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    Summary
    EudraCT Number:2018-000851-42
    Sponsor's Protocol Code Number:ID-084A201
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-06-12
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-000851-42
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, 12-week treatment study to evaluate the effect of ACT-774312 in subjects with bilateral nasal polyposis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect of ACT-774312 in patients with bilateral nasal polyposis
    A.4.1Sponsor's protocol code numberID-084A201
    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 SponsorIdorsia Pharmaceuticals Ltd
    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 supportIdorsia Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIdorsia Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical Trial Disclosure Desk
    B.5.3 Address:
    B.5.3.1Street AddressHegenheimermattweg 91
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number41588441977
    B.5.6E-mailclinical-trials-disclosure@idorsia.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 nameACT-774312
    D.3.2Product code ACT-774312
    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 INNACT-774312
    D.3.9.2Current sponsor codeACT-774312
    D.3.9.3Other descriptive nameACT-774312
    D.3.9.4EV Substance CodeSUB192257
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Bilateral nasal polyposis
    E.1.1.1Medical condition in easily understood language
    Nasal polyps
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028756
    E.1.2Term Nasal polyps
    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 evaluate the effect of ACT-774312 on bilateral nasal polyposis (NP).
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of ACT-774312 during 12 weeks of treatment;
    - To evaluate the pharmacokinetics (PK) of ACT-774312 in subjects with NP;
    - To evaluate the pharmacodynamic (PD) responses to ACT-774312 based on Th-2 biomarkers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed informed consent in the local language prior to any study-mandated procedure.
    • A minimum bilateral nasal polyp score (NPS) of 5 out of a maximum of 8 for both nostrils (with at least a score of 2 for each nostril) despite completion of a prior intranasal corticosteroids (INCS) treatment for at least 8 weeks before screening, with at least the 6 last weeks on INCS spray.
    • Presence of at least 2 of the following symptoms at screening:
    o nasal blockade/obstruction
    o nasal discharge (anterior/posterior nasal drip)
    o reduction or loss of smell
    • Male and female subjects aged between 18 and 70 years (inclusive) at screening.
    • Subjects with a body mass index (BMI) ≥ 18 kg/m2.
    • Systolic blood pressure 90 to 160 mmHg, diastolic blood pressure 50 to 100 mmHg, pulse rate 45 to 100 bpm (inclusive), measured on the dominant arm, after 5 min in the supine position at screening.
    • Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test pre-dose on Day 1. Women of childbearing potential must consistently and correctly use (from at least first dosing, during the entire study, and for at least 30 days after last study treatment intake) 1 highly effective method of contraception with a failure rate of < 1% per year, be sexually abstinent, or have a vasectomized partner. Hormonal contraceptive must have been initiated at least 1 month before first study treatment administration
    E.4Principal exclusion criteria
    • CYP2C9 poor metabolizer subject.
    • Subject with severe renal function impairment (≤ 29 mL/min/1.73 m2) which is defined by eGFR estimated at screening using the Modification of Diet in Renal Disease (MDRD) formula.
    • Subject with Sino-Nasal Outcome Test (SNOT-22) <20.
    • Subject who has required oral corticosteroids (OCS) within the 2 months before screening or is scheduled to receive OCS during the study period for another condition.
    • Subject who has required intranasal corticosteroids (INCS) drops within the 6 weeks before screening.
    • Subject who was injected with long-lasting activity corticosteroids within the 3 months before screening or is scheduled to receive these during the study period for another condition.
    • Subject who has undergone any nasal surgery within 6 months before screening.
    • Subjects with conditions/concomitant diseases making them non-evaluable for the primary efficacy endpoint such as:
    o Antrochoanal polyps
    o Nasal septal deviation that occludes at least one nostril
    o Acute sinusitis, nasal infection or upper respiratory infection at screening or in the 2 weeks before screening
    o Ongoing rhinitis medicamentosa
    o Churg-Strauss syndrome, Young’s syndrome, Kartagener’s syndrome or dyskinetic ciliary syndromes, Cystic fibrosis
    o Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
    • Subjects with co-morbid asthma are excluded if:
    o Forced expiratory volume in one second (FEV1) ≤ 60% of predicted normal
    OR
    o An exacerbation requiring systemic (oral and/or parenteral) steroid treatment or hospitalization (>24 h) for treatment of asthma has occurred within 3 months prior screening
    OR
    o They are on a dose higher than 1000 µg fluticasone or the equivalent of inhaled corticosteroids (ICS)

    • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
    • Subject with active autoimmune disease (e.g., Hashimoto’s thyroiditis, Graves’ disease, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, psoriasis vulgaris, rheumatoid arthritis).
    • Subject with evidence of acute or chronic infection.
    • Subject considered as vulnerable (e.g., sponsor or site employee,
    investigator subordinate, subject incapable of giving consent, subject
    committed to an institution by way of official or judicial order).
    • Subject with liver injury related criteria:
    o Underlying hepatobiliary disease
    OR
    o ALT>3 (Upper Limit of Normal) ULN
    OR
    o or Bilirubin>2 ULN
    • Subject with any contraindications or warning/precautions of use
    related to mometasone furoate nasal spray.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Week 12 in NPS as measured by nasal endoscopy assessed centrally
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 12
    E.5.2Secondary end point(s)
    1) Change from baseline to Week 12 in sinus opacifications as assessed by CT scan using the Zinreich-modified Lund Mackay Score assessed centrally.
    2) Change from baseline to Week 12 in 3D volumetric computerized values.
    3) Change from baseline to Week 2, 4, 8, 12, and EOS in University of Pennsylvania Smell Identification Test (UPSIT).
    4) Change from baseline to Week 2, 4, 8, 12, and EOS in the sum of Visual Analog Scale (VAS) symptoms score for nasal obstruction, nasal discharge, mucus in the throat, loss of smell, and facial pain.
    5) Change from baseline to Week 2, 4, 8, 12, and EOS in Physician Global Assessment (PGA) score.
    6) Change from baseline to Week 2, 4, 8, 12, and EOS in SNOT-22.
    7) Patient global impression of change in disease severity at Week 2, 4, 8, 12, and EOS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1), 2): from baseline to week 12
    3) to 7): from baseline to week 2, 4, 8, 12 and End of study
    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
    Tolerabilty
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    The end of the trial is defined as the last subject last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    After the subject's study completion or premature withdrawal from the study, whichever applies, the investigator / delegate will explain to
    subjects what approved treatment(s) / medical care is necessary and available according to local regulations.
    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 Decision2018-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-27
    P. End of Trial
    P.End of Trial StatusOngoing
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