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    Summary
    EudraCT Number:2012-005750-27
    Sponsor's Protocol Code Number:MT-1303-E06
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-11
    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 ConcernedLatvia - SAM
    A.2EudraCT number2012-005750-27
    A.3Full title of the trial
    A Phase IIa, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects 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 clinical study to investigate the effects of MT-1303 on patients with moderate to severe Chronic Plaque Psoriasis focusing on how safe, tolerable and effective in treating the above condition MT-1303 is.
    A.4.1Sponsor's protocol code numberMT-1303-E06
    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 SponsorMitsubishi Tanabe Pharma Corporation (MTPC)
    B.1.3.4CountryJapan
    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 supportMitsubishi Tanabe Pharma Corporation (MTPC)
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMitsubishi Pharma Europe Ltd. (MPE)
    B.5.2Functional name of contact pointPharmaceutical and Reg. Affairs
    B.5.3 Address:
    B.5.3.1Street AddressDashwood House, 69 Old Broad Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC2M 1QS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)2070655000
    B.5.5Fax number+44(0)2070655050
    B.5.6E-mailregulatory@m-pharma.co.uk
    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 MT-1303
    D.3.4Pharmaceutical form Capsule
    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 INNMT-1303
    D.3.9.2Current sponsor codeMT-1303
    D.3.9.3Other descriptive nameMT-1303
    D.3.9.4EV Substance CodeSUB118859
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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
    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 Plaque Psoriasis (reoccurring disease of the immune system with symptoms such as red patches on the skin commonly found with silvery scale, pain, itching and bleeding).
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    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
    To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe chronic plaque psoriasis.

    To evaluate the efficacy of MT-1303 in subjects with moderate to severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on Psoriasis Area and Severity Index (PASI).
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of MT-1303 in subjects with moderate to severe chronic plaque psoriasis compared to placebo on clinical outcomes (Static Physician Global Assessment [PGA], body surface area [BSA], Nail Psoriasis Severity Index [NAPSI]).

    To evaluate the efficacy of MT-1303 on quality of life as measured by Dermatology Life Quality Index (DLQI).

    To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of MT-1303 and its active phosphorylated metabolite (MT 1303-P).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female 18 to 65 years (limits included) of age at the time of signing the informed consent form.

    2. Able to provide written informed consent and to comply with the requirements of the protocol.

    3. Have been diagnosed with plaque psoriasis for at least 6 months prior to screening.

    4. Have moderate to severe chronic plaque psoriasis as defined by PASI score ≥ 12 and BSA ≥ 10% at baseline.

    5. In the investigator's opinion is a candidate for systemic therapy.

    6. For male and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.

    All males who have not been sterilised (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate) and females who do not meet the criteria for non child bearing potential are considered to have reproductive potential. For females, non-child-bearing potential is defined as either at least 2 years post-menopausal or permanently sterilised, e.g., by bilateral tubal occlusion, hysterectomy or bilateral salpingectomy.

    7. Presence of antibodies (immunoglobulin G [IgG]) to Varicella Zoster Virus (VZV).

    8. Negative results for both QuantiFERON-TB Gold test and chest X-ray (with no evidence of tuberculosis [TB]) at screening. Note: if the chest X-ray has been done in the past 6 months prior to screening, no repeat is necessary. Urine pregnancy test to be obtained and results negative prior to chest X ray.
    E.4Principal exclusion criteria
    1.Non-plaque forms of psoriasis (e.g., guttate, erythrodermic or pustular)

    2.Current drug-induced or aggravated psoriasis

    3.Pregnancy, lactation or a positive serum beta human chorionic gonadotropin (hCG) level measured during screening or at baseline, or intention to become pregnant or to breast-feed during the course of the study

    4.History of cardiovascular diseases as stated in the protocol

    5.Known high risk for QT/QTc prolongation such as a family history of long QT syndrome or sudden death

    6.Low heart rate (< 50 bpm) at screening or baseline (measured using 12-lead electrocardiogram [ECG])

    7.History or known presence of cerebrovascular diseases or ischaemia of the spinal cord

    8.Significant, uncontrolled disease such as respiratory (including chronic, obstructive pulmonary disease), renal, hepatic, endocrine and gastrointestinal disease

    9.Subjects who are currently treated for autoimmune disorders other than psoriasis

    10.History of cancer, in the last 5 years, including both solid tumour and haematological malignancies, but excluding basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved

    11.Known active bacterial, viral, fungal or mycobacterial infection or any major episode of infection requiring hospitalisation or treatment with intravenous antibiotics within 28 days prior to randomisation or oral antibiotics within 14 days prior to randomisation

    12.Known history of recurrent or chronic infection such as TB, hepatitis B, hepatitis C, human immunodeficiency virus or syphilis

    13.Any documented history or diagnosis of diabetes mellitus (Type I or II)

    14.Any significant eye disorder such as macular oedema, uveitis or evolutive retinopathy

    15.History of, or currently active, primary or secondary immunodeficiency

    16.Documented organ transplantation

    17.History of alcohol abuse within 5 years prior to screening and any history of solvent and/or drug abuse

    18.Previous exposure to fingolimod or to any other S1P receptor modulator (investigational products)

    19.Known history of allergy, hypersensitivity or any serious reaction to any component of the study medication (i.e., mannitol, gelatine)

    20.Previous treatment with any investigational agent within 3 months prior to randomisation or five half-lives of the investigational product, whichever is the longer

    21.Receipt of a live vaccine within 28 days prior to randomisation

    22.Have received systemic immunosuppressive agents (e.g., Tacrolimus) within 4 weeks prior to randomisation

    23.Have received disease modifying anti-rheumatic drugs (DMARDs) within 4 weeks prior to randomisation

    24.Topical therapy that could, in the opinion of the Investigator, affect psoriasis or PASI evaluation within 2 weeks prior to randomisation

    25.Any systemic medications or treatments (other than biologics) that affect psoriasis or PASI evaluation including, but not limited to, oral or injectable corticosteroids, psoralens, sulfasalazine, hydroxyurea, fumaric acid esters derivatives within 4 weeks prior to randomisation

    26.Systemic retinoids, 1,25 dihydroxy vitamin D3 and analogues at doses that might, in the opinion of the Investigator, affect psoriasis and PASI evaluation within 4 weeks prior to randomisation. However, vitamin/multivitamin supplements taken at doses at or around the recommended daily dose (RDA) are allowed

    27.Have used phototherapy within 4 weeks prior to randomisation

    28.Have used infliximab, adalimumab, etanercept or ustekinumab within 12 weeks prior to randomisation

    29.Currently receiving lithium carbonate or have received lithium carbonate within 4 weeks prior to randomisation

    30.Subject not willing to avoid excess sun exposure during the study duration

    31.Need for, or likely need for, treatment with Class I or Class III anti-arrhythmic drugs or with heart rate lowering beta blockers or calcium-channel blockers (e.g., verapamil or diltiazem), or with any other drugs which can reduce the heart rate (e.g., ivabradine)

    32.Need for, or likely need for, treatment with non-steroidal anti-inflammatory drugs (NSAIDs) except for subjects with psoriatic arthritis (PsA).

    33.Platelet count < 100,000/µL at screening

    34.Haemoglobin < 10.0 g/dL at screening

    35.White cell count < 3500/µL at screening

    36.Lymphocyte count < 800/µL at screening

    37.Glycosylated haemoglobin (HbA1c) > 6.5% at screening

    38.Liver function tests (aspartate transaminase [AST] or alanine transaminase [ALT]) ≥ 2 x upper limit of normal (ULN) at screening

    39.Clinically significant findings on 12-lead ECG (at screening or baseline) and/or Holter ECG (at screening) that the Investigator considers may jeopardise the subject’s health, e.g., acute ischaemia

    40.Corrected QT-interval using Fridericia’s formula (QTcF) interval ≥ 480 ms for females and ≥ 460 ms for males in 12-lead ECG at screening or baseline

    41.Body mass index > 40 kg/m2 at screening



    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline) at Week 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day -28 to -1 (Screening), Day1, Day 28, Day 56, Day 84, Day 112, Day 140, Day 168, Day 196.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:

    • Proportion of subjects who achieve PASI 90 (at least 90% reduction from baseline in PASI score) at Weeks 4, 8, 12 and 16.

    • Proportion of subjects who achieve PASI 50 (at least 50% reduction from baseline in PASI score) at Weeks 4, 8, 12 and 16.

    • Proportion of subjects who achieve PASI 75 at Weeks 4, 8 and 12.

    • Mean percent change from baseline in PASI score at Weeks 4, 8, 12 and 16.

    • Mean percent change from baseline in Static PGA at Weeks 4, 8, 12 and 16.

    • Mean percent change from baseline in NAPSI score of the worst affected fingernail at Week 16.

    • Quality of life as measured by DLQI at Weeks 4, 8, 12 and 16.

    E.5.2.1Timepoint(s) of evaluation of this end point
    Various time points throughout the study - please refer to the detailed 'Time and Events Schedule' table in the protocol for full details.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 concerned6
    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
    Germany
    Hungary
    Latvia
    Poland
    Russian Federation
    Ukraine
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state22
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 140
    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)
    Following completion of the trial the patient should be returned to the care of a physician and standard therapy as required.
    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 Decision2013-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-21
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