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    Summary
    EudraCT Number:2020-003756-33
    Sponsor's Protocol Code Number:EFC16720
    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:2020-11-27
    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 number2020-003756-33
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multi-center, parallel-group study of dupilumab in patients with chronic inducible cold urticaria who remain symptomatic despite the use of H1-antihistamine treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dupilumab for the treatment of chronic inducible cold urticaria in patients who remain symptomatic despite the use of H1-antihistamine
    A.4.1Sponsor's protocol code numberEFC16720
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1246-6913
    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 SponsorSanofi-aventis recherche et développement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis recherche et développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Deutschland GmbH
    B.5.2Functional name of contact point
    B.5.3.4CountryGermany
    B.5.6E-mailmedinfo.de@sanofi.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 No
    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 nameDupilumab
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDupilumab
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.IMP: 2
    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 No
    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 nameDupilumab
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDupilumab
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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
    D.8 Placebo: 2
    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
    Cold Urticaria
    E.1.1.1Medical condition in easily understood language
    Cold Urticaria
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10009869
    E.1.2Term Cold urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of dupilumab in adult and adolescent participants with primary acquired chronic inducible cold urticaria (ColdU) who remain symptomatic despite the use of an H1-antihistamine
    E.2.2Secondary objectives of the trial
    To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU disease control
    To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU local signs and symptoms (hives/wheals, itch, burning sensation and pain) after provocation test
    To demonstrate the efficacy of dupilumab on on primary acquired chronic inducible ColdU disease activity
    To demonstrate improvement in health-related quality-of-life and overall disease status and severity
    To evaluate the ability of dupilumab in reducing the proportion of participants who require rescue therapy
    To evaluate the proportion of participants with cold exposure triggered urticaria
    To evaluate safety outcome measures
    To evaluate immunogenicity of dupilumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participant must be ≥12 years to 80 years of age inclusive at the time of signing the informed consent
    Participants who have a diagnosis of primary acquired chronic inducible ColdU defined as recurrence of itchy wheals and/or angioedema due to cold for longer than 6 weeks prior to screening visit (Visit 1)
    Participants with positive ice cube provocation test, ie, presenting at least a confluent hive/wheal on the exposed skin area, at the screening visit (Visit 1) and randomization visit (Visit 2)
    Participants meeting at least 1 of the following criteria despite regular/daily or as needed use of H1-AH:
    Urticaria Control Test (UCT) (4 item) <12 at the screening visit (Visit 1) and randomization visit (Visit 2)
    Within 6 months prior to the screening visit, documented medical history of cold exposure triggered anaphylaxis or oropharyngeal edema
    Within 6 months prior to the screening visit, documented medical history of cold exposure triggered urticaria requiring emergency medical care visit or treatment with epinephrine
    Participants using a study defined H1-antihistamine regularly/daily or as needed for primary acquired chronic inducible cold urticaria
    Body weight ≥30 kg
    E.4Principal exclusion criteria
    Participants are excluded from any of the studies if any of the following criteria apply:
    • Clearly defined underlying etiology for urticaria other than primary acquired chronic inducible ColdU
    • Presence of skin morbidities other than cold urticaria that may interfere with the assessment of the study outcomes
    • Active atopic dermatitis
    • Severe concomitant illness(es) that, in the investigator’s judgment, would adversely affect the patient’s participation in the study
    • Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
    • Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection
    • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit and during the screening period
    • Known or suspected immunodeficiency
    • Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
    • History of systemic hypersensitivity or anaphylaxis to omalizumab or any biologic therapy, including any excipients
    • Participation in prior dupilumab clinical study, or have been treated with commercially available dupilumab.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants with negative ice cube provocation test at Week 24 compared with placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    1 - Change from baseline in urticaria control test at Week 24 compared with placebo
    2 - Proportion of well-controlled participants at Week 24 compared with placebo
    3 - Proportion of participants with an improvement of ≥3 in UCT-4 item from baseline to Week 24 compared with placebo
    4 - Change from baseline in local wheal intensity at the provocation site at Week 12 and 24 using the wheal intensity Likert scale compared with placebo
    5 - Change from baseline in local itch severity at the provocation site at Week 12 and 24 using the Peak Pruritus Numerical Rating Scale (NRS) compared with placebo
    6 -Change from baseline in local skin burning sensation at the provocation site at Week 12 and Week 24 using the peak burning sensation NRS compared with placebo
    7 - Change from baseline in local pain severity at the provocation site at Week 12 and Week 24 using the peak pain sensation NRS compared with placebo
    8 - Proportion of participants with negative ice cube provocation test at Week 12 compared with placebo
    9 - Proportion of participants with cold exposure triggered urticaria signs and symptoms at Week 12 and Week 24 as measured by ColdUAS compared with placebo
    10 - Proportion of days with cold exposure triggered urticaria signs and symptoms at Week 12 and Week 24 as measured by ColdUAS compared with placebo
    11 - Proportion of participants with severe cold exposure triggered urticaria signs and symptoms at Week 12 and Week 24 as measured by ColdUAS compared with placebo
    12 - Proportion of days with severe cold exposure triggered urticaria signs and symptoms at Week 12 and Week 24 as measured by ColdUAS compared with placebo
    13 - Change from baseline in health-related quality-of-life (HRQoL) as measured by Dermatology Life Quality Index (DLQI) at Week 24 compared with placebo
    14 - Change from baseline in HRQoL as measured by Children’s Dermatology Life Quality Index (CDLQI) at Week 24 compared with placebo
    15 - Patient Global Impression of Change (PGIC) of primary acquired chronic inducible ColdU at Week 12 and Week 24 compared with placebo
    16 - Change from baseline in Patient Global Impression of Severity (PGIS) of primary acquired chronic inducible ColdU at Week 12 and Week 24 compared with placebo.
    17 - Change from baseline in Cold Urticaria Quality of Life (ColdU QoL) at Week 24 compared with placebo
    18 - Time to first rescue therapy for primary acquired chronic induced ColdU during the planned treatment period compared with placebo
    19 - Proportion of participants receiving rescue therapy for primary acquired chronic inducible ColdU during the planned treatment period compared with placebo
    20 - Proportion of participants with cold exposure urticaria requiring emergency medical care visit or treatment with epinephrine
    21 - Percentages of participants experiencing treatment­emergent adverse events (TEAEs) or serious adverse events (SAEs)
    22 - Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - Baseline to Week 24
    2 - Week 24
    3 - Baseline to Week 24
    4 - Baseline to Week 12 and Week 24
    5 - Baseline to Week 12 and Week 24
    6 - Baseline to Week 12 and Week 24
    7 - Baseline to Week 12 and Week 24
    8 - Week 12
    9 - Week 12 and Week 24
    10 - Week 12 and Week 24
    11 - Week 12 and Week 24
    12 - Week 12 and Week 24
    13 - Baseline to Week 24
    14 - Baseline to Week 24
    15 - Week 12 and Week 24
    16 - Baseline to Week 12 and Week 24
    17 - Baseline to Week 24
    18 - Baseline to Week 24
    19 - Baseline to Week 24
    20 - Baseline to Week 24
    21 - Throughout the study up to Week 36
    22 -Throughout the study up to Week 36
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Canada
    Japan
    United States
    Germany
    Argentina
    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 years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 8
    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: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 138
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 156
    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)
    None
    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 Decision2020-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-20
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