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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2021-005906-83
    Trial protocol
    		 CZ   PL   ES   AT  
    Global end of trial date
    16 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2025
    First version publication date
    26 Jun 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    LYR-210-2021-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05219968
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lyra Therapeutics, Inc.
    Sponsor organisation address
    480 Arsenal Way, Watertown, United States, MA 02472
    Public contact
    Senior Vice President, Clinical Affairs, Lyra Therapeutics, Inc., 1 617-393-4600, lyraclinical@lyratx.com
    Scientific contact
    Senior Vice President, Clinical Affairs, Lyra Therapeutics, Inc., 1 617-393-4600, lyraclinical@lyratx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Mar 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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 chronic rhinosinusitis (CRS) in CRS participants without nasal polyps who had previously failed medical management.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and with all applicable laws and regulations of the locales and countries where the study was conducted, and in compliance with Good Clinical Practice Guidelines.
    Background therapy
    		 All participants were provided with saline and instructions for daily intranasal saline irrigation as background treatment starting from screening through Week 52/End of Study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jan 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 51
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Czechia: 10
    Country: Number of subjects enrolled
    United States: 124
    Worldwide total number of subjects
    196
    EEA total number of subjects
    72
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    171
    From 65 to 84 years
    24
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Week 24 Treatment Period: 2:1 (LYR-210 to Sham) Randomization. Safety Extension Period: Sham participants received LYR-210; LYR-210 participants received LYR-210 or Sham (1:1).

    Pre-assignment
    Screening details
    		 Screening and Run-In Period: 2 to 4 weeks before randomization and treatment procedure.

    Period 1
    Period 1 title
    Week 24 Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Assessor
    Blinding implementation details
    Due to the nature of the procedure, the treating Investigator/surgeon was not blinded to the treatment assignment. Efforts were made to keep the study coordinator and other study staff blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LYR-210 up to 24 Weeks
    Arm description
    		 Single administration of LYR-210 drug matrix (7500 μg). LYR-210: LYR-210 drug matrix (mometasone furoate). Background Therapy: Daily Saline Irrigation
    Arm type
    		 Experimental

    Investigational medicinal product name
    LYR-210
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Nasal use
    Dosage and administration details
    Each LYR-210 contains a total mometasone furoate (MF) dose of 7500 μg. LYR-210 is intended to be administered bilaterally into the middle meatus by an otolaryngologist under endoscopic visualization using the provided single-use applicator. Once administered, each LYR-210 is designed to gradually deliver sustained doses of MF to the inflamed mucosal tissue over a 24-week resident time. Bilateral placement of LYR-210 is designed to deliver a total dose of 15,000 μg MF over the 24 weeks, or an average daily dose of 89 μg MF per human participant (or approximately 45 μg MF per nostril).

    Arm title
    		 Sham Procedure Control up to 24 Weeks
    Arm description
    		 Single mock administration procedure. Sham procedure control: Sham procedure control. Background Therapy: Daily Saline Irrigation
    Arm type
    		 sham

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: Due to the nature of the procedure, the treating Investigator was not blinded to the treatment assignment. Efforts were made to keep the study coordinator and other study staff blinded.
    Number of subjects in period 1
    		LYR-210 up to 24 Weeks Sham Procedure Control up to 24 Weeks
    Started
    130
    66
    Completed
    103
    63
    Not completed
    27
    3
         Consent withdrawn by subject
    2
    2
         Physician decision
    -
    1
         Adverse event, non-fatal
    3
    -
         treatment administration failure/procedure not
    6
    -
         Bilateral dislodgement
    13
    -
         not specified
    3
    -
    Period 2
    Period 2 title
    Safety Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [2]
    Roles blinded
    		 Subject, Assessor
    Blinding implementation details
    Due to the nature of the procedure, the treating Investigator/surgeon was not blinded to the treatment assignment. Efforts were made to keep the study coordinator and other study staff blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LYR-210 - LYR-210 Safety Extension
    Arm description
    		 Repeat administration of LYR-210 at Week 24. Participants randomized to LYR-210 during the Week 24 Treatment Period received LYR-210 in the Safety Extension following 1:1 re-randomization. Background therapy: Saline rinse
    Arm type
    		 Experimental

    Investigational medicinal product name
    LYR-210
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Nasal use
    Dosage and administration details
    Repeat administration of LYR-210 at Week 24. Participants randomized to LYR-210 during the Week 24 Treatment Period received LYR-210 in the Safety Extension. Background therapy: Saline rinse.

    Arm title
    		 LYR-210 - Sham Safety Extension
    Arm description
    		 Crossover from LYR-210 to sham procedure control at Week 24. Participants randomized to LYR-210 during the Week 24 Treatment Period received sham procedure control in the Safety Extension following 1:1 re-randomization. Background therapy: Saline rinse.
    Arm type
    		 sham

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sham - LYR-210 Safety Extension
    Arm description
    		 Crossover from sham procedure control to LYR-210 at Week 24. Participants randomized to sham procedure control during the Week 24 Treatment Period received LYR-210 in the Safety Extension. Background therapy: Saline rinse.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LYR-210
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Nasal use
    Dosage and administration details
    Crossover from sham procedure control to LYR-210 at Week 24. Participants randomized to sham procedure control during the Week 24 Treatment Period received LYR-210 in the Safety Extension. Background therapy: Saline rinse.

    Notes
    [2] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: Due to the nature of the procedure, the treating Investigator was not blinded to the treatment assignment. Efforts were made to keep the study coordinator and other study staff blinded.
    Number of subjects in period 2 [3]
    		LYR-210 - LYR-210 Safety Extension LYR-210 - Sham Safety Extension Sham - LYR-210 Safety Extension
    Started
    42
    42
    52
    Completed
    34
    39
    42
    Not completed
    8
    3
    10
         Consent withdrawn by subject
    2
    -
    4
         Adverse event, non-fatal
    2
    1
    1
         treatment administration failure/procedure not
    -
    1
    4
         Bilateral dislodgement
    4
    -
    1
         Lost to follow-up
    -
    1
    -
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Following the Week 24 Treatment Period, 84 LYR-210 subjects and 52 sham subjects entered the Safety Extension Period. 40 LYR-210 subjects and 14 sham subjects did not enter the Safety Extension Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LYR-210 up to 24 Weeks
    Reporting group description
    		 Single administration of LYR-210 drug matrix (7500 μg). LYR-210: LYR-210 drug matrix (mometasone furoate). Background Therapy: Daily Saline Irrigation

    Reporting group title
    Sham Procedure Control up to 24 Weeks
    Reporting group description
    		 Single mock administration procedure. Sham procedure control: Sham procedure control. Background Therapy: Daily Saline Irrigation

    Reporting group values
    		 LYR-210 up to 24 Weeks Sham Procedure Control up to 24 Weeks Total
    Number of subjects
    		 130 66 196
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 113 58 171
        From 65-84 years
    		 16 8 24
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.2 ( 13.52 ) 44.9 ( 14.42 ) -
    Gender categorical
    Units: Subjects
        Female
    		 56 31 87
        Male
    		 74 35 109
    Subject analysis sets

    Subject analysis set title
    ITT Analysis Set - LYR-210
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Analysis Set was defined as all randomized participants who successfully received the IP (LYR-210 or control) on Day 1.

    Subject analysis set title
    ITT Analysis Set - Sham control procedure
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Analysis Set was defined as all randomized participants who successfully received the IP (LYR-210 or control) on Day 1.

    Subject analysis set title
    ITT Analysis Set Without Nasal Polyps - LYR-210
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Analysis Set Without Nasal Polyps was defined as all randomized participants without nasal polyps who successfully received the IP (LYR-210 or control) on Day 1.

    Subject analysis set title
    ITT Analysis Set Without Nasal Polyps - Sham control procedure
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Analysis Set Without Nasal Polyps was defined as all randomized participants without nasal polyps who successfully received the IP (LYR-210 or control) on Day 1.

    Subject analysis sets values
    		 ITT Analysis Set - LYR-210 ITT Analysis Set - Sham control procedure ITT Analysis Set Without Nasal Polyps - LYR-210 ITT Analysis Set Without Nasal Polyps - Sham control procedure
    Number of subjects
    124
    66
    101
    54
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    107
    58
    88
    47
        From 65-84 years
    16
    8
    13
    7
        85 years and over
    1
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    50 ( 13.65 )
    45 ( 14.42 )
    50 ( 13.49 )
    45 ( 14.79 )
    Gender categorical
    Units: Subjects
        Female
    53
    31
    45
    24
        Male
    71
    35
    56
    30

    End points

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    End points reporting groups
    Reporting group title
    LYR-210 up to 24 Weeks
    Reporting group description
    		 Single administration of LYR-210 drug matrix (7500 μg). LYR-210: LYR-210 drug matrix (mometasone furoate). Background Therapy: Daily Saline Irrigation

    Reporting group title
    Sham Procedure Control up to 24 Weeks
    Reporting group description
    		 Single mock administration procedure. Sham procedure control: Sham procedure control. Background Therapy: Daily Saline Irrigation
    Reporting group title
    LYR-210 - LYR-210 Safety Extension
    Reporting group description
    		 Repeat administration of LYR-210 at Week 24. Participants randomized to LYR-210 during the Week 24 Treatment Period received LYR-210 in the Safety Extension following 1:1 re-randomization. Background therapy: Saline rinse

    Reporting group title
    LYR-210 - Sham Safety Extension
    Reporting group description
    		 Crossover from LYR-210 to sham procedure control at Week 24. Participants randomized to LYR-210 during the Week 24 Treatment Period received sham procedure control in the Safety Extension following 1:1 re-randomization. Background therapy: Saline rinse.

    Reporting group title
    Sham - LYR-210 Safety Extension
    Reporting group description
    		 Crossover from sham procedure control to LYR-210 at Week 24. Participants randomized to sham procedure control during the Week 24 Treatment Period received LYR-210 in the Safety Extension. Background therapy: Saline rinse.

    Subject analysis set title
    ITT Analysis Set - LYR-210
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Analysis Set was defined as all randomized participants who successfully received the IP (LYR-210 or control) on Day 1.

    Subject analysis set title
    ITT Analysis Set - Sham control procedure
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Analysis Set was defined as all randomized participants who successfully received the IP (LYR-210 or control) on Day 1.

    Subject analysis set title
    ITT Analysis Set Without Nasal Polyps - LYR-210
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Analysis Set Without Nasal Polyps was defined as all randomized participants without nasal polyps who successfully received the IP (LYR-210 or control) on Day 1.

    Subject analysis set title
    ITT Analysis Set Without Nasal Polyps - Sham control procedure
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Analysis Set Without Nasal Polyps was defined as all randomized participants without nasal polyps who successfully received the IP (LYR-210 or control) on Day 1.

    Primary: Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps

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    End point title
    		 Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps
    End point description
    The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 ITT Analysis Set Without Nasal Polyps - LYR-210 ITT Analysis Set Without Nasal Polyps - Sham control procedure
    Number of subjects analysed
    101
    54
    Units: Change from Baseline in 3CS Score
        arithmetic mean (standard deviation)
    -2.13 ( 2.172 )
    -2.06 ( 2.136 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A negative change from baseline indicates an improvement from baseline (ie, favorable outcome). The LS means, SEs, CIs, and p-values are from an MMRM for CFBL with the fixed, categorical effects of treatment, visit, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction. CFBL = change from baseline; CI = confidence interval; LS = least squares; MMRM = mixed model with repeated measures; SD = Standard Deviation
    Comparison groups
    ITT Analysis Set Without Nasal Polyps - LYR-210 v ITT Analysis Set Without Nasal Polyps - Sham control procedure
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8995
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24.

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    End point title
    		 CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24.
    End point description
    The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ITT Analysis Set - LYR-210 ITT Analysis Set - Sham control procedure
    Number of subjects analysed
    124
    66
    Units: Change from Baseline in 3CS Score
        arithmetic mean (standard deviation)
    -2.35 ( 2.278 )
    -1.83 ( 2.104 )
    No statistical analyses for this end point

    Secondary: CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24

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    End point title
    		 CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24
    End point description
    The SNOT-22 questionnaire is a 22-item disease-specific quality of life instrument. Each symptom is scored on a 6-point scale where 0 =no problem and 5 = problem as bad as it can be. The total SNOT-22 score is the sum of the 22 items and can range from 0 to 110 with higher scores indicating worse symptoms.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ITT Analysis Set - LYR-210 ITT Analysis Set - Sham control procedure
    Number of subjects analysed
    124
    66
    Units: Change from Baseline in SNOT-22 score
        arithmetic mean (standard deviation)
    -19.7 ( 21.67 )
    -15.7 ( 18.55 )
    No statistical analyses for this end point

    Secondary: CFBL in the 3-D Volumetric CT Score at Week 20

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    End point title
    		 CFBL in the 3-D Volumetric CT Score at Week 20
    End point description
    The percent opacification of the bilateral anterior and posterior ethmoids will be assessed by 3-D volumetric CT analysis at baseline and Week 20. A negative change from Baseline indicates improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    		 ITT Analysis Set - LYR-210 ITT Analysis Set - Sham control procedure
    Number of subjects analysed
    124
    66
    Units: Percent ethmoid opacification
        arithmetic mean (standard deviation)
    -2.705 ( 10.9320 )
    -0.279 ( 9.9706 )
    No statistical analyses for this end point

    Secondary: Participants With Rescue Treatments for CRS Through Week 24

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    End point title
    		 Participants With Rescue Treatments for CRS Through Week 24
    End point description
    This endpoint is descriptively summarized per the prespecified plan. This includes participants that used systemic corticosteroid for any reason as well as participants that were recommended/underwent sinonasal surgery.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ITT Analysis Set - LYR-210 ITT Analysis Set - Sham control procedure
    Number of subjects analysed
    124
    66
    Units: Participants
        number (not applicable)
    12
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are reported throughout the study, from the time the informed consent form (ICF) is signed until completion of all follow-up visits up to Week 52.
    Adverse event reporting additional description
    Week 24 Treatment TEAEs: AEs that start during or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure but no later than 31 days after discontinuation of second study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    LYR-210 up to 24 Weeks
    Reporting group description
    		 Single administration of LYR-210 drug matrix (7500 μg). LYR-210: LYR-210 drug matrix (mometasone furoate). Background Therapy: Daily Saline Irrigation

    Reporting group title
    Sham Procedure Control up to 24 Weeks
    Reporting group description
    		 Single mock administration procedure. Sham procedure control: Sham procedure control. Background Therapy: Daily Saline Irrigation

    Reporting group title
    LYR-210 - LYR-210 Extension
    Reporting group description
    		 Repeat administration of LYR-210 at Week 24. Background Therapy: Daily Saline Irrigation

    Reporting group title
    LYR-210 - Sham Extension
    Reporting group description
    		 Crossover from LYR210 to sham procedure control at Week 24. Background Therapy: Daily Saline Irrigation

    Reporting group title
    Sham - LYR-210 Extension
    Reporting group description
    		 Crossover from sham procedure control to LYR-210 at Week 24. Background Therapy: Daily Saline Irrigation

    Serious adverse events
    		 LYR-210 up to 24 Weeks Sham Procedure Control up to 24 Weeks LYR-210 - LYR-210 Extension LYR-210 - Sham Extension Sham - LYR-210 Extension
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 124 (3.23%)
    4 / 66 (6.06%)
    2 / 42 (4.76%)
    3 / 41 (7.32%)
    3 / 48 (6.25%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal Cancer
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Cervical Vertebral Fracture
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 66 (1.52%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 66 (1.52%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    0 / 124 (0.00%)
    2 / 66 (3.03%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of Consciousness
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 66 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haematemesis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eosinophilic pneumonia
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheal Stenosis
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 66 (1.52%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 66 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colonic Abscess
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 66 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical Device Site Joint Infection
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 66 (1.52%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LYR-210 up to 24 Weeks Sham Procedure Control up to 24 Weeks LYR-210 - LYR-210 Extension LYR-210 - Sham Extension Sham - LYR-210 Extension
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 124 (62.90%)
    26 / 66 (39.39%)
    21 / 42 (50.00%)
    9 / 41 (21.95%)
    19 / 48 (39.58%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 124 (5.65%)
    1 / 66 (1.52%)
    1 / 42 (2.38%)
    2 / 41 (4.88%)
    2 / 48 (4.17%)
         occurrences all number
    9
    1
    1
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    23 / 124 (18.55%)
    7 / 66 (10.61%)
    6 / 42 (14.29%)
    2 / 41 (4.88%)
    4 / 48 (8.33%)
         occurrences all number
    29
    8
    8
    2
    6
    Nasal Odour
         subjects affected / exposed
    23 / 124 (18.55%)
    0 / 66 (0.00%)
    6 / 42 (14.29%)
    0 / 41 (0.00%)
    8 / 48 (16.67%)
         occurrences all number
    27
    0
    7
    0
    10
    Infections and infestations
    Acute Sinusitis
         subjects affected / exposed
    14 / 124 (11.29%)
    0 / 66 (0.00%)
    2 / 42 (4.76%)
    0 / 41 (0.00%)
    4 / 48 (8.33%)
         occurrences all number
    15
    0
    2
    0
    4
    COVID-19
         subjects affected / exposed
    10 / 124 (8.06%)
    4 / 66 (6.06%)
    3 / 42 (7.14%)
    2 / 41 (4.88%)
    1 / 48 (2.08%)
         occurrences all number
    10
    4
    3
    2
    1
    Chronis Sinusitis
         subjects affected / exposed
    14 / 124 (11.29%)
    3 / 66 (4.55%)
    6 / 42 (14.29%)
    4 / 41 (9.76%)
    4 / 48 (8.33%)
         occurrences all number
    19
    4
    7
    5
    5
    Nasopharyngitis
         subjects affected / exposed
    10 / 124 (8.06%)
    6 / 66 (9.09%)
    4 / 42 (9.52%)
    1 / 41 (2.44%)
    2 / 48 (4.17%)
         occurrences all number
    11
    6
    4
    1
    2
    Sinusitis
         subjects affected / exposed
    13 / 124 (10.48%)
    3 / 66 (4.55%)
    4 / 42 (9.52%)
    2 / 41 (4.88%)
    3 / 48 (6.25%)
         occurrences all number
    14
    4
    4
    3
    3
    Upper Respiratory Tract Infection
         subjects affected / exposed
    10 / 124 (8.06%)
    10 / 66 (15.15%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    1 / 48 (2.08%)
         occurrences all number
    11
    13
    1
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Feb 2022
    Changes to primary and secondary objectives. Information regarding primary and secondary endpoints updated. Updated safety endpoints. Added study design rationale section. Updated inclusion and exclusion criteria. Clarifications to prohibited medications. Section Methods and Procedures updated. Section Study assessments, endpoints and activities updated. Removed the requirement for all removed drug matrices to be returned to the Sponsor. Clarified AE meaning. Recalculated sample size. Updated statistical considerations section. Schedule of Assessments updated. Questionnaires updated.
    20 Jul 2022
    Spain specific protocol amendment. Clarified that nonsedating antihistamines included second, third, and fourth generation antihistamines. Removed “Interim Analysis” section from the Protocol. Edited wording to adjust with Clinical Trials Facilitation and Coordination Group guidelines for male contraception.
    25 Jul 2022
    Czech Republic specific protocol amendment. Added “effective treatment will not be withheld from study participants solely for entering the study.” Added a bullet point that allowed for beta-agonists such as LABA and SABA in COPD and asthma patients. Added asthma to the list of patients that are allowed to use inhaled anticholinergic medication. Revised the statement regarding the run-in period to “if a patient requires rescue medication, he/she will not be enrolled into the study.” Added “Discontinuation of Study Participants” section that addressed the withdrawal of patients from the study. Removed “Interim Analysis” section from the Protocol.
    09 Mar 2023
    Updated inclusion and exclusion criteria. Updated permitted and prohibited medications. Updated Methods and procedures section. Added information on safety extension treatment. Added “Discontinuation of Study Participants” section. Updated Study assessments, endpoints, and activities section. Clarified protocol deviations. Removed “Interim Analysis” section from the Protocol. Updated Schedule of Assessments. Clarified nasal polyp grading. Contraception and pregnancy information clarified for US and EU. Edited male contraception information to adjust with Clinical Trials Facilitation and Coordination Group guidelines for male contraception.
    31 Oct 2023
    Changes in the body of the document were updated in the synopsis. A subsection was added to clarify the first 24-week treatment analysis and database lock. Updated Table 1 (Attributes of the Primary Estimand) to mention that data post-rescue would be imputed with the participants’ worst observed score if rescue treatment was required. Removed the CFBL in the 3 individual components of the 3CS score endpoints. Added rescue treatment requirement through Week 24 endpoint. The statistical testing will be conducted from pooled studies. Clarified that the key secondary and secondary endpoints were to be analyzed for all participants. Added “descriptive summary of efficacy data from the safety extension portion” as an endpoint (#23). Updated the analysis method to MMRM. Added “interim analysis” section to the Protocol. No interim analysis was planned. Updated footnote for follow-up CT. Updated footnote for ocular exam to allow for exams to be performed outside of the visit window in case of scheduling issues.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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