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    Summary
    EudraCT Number:2019-001889-15
    Sponsor's Protocol Code Number:RD.06.SPR.118163
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-06-17
    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 ConcernedAustria - BASG
    A.2EudraCT number2019-001889-15
    A.3Full title of the trial
    A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term study to assess the safety and efficacy of Nemolizumab in subjects with Atopic Dermatitis
    A.4.1Sponsor's protocol code numberRD.06.SPR.118163
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03989206
    A.5.4Other Identifiers
    Name:IND numberNumber:117122
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/106/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGalderma S.A.
    B.1.3.4CountrySwitzerland
    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 supportGalderma S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalderma S.A.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressRue entre-deux- Ville 10
    B.5.3.2Town/ cityLa Tour-de-Peilz
    B.5.3.3Post code1814
    B.5.3.4CountrySwitzerland
    B.5.6E-mailCTA.coordinator@galderma.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 nameCD14152
    D.3.2Product code CD14152
    D.3.4Pharmaceutical form Powder 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 INNNEMOLIZUMAB
    D.3.9.1CAS number 1476039-58-3
    D.3.9.2Current sponsor codeCD14152 / CIM331
    D.3.9.3Other descriptive nameHumanised monoclonal antibody IgG2 recognising the interleukin-31 receptor A
    D.3.9.4EV Substance CodeSUB191036
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    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 solution 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
    Atopic Dermatitis
    E.1.1.1Medical condition in easily understood language
    Atopic Dermatitis
    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 10003639
    E.1.2Term Atopic dermatitis
    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 assess the long-term safety of Nemolizumab (CD14152) in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD).
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the long-term efficacy of Nemolizumab (CD14152) in adult and adolescent subjects with moderate-to-severe AD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD including:
    a. Subjects who completed the initial treatment period (Week 16 visit) in a Phase 3 pivotal study (SPR.118161 or SPR.118169) and do not qualify for the maintenance period;
    OR
    b. Subjects who completed the maintenance period (Week 48 visit) in a Phase 3 pivotal study (SPR.118161 or SPR.118169);
    OR
    c. Subjects who completed the treatment period (Week 16 visit) in the Phase 2 vaccination safety study (SPR.118380);
    OR
    d. Subjects who completed the treatment period (Week 16 visit) in the Phase 2 adolescent PK/safety study (SPR.116912);
    OR
    e. Subjects who completed the treatment period (Week 24 visit) in the Phase 2b dose-ranging study (SPR.114322) and remain insufficiently controlled on topical therapy alone;
    OR
    f. Subjects who discontinued study medication in a prior study and completed required study visits prior to LTE participation (Week 16 visit for SPR.118161 and SPR.118169 initial treatment period, Week 32 visit for SPR.118161 and SPR.118169 maintenance period; final study visits for SPR.118380 [Week 16], SPR.116912 [Week 16], and SPR.114322 [Week 24]), unless the subject experienced an AE that may present an unreasonable risk if study medication is continued;
    Note(s): For ongoing studies, transfer into the LTE study should occur as soon as possible to minimize gaps in study medication dosing. Subjects who satisfy inclusion criteria 1a through 1c are permitted to enroll immediately into the LTE study, provided other eligibility criteria are met.
    Subjects satisfying inclusion criterion 1d can be considered for eligibility after interim PK and safety analyses of data from SPR.116912 are conducted by the sponsor and an IDMC to determine whether enrollment of the adolescent age group (12-17 years) is safe. Following Independent Ethics Committees/Institutional Review Boards approval, the sponsor will send
    a written communication to the site confirming that the study is open for enrollment of adolescents. Adolescents and/or subjects from SPR.116912 even if presently 18 years of age must not be enrolled in the study until such communication is received. Subjects who enroll within 28 days of completing the final visit of a lead-in study may use final study assessments for
    the screening visit, unless the subject prematurely discontinued study drug in the lead-in study. All other subjects should complete a separate screening visit within 28 days before the first dose of study medication in the LTE.
    2. Agree to apply a moisturizer at least once daily throughout the study and agree to apply the authorized topical therapy, as determined appropriate by the investigator;
    3. Women of childbearing potential must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. This criterion also applies to a prepubertal female subject who begins menses during the study.
    Effective and approved methods of contraception applicable for the subject and/or her partner are defined below:
    • Progestogen-only oral hormonal contraception;
    • Male or female condom;
    • Cap, diaphragm, or sponge with spermicide;
    • Combination of male or female condom with cap, diaphragm, or sponge with spermicide;
    • Combined (estrogen- and progestogen-containing) oral, intravaginal, or transdermal hormonal contraception;
    • Injectable or implanted hormonal contraception;
    • Intrauterine devices;
    • Bilateral tubal ligation or tube insert (such as the Essure system) at least 3 months before the study;
    • Vasectomy of partner at least 3 months before the study.
    4. Female subjects of non-childbearing potential must meet one of the following criteria:
    • Absence of menstrual bleeding for 1 year prior to screening without any other medical reason;
    • Documented hysterectomy or bilateral oophorectomy at least 3 months before screening.
    5. Subject (and guardian, when applicable) willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol;
    6. Understand and sign an informed consent form (and assent form, when applicable), before any investigational procedure(s) being performed.
    E.4Principal exclusion criteria
    1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject;
    2. Having received any of the treatments listed in Table 6 of the protocol within the specified timeframe before the baseline visit;
    3. Pregnant women (positive pregnancy test result at screening or baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study;
    4. Any medical or psychological condition at the screening visit that may put the subject at significant risk according to the investigator’s judgment, if he/she participates in the clinical study, or may interfere with study assessments (eg, poor venous access or needle-phobia);
    5. Planning or expected to have a major surgical procedure during the clinical study;
    6. Subjects unwilling to refrain from using prohibited medications during the clinical study;
    Additional Exclusion Criteria: For subjects who do not rollover from a prior nemolizumab study within 28 days of completing final study assessments or who discontinued study drug before completing the treatment period during the lead-in study:
    7. Body weight < 30 kg;
    8. Subjects with a history of asthma meeting 1 or more of the following criteria:
    8a. Had an asthma exacerbation requiring hospitalization in the preceding 12 months;
    8b. Reporting asthma that has been not well controlled (ie, symptoms > 2 days per week, nighttime awakenings > 1-3 times per week, or some interference with normal activities) during the preceding 3 months;
    8c. Asthma Control Test (ACT) ≤ 19;
    8d. Peak expiratory flow < 80% of the predicted value.
    9. Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.;
    10. Cutaneous infection within 1 week before the screening visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week before the screening visit. Subjects may be rescreened once the infection has resolved;
    11. Positive serology results (hepatitis B surface antigen or hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus antibody) at the screening visit;
    12. Subjects who failed to respond clinically to previous treatment with a biologic (eg, dupilumab) or a Janus kinase inhibitor;
    13. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for basal cell carcinoma, squamous cell carcinoma in situ (Bowen’s disease), actinic keratoses, or carcinoma in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the screening visit;
    14. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients;
    15. History of intolerance to TCS or for whom TCS is not advisable (eg, hypersensitivity to TCS, significant skin atrophy, etc), unless TCS was not used as background therapy in the lead-in study;
    16. Known active or latent tuberculosis infection;
    17. Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment;
    18. History of or current confounding skin condition (eg, Netherton Syndrome, psoriasis, cutaneous T-cell lymphoma [Mycosis Fungoides or Sezary Syndrome], contact dermatitis, chronic actinic dermatitis, dermatitis herpetiformis);
    19. Any clinically relevant laboratory abnormalities, such as but not limited to elevated ALT or AST (> 3 × upper limit of normal) in combination with elevated bilirubin (> 2 × upper limit of normal), at the screening visit that may put the subject at significant risk according to the investigator’s judgment, if he/she participates in the clinical study;
    20. Currently participating or participated in any other study of a drug or device within the past 2 months before the screening visit, or is in an exclusion period (if verifiable) from a previous study, other than the nemolizumab for AD studies (SPR.114322, SPR.116912, SPR.118380, SPR.118169, and SPR.118161);
    21. History of alcohol or substance abuse within 2 years of the screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints:
    - Incidence and severity of treatment-emergent AEs throughout the study
    - Incidence of serious treatment-emergent AEs throughout the study
    - Incidence and severity of AEs of special interest (AESIs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety Endpoints: throughout the study


    E.5.2Secondary end point(s)
    Efficacy Endpoints:
    - Proportion of subjects with IGA score = 0-1 at each visit through Week 112
    - Proportion of subjects with EASI-75 response at each visit through Week 112
    - Change and percent change from baseline in EASI at each visit through Week 112
    - Proportion of subjects with low disease activity state (ie, IGA ≤ 2) at each visit through Week 112
    - Change and percent change from baseline in SCORing Atopic Dermatitis (SCORAD) score at each visit through Week 112
    - Change and percent change from baseline in subject-reported pruritus using 10-cm visual analogue scale (SCORAD sub-component)
    - Change and percent change from baseline in subject-reported sleep loss using 10-cm visual analogue scale (SCORAD sub-component)
    - Proportion of subjects reporting low disease activity state (clear, almost clear, or mild) based on Patient Global Assessment of Disease 5-point scale at each visit up to Week 112
    - Proportion of subjects satisfied with study treatment (good, very good, or excellent) based on Patient Global Assessment of Treatment 5-point Likert scale at each visit up to Week 112
    - Proportion of subjects receiving any concomitant AD treatment by treatment type (eg, topical, phototherapy, systemic) throughout the treatment period
    - Proportion of subjects receiving any rescue therapy by rescue treatment type at any visit during the treatment period
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified within the list of endpoints
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Quality of life
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Subjects from blinded studies will receive blinded treatment on Day 1 to maintain the blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA162
    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
    Australia
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Estonia
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Netherlands
    New Zealand
    Poland
    Romania
    Singapore
    Spain
    United Kingdom
    United States
    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 years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days23
    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: 200
    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: 200
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1045
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescents aged 12-17
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 639
    F.4.2.2In the whole clinical trial 1300
    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)
    Patients will revert back to their primary physician for further evaluation.
    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 Decision2020-07-09
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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