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    Clinical Trial Results:
    An open-label, single arm phase II study of DFV890 to assess the safety, tolerability and efficacy in participants with familial cold auto-inflammatory syndrome (FCAS)

    Summary
    EudraCT number
    		 2020-005948-33
    Trial protocol
    		 DE   IT   FR  
    Global end of trial date
    05 May 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Nov 2024
    First version publication date
    27 Mar 2024
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CDFV890A12201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04868968
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.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
    05 May 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to assess the efficacy of DFV890 to reduce cold-induced inflammation in participants with Familial cold auto-inflammatory syndrome (FCAS).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Sep 2021
    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
    United States: 1
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 1
    Worldwide total number of subjects
    4
    EEA total number of subjects
    3
    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)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in 3 investigative sites in 3 countries.

    Pre-assignment
    Screening details
    		 During the screening period the participant’s eligibility was assessed at a screening visit and a screening cold challenge was performed.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 DFV890 100mg - Treatment
    Arm description
    		 DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period
    Arm type
    		 Experimental

    Investigational medicinal product name
    DFV890
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DFV890 100 mg oral twice daily

    Number of subjects in period 1
    		DFV890 100mg - Treatment
    Started
    4
    Completed
    3
    Not completed
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DFV890 100mg - Treatment
    Reporting group description
    		 DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period

    Reporting group values
    		 DFV890 100mg - Treatment Total
    Number of subjects
    		 4 4
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 4 4
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.3 ( 15.48 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 1 1
        Male
    		 3 3
    Race/Ethnicity, Customized
    Units: Subjects
        other
    		 1 1
        white
    		 3 3

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    DFV890 100mg - Treatment
    Reporting group description
    		 DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period

    Subject analysis set title
    Screening
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Screening period

    Primary: Ratio of fold change from pre-challenge to the highest post-challenge value of white cell count (WCC) between treatment and screening period

    		 Close Top of page
    End point title
    		 Ratio of fold change from pre-challenge to the highest post-challenge value of white cell count (WCC) between treatment and screening period [1]
    End point description
    A cold challenge was performed during the screening period and on Day 4 of the treatment period. Fold change from pre-challenge to highest post-challenge value of WCC was defined as the ratio of the highest post-challenge WCC value to the pre-challenge WCC value. The ratio of fold change was defined as treatment fold change divided by the screen fold change. A value of less than 1 for the ratio of fold change indicates a lower relative increase of WCC in the treatment than in the screening period, which is a favorable outcome. The log-transformed fold change from pre-challenge to the highest post challenge WCC was analyzed using a log-linear mixed effect model. The analysis was carried out considering the data from -2 to 8 hrs post challenge. The unforeseen screen failure rate and recruitment challenges resulted in early closure of the study. Only 4 out of planned 6 participants were enrolled in the study; thus, the results should be interpreted cautiously.
    End point type
    Primary
    End point timeframe
    Screening period and treatment period (Day 4): pre cold challenge and up to 8 hours post cold challenge. The duration of the cold challenge was 45 minutes.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only analyzed descriptively.
    End point values
    		 DFV890 100mg - Treatment
    Number of subjects analysed
    4
    Units: ratio of fold change
        geometric mean (confidence interval 90%)
    0.82 (0.56 to 1.21)
    No statistical analyses for this end point

    Secondary: Number of participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    		 Number of participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs)
    End point description
    Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation.
    End point type
    Secondary
    End point timeframe
    Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
    End point values
    		 DFV890 100mg - Treatment
    Number of subjects analysed
    4
    Units: participants
        At least one AE
    4
        At least one SAE
    0
        AE leading to discontinuation
    0
        SAE leading to discontinuation
    0
    No statistical analyses for this end point

    Secondary: Physician global assessment of autoinflammatory disease activity

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    End point title
    		 Physician global assessment of autoinflammatory disease activity
    End point description
    The Physician global assessment of autoinflammatory disease activity is a questionnaire completed by the Investigator. It uses a 5-point scale. Lower scores represent better outcomes. 0 = Absent 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe
    End point type
    Secondary
    End point timeframe
    Screening and Treatment (Day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. Scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). The start of the cold challenge is at 1 hour post and the duration is 45 minutes.
    End point values
    		 DFV890 100mg - Treatment Screening
    Number of subjects analysed
    4
    4
    Units: Participants
        1 hour pre|Absent
    2
    0
        2 hours post|Absent
    2
    0
        3 hours post|Absent
    2
    0
        5 hours post|Absent
    2
    0
        9 hours post|Absent
    1
    0
        24 hours post|Absent
    2
    0
        1 hour pre|Minimal
    2
    3
        2 hours post|Minimal
    1
    2
        3 hours post|Minimal
    1
    1
        5 hours post|Minimal
    1
    1
        9 hours post|Minimal
    2
    1
        24 hours post|Minimal
    2
    3
        1 hour pre|Mild
    0
    1
        2 hours post|Mild
    1
    2
        3 hours post|Mild
    1
    3
        5 hours post|Mild
    1
    3
        9 hours post|Mild
    1
    0
        24 hours post|Mild
    0
    1
        1 hour pre|Moderate
    0
    0
        2 hours post|Moderate
    0
    0
        3 hours post|Moderate
    0
    0
        5 hours post|Moderate
    0
    0
        9 hours post|Moderate
    0
    3
        24 hours post|Moderate
    0
    0
        1 hour pre|Severe
    0
    0
        2 hours post|Severe
    0
    0
        3 hours post|Severe
    0
    0
        5 hours post|Severe
    0
    0
        9 hours post|Severe
    0
    0
        24 hours post|Severe
    0
    0
    No statistical analyses for this end point

    Secondary: Physician's severity assessment of autoinflammatory disease signs and symptoms

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    End point title
    		 Physician's severity assessment of autoinflammatory disease signs and symptoms
    End point description
    The Physician's severity assessment of autoinflammatory disease signs and symptoms is a questionnaire completed by the Investigator. It uses a 5-point scale. Lower scores represent better outcomes. 0 = Absent 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe The following items were assessed: • Assessment of skin disease (urticarial skin rash) • Assessment of arthralgia • Assessment of myalgia • Assessment of headache/migraine • Assessment of conjunctivitis • Assessment of fatigue/malaise
    End point type
    Secondary
    End point timeframe
    Screening and Treatment (Day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. Scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). The start of the cold challenge is at 1 hour post and the duration is 45 minutes.
    End point values
    		 DFV890 100mg - Treatment Screening
    Number of subjects analysed
    4
    4
    Units: Participants
        Arthralgia 1 hour pre|Absent
    3
    3
        Arthralgia 2 hours post|Absent
    4
    4
        Arthralgia 3 hours post|Absent
    4
    4
        Arthralgia 5 hours post|Absent
    4
    3
        Arthralgia 9 hours post|Absent
    3
    1
        Arthralgia 24 hours post|Absent
    3
    4
        Conjunctivitis 1 hour pre|Absent
    3
    3
        Conjunctivitis 2 hours post|Absent
    4
    3
        Conjunctivitis 3 hours post|Absent
    4
    3
        Conjunctivitis 5 hours post|Absent
    4
    3
        Conjunctivitis 9 hours post|Absent
    4
    2
        Conjunctivitis 24 hours post|Absent
    2
    3
        Fatigue/Malaise 1 hour pre|Absent
    3
    3
        Fatigue/Malaise 2 hours post|Absent
    3
    3
        Fatigue/Malaise 3 hours post|Absent
    3
    2
        Fatigue/Malaise 5 hours post|Absent
    3
    2
        Fatigue/Malaise 9 hours post|Absent
    3
    2
        Fatigue/Malaise 24 hours post|Absent
    3
    3
        Headache/Migraine 1 hour pre|Absent
    4
    4
        Headache/Migraine 2 hours post|Absent
    4
    4
        Headache/Migraine 3 hours post|Absent
    4
    4
        Headache/Migraine 5 hours post|Absent
    4
    4
        Headache/Migraine 9 hours post|Absent
    4
    3
        Headache/Migraine 24 hours post|Absent
    4
    4
        Myalgia 1 hour pre|Absent
    4
    3
        Myalgia 2 hours post|Absent
    3
    4
        Myalgia 3 hours post|Absent
    4
    3
        Myalgia 5 hours post|Absent
    4
    3
        Myalgia 9 hours post|Absent
    4
    3
        Myalgia 24 hours post|Absent
    4
    4
        Skin disease 1 hour pre|Absent
    1
    0
        Skin disease 2 hours post|Absent
    1
    0
        Skin disease 3 hours post|Absent
    2
    0
        Skin disease 5 hours post|Absent
    2
    0
        Skin disease 9 hours post|Absent
    1
    0
        Skin disease 24 hours post|Absent
    2
    0
        Arthralgia 1 hour pre|Minimal
    1
    1
        Arthralgia 2 hours post|Minimal
    0
    0
        Arthralgia 3 hours post|Minimal
    0
    0
        Arthralgia 5 hours post|Minimal
    0
    0
        Arthralgia 9 hours post|Minimal
    1
    3
        Arthralgia 24 hours post|Minimal
    1
    0
        Conjunctivitis 1 hour pre|Minimal
    1
    0
        Conjunctivitis 2 hours post|Minimal
    0
    0
        Conjunctivitis 3 hours post|Minimal
    0
    0
        Conjunctivitis 5 hours post|Minimal
    0
    0
        Conjunctivitis 9 hours post|Minimal
    0
    0
        Conjunctivitis 24 hours post|Minimal
    2
    0
        Fatigue/Malaise 1 hour pre|Minimal
    0
    0
        Fatigue/Malaise 2 hours post|Minimal
    0
    0
        Fatigue/Malaise 3 hours post|Minimal
    0
    1
        Fatigue/Malaise 5 hours post|Minimal
    0
    0
        Fatigue/Malaise 9 hours post|Minimal
    0
    0
        Fatigue/Malaise 24 hours post|Minimal
    1
    1
        Headache/Migraine 1 hour pre|Minimal
    0
    0
        Headache/Migraine 2 hours post|Minimal
    0
    0
        Headache/Migraine 3 hours post|Minimal
    0
    0
        Headache/Migraine 5 hours post|Minimal
    0
    0
        Headache/Migraine 9 hours post|Minimal
    0
    0
        Headache/Migraine 24 hours post|Minimal
    0
    0
        Myalgia 1 hour pre|Minimal
    0
    1
        Myalgia 2 hours post|Minimal
    1
    0
        Myalgia 3 hours post|Minimal
    0
    0
        Myalgia 5 hours post|Minimal
    0
    0
        Myalgia 9 hours post|Minimal
    0
    1
        Myalgia 24 hours post|Minimal
    0
    0
        Skin disease 1 hour pre|Minimal
    3
    3
        Skin disease 2 hours post|Minimal
    3
    2
        Skin disease 3 hours post|Minimal
    2
    1
        Skin disease 5 hours post|Minimal
    2
    1
        Skin disease 9 hours post|Minimal
    3
    1
        Skin disease 24 hours post|Minimal
    2
    3
        Arthralgia 1 hour pre|Mild
    0
    0
        Arthralgia 2 hours post|Mild
    0
    0
        Arthralgia 3 hours post|Mild
    0
    0
        Arthralgia 5 hours post|Mild
    0
    1
        Arthralgia 9 hours post|Mild
    0
    0
        Arthralgia 24 hours post|Mild
    0
    0
        Conjunctivitis 1 hour pre|Mild
    0
    1
        Conjunctivitis 2 hours post|Mild
    0
    1
        Conjunctivitis 3 hours post|Mild
    0
    1
        Conjunctivitis 5 hours post|Mild
    0
    1
        Conjunctivitis 9 hours post|Mild
    0
    1
        Conjunctivitis 24 hours post|Mild
    0
    1
        Fatigue/Malaise 1 hour pre|Mild
    1
    1
        Fatigue/Malaise 2 hours post|Mild
    0
    1
        Fatigue/Malaise 3 hours post|Mild
    0
    0
        Fatigue/Malaise 5 hours post|Mild
    0
    2
        Fatigue/Malaise 9 hours post|Mild
    0
    1
        Fatigue/Malaise 24 hours post|Mild
    0
    0
        Headache/Migraine 1 hour pre|Mild
    0
    0
        Headache/Migraine 2 hours post|Mild
    0
    0
        Headache/Migraine 3 hours post|Mild
    0
    0
        Headache/Migraine 5 hours post|Mild
    0
    0
        Headache/Migraine 9 hours post|Mild
    0
    1
        Headache/Migraine 24 hours post|Mild
    0
    0
        Myalgia 1 hour pre|Mild
    0
    0
        Myalgia 2 hours post|Mild
    0
    0
        Myalgia 3 hours post|Mild
    0
    1
        Myalgia 5 hours post|Mild
    0
    1
        Myalgia 9 hours post|Mild
    0
    0
        Myalgia 24 hours post|Mild
    0
    0
        Skin disease 1 hour pre|Mild
    0
    1
        Skin disease 2 hours post|Mild
    0
    2
        Skin disease 3 hours post|Mild
    0
    3
        Skin disease 5 hours post|Mild
    0
    3
        Skin disease 9 hours post|Mild
    0
    0
        Skin disease 24 hours post|Mild
    0
    1
        Arthralgia 1 hour pre|Moderate
    0
    0
        Arthralgia 2 hours post|Moderate
    0
    0
        Arthralgia 3 hours post|Moderate
    0
    0
        Arthralgia 5 hours post|Moderate
    0
    0
        Arthralgia 9 hours post|Moderate
    0
    0
        Arthralgia 24 hours post|Moderate
    0
    0
        Conjunctivitis 1 hour pre|Moderate
    0
    0
        Conjunctivitis 2 hours post|Moderate
    0
    0
        Conjunctivitis 3 hours post|Moderate
    0
    0
        Conjunctivitis 5 hours post|Moderate
    0
    0
        Conjunctivitis 9 hours post|Moderate
    0
    1
        Conjunctivitis 24 hours post|Moderate
    0
    0
        Fatigue/Malaise 1 hour pre|Moderate
    0
    0
        Fatigue/Malaise 2 hours post|Moderate
    1
    0
        Fatigue/Malaise 3 hours post|Moderate
    1
    1
        Fatigue/Malaise 5 hours post|Moderate
    1
    0
        Fatigue/Malaise 9 hours post|Moderate
    1
    1
        Fatigue/Malaise 24 hours post|Moderate
    0
    0
        Headache/Migraine 1 hour pre|Moderate
    0
    0
        Headache/Migraine 2 hours post|Moderate
    0
    0
        Headache/Migraine 3 hours post|Moderate
    0
    0
        Headache/Migraine 5 hours post|Moderate
    0
    0
        Headache/Migraine 9 hours post|Moderate
    0
    0
        Headache/Migraine 24 hours post|Moderate
    0
    0
        Myalgia 1 hour pre|Moderate
    0
    0
        Myalgia 2 hours post|Moderate
    0
    0
        Myalgia 3 hours post|Moderate
    0
    0
        Myalgia 5 hours post|Moderate
    0
    0
        Myalgia 9 hours post|Moderate
    0
    0
        Myalgia 24 hours post|Moderate
    0
    0
        Skin disease 1 hour pre|Moderate
    0
    0
        Skin disease 2 hours post|Moderate
    0
    0
        Skin disease 3 hours post|Moderate
    0
    0
        Skin disease 5 hours post|Moderate
    0
    0
        Skin disease 9 hours post|Moderate
    0
    3
        Skin disease 24 hours post|Moderate
    0
    0
        Arthralgia 1 hour pre|Severe
    0
    0
        Arthralgia 2 hours post|Severe
    0
    0
        Arthralgia 3 hours post|Severe
    0
    0
        Arthralgia 5 hours post|Severe
    0
    0
        Arthralgia 9 hours post|Severe
    0
    0
        Arthralgia 24 hours post|Severe
    0
    0
        Conjunctivitis 1 hour pre|Severe
    0
    0
        Conjunctivitis 2 hours post|Severe
    0
    0
        Conjunctivitis 3 hours post|Severe
    0
    0
        Conjunctivitis 5 hours post|Severe
    0
    0
        Conjunctivitis 9 hours post|Severe
    0
    0
        Conjunctivitis 24 hours post|Severe
    0
    0
        Fatigue/Malaise 1 hour pre|Severe
    0
    0
        Fatigue/Malaise 2 hours post|Severe
    0
    0
        Fatigue/Malaise 3 hours post|Severe
    0
    0
        Fatigue/Malaise 5 hours post|Severe
    0
    0
        Fatigue/Malaise 9 hours post|Severe
    0
    0
        Fatigue/Malaise 24 hours post|Severe
    0
    0
        Headache/Migraine 1 hour pre|Severe
    0
    0
        Headache/Migraine 2 hours post|Severe
    0
    0
        Headache/Migraine 3 hours post|Severe
    0
    0
        Headache/Migraine 5 hours post|Severe
    0
    0
        Headache/Migraine 9 hours post|Severe
    0
    0
        Headache/Migraine 24 hours post|Severe
    0
    0
        Myalgia 1 hour pre|Severe
    0
    0
        Myalgia 2 hours post|Severe
    0
    0
        Myalgia 3 hours post|Severe
    0
    0
        Myalgia 5 hours post|Severe
    0
    0
        Myalgia 9 hours post|Severe
    0
    0
        Myalgia 24 hours post|Severe
    0
    0
        Skin disease 1 hour pre|Severe
    0
    0
        Skin disease 2 hours post|Severe
    0
    0
        Skin disease 3 hours post|Severe
    0
    0
        Skin disease 5 hours post|Severe
    0
    0
        Skin disease 9 hours post|Severe
    0
    0
        Skin disease 24 hours post|Severe
    0
    0
    No statistical analyses for this end point

    Secondary: Patient’s global assessment of disease activity

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    End point title
    		 Patient’s global assessment of disease activity
    End point description
    Patient’s global assessment of disease activity is a questionnaire completed by the patient. It uses a 5-point scale. The patient selected a rating based on the patient's current disease activity at the time of the assessment. Lower scores represent better outcomes. 0 = Absent 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe
    End point type
    Secondary
    End point timeframe
    Screening and Treatment (Day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. Scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). The start of the cold challenge is at 1 hour post and the duration is 45 minutes.
    End point values
    		 DFV890 100mg - Treatment Screening
    Number of subjects analysed
    4
    4
    Units: Participants
        1 hour pre|Absent
    3
    2
        2 hours post|Absent
    3
    0
        3 hours post|Absent
    3
    0
        5 hours post|Absent
    2
    0
        9 hours post|Absent
    2
    0
        24 hours post|Absent
    2
    1
        1 hour pre|Minimal
    1
    2
        2 hours post|Minimal
    0
    4
        3 hours post|Minimal
    0
    2
        5 hours post|Minimal
    2
    2
        9 hours post|Minimal
    2
    1
        24 hours post|Minimal
    2
    3
        1 hour pre|Mild
    0
    0
        2 hours post|Mild
    1
    0
        3 hours post|Mild
    1
    2
        5 hours post|Mild
    0
    2
        9 hours post|Mild
    0
    2
        24 hours post|Mild
    0
    0
        1 hour pre|Moderate
    0
    0
        2 hours post|Moderate
    0
    0
        3 hours post|Moderate
    0
    0
        5 hours post|Moderate
    0
    0
        9 hours post|Moderate
    0
    1
        24 hours post|Moderate
    0
    0
        1 hour pre|Severe
    0
    0
        2 hours post|Severe
    0
    0
        3 hours post|Severe
    0
    0
        5 hours post|Severe
    0
    0
        9 hours post|Severe
    0
    0
        24 hours post|Severe
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    DFV890 treatment
    Reporting group description
    		 DFV890 treatment

    Serious adverse events
    		 DFV890 treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DFV890 treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Chills
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Cold urticaria
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Dermatitis
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 4 (75.00%)
         occurrences all number
    3
    Myalgia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Mar 2021
    The primary purpose of this protocol amendment is to address comments raised by the Health Authorities during their review of the original protocol. Changes related to study stopping rules, the individual treatment stopping criteria and requirements for the cold challenge have been implemented. In addition, exclusion criterion 12 has been updated to exclude participants with a known history of renal disease including nephrolithiasis.
    21 Apr 2021
    The primary purpose of this protocol amendment is to address comments raised by Health Authorities and Institutional Review Board (IRBs)/Independent Ethics Committee (IECs) during their review of the original protocol. Changes related to the study stopping rules and requirements for the cold challenge has been implemented.
    18 Jun 2021
    The primary purpose of this protocol amendment is to address comments raised by Health Authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) during their review of the original protocol. Additional information has been added and changes have been implemented related to the distinction between familial cold autoinflammatory syndrome (FCAS) and cold urticaria, the design of the cold challenge procedure, risks and mitigation of any risks introduces by cold challenge, individual and study stopping rules and requirements for the cold challenge. In addition, exclusion criterion 23 has been updated to exclude participants with cold urticaria study stopping rules and requirements for the cold challenge have been implemented.
    19 May 2022
    The main purpose of this protocol amendment is to align inclusion and exclusion criteria defined in this study based on the observation from the screening cold challenge.

    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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