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    Summary
    EudraCT Number:2015-005159-28
    Sponsor's Protocol Code Number:MP1032-CT02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-18
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2015-005159-28
    A.3Full title of the trial
    A randomized (1:1), double-blind, parallel, placebo-controlled exploratory pilot study to evaluate the safety, pharmacokinetics and efficacy of systemic (po) application of MP1032 in patients with moderate to severe chronic plaque psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the safety, pharmacokinetics and efficacy of MP1032 after oral administration in patients with moderate to severe chronic plaque psoriasis.
    A.4.1Sponsor's protocol code numberMP1032-CT02
    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 SponsorMetrioPharm AG
    B.1.3.4CountrySwitzerland
    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 supportMetrioPharm AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMetrioPharm Deutschland GmbH
    B.5.2Functional name of contact pointDr. Petra Schulz
    B.5.3 Address:
    B.5.3.1Street AddressAm Borsigturm 100
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13507
    B.5.3.4CountryGermany
    B.5.4Telephone number+493033 84 395 36
    B.5.5Fax number+493033 84 395 99
    B.5.6E-mailp.schulz@metriopharm.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 nameMP1032 Hard Gelatine Capsules 50 mg
    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 INNnot available
    D.3.9.1CAS number 20666-12-0
    D.3.9.2Current sponsor codeMP1032
    D.3.9.3Other descriptive nameMP1032
    D.3.9.4EV Substance CodeSUB175038
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Moderate to severe chronic plaque psoriasis
    E.1.1.1Medical condition in easily understood language
    Moderate to severe chronic plaque psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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 evaluate the safety and pharmacokinetics (PK) of orally administered 100 mg MP1032 twice a day (bid) when taken for 42 days by patients with moderate to severe chronic plaque psoriasis
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of orally administered 100 mg MP1032 bid when taken for 42 days by patients with moderate to severe chronic plaque psoriasis as assessed by:
    - Psoriasis Area Severity Index (PASI)
    - Physician’s Global Assessment (PGA)
    - Dermatology Life Quality Index (DLQI)
    - EQ-5D 5L visual analogue scale (VAS)
    - Modified Nail Psoriasis Severity Index (mNAPSI)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Participants legally competent to sign and give informed consent.
    2.Adult male and female patients aged 18 to 65 years with chronic plaque psoriasis:
    a.PASI score > 10 at screening and
    b.Disease duration of ≥ 6 months at the initiation of study medication.
    3.Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.
    4.Diagnosis of chronic plaque psoriasis confirmed by a dermatologist/physician.
    5.Women of childbearing potential (WCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active WCBP must agree to use 2 forms of adequate contraception throughout the trial. (See protocol section 5.8 for more details on adequate contraception).
    6.Post-menopausal women with spontaneous amenorrhea for at least 12 months and serum follicle stimulating hormone (FSH) levels indicating post-menopausal state as per local laboratory reference ranges. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study. Sterilized women may be included. (See Section 5.8 for more details on sterile definition).
    7.Patients must meet the following clinical laboratory criteria:
    a)White blood cell count ≥ 3.5 x 109/L
    b)Platelet count ≥ 100 x 109/L
    c)Serum creatinine ≤ 1.5 x upper limit of normal (ULN); estimated glomerular filtration rate > 60 mL/min
    d)Total bilirubin ≤ 1.5 x ULN
    e)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 x ULN
    f) Hemoglobin ≥ lower limit of normal as per local laboratory reference ranges for women and men accordingly.
    g)No coagulopathy (International Normalized Ratio [INR] < 1.5).
    8.Patients agree not to increase their normal sun exposure during the course of the study.
    9.Patients are able to swallow 2 small capsules during each administration.
    10.Patients are considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator.
    E.4Principal exclusion criteria
    1.Patients with non-plaque form of psoriasis (erythrodermic, guttate, pustular or palmo-plantar psoriasis; severe form of psoriasis arthritis, inverse form of psoriasis). Mild to moderate cases of psoriasis arthritis are allowed provided there is no impact on study objectives as determined by the Investigator.
    2.Patients with drug-induced psoriasis.
    3.Evidence of skin conditions at the time of screening visit other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
    4.Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent them from signing the informed consent form.
    5.Pregnant or lactating females or females planning to become pregnant during the study and/or within 28 days following the last dose of study medication.
    6.Male patients planning a partner pregnancy or sperm donation during the study or within 3 months following the last dose of study medication.
    7.Known allergies to mannitol, macrophage modulators, and gelatin.
    8.Patients with a recent history or current signs or symptoms, as determined by the Investigator, of severe, progressive viral or bacterial infections, of clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic insufficiency disease (excluding psoriasis) requiring systemic treatment or other major diseases, which are not well controlled and may interfere with the conduct of the trial.
    9.Patients with active malignancy or history of malignancy, except for basal cell or squamous cell carcinoma and actinic keratosis. Basal cell carcinoma and small squamous cell carcinoma of the skin which have been excised according to guidelines within the last 5 years or in situ cervical carcinoma that has been fully treated and shows no evidence of recurrence are allowed.
    10.Clinically significant abnormality on 12 lead electrocardiogram (ECG) at screening.
    11.Positive human immunodeficiency virus (HIV), hepatitis B or hepatitis C laboratory result.
    12.Previous strong sun exposure (eg, sea holiday) in the 28 days before study medication initiation.
    13.Known photo allergy and/or experienced drug-induced photo toxicity.
    14.Elective (planned) hospitalization or medical intervention preventing patient from following the protocol requirements.
    15.Prior treatments with Topical psoriasis medications, Topical immunosuppressive drugs , Systemic treatment (non-biologic), Phototherapy or photochemotherapy/photosensitizing drugs, Systemic retinoids, Any Anti TNFs, Other biologics and other systemic therapies, and Rituximab (see protocol)
    16.Drinking or ingesting grapefruit, pomegranate, grapefruit juice or grapefruit containing products within 14 days of study medication initiation.
    17.Planned use of any ultraviolet (UV) phototherapy or photochemotherapy/ photosensitizing drugs during the course of the study and within 28 days following the last dose of the study medication.
    18.Patients with a history of chronic alcohol or drug abuse within 6 months of study medication initiation.
    19.Patients employed by MetrioPharm or a contract research organization (CRO) involved in the clinical study.
    20.Vulnerable patients (eg, patients kept in detention).
    21.Patients who are unable to communicate, read and understand the local language, or who display any other condition, which, in the Investigator’s opinion, makes them unsuitable for clinical study participation.
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    Pharmacokinetics
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety:
    Safety will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit on Day 71.

    Pharmacokinetics:
    Pharmacokinetic sampling will occur on Day 1, Day 15, Day 29 and Day 43: Day 1: at 15 minutes, 30 minutes, 1 hour, and 2 hours postdose Day 15: any time postdose (time of the last dose will be recorded) Day 29: any time postdose (time of the last dose will be recorded) Day 43: postdose (time of the last dose will be recorded).
    E.5.2Secondary end point(s)
    Efficacy variables:
    - Psoriasis Area Severity Index (PASI)
    - Physician's Global Assessment (PGA)
    - Dermatology Life Quality Index (DLQI)
    - EQ-5D 5L visual analogue scale (VAS)
    - Modified Nail Psoriasis Severity Index (mNAPSI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All of the efficacy variables will be assessed at the screening visit (Visit 1, up to 28 days prior to randomization), during the treatment period (Days 1, 15, 29 and 43) 2 weeks after the last treatment day (Day 57) and at the End of Study Follow-up visit (Day 71)
    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 trial2
    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 No
    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 months10
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days14
    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: 44
    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 state44
    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)
    No post-study medication will be provided. The investigator is responsible for ensuring that consideration has been given to the post-study care of patient’s medical condition.
    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 Decision2016-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-29
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