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    Clinical Trial Results:
    Proof-of-concept, multi-center, randomized, double-blind, placebo-controlled, two-way crossover study to investigate the effect strength of BAY 2586116 on the apnea-hypopnea-index after repetitive nasal doses compared to placebo in 80 valid participants with moderate to severe obstructive sleep apnea

    Summary
    EudraCT number
    		 2020-000520-19
    Trial protocol
    		 DE  
    Global end of trial date
    11 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Nov 2022
    First version publication date
    15 Nov 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY2586116/20849
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04713826
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    Public contact
    Bayer Clinical Trials Contact, Bayer AG, +49 30300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Bayer Clinical Trials Contact, Bayer AG, +49 30300139003, clinical-trials-contact@bayer.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
    11 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect strength of BAY2586116 on obstructive sleep apnea (OSA) severity after repetitive doses compared to placebo
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 62
    Country: Number of subjects enrolled
    Switzerland: 31
    Worldwide total number of subjects
    93
    EEA total number of subjects
    62
    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)
    63
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 3 centers, 2 centers in Germany and 1 center in Switzerland with first subject first visit on 03-Mar-2021 and last subject last visit on 13-Sep-2021

    Pre-assignment
    Screening details
    		 120 subjects were screened, 93 subjects were randomized, 47 subjects to BAY2586116–Placebo intervention sequence and 46 to Placebo-BAY2586116 intervention sequence. 2 of these subjects didn’t receive treatment as planned, 1 received BAY2586116 twice and 1 received placebo twice. All 93 randomized subjects received at least 1 dose of study drug.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BAY2586116 160ug (nasal spray) - Placebo
    Arm description
    		 Subjects received multiple daily doses of 160 μg BAY2586116 nasal spray first in treatment period 1, and matching placebo in treatment period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAY2586116
    Investigational medicinal product code
    BAY2586116
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    160 μg BAY2586116 nasally. Applied once per night for 6 days (+ 1 optional day) and 1 single dose prior to overnight polysomnography (PSG).

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Placebo nasally. Applied once per night for 6 days (+ 1 optional day) and 1 single dose prior to overnight PSG.

    Arm title
    		 Placebo - BAY2586116 160ug (nasal spray)
    Arm description
    		 Subjects received matching placebo first in treatment period 1, and multiple daily doses of 160 μg BAY2586116 nasal spray in treatment period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Placebo nasally. Applied once per night for 6 days (+ 1 optional day) and 1 single dose prior to overnight PSG.

    Investigational medicinal product name
    BAY2586116
    Investigational medicinal product code
    BAY2586116
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    160 μg BAY2586116 nasally. Applied once per night for 6 days (+ 1 optional day) and 1 single dose prior to overnight PSG.

    Arm title
    		 BAY2586116 160ug (nasal spray)-BAY2586116 160ug (nasal spray)
    Arm description
    		 Subject received multiple daily doses of 160 μg BAY2586116 nasal spray first in treatment period 1, and then multiple daily doses of 160 μg BAY2586116 nasal spray in treatment period 2 by mistake
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAY2586116
    Investigational medicinal product code
    BAY2586116
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    160 μg BAY2586116 nasally. Applied once per night for 6 days (+ 1 optional day) and 1 single dose prior to overnight PSG.

    Arm title
    		 Placebo - Placebo
    Arm description
    		 Subject received matching placebo first in treatment period 1, and then matching placebo in treatment period 2 by mistake
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Placebo nasally. Applied once per night for 6 days (+ 1 optional day) and 1 single dose prior to overnight PSG.

    Number of subjects in period 1
    		BAY2586116 160ug (nasal spray) - Placebo Placebo - BAY2586116 160ug (nasal spray) BAY2586116 160ug (nasal spray)-BAY2586116 160ug (nasal spray) Placebo - Placebo
    Started
    46
    45
    1
    1
    Completed
    46
    44
    1
    1
    Not completed
    0
    1
    0
    0
         Adverse event, non-fatal
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BAY2586116 160ug (nasal spray) - Placebo
    Reporting group description
    		 Subjects received multiple daily doses of 160 μg BAY2586116 nasal spray first in treatment period 1, and matching placebo in treatment period 2

    Reporting group title
    Placebo - BAY2586116 160ug (nasal spray)
    Reporting group description
    		 Subjects received matching placebo first in treatment period 1, and multiple daily doses of 160 μg BAY2586116 nasal spray in treatment period 2

    Reporting group title
    BAY2586116 160ug (nasal spray)-BAY2586116 160ug (nasal spray)
    Reporting group description
    		 Subject received multiple daily doses of 160 μg BAY2586116 nasal spray first in treatment period 1, and then multiple daily doses of 160 μg BAY2586116 nasal spray in treatment period 2 by mistake

    Reporting group title
    Placebo - Placebo
    Reporting group description
    		 Subject received matching placebo first in treatment period 1, and then matching placebo in treatment period 2 by mistake

    Reporting group values
    		 BAY2586116 160ug (nasal spray) - Placebo Placebo - BAY2586116 160ug (nasal spray) BAY2586116 160ug (nasal spray)-BAY2586116 160ug (nasal spray) Placebo - Placebo Total
    Number of subjects
    		 46 45 1 1 93
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 30 33 0 0 63
        From 65-84 years
    		 16 12 1 1 30
    Gender categorical
    Units: Subjects
        Female
    		 10 13 0 0 23
        Male
    		 36 32 1 1 70
    Baseline AHI Group
    AHI: apnea-hypopnea index
    Units: Subjects
        Baseline AHI <15
    		 3 4 0 0 7
        Baseline AHI 15-30 (moderate OSA)
    		 18 17 0 0 35
        Baseline AHI >30 (severe OSA)
    		 24 23 1 1 49
        Missing baseline AHI
    		 1 1 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    BAY2586116 160ug (nasal spray) - Placebo
    Reporting group description
    		 Subjects received multiple daily doses of 160 μg BAY2586116 nasal spray first in treatment period 1, and matching placebo in treatment period 2

    Reporting group title
    Placebo - BAY2586116 160ug (nasal spray)
    Reporting group description
    		 Subjects received matching placebo first in treatment period 1, and multiple daily doses of 160 μg BAY2586116 nasal spray in treatment period 2

    Reporting group title
    BAY2586116 160ug (nasal spray)-BAY2586116 160ug (nasal spray)
    Reporting group description
    		 Subject received multiple daily doses of 160 μg BAY2586116 nasal spray first in treatment period 1, and then multiple daily doses of 160 μg BAY2586116 nasal spray in treatment period 2 by mistake

    Reporting group title
    Placebo - Placebo
    Reporting group description
    		 Subject received matching placebo first in treatment period 1, and then matching placebo in treatment period 2 by mistake

    Subject analysis set title
    Safety Analysis Set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to the intervention they actually received.

    Subject analysis set title
    Efficacy Analysis Set (EAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects who had valid AHI by PSG in sleep laboratory in all three nights and took at least 80% of the study medication in each period.

    Subject analysis set title
    BAY2586116
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects who received BAY2586116

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects who received placebo

    Primary: Responder rates for BAY2586116 and placebo

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    End point title
    		 Responder rates for BAY2586116 and placebo
    End point description
    A response was defined as reduction of AHI from baseline by ≥50%
    End point type
    Primary
    End point timeframe
    At day -1, and day 7 in Period 1, and day 7 in Period 2
    End point values
    		 BAY2586116 Placebo
    Number of subjects analysed
    84 [1]
    84 [2]
    Units: percentage
        number (not applicable)
    11.9
    8.3
    Notes
    [1] - EAS
    [2] - EAS
    Statistical analysis title
    		 Difference in responder rates between treatment
    Statistical analysis description
    Success criterion: Prob(Responder rate "Placebo"<Responder rate "BAY 2586116" | data) ≥ 95%. Responder rates were compared using a Bayesian logistic regression. The posterior probability Prob(Responder rate "Placebo"<Responder rate "BAY 2586116" | data) = 80.54%, estimated difference in responder rates and 90% credible intervals were presented. Erroneously, database auto calculates the total number of subjects for the selected arms. Number of subjects evaluated in this analysis was 84.
    Comparison groups
    Placebo v BAY2586116
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.05

    Secondary: Number of subjects with at least one treatment-emergent adverse event (TEAE) and maximum severity of TEAEs per subject

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    End point title
    		 Number of subjects with at least one treatment-emergent adverse event (TEAE) and maximum severity of TEAEs per subject
    End point description
    An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject whether or not considered related to the study intervention AEs were considered to be treatment-emergent if they started or worsened after first application of study intervention in each period up to 2 days after end of treatment in each period with study intervention An serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose: a. Results in death b. Is life-threatening c. Requires inpatient hospitalization or prolongation of existing hospitalization d. Results in persistent disability/incapacity e. Is a congenital anomaly/birth defect f. Other situations
    End point type
    Secondary
    End point timeframe
    From first application of study intervention up to 2 days after end of treatment in each period with study intervention
    End point values
    		 BAY2586116 Placebo
    Number of subjects analysed
    92 [3]
    92 [4]
    Units: subject
        Any AE
    18
    20
        Maximum intensity for any AE: MILD
    16
    17
        Maximum intensity for any AE: MODERATE
    2
    2
        Maximum intensity for any AE: SEVERE
    0
    1
        Any study drug-related AE
    5
    8
        Any AE related to procedures required by protocol
    5
    8
        Any AE leading to discontinuation of study drug
    1
    0
        Any SAE
    0
    1
    Notes
    [3] - SAF
    [4] - SAF
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dosing up to 2 days after end of treatment in each period with study intervention. Adverse event reporting for the deaths (all causes) considers all deaths that occurred at any time during the study before the last contact.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    BAY2586116
    Reporting group description
    		 All subjects who received BAY2586116.

    Reporting group title
    Placebo
    Reporting group description
    		 All subjects who received placebo.

    Serious adverse events
    		 BAY2586116 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 BAY2586116 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 92 (19.57%)
    20 / 92 (21.74%)
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 92 (0.00%)
    2 / 92 (2.17%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 92 (1.09%)
    2 / 92 (2.17%)
         occurrences all number
    1
    2
    Throat irritation
         subjects affected / exposed
    3 / 92 (3.26%)
    0 / 92 (0.00%)
         occurrences all number
    3
    0
    Nasal discomfort
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    Pharyngeal hypoaesthesia
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 92 (2.17%)
    1 / 92 (1.09%)
         occurrences all number
    2
    1
    Pharyngeal paraesthesia
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Initial insomnia
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    Nightmare
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Panic attack
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Thought blocking
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Lipase increased
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Inflammatory marker increased
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Post procedural haematuria
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Depressed level of consciousness
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 92 (1.09%)
    2 / 92 (2.17%)
         occurrences all number
    1
    2
    Headache
         subjects affected / exposed
    2 / 92 (2.17%)
    2 / 92 (2.17%)
         occurrences all number
    2
    2
    Somnolence
         subjects affected / exposed
    3 / 92 (3.26%)
    4 / 92 (4.35%)
         occurrences all number
    3
    4
    Blood and lymphatic system disorders
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Eye disorders
    Pupils unequal
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 92 (2.17%)
    1 / 92 (1.09%)
         occurrences all number
    2
    1
    Abdominal rigidity
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Dry mouth
         subjects affected / exposed
    1 / 92 (1.09%)
    1 / 92 (1.09%)
         occurrences all number
    1
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 92 (1.09%)
    1 / 92 (1.09%)
         occurrences all number
    1
    1
    Hepatobiliary disorders
    Ocular icterus
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    Chronic kidney disease
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Feb 2021
    Amendment 1 dated 26 FEB 2021, was a substantial amendment. It was issued to globally implement changes requested by the German and Swiss Competent Authorities after review of the clinical study protocol and before approval. The amendment included the following key modifications: • The description of the selected study population was changed from “Male and female participants with OSA who are otherwise healthy” to “Male and female participants with OSA” • Exclusion criteria for heart failure, uncontrolled arterial hypertension and chronic obstructive pulmonary disease (COPD) were added • Prohibited medication in concomitant medication was specified • Definitions to exclude disease related findings from laboratory/AE assessment were deleted • Data Monitoring Committee (DMC) was added • Treatable traits were adapted to include traits derived from treatment PSGs • Other treatments of OSA in addition to continuous positive airway pressure (CPAP) for pre-treatment of OSA were included • The timepoints for activities before start of PSG were adapted • The wording of the primary endpoint was changed

    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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