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    Clinical Trial Results:
    A multi-center, randomized, double blind, dose escalating phase III study on the efficacy, safety and long term outcome of continuous vs. on demand treatment of chronic spontaneous urticaria with rupatadine

    Summary
    EudraCT number
    		 2013-003542-17
    Trial protocol
    		 DE   ES  
    Global end of trial date
    20 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 May 2023
    First version publication date
    25 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CU-LATER
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité- Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Allergie-Centrum-Charité Department, Charité Universitätsmedizin Berlin, 49 30450 518043, marcus.maurer@charite.de
    Scientific contact
    Allergie-Centrum-Charité Department, Charité Universitätsmedizin Berlin, 49 30450 518043, marcus.maurer@charite.de
    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 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare CSU disease activity at the end of the follow up phase between patients that had been treated daily continuously vs. on-demand in the treatment phase.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2014
    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
    Spain: 16
    Country: Number of subjects enrolled
    Germany: 47
    Worldwide total number of subjects
    63
    EEA total number of subjects
    63
    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)
    57
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 5 study centers in Germany 4 in Spain, first patient in was on 10/02/2015.

    Pre-assignment
    Screening details
    		 A total of 77 number subjects entered the screening period (up to 2 weeks), of whom 14 patients excluded before randomization. The remaining number of 63 subjects were randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo-Group
    Arm description
    		 Patients received on demand tablet of rupatadine 10 mg x 14 ± 2 days (intake only if needed). The following ingredients are used to manufacture the placebo: pregelatinised maize-starch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate, magnesium stearate. The proportions of these ingredients are similar to those used in the rupatadine active product.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received two weeks one tablets of placebo daily x 14 ± 2 days (1-0-0) from Visit 3 to Visit 4, than up dosing to the end of treatment phase --> Group A2 received two tablets of placebo daily (morning and evening intake, 1-0-1) / one on demand tablet of rupatadine 10 mg x 14 ± 2 days (intake only if needed).

    Arm title
    		 Rupatadine 10-20mg daily continuous
    Arm description
    		 Patients received two weeks one tablets of rupatadine (10 mg) daily x 14 ± 2 days (1-0-0) from Visit 2 to Visit 3, than up dosing to 20 mg twice daily (1-0-1) from Visit 3 to Visit 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rupadatine
    Investigational medicinal product code
    182349-12-8
    Other name
    Urtimed
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Group B1 received 10 mg rupatadine continuously: one tablet of rupatadine 10 mg once daily ( 1-0-0 two weeks), than dosing up to 20 mg daily, Group B2: intake twice daily 10mg rupatadine, 1-0-1 / one on-demand tablet of placebo x 14 ± 2 days (intake only if needed).

    Number of subjects in period 1
    		Placebo-Group Rupatadine 10-20mg daily continuous
    Started
    21
    42
    Completed
    19
    38
    Not completed
    2
    4
         Consent withdrawn by subject
    -
    1
         lost of contact
    2
    2
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo-Group
    Reporting group description
    		 Patients received on demand tablet of rupatadine 10 mg x 14 ± 2 days (intake only if needed). The following ingredients are used to manufacture the placebo: pregelatinised maize-starch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate, magnesium stearate. The proportions of these ingredients are similar to those used in the rupatadine active product.

    Reporting group title
    Rupatadine 10-20mg daily continuous
    Reporting group description
    		 Patients received two weeks one tablets of rupatadine (10 mg) daily x 14 ± 2 days (1-0-0) from Visit 2 to Visit 3, than up dosing to 20 mg twice daily (1-0-1) from Visit 3 to Visit 4.

    Reporting group values
    		 Placebo-Group Rupatadine 10-20mg daily continuous Total
    Number of subjects
    		 21 42 63
    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)
    		 11 21 32
        From 65-84 years
    		 1 3 4
        85 years and over
    		 0 0 0
        not recorded
    		 9 18 27
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 42 (21 to 72) 43 (19 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 12 32 44
        Male
    		 9 10 19
    UAS-7
    Units: Score
        arithmetic mean (full range (min-max))
    		 18.62 (13.65 to 23.58) 18.78 (15.98 to 21.57) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo-Group
    Reporting group description
    		 Patients received on demand tablet of rupatadine 10 mg x 14 ± 2 days (intake only if needed). The following ingredients are used to manufacture the placebo: pregelatinised maize-starch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate, magnesium stearate. The proportions of these ingredients are similar to those used in the rupatadine active product.

    Reporting group title
    Rupatadine 10-20mg daily continuous
    Reporting group description
    		 Patients received two weeks one tablets of rupatadine (10 mg) daily x 14 ± 2 days (1-0-0) from Visit 2 to Visit 3, than up dosing to 20 mg twice daily (1-0-1) from Visit 3 to Visit 4.

    Primary: change in UAS-7

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    End point title
    		 change in UAS-7
    End point description
    Full analysis set: Based on Generalised Estimating Equations (GEE) to account for centre heterogeneity with adjusted for baseline UAS-7 and based on multiple imputation to account for missing values (10 imputed datasets), # Rupatadine 10 mg (n=3) and 20 mg (n=36) in daily continuously group.
    End point type
    Primary
    End point timeframe
    from baseline to visit 5 (week 16)
    End point values
    		 Placebo-Group Rupatadine 10-20mg daily continuous
    Number of subjects analysed
    19
    38
    Units: Score
        arithmetic mean (full range (min-max))
    -3.0 (-8.0 to 1.9)
    -6.4 (-9.5 to -3.3)
    Attachments
    		 secondary_endpoints
    Statistical analysis title
    		 group difference UAS-7 from baseline to Visit 5
    Comparison groups
    Placebo-Group v Rupatadine 10-20mg daily continuous
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    		 GEEs
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.9
         upper limit
    		 0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.24
    Notes
    [1] - Primary outcome (UAS-7 change from baseline to visit 5) was analysed by using Generalized Estimating Equations (GEEs) with Gaussian family, identity link function and exchangeable correlation structure to account for centre heterogeneity and adjusted for baseline UAS-7.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline (visit2) up to the end of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 10 mg Rupadatine on demand

    Reporting group title
    Rupatadine 10-20mg continuoisly
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Rupatadine 10-20mg continuoisly
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 42 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Rupatadine 10-20mg continuoisly
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 21 (57.14%)
    24 / 42 (57.14%)
    Investigations
    CK-elevation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    side effects due to single use of symbioflor1 (higher heartrate, dry mouth )
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    lump in right mamma
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 21 (9.52%)
    7 / 42 (16.67%)
         occurrences all number
    2
    11
    General disorders and administration site conditions
    tiredness
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 42 (0.00%)
         occurrences all number
    2
    0
    fever
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    swelling of cheek /Edema face
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Epigastric pain/Diarrhea
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 42 (4.76%)
         occurrences all number
    1
    2
    dental root infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    increased stool volume
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    heartburn
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    Additional description: with known allergic asthma
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    2
    sore throat
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    eczema of the foot/hands
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 42 (4.76%)
         occurrences all number
    0
    2
    Xerosis cutis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 42 (4.76%)
         occurrences all number
    2
    2
    Muscle pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    pain knee
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    common cold/ upper resp. Infection
         subjects affected / exposed
    5 / 21 (23.81%)
    14 / 42 (33.33%)
         occurrences all number
    5
    14
    otitis externa
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 42 (4.76%)
         occurrences all number
    0
    2
    folliculitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 42 (0.00%)
         occurrences all number
    0
    0
    cystitis
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    0
    3
    Herpes simplex reactivation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Paronychia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperkalaemia
    Additional description: (5.7 mmol/l)
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 42 (0.00%)
         occurrences all number
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jun 2014
    change of the trial protocol
    28 Oct 2016
    request for prolongation of recruitment period

    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
    For support, Contact us.
    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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