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    Summary
    EudraCT Number:2017-001724-22
    Sponsor's Protocol Code Number:GA39688
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-09
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2017-001724-22
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL OF OMALIZUMAB IN PATIENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Clinical Trial of Omalizumab for Chronic Rhinosinusitus with Nasal Polyps
    A.4.1Sponsor's protocol code numberGA39688
    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 SponsorF. Hoffmann-La Roche 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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 Yes
    D.2.1.1.1Trade name XOLAIR
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameOmalizumab
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOMALIZUMAB
    D.3.9.1CAS number 242138-07-4
    D.3.9.3Other descriptive nameRO5489789
    D.3.9.4EV Substance CodeSUB12543MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic rhinosinusitis with nasal polyps
    E.1.1.1Medical condition in easily understood language
    Chronic rhinosinusitis with nasal polyps is a condition in which painless growths called polyps are formed in the nasal passages and the sinuses along with inflammation and swelling
    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 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 efficacy of omalizumab compared with placebo
    E.2.2Secondary objectives of the trial
    •To further evaluate the efficacy of omalizumab compared with placebo
    •To evaluate the safety of omalizumab compared with placebo
    •To evaluate the pharmacokinetics and pharmacodynamics of omalizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age 18 75 years, inclusive, at time of signing Informed Consent Form
    -Ability to comply with the study protocol, in the investigator's judgment
    -Nasal polyp score (NPS) >= 5, with a unilateral score of >= 2 for each nostril, at screening (Day -35), and on Day -7
    -Sino-Nasal Outcome Test-22 (SNOT-22) score >=20 at screening (Day -35) and at randomization (Day 1)
    -Treatment with at least nasal mometasone 200 micro gram per day, or equivalent daily dosing of nasal corticosteroid (CS), for at least 4 weeks before screening (Day -35)
    -Treatment with nasal mometasone 200 micro gram twice a day (BID) (or QD if intolerant to twice daily) during the run-in period with an adherence rate of at least 70%
    - Presence of nasal blockage/congestion with NCS >=2 (1 week recall) at Day -35 and an average of the daily NCS score over the 7 days prior to randomization of NCS >1 with at least one of the following symptoms prior to screening: nasal discharge (anterior/posterior nasal drip) and/or reduction or loss of smell
    - Eligibility per the study drugdosing table (serum IgE level >= 30 to =<1500 IU/mL and body weight >= 30 to =< 150 kg) and ability to be dosed per the dosing table
    - Willingness to maintain all background medications stable for the duration of the treatment and follow-up periods
    - Willingness and ability to use electronic device to enter study-related information in electronic devices (electronic diary [eDiary]/electronic tablet [eTablet])
    - Demonstration of at least 70% adherence to eDiary daily symptom assessment during run in period, with fully completed entries on at least 4 days in the week prior to randomization
    - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 60 days after the last dose of study drug
    E.4Principal exclusion criteria
    -Known history of anaphylaxis/hypersensitivity to omalizumab
    -Treatment with investigational drugs within 12 weeks or 5 half lives (whichever is longer) prior to screening (Day -35)
    -Treatment with monoclonal antibodies (e.g., omalizumab, mepolizumab) for 6 months prior to screening (Day -35)
    -Current treatment with leukotriene antagonists/modifiers, unless patient has been on stable dosing of such medication for at least 1 month prior to screening (Day -35)
    -Treatment with non-steroid immunosuppressants within 2 months or 5 half-lives, whichever is longer, prior to screening (Day -35)
    -Treatment with systemic corticosteroids, except when used as treatment for nasal polyposis, within 2 months prior to screening (Day -35)
    -Usage of systemic CS during the run-in period. Patients requiring systemic CS during run-in may be rescreened after completing systemic CS.
    -Treatment with intranasal CS drops or CSadministering devices (e.g., OptiNose device or stents) within 1 month prior to screening (Day -35) or during the run-in period
    -History of nasal surgery (including polypectomy) within 6 months prior to screening
    -History of sinus or nasal surgery modifying the structure of the nose such that assessment of NPS is not possible
    -Uncontrolled epistaxis requiring surgical or procedural intervention, including nasal packing, within 2 months prior to screening
    -Known or suspected diagnosis of cystic fibrosis, primary ciliary dyskinesia (e.g., Kartagener syndrome) or other dyskinetic ciliary syndromes, hypogammaglobulinemia or other immune deficiency syndrome, chronic granulomatous disease and granulomatous vasculitis, granulomatosis with polyangiitis (e.g., Wegener’s Granulomatosis), or eosinophilic granulomatous with polyangiitis (EGPA) (e.g., Churg-Strauss syndrome)
    -Presence of antrochoanal polyps
    -Concomitant conditions that interfere with evaluation of primary endpoint:
    •Nasal septal deviation occluding one or both nostrils
    •Ongoing rhinitis medicamentosa
    •Acute sinusitis, nasal infection, or upper respiratory infection during the run-in period
    •Known or suspected invasive or expansive fungal rhinosinusitis
    -Known HIV infection at screening
    -Known acute and chronic infections with hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening
    -History of myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack or a known history of a hypercoagulable disorder
    -Active tuberculosis requiring treatment within 12 months prior to screening (Day -35)
    -Initiation of or change in allergen immunotherapy within 3 months prior to screening (Day -35) or during the run-in period
    -Initiation of or change in aspirin desensitization within 4 months prior to screening (Day -35) or during the run-in period
    -Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab
    -Current malignancy or history of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma that has been treated or excised and is considered resolved
    -Any serious medical condition (including but not limited to significant arrhythmia, uncontrolled hypertension, significant pulmonary disease other than asthma) or abnormality in clinical laboratory tests that precludes the patient’s safe participation in and completion of the study
    -History of alcohol, drug, or chemical abuse within 6 months of screening
    E.5 End points
    E.5.1Primary end point(s)
    1.Change from baseline at Week 24 in average daily NCS
    2.Change from baseline at Week 24 in nasal polyps score NPS
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2.Baseline and Week 24
    E.5.2Secondary end point(s)
    1.Change from baseline at Week 24 in the average daily total nasal symptom score (TNSS)
    2.Change from baseline at Week 24 in the average daily sense of smell score
    3.Change from baseline at Week 24 in the average daily posterior rhinorrhea score
    4.Change from baseline at Week 24 in the average daily anterior rhinorrhea score
    5.Change from baseline at Week 24 in patient reported health-related quality of life (HRQoL) as assessed by the total SNOT-22
    6.Change from baseline at Week 24 in sense of smell, as assessed by the University of Pennsylvania Smell Identification Test (UPSIT)
    7.Change from baseline at Week 24 in Asthma Quality of Life Questionnaire (AQLQ) of >= 0.5 (in patients with comorbid asthma only)
    8.Change from baseline at Week 16 in the average daily NCS
    9.Change from baseline at Week 16 in NPS
    10.Reduction in the need for surgery by Week 24, as defined by an NPS of <= 4 (unilateral score of <= 2 on each side) and improvement in SNOT-22 score of >= 8.9
    11.Requirement of rescue treatment (systemic CS for >= 3 consecutive days) or having had surgery for nasal polyps through Week 24
    12.Requirement of rescue treatment (systemic CS for >=3 consecutive days) through Week 24
    13.Having had surgery for nasal polyps through Week 24
    14.Incidence of adverse events
    15.Incidence of serious adverse events
    16.Incidence of adverse events leading to omalizumab/placebo discontinuation
    17.Clinically significant change in laboratory values
    18.Serum concentration of omalizumab at specified timepoints
    19.Serum concentration of total and free IgE at specified timepoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-7.Baseline and Week 24
    8-9.Baseline and Week 16
    10-13.Up to Week 24
    14-17.Up to Week 28
    18. Day 1,Week 16, Week 24, Week 28
    19.Screening (Day -35), Day 1, Week 16, Week 24, Week 28
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 EEA30
    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
    Canada
    Czech Republic
    Germany
    Mexico
    Poland
    Portugal
    Russian Federation
    Ukraine
    United Kingdom
    United States
    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 study is defined as the date of the last patient's last visit (LPLV). The LPLV is expected to occur at a maximum of 28 weeks after the last patient is randomized.
    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 months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 120
    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)
    Patients may be eligible to receive omalizumab as part of another available sponsor- permitted study of omalizumab in nasal polyps. The Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following Web site: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2018-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-11
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