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    Summary
    EudraCT Number:2018-004621-89
    Sponsor's Protocol Code Number:LYR-210-2018-002
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-09
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2018-004621-89
    A.3Full title of the trial
    A Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis (LANTERN Study)
    Randomizované, zaslepené, předstíranou procedurou kontrolované klinické
    hodnocení fáze II s paralelními skupinami posuzující účinnost, bezpečnost
    a snášenlivost přípravku LYR-210 u dospělých pacientů s chronickou
    sinusitidou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, Safety, Tolerability Study of LYR-210 Depot in Chronic Sinusitis
    A.4.1Sponsor's protocol code numberLYR-210-2018-002
    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 SponsorLyra Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportLyra Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLyra Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address480 Arsenal Way
    B.5.3.2Town/ cityWatertown
    B.5.3.3Post codeMA 02472
    B.5.3.4CountryUnited States
    B.5.6E-mailLYR-210-clinicaltrialinfo@lyratx.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 nameLYR-210
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    Implantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMometasone furoate
    D.3.9.1CAS number 83919-23-7
    D.3.9.3Other descriptive nameMOMETASONE FUROATE
    D.3.9.4EV Substance CodeSUB03318MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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 Yes
    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.IMP: 2
    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 nameLYR-210
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    Implantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMometasone furoate
    D.3.9.1CAS number 83919-23-7
    D.3.9.3Other descriptive nameMOMETASONE FUROATE
    D.3.9.4EV Substance CodeSUB03318MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7500
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic sinusitis
    E.1.1.1Medical condition in easily understood language
    Chronic sinusitis
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10009137
    E.1.2Term Chronic sinusitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 LYR-210 in improving the composite score of 7-day average scores of 4 CS cardinal symptoms (CS7DA4S) at Week 4
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of LYR-210 in improving CS7DA4S score at end
    of treatment
    - To evaluate the effect of LYR-210 in reducing sinus inflammation as per
    magnetic resonance imaging (MRI)
    - To evaluate the time to treatment failure
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18.
    2. A CS subject who
    a. has twelve weeks or longer of two or more of the following symptoms:
    • nasal blockage/obstruction/congestion
    • nasal discharge (anterior, posterior, or both)
    • facial pain/pressure
    • reduction/loss of sense of smell and one or more of the following
    findings:
    • evidence of inflammation within paranasal sinuses or ostiomeatal
    complex on MRI
    • evidence of purulence coming from paranasal sinuses or ostiomeatal
    complex
    • nasal polyps
    b. has a composite score of 7-day average scores of 4 CS cardinal
    symptoms [2, 3] (CS7DA4S) ≥ 7 (0-3 scale for each of the symptoms) at
    Day 1 visit, and
    c. has had at least two trials of medical treatments in the past, one of
    which must include intranasal corticosteroid sprays (INCS) for a
    minimum of 4 weeks.
    3. Must be able to cease treatment with intranasal corticosteroid and
    decongestant sprays at Screening
    4. Ability to tolerate topical anesthesia.
    5. Has been informed of the nature of the study and has provided written
    informed consent as approved by the Institutional Review Board
    (IRB)/Ethics Committee (EC) of the respective clinical site or regulatory
    authority if applicable by national law.
    6. Agrees to comply with all study requirements.
    E.4Principal exclusion criteria
    1. With previous balloon sinuplasty or any endo-nasal surgery (including
    sinus surgery), except for septoplasty or surgical manipulation to nasal
    turbinates more than 6 months prior to the Screening visit.
    2. Seasonal allergic rhinitis (SAR) subjects with symptoms and/or, based
    on time of year, would anticipate onset of symptoms within 4 weeks of
    randomization.
    3. Perennial allergic rhinitis (PAR) subjects whose symptoms are well
    controlled by regular use of intranasal corticosteroids.
    4. With severe asthma or with one or more exacerbations of asthma
    requiring systemic corticosteroid use within the 6 months prior to the
    Screening visit. Subjects with moderate or severe asthma will also be
    excluded if they have not been on a stable regimen of inhaled
    corticosteroids for asthma for a minimum of 3 months prior to the
    Screening visit.
    5. Endoscopic exclusion criteria:
    a. Complete/near complete middle meatal obstruction preventing proper
    placement and/or visualization of LYR-210.
    b. Evidence of mucosal erosion or ulceration.
    c. Ongoing nasal infection.
    d. Evidence of nasal septal perforation.
    6. MRI exclusion criteria:
    a. A bilateral Zinreich score < 4 in all 3 pairs of the posterior ethmoid,
    frontal, or sphenoid sinuses (0-5 scale for each of sinuses) on Screening
    MRI.
    b. Anatomic variation which, in the opinion of the Investigator, would
    adversely impact placement of LYR-210.
    c. Structural, non-inflammatory related CS (e.g., large concha bullosa,
    tumor).
    d. Sinus disease extended into orbital or intracranial space.
    e. Evidence of mycetoma/fungal ball, allergic fungal rhinosinusitis.
    f. Sinus mucocele.
    7. History or clinical evidence or suspicion of invasive fungal sinusitis,
    allergic fungal rhinosinusitis, or atrophic rhinitis.
    8. Known history of hypersensitivity or intolerance to corticosteroids.
    9. Oral-steroid or monoclonal antibody (Xolair, Nucala) dependent
    condition.
    01. Having had systemic corticosteroids within 1 month prior to
    Screening visit.
    11. Known history of hypothalamic pituitary adrenal axial dysfunction or
    having a clinically significant out of normal range morning serum cortisol level at screening outside of the normal
    range.
    12. Previous pituitary or adrenal surgery.
    13. Has had more than 1 episode of epistaxis with frank bleeding
    requiring medical attention within 2 months of Screening visit or more
    than 1 episode of epistaxis with frank bleeding within 1 month of
    Screening visit.
    14. Has had acute exacerbation of nasal allergy or chronic sinusitis,
    upper respiratory tract infection (URTI), or common cold within 4 weeks
    of the Screening visit.
    15. Had dental procedure/implant on maxillary dentition within 4 weeks
    of the Screening visit.
    16. Has past or present acute or chronic intracranial or orbital
    complications of CS (e.g., brain abscess, related problems with eyes or
    central nervous system).
    17. History or diagnosis (in either eye) of glaucoma or ocular
    hypertension (IOP > 21 mmHg).
    18. With prior cataract surgery or presence (in either eye) of posterior
    subcapsular cataract of grade 2 or higher, nuclear sclerosis of grade 3 or
    higher, or cortical cataract of grade 2 or higher or involving a minimum
    of center optic zone of 3 mm diameter.
    29. Past or present functional vision in only one eye.
    20. Diagnosed with ongoing rhinitis medicamentosa.
    21. Known history of immune dysfunction including immune deficiency
    (IgG subclass deficiency or IgA deficiency) or autoimmune disease (e.g.,
    Wegener's granulomatosis, sarcoidosis).
    22. Past, present, or planned organ transplant or chemotherapy with
    immunosuppression.
    23. History or diagnosis of ciliary dysfunction (e.g., cystic fibrosis,
    primary ciliary dyskinesia [Kartagener syndrome]).
    24. Past or present systemic vasculitis (e.g., granulomatosis with
    polyangiitis).
    25. Evidence of disease or condition expected to compromise survival or
    ability to complete follow-up assessments.
    26. Pregnant or breast feeding. Females of child-bearing potential must
    test negative for pregnancy at the time of screening based on a serum
    pregnancy test and reverified at the time of enrollment based on a urine
    pregnancy test. Both male and female subjects of reproductive potential
    must agree to use highly effective methods of birth control, throughout
    the study.
    27. Previously participated in LYR-210 Phase I clinical study or received
    an experimental treatment in another clinical study within 5 half-lives of
    Screening visit.
    28. Currently participating in an investigational drug or device study.
    29. Determined by the Investigator as not suitable to be enrolled for
    reasons not already specified if the health of the subject or the validity
    of the study outcomes may be compromised.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline (CFBL) in average daily nasal blockage/obstruction/congestion (CS7DA4S) score at Week 4
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4
    E.5.2Secondary end point(s)
    - CFBL in CS7DA4S score at Week 24
    - Percentage of subjects with at least 1 point of decrease in the bilateral
    Zinreich score in at least 1 pair of the anterior ethmoid, maxillary,
    posterior ethmoid, frontal, or sphenoid sinuses at Week 24
    - Time to treatment failure
    sphenoid sinuses at Week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints as indicated in the secondary endpoints
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Investigator and clinic staff blinded to LYR-210 dose but not to sham procedure
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sham procedure
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Australia
    Czech Republic
    New Zealand
    Poland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    Last patient last visit
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 59
    F.4.2.2In the whole clinical trial 70
    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 return to standard of care
    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 Decision2019-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-04
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