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    Summary
    EudraCT Number:2021-005906-83
    Sponsor's Protocol Code Number:LYR-210-2021-004
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-06-20
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-005906-83
    A.3Full title of the trial
    ENLIGHTEN 1: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults
    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-210-2021-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05219968
    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, MA
    B.5.3.3Post code02472
    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.3.2Product code LYR-210
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    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 Rhinosinusitis (CRS) in Adults
    E.1.1.1Medical condition in easily understood language
    Chronic Rhinosinusitis (CRS) in Adults
    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
    The primary objective is to evaluate the efficacy of LYR-210, compared with a sham procedure control, in improving the 3 cardinal symptoms of CRS in CRS participants without nasal polyps who had previously failed medical management.
    E.2.2Secondary objectives of the trial
    Evaluate the efficacy of LYR-210, compared with sham control, in improving the 3 cardinal symptoms of CRS in CRS participants without nasal polyps or with nasal polyps of grade 1 who had previously failed medical management.

    Evaluate the efficacy of LYR-210, compared with sham control, in improving CRS related quality of life, CRS symptoms, the extent of inflammation in the ethmoid sinuses, and the need for rescue
    treatment in surgery naïve CRS participants without nasal polyps or who had previously failed medical management.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥18
    - Diagnosed as having CRS
    - Bilateral ethmoid disease confirmed on computed tomography (CT)
    - Mean 3 cardinal symptom (3CS) score
    - Undergone at least 2 trials of medical treatments in the past
    - Has been informed of the nature of the study and provided written informed consent
    - Agrees to comply with all study requirements
    - Willing to cancel or be removed from waitlist for any preplanned elective sinonasal surgery for the duration of the study
    E.4Principal exclusion criteria
    - Inability to tolerate topical anesthesia
    - Previous ethmoidectomy, or surgery of the middle meatus and/or middle turbinate preventing proper placement and retention of LYR-210
    - Previous nasal surgery or polypectomy within 3 months of screening
    - Presence of nasal polyp grade 2 or higher
    - Seasonal allergic rhinitis
    - Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids
    - Severe asthma
    - Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy and CT
    - History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
    - Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
    - Known history of hypersensitivity or intolerance to corticosteroids
    - Oral steroid or monoclonal antibody dependent condition, including biologics use within 3 months of screening and systemic steroids use
    within 1 month of screening
    - SCS administered within 1 month prior to Screening visit
    - Known history of hypothalamic pituitary adrenal axial dysfunction
    - Previous pituitary or adrenal surgery
    - More than 1 episode of epistaxis with frank bleeding requiring medical attention within 2 months of Screening visit
    - Acute exacerbation of nasal allergy or CRS, upper respiratory tract infection (URTI), or common cold within 4 weeks of the Screening visit
    - Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
    - Past or present acute or chronic intracranial or orbital complications of CRS
    - History or diagnosis (in either eye) of glaucoma or ocular hypertension
    - Presence 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
    - Loss of functional vision in 1 or both eyes
    - Diagnosed with ongoing rhinitis medicamentosa
    - Known history of immune dysfunction including immune deficiency
    - Past, present, or planned organ transplant or chemotherapy with immunosuppression
    - Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection
    - History or diagnosis of ciliary dysfunction
    - Past or present systemic vasculitis
    - Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening
    - Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments
    - Previously received an experimental treatment another clinical study within 5 half-lives or 30 days
    - Currently participating in an investigational drug or device study
    - Determined by the investigator as not suitable to be enrolled
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline (CFBL) in the 7-day average composite score of the 3 cardinal symptoms (3CS) of nasal blockage/obstruction/congestion, facial pain/pressure,
    and anterior/posterior nasal discharge at Week 24 in participant without nasal polyps.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    1.CFBL in the 7-day average composite score of 3CS at Week 24
    2.CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24
    3.Rescue treatment through Week 24
    4.CFBL in the 3-D volumetric CT analysis at Week 20
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    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 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 Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sham procedure
    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 concerned12
    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
    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 (EOS) is defined as the date of the last EOS visit of the last participant of the study.
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 180
    F.1.3Elderly (>=65 years) No
    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 state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 180
    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)
    Subjects will continue being followed by their physician/rhinologist for their CRS symptoms. Subjects will be followed by their Primary Care Physician for any other symptoms.
    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 Decision2022-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-09-16
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