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    Summary
    EudraCT Number:2017-001262-25
    Sponsor's Protocol Code Number:D-001-02
    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:2018-08-06
    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 number2017-001262-25
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, proof-of-concept, multicenter, 16-week treatment study with a 16 week follow-up period to assess the exploratory efficacy and safety of Dupilumab (anti-IL4Ra) in adult patients with cholinergic 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 cholinergic urticaria patients
    A.4.1Sponsor's protocol code numberD-001-02
    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 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 organisationCharité - Universitätsmedizin Berlin; Institute for Allergology
    B.5.2Functional name of contact pointMarcus Maurer
    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 number0049030450518043
    B.5.5Fax number0049030450518972
    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 Dupixent
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Groupe
    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
    Cholinergic urticaria despite H1-antihistamine treatment
    E.1.1.1Medical condition in easily understood language
    Cholinergic urticaria is characterized by the occurence of recurrent wheals, pruritus and or angioedema which can affect the whole body upon exercise.
    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
    The primary objective is the evaluation of Dupilumab 600 mg as loading dose and/or Dupilumab 300 mg and/or placebo in patients with CholU regarding the difference in the change of CholUAS7 (Itch 7) from baseline to week 16 in adult patients with H1-antihistamine resistent CholU.
    E.2.2Secondary objectives of the trial
    CholU when added to H1-AH alone based on changes of following secondary objectives:
    Itch score, UCT (Urticaria control test), CholU-QoL (cholinergic urticaria quality of life questionnaire), Symptom free days, DLQI, Time to first recurrence after discontinuation of Dupilumab in comparison to placebo therapy within follow-up period, Need for non-sedating H1-antihistamine rescue medication, 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 of any race
    4. Patient is 18-70 years of age
    5. Patient is diagnosed with moderate to severe CholU 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 licensed dose H1 antihistamine
    • UCT <12 prior to randomization (Day 1)
    • Patients must have been on standard of care for treatment of CholU for at least the 3 consecutive days immediately prior to the screening visit and must have documented current use on the day of the initial screening visit.
    • CholU diagnosis for >= 6 months
    6. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
    7. Patients must not have had any missing eDiary entries 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. History of hypersensitivity to Dupilumab or their components.
    2. Clearly dominating other form of urticaria as etiology for wheal and flare type reactions. This includes the following:
    - Chronic spontaneous urticaria
    - Inducible urticaria: urticaria factitia, cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, or contact-urticaria
    These diseases are allowed a comorbidities, if cholinergic urticaria is the dominating form of chronic urticaria
    3. Any other active severe skin disease associated with chronic itching that might confound the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus etc.)
    4. Previous treatment with omalizumab within 3 months prior to screening.
    5. History of anaphylactic shock.
    6. Patients with confirmed active SARS-CoV-2 infection
    E.5 End points
    E.5.1Primary end point(s)
    difference in the change of CholUAS7 (Itch 7)
    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)
    changes of following secondary objectives:
    Itch score, UCT (Urticaria control test), CholU-QoL (cholinergic urticaria quality of life questionnaire), Symptom free days, DLQI, Time to first recurrence after discontinuation of Dupilumab in comparison to placebo therapy within follow-up period, Need for non-sedating H1-antihistamine rescue medication, Investigator’s Global Assessment of efficacy, Patient´s Global Assessment of efficacy
    E.5.2.1Timepoint(s) of evaluation of this end point
    from baseline (visit 1) to week 16 (visit 9).
    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 concerned8
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state48
    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 Decision2018-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-28
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