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    Summary
    EudraCT Number:2019-003774-41
    Sponsor's Protocol Code Number:EFC16459
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-003774-41
    A.3Full title of the trial
    A randomized, double blind, placebo-controlled, multi-center, parallel group study to evaluate the efficacy and safety of dupilumab in patients with prurigo nodularis who are inadequately controlled on topical prescription therapies or when those therapies are not advisable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of dupilumab for the treatment of patients with prurigo nodularis, inadequately controlled on topical prescription therapies or when those therapies are not advisable
    A.3.2Name or abbreviated title of the trial where available
    PRIME
    A.4.1Sponsor's protocol code numberEFC16459
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04183335
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1241-8153
    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 & 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 & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-aventis France
    B.5.2Functional name of contact pointDirection des Opérations cliniques
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Pierre Brossolette
    B.5.3.2Town/ cityChilly-Mazarin
    B.5.3.3Post code91385
    B.5.3.4CountryFrance
    B.5.4Telephone number0 800 222 555
    B.5.6E-mailPublic.Registry-MA-France@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.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
    Prurigo Nodularis
    E.1.1.1Medical condition in easily understood language
    Prurigo Nodularis
    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 10029263
    E.1.2Term Neurodermatitis
    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 on itch response in patients with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable
    E.2.2Secondary objectives of the trial
    - To demonstrate the efficacy of dupilumab on additional itch endpoints in patients with PN, inadequately controlled on topical prescription therapy or when those therapies are not advisable
    - To demonstrate efficacy of dupilumab on skin lesions of PN
    - To demonstrate the improvement in health-related quality of life
    - To evaluate safety outcome measures
    - To evaluate immunogenicity of dupilumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Must be 18 to 80 years of age, at the time of signing the informed consent.
    With a clinical diagnosis of PN defined by all of the following:
    - Diagnosed by a dermatologist for at least 3 months before the Screening visit
    - On the WI-NRS ranging from 0 to 10, patients must have an average worst itch score of ≥7 in the 7 days prior to Day1.
    - Patients must have a minimum of 20 PN lesions in total on both legs, and/or both arms and/or trunk, at Screening visit and Day 1
    - History of failing a 2-week course of medium-to-superpotent topical corticosteroids (TCS) or when TCS are not medically advisable
    - Have applied a stable dose of topical emollient (moisturizer) once or twice daily for at least 5 out of the 7 consecutive days immediately before Day 1
    Must be willing and able to complete a daily symptom eDiary for the duration of the study
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    - Presence of skin morbidities other than PN and mild atopic dermatitis that may interfere with the assessment of the study outcomes
    - PN secondary to medications
    - PN secondary to medical conditions such as neuropathy or psychiatric disease
    - Within 6 months before the screening visit, or documented diagnosis of moderate to severe AD from screening visit to randomization visit
    - Severe concomitant illness(es) under poor control that, in the investigator’s judgment, would adversely affect the patient’s participation in the study
    - Severe renal conditions (eg, patients with uremia and/or on dialysis)
    - Participants with uncontrolled thyroid disease.
    - 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, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization.
    - Active chronic or acute infection (except HIV 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.
    E.5 End points
    E.5.1Primary end point(s)
    mprovement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥ 4 ; Proportion of participants with improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 from baseline to Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12
    E.5.2Secondary end point(s)
    1 - Improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥ 4 ; Proportion of participants with improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 from baseline to Week 24
    Proportion of participants with Investigator’s Global Assessment 0 or 1 score for PN-stage at Week 24 ; Proportion of participants with Investigator’s Global Assessment 0 or 1 score for PN-Stage (IGA PN-S) at Week 24.
    2 - Time to onset of effect on pruritus ; Time to onset of effect on pruritus as measured by proportion of participants with an improvement (reduction) in WI-NRS by ≥4 from baseline during the 24-week treatment period
    3 - Change from baseline in WI-NRS ; Change from baseline in WI-NRS at Week 12 and Week 24
    4 - Percent change from baseline in WI-NRS ; Percent change from baseline in WI-NRS at Week 2, Week 4, Week 12 and Week 24
    5 - Percent change from baseline in WI-NRS over time ; Percent change from baseline in WI-NRS over time until Week 24
    6 - Proportion of participants with WI-NRS reduction ≥4 at Week 4 ; Proportion of participants with WI-NRS reduction ≥4 at Week 4
    Proportion of participants with WI-NRS reduction ≥ 4 over time ; Proportion of participants with WI-NRS reduction ≥ 4 over time until Week 24
    7 - Onset of action in change from baseline in WI-NRS ; Onset of action in change from baseline in WI-NRS (first p<0.05 difference from placebo in the daily WI-NRS that remains significant at subsequent measurements) until Week 12
    8 - Proportion of participants with Investigator’s Global Assessment 0 or 1 score for PN-stage ; Proportion of participants with Investigator’s Global Assessment 0 or 1 score for PN-Stage (IGA PN-S) at Week 4, Week 8, and Week 12
    9 - Change from baseline in IGA PN-S score ; Change from baseline in IGA PN-S score at Week 4, Week 8, Week 12 and Week 24
    10 - Proportion of participants with Investigator’s Global Assessment 0 or 1 score for PN-Activity ; Proportion of participants with Investigator’s Global Assessment 0 or 1 score for PN-Activity (IGA PN-A) at Week 4, Week8, Week 12, and Week 24
    11 - Change from baseline in health-related quality-of-life ; Change from baseline in health-related quality-of-life, as measured by Dermatology Life Quality Index (DLQI) to Week 12 and Week 24
    12 - Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through Week 24 ; Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through Week 24
    13 - Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab over time ; Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 12,13 : Baseline to Week 24
    2, 5 : Baseline to overtime until Week 24
    3, 11 : Baseline to Week 12 and Week 24
    4 : Baseline to Week 2, Week 4, Week 12 and Week 24
    6 : Baseline to Week 4
    Baseline to overtime until Week 24
    7 : Baseline to overtime until Week 12
    8 : Baseline to Week 4, Week 8 and Week 12
    9, 10 : Baseline to Week 4, Week 8, Week 12, and Week 24
    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 Yes
    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 concerned5
    E.8.5The trial involves multiple Member States No
    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
    Argentina
    China
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    United States
    France
    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 years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 102
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 73
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 175
    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 Decision2021-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-03
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