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    Summary
    EudraCT Number:2018-003337-15
    Sponsor's Protocol Code Number:CLR_18_06
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-26
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2018-003337-15
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease
    RANDOMIZOVANÉ, DVOJITO ZASLEPENÉ, PLACEBOM KONTROLOVANÉ SKÚŠANIE FÁZY II HODNOTIACE PRÍPRAVOK K0706 U PACIENTOV V RANOM ŠTÁDIU PARKINSONOVEJ CHOROBY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease.
    A.4.1Sponsor's protocol code numberCLR_18_06
    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 SponsorSun Pharma Advanced Research Company (SPARC) Limited
    B.1.3.4CountryIndia
    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 supportSun Pharma Advanced Research Company Limited (SPARC)
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSun Pharma Advanced Research Company Limited (SPARC)
    B.5.2Functional name of contact pointSponsor represent - Orest Hurko
    B.5.3 Address:
    B.5.3.1Street Address7/B, Mahal Industrial Estate, Off Mahakali Caves Road
    B.5.3.2Town/ cityAndheri (E), Mumbai
    B.5.3.3Post code400093
    B.5.3.4CountryIndia
    B.5.6E-mailOrest.Hurko@sparcmail.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.3.2Product code K0706
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNK0706
    D.3.9.1CAS number 1388803-90-4
    D.3.9.3Other descriptive nameK0706
    D.3.9.4EV Substance CodeSUB184023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number96
    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.IMP: 2
    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.3.2Product code K0706
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNK0706
    D.3.9.1CAS number 1388803-90-4
    D.3.9.3Other descriptive nameK0706
    D.3.9.4EV Substance CodeSUB184023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number192
    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.IMP: 3
    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.3.2Product code K0706
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNK0706
    D.3.9.1CAS number 1388803-90-4
    D.3.9.3Other descriptive nameK0706
    D.3.9.4EV Substance CodeSUB184023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number384
    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 placeboPowder for oral suspension
    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
    Early Parkinson’s Disease
    E.1.1.1Medical condition in easily understood language
    A progressive disease of the nervous system characterised by tremor,
    muscular rigidity, and slow, imprecise movement.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if K0706 reduces the rate of progression of early-stage Parkinson's disease (PD) versus placebo over 40 weeks, as assessed by
    the MDS-UPDRS (Movement Disorder Society – Unified Parkinson's Disease Rating Scale)
    Part III (motor examination) total score.
    E.2.2Secondary objectives of the trial
    To determine if K0706 reduces the rate of progression of early-stage PD versus placebo over 40 weeks by a greater magnitude in the subgroup of
    patients excluding mild-motor predominant sub-type (hereinafter Subgroup A). The rate of progression is assessed by the MDS-UPDRS
    Part III total score.
    To determine if K0706 reduces the rate of progression of early-stage PD versus placebo over 40 weeks by a greater magnitude in the subgroup of
    patients with serum neurofilament light (NfL) value ≥ 13 pg/mL at baseline (hereinafter Subgroup B). The rate of progression is assessed by the MDS-UPDRS Part III total score.
    To determine if K0706 reduces the rate of progression of early-stage PD versus placebo over 40 weeks, as assessed by the sum of the MDSUPDRS
    Parts II and III total scores.
    To determine if K0706 slows early-stage PD progression compared to placebo by increasing the time to significant worsening on the MDSUPDRS
    Parts I, II and III.
    Refer protocol for complete secondary objectives.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biomarker substudy
    E.3Principal inclusion criteria
    Part 1:
    1. The subject has given written informed consent and is willing to participate in the study;
    2. Subject is able to understand and comply with all study procedures (requires literacy in the available language of all patient-reported outcome measures);
    3. Males or females aged ≥ 50 years;
    4. Body mass index (BMI) greater than 18.5 kg/m2 and less than 45 kg/m2;
    5. Diagnosed with “Clinically Probable PD” according to the MDS clinical diagnostic criteria, with documented diagnosis of PD per treating physician’s records within three years of the Screening visit. Disease severity according to modified Hoehn & Yahr stage ≤ 2;
    6. Projected to not require to start dopaminergic therapy within 9 months from Baseline;
    7. Female subjects must be not of childbearing potential, e.g., documented evidence that they are surgically sterile (e.g., hysterectomy, partial hysterectomy, bilateral oophorectomy, bilateral tubal ligation), or post-menopausal (at least 12 months since last menses) prior to Screening.

    8. Male subjects enrolled in the study should not father a child and are advised to prevent the passage of semen to their sexual partner during intercourse using an effective method as judged by the Investigator for the duration of the study and for 3 months after the last dose of study the study drug;
    9. Willingness to consider lumbar puncture and skin biopsy, and other procedures of the Biomarker sub-study for future testing of substances
    related to PD or K0706 target engagement.
    Part 2:
    1. Subject has completed the part 1 of the study.
    2. Subject projected not to need dopaminergic treatment except for treatment with Monoamine Oxidase B (MAOB) inhibitors. MAOB inhibitors will be allowed if the patient was already taking the same during part 1 of the study.
    3. Subject has received K0706/placebo, as appropriate, within 4 weeks prior to end of part 1 of the study.
    4. Male subjects enrolled in the study should not father a child and are advised to prevent passage of semen to their sexual partner during intercourse using an effective method, as judged by the Investigator, for
    the duration of the study and for 3 months after the last dose of study drug.
    E.4Principal exclusion criteria
    Part 1: 1.Current, or within 60D of Screening, use of any prescription, investigational, or over the counter medication for the symptomatic treatment of PD or to slow the progression of PD. Treatment with (MAOB) inhibitors will be allowed if the dose is stable for at least 30 days prior to Screening and subjects agree to remain on it for the duration of the study;
    2. Prior use of dopaminergic therapy for 30 or more days at any time in the past;
    3.A diagnosis of a significant central or peripheral nervous system disease affecting the subject's cognition or motor function at any time, such as another neurodegenerative disorder, multiple sclerosis or stroke.This does not include transient neurological deficits such as transient ischemic attacks or migraine aura;
    4. A diagnosis of a medical condition that could interfere with the interpretation of the MDS-UPDRS during the trial;
    5. Contraindications to receiving an MRI;
    6. Contraindications to receiving a DaT SPECT scan if a new DaT SPECT scan is required for the study;
    7. Most recent DaT SPECT scan not compatible with PD (i.e., Scans Without Evidence of Dopaminergic Deficit [SWEDD]) based on a central reading by a study physician;
    8. MRI scan of the brain performed after the onset of PD suggestive of secondary Parkinsonism;
    9. Severe tremors as defined by a score of "severe" on any of the MDSUPDRS Parts II and III.
    10. Montreal cognitive assessment score < 25;
    11. History of any surgery on the brain itself including deep brain stimulation for PD;
    12. History of hypersensitivity to contents of the study drug or other tyrosine kinase inhibitors; 13. Clinically significant or unstable psychiatric or medical condition, vital sign, or laboratory abnormality that in the opinion of the
    investigator interferes with participation in the study;
    14. Any clinically significant cardiac abnormality in the opinion of the investigator. This would include myocardial infarction in the six months prior to screening, or significant ECG abnormality, including heart-rate corrected interval QT (QTc) based on Fridericia's correction formula >
    450 milliseconds for males and > 470 milliseconds for females;
    15. History or presence of any gastrointestinal disorder or malabsorption syndrome, what might affect the absorption of study drug;
    16. Subject report of recent (within the previous 6-months) illicit drug use (other than marijuana), or intake of alcohol that is excessive in the opinion of the investigator, or positive urine drug screen at Screening;
    17. Subject report of the use of marijuana within one month of Screening or lack of wiliness to forgo the use of marijuana during the trial;
    18. History of surgery within 4 weeks prior to the Screening visit or expectation of a planned surgical or invasive diagnostic procedure
    during the course of the study;
    19. Participation in other investigational drug trials within 30 days prior to Screening;
    20. Any concomitant medication or medication excluded that could put subject at risk,or interfere with study evaluations (See Protocol Section6.4 for details);
    21. Recent use of medications that can cause Parkinsonism and suspicion of the investigator that it could have worsened the subject's
    Parkinsonism. This includes neuroleptics, some anti-nausea medications and others;
    22. Use of medications that affect the dopaminergic system, within 60 days of Screening. This includes stimulants and Monoamine Oxidase A(MAOA) inhibitors (e.g., phenelzine, and tranylcypromine). Note that antidepressants are acceptable as long as the subject has remained on them at a stable dose for over 60 days prior to Screening and plans to remain on them through the study;
    23. Any malignant disease other than basal cell carcinoma of the skin with evidence of disease within the past 5 years and with the potential for recurrence;
    24. Female subjects presently lactating.
    Exclusion criteria specific for the Biomarker sub study:
    25. Contraindications to undergoing a skin biopsy (e.g., allergy to the anesthetic used, use of anticoagulants or dual anti-platelet agents, history of impaired wound healing, history of keloid formation);
    26. Contraindications for performing lumbar puncture such as coagulation disorders, back surgery that might interfere with the procedure, anticoagulants, etc.
    Part 2:
    1. Clinically significant or unstable psychiatric or medical condition, vital sign, or laboratory abnormality that in the opinion of the investigator
    interferes with participation in the study
    2. Any condition that in the opinion of the Investigator represents an
    obstacle for study conduct and/or represents a potential unacceptable risk for the subject.
    3. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause continued treatment to be detrimental to the subject.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Week 40 in the sum of MDS-UPDRS Part III total score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 40 (Part III)
    E.5.2Secondary end point(s)
    Change from baseline to Week 40 in the sum of the MDS-UPDRS Parts II and III total scores.
    Change from Baseline to Weeks 8 through 40 in MDS-UPDRS Part IA, Part IB, Part I total, Part II total, and Part III sub-scores,
    Change in MDS-UPDRS grand total score (sum of Parts I, II and III) from the baseline
    Evaluation of slopes of the mean MDS-UPDRS Parts II and III scores over time during Part 1 by treatment group.
    Time from the first dose in Part 1 to initiation of symptomatic PD medications.
    Change in HRQoL using the EQ-5D-5L from Baseline to Week 40
    Change in CGIS from Baseline to Week 40
    Change in the SCOPA-AUT from Baseline to Week 40
    Pharmacokinetics – Plasma and CSF levels of K0706 and any relevant metabolites
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 40
    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.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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    India
    United States
    Hungary
    Poland
    Slovakia
    Spain
    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 months10
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days18
    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: 252
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 252
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 222
    F.4.2.2In the whole clinical trial 504
    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 Decision2019-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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