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    Summary
    EudraCT Number:2013-003542-17
    Sponsor's Protocol Code Number:CU-LATER
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2013-003542-17
    A.3Full title of the trial
    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
    Multizentrische, randomisierte, doppelblinde, dosiseskalierende, Phase III Studie zur Untersuchung der Wirksamkeit, der Sicherheit und des Langzeiteffekts einer kontinuierlichen vs. bedarfsgesteuerten Therapie der chronischen spontanen Urtikaria (CSU) mit Rupatadin.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    Multizentrische, randomisierte, doppelblinde, dosiseskalierende, Phase III Studie zur Untersuchung der Wirksamkeit, der Sicherheit und des Langzeiteffekts einer kontinuierlichen vs. bedarfsgesteuerten Therapie der chronischen spontanen Urtikaria (CSU) mit Rupatadin.
    A.4.1Sponsor's protocol code numberCU-LATER
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCharité Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGA²LEN e.V.
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité Universitätsmedizin Berlin
    B.5.2Functional name of contact pointAllergie-Centrum-Charité Department
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number4930450 518043
    B.5.5Fax number4930450 518972
    B.5.6E-mailmarcus.maurer@charite.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Urtimed 10mg Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderJ.Uriach Cia., S.A.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrupatadine
    D.3.9.1CAS number 182349-12-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Spontaneous Urticaria
    Chronic Spontaneous Urticaria
    E.1.1.1Medical condition in easily understood language
    Chronic Spontaneous Urticaria
    Chronische Nesselsucht
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    • To compare CSU disease activity during the follow up phase between patients with response vs. non-response at the end of the treatment phase.
    • To compare CSU disease activity during the follow up phase between patients that had been treated daily continuously vs. on-demand in the treatment phase.
    • To compare the efficacy of rupatadine 10 mg during the treatment phase between patients treated daily continuously vs. on-demand.
    • To assess the efficacy of rupatadine 20 mg in CSU patients who not show complete symptom control with the 10 mg dose.
    • Evaluation of the safety profile of the rupatadine 20 mg dose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female aged 18 years and older
    • Documented history of active CSU (urticaria and wheals) with or without an
    associated angioedema for at least three days per week over the last 6
    weeks prior to visit 1 (screening). Urticaria symptoms must comprise wheals
    and itch
    • UAS7 of ≥6 during the screening phase
    • Overall duration of chronic spontaneous urticaria for at least 3 months
    • Informed consent signed and dated
    Able to read, understand and willing to sign the informed consent form and
    abide with study procedures
    • Willing, committed and able to return for all clinic visits and complete all
    study-related procedures
    • In females of childbearing potential: negative pregnancy test; females willing
    to use highly effective contraception (Pearl-Index < 1) a woman will be
    considered not of childbearing potential if she is post-menopausal for > 2
    years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or
    hysterectomy)
    • No participation in other clinical trials 4 weeks before and after participation in
    this study
    E.4Principal exclusion criteria
    Chronic spontaneous urticaria patients with a known resistance to nsAH in 4
    times the licensed doses
    • Chronic spontaneous urticaria patients with a known resistance to rupatadine
    • Isolated presence or domination of inducible forms of urticaria or cholinergic
    urticaria (no chronic spontaneous urticaria)
    • History of adverse reactions to rupatadine or known hypersensitivity to
    rupatadine or its ingredients
    • Intake of oral corticosteroids or intravenously applied corticosteroids within
    28 days prior to screening visit
    • Use of depot corticosteroids within 3 months prior to screening visit (inhaled
    corticosteroids are allowed)
    • Use of systemic immunosupressants/immunomodulators such as ciclosporin,
    dapsone, metotrexate, and comparable drugs within 28 days prior to
    screening visit.
    • Significant medical condition, in the opinion of the Investigator, rendering the
    patient immunocompromised or not suitable for a clinical trial
    • Significant concomitant illness, in the opinion of the Investigator, that would
    adversely affect the subject’s participation or evaluation in this study
    • Subjects for whom there is concern, in the opinion of the Investigator, about
    compliance with the protocol procedures
    • The presence of a permanent gastrointestinal condition which may influence
    the oral therapy (chronic diarrhoea diseases, congenital malformations or
    surgical mutilations of gastrointestinal tract)
    Presence of active cancer which requires chemotherapy or radiation therapy
    • History or presence of epilepsy, significant neurological disorders,
    cerebrovascular attacks or ischemia
    • History or presence of myocardial infarction or acute myocardial ischemia
    • History or presence of cardiac arrhythmia which requires drug therapy
    • History or presence of clinically significant bradycardia (<50 bpm)
    • ECG alterations of repolarisation (QTc prolongations >450ms in females,
    >430ms in males)
    • Blood pressure >180/100 mmHg and/or heart rate >100/min
    • Presence of uncorrected hypokalemia or hyperkalemia
    • Evidence of significant hepatic or renal disease (GOT and/or GPT >2 times
    above the upper reference value, serum creatinine 1.5 times above the upper
    reference value)
    • Presence of galactose intolerance, Lapp lactase deficiency or glucosegalactose
    malabsorption
    • Medication with HMG-CoA reductase inhibitors (statins)
    • Presence of alcohol abuse or drug addiction
    • Pregnancy or breast-feeding
    • Subjects who are inmates of psychiatric wards, prisons, or other state
    institutions. Existing or planned placement in an institution after ruling
    according to § 40 passage 1, number 4 AMG (Arzneimittelgesetz).
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of the UAS7 values (change from baseline) at the end of the
    follow-up phase between patients that had been treated daily continuously
    vs. on-demand in the treatment phase.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Comparison of the UAS7 values (change from baseline) at the end of the follow-up
    phase (week 15 and 16) between patients that had been treated daily continuously vs.
    on-demand in the treatment phase.
    E.5.2Secondary end point(s)
    Comparison of the UAS7 values (change from baseline) during the follow-up phase
    between patients with response vs. non-response at the end of the treatment phase.
    • Comparison of the UAS7 values (change from baseline) during the follow-up phase
    (period from week 10 to week 14) between patients that had been treated daily
    continuously vs. on-demand in the treatment phase.
    • Comparison of the UAS7 values during the treatment phase (week 4, treatment with
    rupatadine 10 mg) between patients treated daily continuously vs. on-demand.
    • Comparison of the UAS7 values during the treatment phase between patients treated
    daily continuously vs. on demand during weeks 5 to 10.
    Comparison of the UAS7 values during treatment with rupatadine 10 mg and treatment
    with rupatadine 20 mg in patients who received an updosing of rupatadine (paired
    analysis).
    • Comparison of the proportion of patients with response (based on the UAS7) during the
    follow up phase in patients treated daily continuously vs on-demand in the treatment
    phase and in patients with response vs. non-response at the end of the treatment
    phase.
    • Assessment of the safety and tolerability of rupatadine 20 mg (based on the physical
    examinations, vital signs, clinical observations, monitoring lab, and adverse event
    reporting)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Comparison of the UAS7 values (change from baseline) at the end of the follow-up
    phase (week 15 and 16) between patients that had been treated daily continuously vs.
    on-demand in the treatment phase.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    dose escalating study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 172
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 192
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the completion of the study for a patient, the patient will receive continued treatment in the clinic, offerring a therapy as part of standard care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-20
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