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    Summary
    EudraCT Number:2013-004669-15
    Sponsor's Protocol Code Number:CP007A
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-04-15
    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 - PEI
    A.2EudraCT number2013-004669-15
    A.3Full title of the trial
    An Optional Prospective Follow-on Study to Evaluate the Continued Efficacy and Safety of Cat-PAD in Cat Allergic Subjects up to Five Years after the Administration of Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Optional Follow-up Study to Evaluate the Continued Effectiveness and Safety of Cat-PAD in Cat Allergic Subjects up to Five Years after the Administration of Treatment
    A.3.2Name or abbreviated title of the trial where available
    not available
    A.4.1Sponsor's protocol code numberCP007A
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02040844
    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 SponsorCircassia Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCircassia Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCircassia Limited
    B.5.2Functional name of contact pointCP007A-ClinicalTrialInformationDesk
    B.5.3 Address:
    B.5.3.1Street AddressMagdalen Centre, Robert Robinson Avenue, The Oxford Science Park
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX4 4GA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441865598078
    B.5.5Fax number+447092987560
    B.5.6E-mailCP007AClinicalTrialInformationDesk@circassia.co.uk
    D. IMP Identification
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of cat allergen induced rhinoconjunctivitis in patients with clinically relevant symptoms
    E.1.1.1Medical condition in easily understood language
    perennial allergic rhinitis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10034382
    E.1.2Term Perennial allergic rhinitis
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the continued efficacy of Cat-PAD, the first in a new class of
    Synthetic Peptide Immuno-Regulatory Epitopes, for a total of up to five years after the administration of treatment, based on the reduction of symptoms and the use of allergy medication in subjects previously participating in CP007.
    E.2.2Secondary objectives of the trial
    To evaluate the continued safety and tolerability of Cat-PAD for up to five years after the administration of treatment.

    To evaluate the effect of Cat-PAD on RQLQ for up to five years after the
    administration of treatment.

    To evaluate the effect of Cat-PAD on the onset of asthma for up to five years after the administration of treatment.

    To evaluate the effect of Cat-PAD on asthma progression in subjects
    previously enrolled in CP007 with GINA 1 asthma for up to five years after the administration of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Previously randomised into the clinical study CP007 and completed PAC3.
    2. Provide written informed consent or assent, as appropriate. (For subjects less than 18 years a Parent/Guardian will also be required to provide written informed consent).
    3. Willing and able to comply with the study requirements.
    E.4Principal exclusion criteria
    1. Started allergen immunotherapy since completing CP007.
    2. Has been informed of the treatment received in study CP007.
    3. Dependent on the Investigator/site either for employment or
    education or are
    first degree relatives or partners of the Investigator/study staff.
    4. Subjects institutionalised due to a legal or regulatory order
    E.5 End points
    E.5.1Primary end point(s)
    Mean Combined Score (CS) consisting of (TRSS/8 + Allergy Medication Score [AMS]).

    The TRSS range of scores (0-24) will be divided by the number of symptoms (8) to provide an average score per symptom of 0-3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The first analysis of the data will be performed on the first year’s data after all subjects have completed one year in this study. Additional analyses of the second, third and fourth year in the study will be performed after all subjects have completed each additional year in the study.
    E.5.2Secondary end point(s)
    - Mean TRSS
    - Mean component scores of the TRSS (nasal and ocular)
    - Mean Allergy Medication Score (AMS)
    - Mean RQLQ Score
    - Concomitant medications
    - Adverse Events (AEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The first analysis of the data will be performed on the first year’s data after all subjects have completed one year in this study. Additional analyses of the second, third and fourth year in the study will be performed after all subjects have completed each additional year in the study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Superiority
    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 trial3
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Czech Republic
    Germany
    Poland
    United States
    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
    last subject completes the last 4-year follow up assessment
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 236
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 236
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 946
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-04-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children between 12-17 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 559
    F.4.2.2In the whole clinical trial 1182
    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)
    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 Decision2014-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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