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    Summary
    EudraCT Number:2017-003484-36
    Sponsor's Protocol Code Number:MP1032-CT04
    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:2017-09-27
    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 number2017-003484-36
    A.3Full title of the trial
    A Phase II, Multicenter, Double-blind, Placebo-controlled, Efficacy and Safety Study of Two Oral Doses (150 mg bid / 300 mg bid) of MP1032 in Male and Female 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
    A study to evaluate the efficacy of the new drug MP1032 in patients with moderate-to-severe psoriasis
    A.4.1Sponsor's protocol code numberMP1032-CT04
    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 pointInfo
    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+4930338439502
    B.5.5Fax number+4960338439599
    B.5.6E-mailinfo@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 gelatin capsules 50 mg
    D.3.2Product code MP1032
    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.3.9.1CAS number 20666-12-0
    D.3.9.2Current sponsor codeMP1032
    D.3.9.3Other descriptive nameMP1032
    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
    chronic Psoriasis Plaque moderate-to-severe
    chronische Schuppenflechte mit einer moderaten-bis-schweren Ausprägung
    E.1.1.1Medical condition in easily understood language
    chronic Psoriasis Plaque moderate-to-severe
    chronische Schuppenflechte mit einer moderaten-bis-schweren Ausprägung
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to evaluate the clinical efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) when taken for 12 weeks by patients with moderate-to-severe chronic plaque psoriasis
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of each oral doses of MP1032 (150 mg bid
    and 300 mg bid) compared to placebo on the PASI score
    - To evaluate the effect of each oral doses of MP1032 (150 mg bid
    and 300 mg bid) compared to placebo on the PGA score
    - To evaluate the effect of each oral doses of MP1032 (150 mg bid
    and 300 mg bid) compared to placebo on the BSA score
    - To evaluate systemic exposure of two oral doses of MP1032 (150 mg
    bid and 300 mg bid) when taken for 12 weeks by patients with
    moderate to severe chronic plaque psoriasis
    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 between 18 years and 70 years with moderate-to-severe chronic plaque psoriasis (diagnosed by Investigator):
    a) PASI score ≥10 - ≤20 at baseline
    b) BSA score: > 10%
    c) Stable disease duration of ≥ 6 months at the initiation of IMP.
    d) topical therapy fails to control the disease
    3. Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.
    4. Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use adequate contraception throughout the trial (see Section 3.2 for more details on adequate contraception):
    a) A method with less than 1% failure rate OR
    b) Abstinence
    5. Post-menopausal women with spontaneous amenorrhea for at least 12 months and women on hormonal replacement therapy (HRT). The use of hormonal replacement therapy (HRT) during the trial is permitted, however for these patients an appropriate contraception method according to Inclusion Criterion 4 must be ensured. Sterilized women may be included (see Section 3.2 for more details on sterile definition)
    6. Male patients who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least six months prior to treatment) must agree to inform their female sexual partner to use an acceptable form of birth control as described in the informed consent form. For females, an acceptable method (Pearl Index < 1%) would be to use implants, injectable, combined oral contraceptives, some intrauterine devices, or be postmenopausal, be surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
    7. In good health as judged by the investigator, based on medical history, physical examination, serum chemistry, hematology and urinalysis
    8. Patients must meet the following clinical laboratory criteria:
    • White blood cell count ≥3.5 × 109/L
    • Platelet count ≥100 × 109/L
    • Serum creatinine ≤1.5 × upper limit of normal (ULN); estimated glomerular filtration rate >60 mL/min
    • Total bilirubin ≤1.5 × ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
    • Hemoglobin ≥ lower limit of normal as per central laboratory reference ranges for women and men accordingly
    • No coagulopathy (International Normalized Ratio [INR] <1.5)
    9. Patients agree to minimize normal sun exposure during the course of the trial
    10. Patients are considered reliable and capable of adhering to the protocol (e.g. able to understand the patient information 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 form of psoriasis). Associated psoriasis arthritis is allowed provided no other in-/exclusion criteria are influenced, no forbidden concomitant therapy is required for the well-being of the patient and there is no impact on trial objectives as determined by the Investigator.
    2. Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, beta-blockers or ACE inhibitors unless on a stable dose for 3 months before IMP intake.
    3. Evidence of skin conditions at the time of Screening Visit other than psoriasis that would interfere with evaluations of the effect of the IMP on psoriasis.
    4. Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the ICF, as assessed by the investigator.
    5. Pregnant or lactating women or women planning to become pregnant during the trial and / or within 28 days following the last dose of IMP.
    6. Male patients planning a partner pregnancy or sperm donation during the trial including follow up period.
    7. Known allergies to any ingredient of the IMP e.g. mannitol, macrophage modulators, or gelatin.
    8. History or symptoms of a clinically significant illness in the four weeks before first treatment and during the trial that in the opinion of the investigator may place the patient at risk by trial participation or influence the outcome of the trial. Well controlled diseases such as hypertension, hyperlipidemia, diabetes or hypothyroidism are permitted.
    9. Patients with active malignancy or history of malignancy, except for basal cell and actinic keratosis. Basal cell carcinoma of the skin or in situ cervical carcinoma that have been fully treated and show no evidence of recurrence are allowed.
    10. Positive HIV-Antibody, HBs-Antigen or HCV-Antibody-Test at screening.
    11. Previous strong sun exposure (e.g. sea holiday) within 28 days or UV treatment within 24 weeks before IMP initiation.
    12. Known photo allergy and / or experienced drug-induced photo toxicity.
    13. Elective (planned) hospitalization or medical intervention preventing patient from following the protocol requirements.
    14. Prior treatment not adhering to Table 2.
    15. Planned use of any ultraviolet (UV) phototherapy or photochemotherapy / photosensitizing drugs during the course of the trial and within 28 days/24 weeks following the last dose of the IMP.
    16. Patients with a history of chronic alcohol or drug abuse within 6 months of IMP initiation.
    17. Patients with a blood pressure outside the given range of 160 mm Hg (systolic) and 95 mm Hg (diastolic)
    18. Patients who are employed by MetrioPharm, contract research organization (CRO) or clinical site involved in the clinical trial.
    19. Vulnerable patients (e.g. patients kept in detention).
    20. Patients who are unable to communicate, read or understand the local language, or who display another condition, which, in the Investigator’s opinion, makes them unsuitable for clinical trial participation.
    21. Patient is institutionalized because of legal or regulatory order.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of each (PASI):
    1. Percentage of patients who achieve a 75% improvement (response)
    in their PASI score (PASI 75) at Week 12 (Day 84) compared to
    baseline treated with 300 mg bid of MP1032 compared to placebo
    2. Percentage of patients who achieve a 75% improvement (response)
    in their PASI score (PASI 75) at Week 12 (Day 84) compared to
    baseline treated with 150 mg bid of MP1032 compared to placebo
    And comparison of each (PGA):
    3. Improvement (1 or more points on a 7 Point Scale) in PGA at Week
    12 (Day 84) compared to baseline treated with 300 mg bid of
    MP1032 compared to placebo
    4. Improvement (1 or more points on a 7 Point Scale) in PGA Score at
    Week 12 (Day 84) compared to baseline treated with 150 mg bid of
    MP1032 compared to placebo
    5. Adverse events, clinical laboratory, vital signs, PK data, physical
    examination
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 84
    E.5.2Secondary end point(s)
    • Proportion of patients treated with 300 bid MP1032 compared to
    placebo who achieve PASI 50 at Week 12 (d84)
    • Proportion of patients treated with 150 bid MP1032 compared to
    placebo who achieve PASI 50 at Week 12 (d84)
    • PASI score and change to baseline at Week 4 (d28), 8 (d56), 12 (d84)
    and week 16 (d112) on the level of individual patients
    • Time to achieve PASI 50 and PASI 75
    • Mean PASI score and change from Baseline at Week 4 (d28), 8
    (d56), and 12 (d84), 16 (d112)
    • Mean score and change from Baseline at Week 4 (d28), 8 (d56), and
    12 (d84), 16 (d112) in the PGA
    • Mean score and change from Baseline at Week 4 (d28), 8 (d56),
    and 12 (d84), 16 (d112) in the BSA
    • PK data analysis

    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 4 (d28), 8 (d56), and 12 (d84), 16 (d112)
    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 concerned14
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    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: 140
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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 Trial Treatment planned
    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 Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-12
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