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    Clinical Trial Results:
    A randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis

    Summary
    EudraCT number
    		 2020-000082-16
    Trial protocol
    		 DE   NL   PL  
    Global end of trial date
    09 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2024
    First version publication date
    14 Jul 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACESO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04849390
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    EsoCap AG
    Sponsor organisation address
    Malzgasse 9, Basel, Switzerland, 4052
    Public contact
    CEO, EsoCap AG, +43 69914950300, isabelle.racamier@esocapbiotech.com
    Scientific contact
    CEO, EsoCap AG, +43 69914950300, isabelle.racamier@esocapbiotech.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
    09 Oct 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Oct 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy based on the histological response
    Protection of trial subjects
    This trial was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki, independent ethics committee (IEC) informed consent regulations, and ICH GCP Guidelines. In addition, all national and local regulatory requirements were followed. Before any clinical trial-related activities were performed, the investigator (or authorized designee) reviewed the informed consent form and explained the trial to potential trial patients. The investigator ensured that the patient was fully informed about the aims, procedures, potential risks, any discomforts, and expected benefits of the clinical trial. Insurance coverage for all participating patients was guaranteed according to applicable legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Oct 2020
    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
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Spain: 31
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Switzerland: 3
    Worldwide total number of subjects
    43
    EEA total number of subjects
    40
    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)
    42
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 59 patients were screened: 9 patients at 2 centers in Germany, 6 patients at 2 centers in The Netherlands, 3 patients at 1 center in Poland, 38 patients at 8 centers in Spain, and 3 patients at 1 center in Switzerland. 16 patients were screening failures (6 in Germany, 3 in The Netherlands, and 7 in Spain) and 43 patients were randomized.

    Pre-assignment
    Screening details
    		 Patients who met all inclusion and none of the exclusion criteria were eligible to participate in the trial.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    ESO-101 and placebo capsules were identical in appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ESO-101
    Arm description
    		 Dispersible polymer film (thin film) loaded with 800 µg mometasone furoate rolled in a hard gelatin capsule administered orally once-daily for 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ESO-101
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal film, Capsule, hard
    Routes of administration
    Oropharyngeal use
    Dosage and administration details
    Patients took one oral capsule once daily in the evening at bedtime, ie, after eating dinner and after oral hygiene, for 28±2 consecutive days. Patients were not allowed to eat until they awoke the next morning and were not to drink for at least 2 hours after investigational medicinal product (IMP) intake.

    Arm title
    		 Placebo
    Arm description
    		 Dispersible polymer film (thin film) without drug substance rolled in a hard gelatin capsule administered orally once-daily for 28 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal film, Capsule, hard
    Routes of administration
    Oropharyngeal use
    Dosage and administration details
    Patients took one oral capsule once daily in the evening at bedtime, ie, after eating dinner and after oral hygiene, for 28±2 consecutive days. Patients were not allowed to eat until they awoke the next morning and were not to drink for at least 2 hours after IMP intake.

    Number of subjects in period 1
    		ESO-101 Placebo
    Started
    28
    15
    Completed
    27
    13
    Not completed
    1
    2
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ESO-101
    Reporting group description
    		 Dispersible polymer film (thin film) loaded with 800 µg mometasone furoate rolled in a hard gelatin capsule administered orally once-daily for 28 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Dispersible polymer film (thin film) without drug substance rolled in a hard gelatin capsule administered orally once-daily for 28 days.

    Reporting group values
    		 ESO-101 Placebo Total
    Number of subjects
    		 28 15 43
    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)
    		 28 14 42
        From 65-84 years
    		 0 1 1
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 38.5 (19 to 59) 47.0 (19 to 65) -
    Gender categorical
    Units: Subjects
        Female
    		 6 4 10
        Male
    		 22 11 33
    Peak eosinophil count
    The number of eosinophils was normalized using a standard high-power field (hpf) size of 0.3 mm2.
    Units: 1/hpf
        arithmetic mean (standard deviation)
    		 86.95 ( 59.57 ) 84.65 ( 49.38 ) -

    End points

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    End points reporting groups
    Reporting group title
    ESO-101
    Reporting group description
    		 Dispersible polymer film (thin film) loaded with 800 µg mometasone furoate rolled in a hard gelatin capsule administered orally once-daily for 28 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Dispersible polymer film (thin film) without drug substance rolled in a hard gelatin capsule administered orally once-daily for 28 days.

    Primary: Change in peak eosinophil count

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    End point title
    		 Change in peak eosinophil count
    End point description
    For the assessment of the eosinophil count, 6 biopsy samples of the esophagus were taken (2 each from the proximal, mid, and distal segment of the esophagus) at Visit 2 (Baseline) and Visit 5 (end of treatment [EOT]). In general only one biopsy per segment was analyzed. If the data were not conclusive, the second biopsy was analyzed. In each analyzed biopsy sample, the peak eosinophil count was determined in 3 hpfs. For the analysis all analyzed hpfs were considered. The number of eosinophils was normalized using a standard hpf size of 0.3 mm².
    End point type
    Primary
    End point timeframe
    Change from Baseline to EOT (Visit 5, Day 28)
    End point values
    		 ESO-101 Placebo
    Number of subjects analysed
    27
    13
    Units: 1/hpf
    arithmetic mean (standard deviation)
        EOT
    -49.11 ( 88.42 )
    6.63 ( 65.11 )
    Statistical analysis title
    		 Difference in change from Baseline
    Statistical analysis description
    The difference in the mean changes from Baseline between ESO-101 and placebo was tested using a 2-sided 2-sample t-test.
    Comparison groups
    ESO-101 v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 = 0.0318 [2]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -55.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -106.3
         upper limit
    		 -5.2
    Notes
    [1] - The null hypothesis was defined as H0: µ1 = µ2 with µ1 being the mean absolute chanage from Baseline to EOT in overall peak eosinophil count in the ESO-101 group and µ2 the mean absolute chanage from Baseline to EOT in overall peak eosinophil count in the placebo group.
    [2] - 5% confidence level

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From providing written informed consent until trial completion.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    ESO-101
    Reporting group description
    		 Dispersible polymer film (thin film) loaded with 800 µg mometasone furoate rolled in a hard gelatin capsule administered orally once-daily for 28 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Dispersible polymer film (thin film) without drug substance rolled in a hard gelatin capsule administered orally once-daily for 28 days.

    Serious adverse events
    		 ESO-101 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Large intestine polyp
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ESO-101 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 28 (64.29%)
    9 / 15 (60.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Headache
         subjects affected / exposed
    4 / 28 (14.29%)
    3 / 15 (20.00%)
         occurrences all number
    16
    6
    Somnolence
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Swelling face
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Dyspepsia
         subjects affected / exposed
    5 / 28 (17.86%)
    0 / 15 (0.00%)
         occurrences all number
    14
    0
    Eosinophilic oesophagitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hyperchlorhydria
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Nausea
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Odynophagia
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Oesophageal food impaction
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Dry throat
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Throat irritation
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 15 (6.67%)
         occurrences all number
    1
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Pain in extremity
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Oct 2021
    Adaptation of 1 exclusion criterion for clarification and update of trial start and end dates

    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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    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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