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    Summary
    EudraCT Number:2017-004458-41
    Sponsor's Protocol Code Number:D-001-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-07-09
    Trial 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 number2017-004458-41
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, phase 2, 16-week treatment study with a 16 week follow-up period to assess the efficacy and safety of Dupilumab (anti-IL4Ra) in adult patients with chronic spontaneous urticaria despite H1-antihistamine treatment.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dupilumab tested in chronic spontaneous urticaria patients
    A.4.1Sponsor's protocol code numberD-001-01
    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 Klinik für Dermatologie und Allergologie
    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 supportSanofi-Aventis Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationproinnovera GmbH
    B.5.2Functional name of contact pointAnnika Michaelis
    B.5.3 Address:
    B.5.3.1Street AddressWienburgstraße 201
    B.5.3.2Town/ cityMünster
    B.5.3.3Post code49159
    B.5.3.4CountryGermany
    B.5.4Telephone number0049251270778282
    B.5.5Fax number00492512707786282
    B.5.6E-mailannika.michaelis@proinnovera.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 Dupixent
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Group
    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.3.1Product nameDupixent
    D.3.2Product code SAR231893
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 placeboSolution for injection in pre-filled syringe
    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
    chronic spontaneous urticaria despite H1-antihistamine treatment
    chronische spontane urticaria
    E.1.1.1Medical condition in easily understood language
    Chronic spontaneous urticaria is characterized by the occurence of recurrent wheals, pruritus and or angioedema which can affect the whole body.
    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 21.1
    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 the evaluation of Dupilumab (600 mg loading dose and subsequent 300 mg regular long term dose) being superior to placebo regarding be the difference in the change in urticaria activity score 7 (UAS7) from baseline to week 16 in adult patients with moderate to severe CSU and with H1-antihistamine resistant alone or in combination with LTRA.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of Dupilumab based on changes of following secondary objectives:
    Itch score (ISS) complete itch response is defined as 0 or a reduction of ≥ 90% compared to baseline; UCT (Urticaria control test): UCT response is defined as ≥ 12, complete UCT response is defined as 16; CU-Q2oL (Chronic Urticaria Quality of Life questionnaire), mean improvement and responder as defined as rate of patients achieving at least the defined minimal important difference; Angioedema burdened days (if applicable); AAS (Angioedema Activity Score) (if applicable); AE-QoL (Angioedema Quality-of-Life questionnaire) (if applicable); DLQI (Dermatology Quality of Life Index); Time to first recurrence after discontinuation of Dupilumab in comparison to placebo therapy within follow-up period; Need for non-sedating H1-antihistamine and corticosteroids based rescue medication (as specified under 6.5.5); Investigator’s Global Assessment of efficacy; Patient´s Global Assessment of efficacy

    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
    4. Patient is 18-75 years of age
    5. Patient is diagnosed with moderate to severe CSU and refractory to standard of care treatment at the time of randomization, as defined by the following:
    • The presence of itch, hives and recurrent angioedema for ≥ 6 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine
    • UAS7 score ≥ 16, 7 days prior to randomization (Day 1)
    • CSU diagnosis for  6 months
    6. Willing and able to complete a daily symptom Diary for the duration of the study and adhere to the study visit schedules.
    7. Patients must not have more than one missing Diary entry in the 7 days prior to randomization. Re-screening may be considered.
    8. Women of childbearing potential have to agree to use an acceptable form of contraception (as determined by the site investigator) and have to continue its use for the duration of the study.
    E.4Principal exclusion criteria
    1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
    2. History of hypersensitivity to any of the study drugs (Dupilumab, rescue medication) or to drugs of similar chemical classes.
    3. Patients whose urticaria is solely due to inducible urticaria
    4. Other diseases with symptoms of urticaria or angioedema, including urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
    5. Any other skin disease associated with chronic itching that might confound the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, etc.)
    6.
    7. Patients who have received concomitant prohibited medication within the last 3 months prior to screening:
    • Anti-IgE therapy (e.g. omalizumab)
    • Routine (daily or every other day during 5 or more consecutive days) doses of systemic corticosteroids or other immunosupressants
    • Intravenous immunoglobulins
    • Biological therapy
    • Systemic immunosuppressants
    • Live/attenuated vaccines
    8. Other investigational drugUse of prohibited treatment detailed in protocol (see under 6.5.8 Table 3)
    9. History of anaphylaxis
    10. Presence of hypereosinophilic diseases (blood eosinophils >1500 cells/mm3 at the latest available test).
    11. 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.
    12. Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions for the duration of the study. Any items that are cause for uncertainty must be reviewed with the Medical Monitor.
    13. Inability to comply with study and follow-up procedures.
    14. History of malignancy of any organ system (other than localized basal cell carcinoma or actinic keratosis or Bowen disease: carcinoma in situ of skin; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
    15. Evidence of severe renal dysfunction at screening
    14. Patient considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits.
    15. History or evidence of ongoing drug or alcohol abuse, within the last 6 months prior to randomization.
    16. Patient unable to complete a patient diary or complete questionnaires on paper.
    17. Any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule.
    18. Study personnel or first-degree relatives of investigator(s) must not be included in the study.
    19. Subjects who live in detention on court order or on regulatory action as per local and national law (see §40 subsection 1 sentence 3 no. 4 Arzneimittelgesetz)
    20. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
    21. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are using effective methods of contraception during the duration of the study.
    E.5 End points
    E.5.1Primary end point(s)
    difference in the change of UAS7 at week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    When all of the planned patients have completed the Week 16 visit (or discontinued prior to that).
    E.5.2Secondary end point(s)
    To evaluate the efficacy of Dupilumab based on changes of following secondary objectives:
    Itch score (ISS) complete itch response is defined as 0 or a reduction of ≥ 90% compared to baseline; UCT (Urticaria control test): UCT response is defined as ≥ 12, complete UCT response is defined as 16; CU-Q2oL (Chronic Urticaria Quality of Life questionnaire), mean improvement and responder as defined as rate of patients achieving at least the defined minimal important difference; Angioedema burdened days (if applicable); AAS (Angioedema Activity Score) (if applicable); AE-QoL (Angioedema Quality-of-Life questionnaire) (if applicable); DLQI (Dermatology Quality of Life Index); Time to first recurrence after discontinuation of Dupilumab in comparison to placebo therapy within follow-up period; Need for non-sedating H1-antihistamine and corticosteroids based rescue medication (as specified under 6.5.5); Investigator’s Global Assessment of efficacy; Patient´s Global Assessment of efficacy

    E.5.2.1Timepoint(s) of evaluation of this end point
    The Continuous secondary efficacy endpoints will be analyzed analogous to the primary endpoint, as a mean difference from baseline (visit 1) to week 16 (visit 9) and other time points.
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned3
    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 Yes
    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
    Before study start a CRO representative will review the protocol and CRFs with the investigators and their staff. During the study, the field monitor will visit the site regularly to check the completeness of patient records, the accuracy of entries on the CRFs, the adherence to the protocol and to Good Clinical Practice, the progress of enrollment, and to ensure that study drug is being stored, dispensed, and accounted for according to specifications.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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.1.2.1Number of subjects for this age range: 52
    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 Yes
    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 state72
    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)
    Patient will be treated in outpatient clinic.
    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 Decision2018-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-05
    P. End of Trial
    P.End of Trial StatusOngoing
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