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    Summary
    EudraCT Number:2020-002316-51
    Sponsor's Protocol Code Number:02PDE2019
    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:2020-11-25
    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 number2020-002316-51
    A.3Full title of the trial
    Phase II, Double blind, Randomized, Placebo Controlled, Parallel Group, Trial to Explore Efficacy, Safety and Pharmacokinetics of CPL500036 (PDE10A inhibitor) in Patients with an Acute Exacerbation of Schizophrenia.
    II. fázisú, kettősvak, randomizált, placebo kontrollált, paralel csoportos vizsgálat a CPL500036 (PDE10A inhibitor) hatékonyságának, biztonságosságának és farmakokinetikájának vizsgálatára, skizofrén betegek akut exacerbációjában.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II clinical study of product CPL500036 in patients with an acute exacerbation of schizophrenia
    A CPL500036 készítmény II. fázisú vizsgálata a skizofrén betegek akut exacerbációjában.
    A.4.1Sponsor's protocol code number02PDE2019
    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 SponsorCelon Pharma SA
    B.1.3.4CountryPoland
    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 supportThe national centre for Research and Development Poland
    B.4.2CountryPoland
    B.4.1Name of organisation providing supportCelon Pharma SA
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJoanna Sierzputowska-Prarat, Celon Pharma SA
    B.5.2Functional name of contact pointClinical Trials Specialist
    B.5.3 Address:
    B.5.3.1Street AddressOgrodowa 2A, Kiełpin
    B.5.3.2Town/ cityŁomianki
    B.5.3.3Post code05-092
    B.5.3.4CountryPoland
    B.5.4Telephone number+4822751 59 33128
    B.5.6E-mailjoanna.sierzputowska@celonpharma.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 PG203
    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.3.8INN - Proposed INNCPL500036
    D.3.9.2Current sponsor codeCZ20
    D.3.9.3Other descriptive nameCPL500036
    D.3.9.4EV Substance CodeSUB193569
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Acute exacerbation of schizophrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia with exacerbated symptoms
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    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 CPL500036 administered for 28 days can attenuate the positive symptoms associated with schizophrenia
    E.2.2Secondary objectives of the trial
    •To determine if CPL500036 administered for 28 days can attenuate the negative symptoms associated with schizophrenia.
    •To determine if CPL500036 administered for 28 days results in overall clinical improvement as assessed by the Clinical Global Impression Scale Improvement (CGI-I).
    •To determine if CPL500036 administered for 28 days results in overall clinical improvement as assessed by the Positive and Negative Symptom Scale (PANSS).
    •To assess the safety and tolerability of CPL500036 administered for 28 days.
    •To assess the pharmacokinetic (PK) profile of CPL500036 administered for 28 days.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient has a primary diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition [DSM 5], 295.90) confirmed by clinical interview (Structured Clinical Interview for DSM 5 Clinical Trial Version [SCID 5 CT]). The participant's initial diagnosis must be greater than or equal to (≥) 2 years before Screening.
    2. Male or female patient aged 18 to 65, inclusive, at Screening.
    3. The patient's psychotic symptoms were exacerbated within 2 months (60 days) prior to Screening (e.g., aggravated delusion).
    4. The patient has a score of 5 (moderate severe) or higher in 3 or more items of the following PANSS items at Screening and Day -1: delusions (P1), conceptual disorganization (P2), hallucinations (P3), suspiciousness (P6), and unusual thought content (G9).
    5. The patient has a PANSS Total Score of 80 or higher during Screening and on Day -1.
    6. A female is eligible to participate if she is not pregnant (negative serum pregnancy test at Screening and Day -1), not breastfeeding, and at least 1 of the following conditions applies:
    a) Not a woman of childbearing potential (a woman is considered to be of non childbearing potential if she is post-menopausal for at least 12 months or is surgically sterile [hysterectomy, bilateral oophorectomy, tubal ligation]).
    b) Woman of childbearing potential, who agree to use contraceptive methods during the Treatment Period and for at least 28 days after the last dose of the study drug.
    The following are acceptable contraceptive methods: bilateral tubal occlusion, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices, male or female condom with spermicide; and cap, diaphragm, or sponge with spermicide.
    7. Male patients must agree to use a barrier method of contraceptive (condom + spermicide gel) for at least 90 days after the last dose of the study drug.
    8. The patient has a Clinical Global Impression Scale Severity of Illness Scale (CGI S) of 4 or greater at Screening and Day -1.
    9. The patient is able to and agrees to remain off prior antipsychotic medication and all excluded medications as outlined in the protocol for the duration of the Treatment Period.
    10. The patient is able to sign informed consent after receiving information about the trial.
    11. The patient has the ability and willingness to comply with the requirements and restrictions of the study protocol.
    E.4Principal exclusion criteria
    1. The patient has a decrease in the PANSS Total Score by 20 percent (%) or more at Baseline (Day -1) compared with the Total Score at Screening ([PANSS Total Score at Screening PANSS Total Score at Baseline]/[PANSS Total Score at Screening 30)]*100 ≥ 20%).
    2. Patient participated in another interventional clinical study with an IMP during the last 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
    3. The patient has uncontrolled, hypertension, hypotension, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the patient to participate or potentially confound the study results.
    4. The patient has a history of severe head injury, traumatic brain injury, myocardial infarction or stroke.
    5. The patient has a positive urine drug result (illicit, illegal or without valid prescription or medical need) at Screening.
    6. The patient has a moderate or severe substance use disorder (meeting more than 5 diagnostic criteria of DSM 5 either currently or within the last 6 months) for alcohol or other substances of abuse except nicotine or caffeine.
    7. If female, the patient is pregnant (a positive pregnancy test at Screening or Day -1) or lactating or intending to become pregnant or intending to donate ova, before or during the course of the study or within 12 weeks after the last dose.
    8. The patient has a history of or known personality disorder or other psychiatric disorder that, in the opinion of the Investigator, would interfere with participation in the study.
    9. The patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus or other conditions that may interfere with absorption of study drug.
    10. The patient is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property or participants who within the past year prior to Screening have attempted suicide or have positive answers on item 4 or 5 on the C SSRS at Screening or on Day -1.
    11. The patient has Parkinson’s disease, tardive dyskinesia, or other chronic movement disorder that may interfere with the interpretation of study results.
    12. The patient has any existing or previous history of cancer that has been in remission for less than 5 years prior to Screening.
    Note: this criterion does not include those participants with basal cell, stage I squamous cell skin cancer or in situ cervical cancer.
    13. The patient has newly diagnosed diabetes or requires insulin for their treatment; diabetic patients that have had changes to their diabetic treatment regimen within 30 days prior to Screening or diabetic patients that have been hospitalized for their diabetes and/or diabetes related conditions in the past year prior to Screening.
    14. The patient has long QT syndrome or is under treatment with Class 1A (e.g., quinidine, procainamide) or Class 3 (e.g., amiodarone, sotalol) anti arrhythmic drugs.
    15. The patients with acute or chronic hepatitis B or C infection (positive test for hepatitis B surface antigen; positive hepatitis C antibody), known human immunodeficiency virus (HIV) infection, or other acute or ongoing clinically significant viral or bacterial infections..
    16. The patient has received any depot preparation (sustained release formulation) of antipsychotic drugs within 1 month (30 days) prior to Screening.
    17. The patient is considered to be treatment resistant. Treatment resistance is defined as prior non response to 2 courses of treatment with anti-psychotics of different chemical classes for at least 4 weeks each at doses considered to be effective.
    18. The patient has received monoamine oxidase (MAO) inhibitors or fluoxetine within 1 month (30 days) before Screening.
    19. The patient has received electroconvulsive therapy within 6 months (180 days) before Screening.
    20. The patient has 1 or more laboratory values outside the normal range that are considered by the Investigator to be clinically significant at Screening; or has any of the following at Screening:
    o A serum creatinine value > 1.5 times the upper limit of normal (ULN).
    o A total serum total bilirubin value > 1.5*ULN.
    o A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 2*ULN.
    E.5 End points
    E.5.1Primary end point(s)
    •Change from baseline in PANSS positive subscale at Week 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the treatment phase on Day 28
    E.5.2Secondary end point(s)
    •Change from baseline in PANSS positive subscale at Week 1, 2 and 3,
    •Change from baseline in PANSS Total Score at Weeks 1, 2, 3, 4,
    •Change from Baseline in PANSS Subscales Using the Marder 5 factor Model at Weeks 1, 2, 3, and 4,
    •Change from Baseline in PANSS Negative Subscales at Weeks 1, 2, 3 and 4,
    •Change from Baseline in PANSS general psychopathology Subscale at Weeks 1, 2, 3 and 4,
    •Percentage of Clinical Responders Based on the PANSS Total Score. A clinical responder is defined as a ≥ 30% decrease from baseline,
    •Change from Baseline in Clinical Global Impression Severity (CGI-S) Score at Weeks 1, 2, 3, and 4,
    •Clinical Global Impression Scale Improvement (CGI-I) Score at Weeks 1, 2, 3, 4,
    •Percentage of Responders Based on CGI-I Ratings Score at weeks 1, 2, 3, 4. A responder is defined as a rating of ‘much improved’ or ‘very much improved’,
    •Change from Baseline in Brief Assessment of Cognition in Schizophrenia (BACS) Score at Weeks 2 and 4,
    •Physical, neurological, ophthalmological, and dermatological examination findings,
    •Adverse event assessments,
    •Hematologic, clinical chemistry, and urinalysis results,
    •Electrocardiogram (ECG) results,
    •Extrapyramidal side effects monitoring using the Extrapyramidal Symptom Rating Scale (ESRS).
    •Pharmacokinetic parameters: Cmax, tmax, AUC0-24, (t1/2), CL/F, Vz/F, Ctrough.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the double-blind treatment phase and during follow-up phase
    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 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 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 EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 165
    F.1.3Elderly (>=65 years) No
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    F.4.2.2In the whole clinical trial 165
    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
    N/A
    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 Decision2021-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
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