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    Summary
    EudraCT Number:2011-004254-25
    Sponsor's Protocol Code Number:CIGE025EDE16
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-12
    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 number2011-004254-25
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter, 28-week treatment study with an 8 week follow-up period to investigate the impact of subcutaneous Omalizumab on quality of life measures as well as the incidence and severity of angioedema in patients with chronic spontaneous urticaria having a history of angioedema despite H1-antihistamine therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the impact of Omalizumab on quality of life measures as well as incidence and severity of angioedema in patients with spontaneous urticaria
    A.3.2Name or abbreviated title of the trial where available
    X-ACT
    A.4.1Sponsor's protocol code numberCIGE025EDE16
    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 SponsorNovartis Pharma GmbH
    B.1.3.4CountryGermany
    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 supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice
    B.5.3 Address:
    B.5.3.1Street AddressRoonstr. 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number00491802232300
    B.5.5Fax number004991127312160
    B.5.6E-mailinfoservice.novartis@novartis.com
    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 Xolair
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOMALIZUMAB
    D.3.9.1CAS number 242138-07-4
    D.3.9.2Current sponsor codeIGE025
    D.3.9.4EV Substance CodeSUB12543MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboPowder and solvent for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    moderate to severe chronic spontaneous urticaria with angioedema
    E.1.1.1Medical condition in easily understood language
    moderate to severe chronic spontaneous urticaria with angioedema
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10009159
    E.1.2Term Chronic urticaria
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate the superiority of omalizumab 300 mg versus placebo in patients with moderate to severe CSU regarding QoL measures. This will be done by evaluating the change of total CU-Q2oL scores in moderate to severe CSU patients with a history of angioedema and insufficient treatment response to a high dose of nsH1-antihistamines (second line treatment: up to 4x of the approved nsH1-Antihistamine dose). Scores will be calculated from baseline (visit 2) to week 28 (visit 9) with secondary objective(s).
    E.2.2Secondary objectives of the trial
     Angioedema burdened days
     Angioedema Activity Score (AAS)
     AE-Q2oL (Angioedema Quality-of-Life Score)
     Time to first angioedema episode following initiation of study therapy
     Time interval between successive angioedema episodes following initiation of therapy
     Time to first recurrence after discontinuation of omalizumab /placebo therapy within follow-up period
     Need for sedating H1-antihistamine and corticosteroids based rescue medication (as specified under 6.6.4)
     UAS7 (weekly Urticaria Activity Score)
     DLQI (Dermatology Quality of Life Index)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is informed about study procedures and medications and has given written informed consent before any assessment.
    2. Patient is able to communicate with the investigator, understands and complies with the requirements of the study.
    3. Male or Female of any race aged 18-75 years
    4. Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1 antihistamines at Baseline (Day -14) based on patient’s medical history, as defined by all of the following:
    • The presence of itch and hives for > 6 weeks
    • UAS7 score (range 0−42) ≥ 14
    5. Patient has a history of insufficient response to 4x of the approved dose of nsH1-antihistamines.
    6. Patients on high dose nsH1-antihistamine (2-4x of the approved dose) for at least 3 consecutive days immediately prior to the Day -14 screening visit (current use must be documented on the day of screening visit).
    7. CU-Q2oL Score ≥ 30 at baseline
    8. CSU diagnosis for ≥ 6 months
    9. CSU with occurrence of angioedema at least 4x in the last 6 months
    E.4Principal exclusion criteria
    1. Patients with non urticaria associated angioedema
    2. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of the compound, whichever is longer
    3. History of hypersensitivity to any of the study drugs (omalizumab) or rescue medication or to drugs of similar chemical structures.
    4. Evidence of parasitic infection.
    5. Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch.
    6. Previous treatment with omalizumab within 6 months prior to screening.
    7. Treatment with defined comedications
    8. History of anaphylactic shock.
    9. Presence of clinically significant cardiovascular, bronchial, neurological, psychiatric, metabolic or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients.
    10. Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions.
    11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
    12. Women who are pregnant or breast feeding or capable of becoming pregnant and not practicing a medically approved method of contraception1.
    15. Permanent severe diseases, especially those affecting the immune system, except CSU.
    16. Presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of gastrointestinal tract).
    17. History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia.
    18. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy.
    19. Evidence of severe renal dysfunction.
    20. Evidence of significant hepatic disease.
    21. Patient considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits.
    22. Serious psychiatric and/or psychological disturbances.
    23. History of drug or alcohol abuse.
    24. Patient unable to complete a patient diary or complete questionnaires on paper.
    25. Any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule.
    12.26. Patients, who have already been randomized into this trial earlier must not be included a second time.
    13.27. Study personnel or first degree relatives of investigator(s) must not be included in the study.

    E.5 End points
    E.5.1Primary end point(s)
    The primary variable is the change from baseline to week 28 of the CU-Q2oL questionnaire.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 28
    E.5.2Secondary end point(s)
    The AAS, AE-Q2oL, UAS7 and DLQI will be analyzed analogous to the primary endpoint, as a mean difference from baseline (visit 2) to week 28 (visit 9). Time courses will be displayed descriptively and graphically. For these analyses, values of patients requiring rescue medication will not be used for 6 weeks (resp. 4 weeks for the DLQI) following the last corticosteroid intake. Other secondary or exploratory objectives (e.g. rescue medication use, angioedema burdened days) will be summarized descriptively by treatment group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 28
    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 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 No
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    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 concerned26
    E.8.5The trial involves multiple Member States No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    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.1.3Elderly (>=65 years) Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    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 Decision2012-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-09
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