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    The EU Clinical Trials Register currently displays   38177   clinical trials with a EudraCT protocol, of which   6271   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-005164-17
    Sponsor's Protocol Code Number:FP02C-18-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-03-22
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-005164-17
    A.3Full title of the trial
    The effect of FP-025, a MMP-12 inhibitor, on allergen-induced airway responses, airway inflammation and aspects of airway remodeling in subjects with mild eosinophilic house dust mite (HDM)-allergic asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of multiple doses of FP-025 on allergen induced airway responses in people with mild house dust mite allergic asthma.
    A.4.1Sponsor's protocol code numberFP02C-18-001
    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 SponsorForesee Pharmaceuticals co, Ltd.
    B.1.3.4CountryTaiwan
    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 supportForesee Pharmaceuticals Co., Ltd.
    B.4.2CountryTaiwan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationForesee Pharmaceuticals Co., Ltd.
    B.5.2Functional name of contact pointDavid Lau, Ph.D.
    B.5.3 Address:
    B.5.3.1Street Address3F., No. 19-3, Sanchong Rd., NanKang District.
    B.5.3.2Town/ cityTaipei
    B.5.3.3Post code115
    B.5.3.4CountryTaiwan
    B.5.4Telephone number+1650518-9886
    B.5.6E-maildavid.lau@foreseepharma.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 nameN.A.
    D.3.2Product code FP-025
    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 INNN.a.
    D.3.9.1CAS number 877176-23-3
    D.3.9.2Current sponsor codeFP-025
    D.3.9.3Other descriptive name5-[3-[[4-[(3-METHYLPHENYL)METHOXY]PHENYL]THIO]-2-FURANYL]-2,4-IMIDAZOLIDINEDIONE.
    D.3.9.4EV Substance CodeSUB188277
    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
    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 Asthma and/or COPD
    E.1.1.1Medical condition in easily understood language
    Asthma, COPD
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 the effect of FP-025 vs placebo on the allergen (HDM)-induced late asthmatic response expressed as FEV1 AUC3-8h in subjects with clinically stable, mild allergic asthma and blood eosinophilia.
    E.2.2Secondary objectives of the trial
    To determine the pharmacodynamics of FP-025 vs placebo (in blood, exhaled air, additional markers of airway physiology) following inhaled HDM challenge in subjects with clinically stable, mild allergic asthma and blood eosinophilia.

    To determine the safety and tolerability of multiple oral doses of FP-025 vs placebo in subjects with clinically stable, mild allergic asthma and blood eosinophilia.

    To assess the pharmacokinetics of FP-025 vs placebo during the allergen challenge day in subjects with clinically stable, mild allergic asthma and blood eosinophilia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Females or males, between 18 and 55 years of age at Screening, inclusive, on the day of signing the Informed Consent Form (ICF).
    2. Apart from a clinically stable asthma and HDM-allergy, subjects should be generally healthy with no history of a clinically relevant medical condition that in the opinion of the investigator might interfere with successful study conduct and no clinically relevant abnormalities on medical history, physical exam, vital signs, laboratory parameters or ECG at Screening.
    3. Subject has a BMI ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 (and weighs ≥50 kg).
    4. Subjects have been diagnosed with asthma cf GINA guidelines.
    5. Subjects should have established allergy for HDM (serum HDM-specific IgE or positive SPT at Screening or documented within 1 year pre-screening).
    6. No severe exacerbation of asthma within past 1 year requiring hospital admission and/or treatment with oral corticosteroids; no (never) intensive care admissions for asthma or intubation).
    7. FEV1 should be ≥70% of predicted on Screening Day 2.
    8. On Screening Day 2, PC20FEV1(Meth) should be <16 mg/mL if methacholine chloride is used (or adjusted by a factor of 1.2 if methacholine bromide is used).
    9. Baseline blood eosinophils should be ≥150 cells/μL at Screening or documented within 3 months before Screening Day 1.
    10. Subjects should have a documented airway late response to inhaled HDM on Screening Day 3.
    11. Subjects of childbearing potential must be willing to use adequate contraception (double-barrier) or must refrain from intercourse.
    12. Female subjects of non-childbearing potential must have had ≥ 12 months of spontaneous amenorrhea (with follicle-stimulating hormone [FSH] ≥ 30 mIU/mL). Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy (for ‘benign’ reasons), or bilateral tubal ligation.
    13. All female subjects should have a negative pregnancy test at Screening and on Day -1.
    14. Negative alcohol breath test on Screening Day 1 and Day -1.
    15. Negative cotinine test on Screening Day 1 and Day -1.
    16. Negative urine drug screen for recreational and other drugs on Screening Day 1 and Day -1.
    17. Subjects are non-smokers. A non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to Screening Day 1. Number of years smoked x number of packs per day should be <5 pack years.
    18. Subject should be willing and able to perform the lung function tests and other study-related procedures and comply with study protocol requirements.
    19. Subject should provide a signed and dated informed consent.
    E.4Principal exclusion criteria
    1. Subject has any active and/or chronic (physical or mental) condition requiring maintenance (pharmaco)therapy or which otherwise precludes subject from safe or adequate study participation (ineligibility will be assessed by the PI).
    2. Subject has a history of cancer (exception: localized basalioma or cervix carcinoma in situ).
    3. Subject had any major (nasal) surgery in the 6 months before Screening Day 1.
    4. Subject is pregnant or lactating.
    5. Subject is using immunotherapy that according to the PI may interfere with the study (e.g. in case of immunotherapy with HDM or when subject is in the updosing phase of any immunotherapy).
    6. Subject regularly used alcohol (intake of >21 units/wk for males and >14 units/wk for females) and/or recreational drugs within the last 6 months prior to screening.
    7. Subject had any respiratory (viral) infections (e.g. common cold) within 3 weeks of Screening Day 1 or on Day -1.
    8. Subject is using maintenance asthma therapy or long-acting bronchodilators or any other anti-asthma or anti-allergic medications (as detailed in the protocol) other than infrequent use of SABA prn only.
    9. Subject is using prohibited medications as detailed in the protocol.
    10. Multi-sensitized symptomatic subjects with seasonal (pollen) allergies should be included outside of the relevant allergen season and/or should not be in frequent contact with the relevant allergen during the study.
    11. Subject has any known allergic response for the medications used or known severe allergic reactions or anaphylaxis (to food/medications/insect venoms).
    12. Subject participated in medical studies in the past 3 months (non-biologicals) or in the past 6 months (biologicals).
    13. Subject is anticipated not to comply with study medication or other aspects of the study (at the discretion of the investigator).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the effect of study treatments on FEV1 AUC3-8h during the LAR (FP-025 vs placebo).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After database lock, before clinical study report.
    E.5.2Secondary end point(s)
    • Pharmacodynamic endpoints include the effect of study treatments on:
    o HDM-induced LAR expressed as max% fall in FEV1 from post-diluent baseline;
    o HDM-induced early asthmatic response (EAR) expressed as FEV1 AUC0-3h;
    o HDM-induced EAR expressed as max% fall in FEV1 from post-diluent baseline;
    o Changes in airway hyperresponsiveness expressed as PC20FEV1(Meth) (Day 1-Day 10 and Day 10-Day 12);
    o Small airway parameters following HDM-challenge (i.e. R5, R5-R20, X5, Fres;
    o Fractionated nitric oxide (FeNO);
    o Blood eosinophils.
    • Safety parameters include physical examination, clinical signs/symptoms reporting (MedDRA), (S)AEs, vital signs, lung function measurements, ECG and clinical safety laboratory outcomes (blood/urine).
    • Pharmacokinetic parameters of FP-025 in blood (plasma) include Cmax, tmax and AUC0-tau.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After database lock, before clinical study report.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Proof of concept, phase 2A study
    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 No
    E.8.1.6Cross over Yes
    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 trial1
    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 concerned2
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 32
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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)
    There will be a follow up of adverse events to a maximum of 28 days after study drug discontinuation.
    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 Decision2018-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-22
    P. End of Trial
    P.End of Trial StatusOngoing
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