defined as completers of studies CRN00808-02 or
    CRN00808-03 by receiving a rescue injection of long acting somatostatin agonist during
    the Follow-up Period of the parent studies;
    c. Group 3: Subjects with uncontrolled acromegaly who are not being treated with
    acromegaly medications. These subjects will be recruited de novo at investigative sites.
    These subjects must be medically stable males or females aged 18 to 75 inclusive with at
    least one elevated IGF-1 level documented during the Screening Period. Documentation
    of a pituitary tumor and elevated IGF-1 (e.g., >ULN) should be available to confirm the
    initial diagnosis of acromegaly. Subjects who have had pituitary surgery must have had
    surgery 3 or more months prior to Screening. Use of long acting somatostatin agonists is
    not allowed within 3 months prior to Screening. Use of dopamine agonists, short acting
    somatostatin agonists, or pegvisomant is not allowed within 1 month prior to screening
    2. Subjects with adrenal insufficiency must be on adequate adrenal replacement therapy at the time
    of Screening as determined by the investigator;
    3. If the subject is female, she must be of non-childbearing potential (defined as either surgically
    sterilized [i.e., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy] or at least 1 year
    of amenorrhea) OR must agree to one of the following from Screening until 28 days following the
    last dose of study medication:
    Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable
    method of contraception only when it is in line with the subject’s preferred and usual lifestyle.
    Or
    Consistent and correct use of 1 of the following highly effective contraception methods of birth
    control i.e., intrauterine device (IUD) with a failure rate of <1% per year, tubal sterilization,
    vasectomy in the male partner (provided that the partner is the sole sexual partner and had
    confirmation of surgical success 3 months after procedure). Should female subjects wish to use a
    hormonally-based method; use of a male condom by the female subject’s male partner is required.
    Subjects who utilize a hormonal contraceptive as one of their birth control methods must have
    used the same method for at least 3 months prior to study dosing. Hormonally-based
    contraceptives permitted for use in this protocol are as follows, oral contraceptives (either
    combined or progesterone only), injectable progesterone, implants of levonorgestrel, transdermal
    contraceptive patch, contraceptive vaginal ring.
    4. If the subject is male, the subject must use a condom, or his female partner of childbearing
    potential must use an effective form of contraception as described above, from the beginning of Screening to the last study visit. Male subjects must also agree not to donate sperm for the
    duration of the study and until at least 3 months after the last dose of the study medication;
    5. Subjects must be willing and able to comply with the study procedures as specified in the
    protocol and comply with the study treatment;
    6. Written informed consent provided prior to any study-related procedures.
    E.4Principal exclusion criteria
    Gp 1 & Gp 3 -1st ten are listed and the remaining 12 (22 total) are given in the protocol:
    1. Clinically significant concomitant disease including: CV disease; moderate or severe renal insufficiency,significant liver disease (including cirrhosis) at Screening;
    2. Pituitary radiation treatment at any time (Gp 3) or since completing in study CRN00808-02/03 (Gp 1);
    3. Myocardial infarction, cardiac surgery revascularization ,cerebrovascular accident or stroke, or transient ischemic attack. Syncope or marked presyncope that is unexplained or related to cardiovascular disease within the last 5 years;
    4. Any of: cardiac arrest or long QT syndrome, evidence for a familial sudden death syndrome, hemodynamically significant cardiac valvulopathy, greater than Canadian Cardiovascular Society Class 1 angina pectoris or unstable angina, greater than NY Heart Association Class 1 CHF, ongoing episodes of symptomatic bradycardia, known history of sustained ventricular tachycardia, hemodynamically significant pulmonary arterial hypertension; uncontrolled symptomatic supraventricular tachycardia, uncontrolled atrial fibrillation type 2 second degree, or third degree atrioventricular block;
    5. Based on Holter monitor performed during the Screening Period: Symptomatic bradycardia, type 2 second degree, or third degree atrioventricular block, pause >3 sec, sustained ventricular or supraventricular tachycardia, previously undiagnosed paroxysmal atrial fibrillation, or torsades depointes;
    6. Supine systolic blood pressure >150 mmHg and/or supine diastolic blood pressure >95 mmHg at Screening (if the initial measurement is out of range, may be repeated 2 more times after 15 min and exclusion will be based on the average of the 3 measurements);
    7. Resting (+ 10 minutes) palpated pulse rate <50 bpm or >105 bpm at Screening. If either of these criteria are met, the assessment should be repeated 2 more times and the average should be used to determine the subject's eligibility;
    8. Receiving medications known to cause heart rate slowing (beta-blockers, verapamil, diltiazem, or ivabradine) if resting heart rate is <60 bpm during Screening;
    9. Corrected QT interval by Fredericia formula (QTcF) interval >450 msec (or QTc >480 msec in the presence of a bundle branch block) or PR interval >240 msec at Screening based on a central reading of an average of 3 (ECGs) each separated in time by 1 to 3 minutes after rested supine for 5 minutes;
    10. Medications associated with torsades de pointes within 2 weeks of study medication dosing

    All Subjects:
    1. Clinically significant abnormal findings/medical/lab during the Screening Period, that in the opinion of the investigator, might jeopardize subject safety or ability to complete the study;
    2. Compression of the optic chiasm causing any visual field defect or symptom associated with tumor compression;
    3. Pregnant or lactating;
    4. Known history of (within 12 months), or current alcohol or drug abuse;
    5. Any mental condition which the nature, scope, and possible consequences of the study are not understood, evidence of poor compliance with medical instructions;
    6. Known allergy, hypersensitivity to any of the test materials or related compounds;
    7. Employee or immediate family member of an employee of Crinetics;
    8. Investigational drug (other than CRN00808) in any prior clinical study within 30 days or 5 half-lives (whichever is longer) prior to Screening.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    The primary endpoint is the incidence of treatment-emergent AEs (TEAEs) throughout the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    study duration
    E.5.2Secondary end point(s)
    Secondary endpoints:
    -Change from W16 to W52 in IGF-1 levels;
    -Change from W16 to W52 in growth hormone (GH) levels;
    -Change from baseline to W12 in IGF-1 levels (Group 3 only).
    Exploratory endpoints:
    -Proportion of subjects with the mean of their last 2 consecutive IGF-1 measurements ≤ULN at
    W52;
    -Proportion of subjects with the mean of their last 2 consecutive IGF-1 measurements ≤1.3×ULN
    at W52;
    -Proportion of subjects who achieve serum GH <5.0 ng/mL at W52;
    -Proportion of subjects who achieve serum GH <2.5 ng/mL at W52;
    -Number of consecutive visits through W52 with IGF-1 ≤ULN;
    -Number of consecutive visits through W52 with IGF-1 ≤1.3×ULN;
    -Change from baseline in serum Insulin-like growth factor binding protein-3 (IGFBP-3) levels
    measured at W52;
    - Increase in serum GH, IGF-1, and IGFBP-3 levels 3+ weeks after withdrawal of CRN00808;
    - Change from baseline in Acromegaly Quality of Life (AcroQoL) Questionnaire at W52;
    - Change from baseline in acromegaly symptom diary Scores at W52;
    - Time to IGF-1 <ULN (Group 3 only);
    - Change from baseline in serum IGF-1 levels measured at W52 (Group 3 only);
    - Change from baseline in serum IGF-1 levels measured at each visit a dose is adjusted during the
    titration period (Group 3 only);
    - Change from baseline in serum GH levels measured at W12 (Group 3 only);
    - Change from baseline in serum GH levels measured at W52 (Group 3 only);
    - Change from baseline in serum GH levels measured at each visit a dose is adjusted during the
    titration period (Group 3 only).

    Safety Endpoints:
    - Clinical laboratory tests (hematology, serum chemistry, and urinalysis) at each post-baseline
    study visit;
    - Vital signs at each post-baseline study visit;
    - 12-lead ECG at each post-baseline study visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Specific time points are given in E.5.2
    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 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.6.13.1Other scope of the trial description
    N/A
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Australia
    Brazil
    Germany
    Greece
    Hungary
    Italy
    New Zealand
    Poland
    Romania
    Serbia
    Slovakia
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 125
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 135
    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)
    return to previous standard of care package
    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 Decision2020-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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