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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:Ongoing
    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/201/2022
    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 AddressZählerweg 10
    B.5.3.2Town/ cityZug
    B.5.3.3Post code6300
    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 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
    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
    To be eligible for study entry, subjects must satisfy all of the following
    criteria:

    1. Adolescent subjects (aged 12-17) who have not participated in a previous nemolizumab study (selected countries/selected sites) or 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 XML File Identifier: gijajYPBZAJjgBxpjNHWYfpqFkA=
    Page 11/25 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], SPR.114322 [Week 24], SPR.201591 [Week 16], and SPR.201593 [Week 13] unless the subject experienced an AE that may present an unreasonable risk if study medication is continued;
    OR
    g. Subjects who completed the treatment period (Week 16) in the Phase 3b study (SPR.201591);
    OR
    h. Subjects who completed the treatment period (Week 13) in the Phase 2 DDI study (SPR.201593)
    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 (ie, fertile, following menarche and until becoming postmenopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this is in line with the
    preferred and usual lifestyle of the subject, or to use an adequate 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.
    Adequate and approved methods of contraception applicable for the subject and/or her partner are defined below:
    - Progestogen-only oral hormonal contraception;
    - Combination of male condom with cap, diaphragm, or sponge with spermicide (double barrier methods);
    - Combined (estrogen- and progestogen-containing) oral, intravaginal, or transdermal hormonal contraception;
    - Injectable or implanted hormonal contraception;
    - Intrauterine devices or intrauterine hormone-releasing system;
    - Bilateral tubal ligation or tube insert (such as the Essure system) at least 3 months before the study;
    - Bilateral 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, confirmed with follicle stimulating hormone (FSH) level in the postmenopausal range;
    - Documented hysterectomy, bilateral salpingectomy, 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 ICF / Assent before any investigational procedures
    Additional Inclusion Criteria: For adolescent subjects (age 12-17) who have not participated in a previous clinical study with nemolizumab only (selected countries/selected sites):
    7. Chronic AD for at least 2 years before the screening visit, and confirmed according to American Academy of Dermatology Consensus Criteria (Appendix 1)2 at the time of the screening visit.
    8. EASI score ≥ 16 at both the screening and baseline visits.
    9. IGA score ≥ 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits.
    10. AD involvement ≥ 10% of body surface area (BSA) at both the screening and baseline visits. Note: BSA to be derived from the SCORAD.
    11. SCORAD pruritus VAS score of at least 4.0 at the screening and baseline visit.
    12. Documented recent history (within 6 months before the screening visit) of inadequate response to topical medications (TCS with or without TCI).
    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 10 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 new adolescent subjects or for subjects
    who do not rollover from a prior nemolizumab study within 28 days of
    completing final study assessments in the lead-in study:
    7. Body weight < 30 kg;
    8. Subjects meeting 1 or more of the following criteria at screening or
    baseline:
    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 2 or more times per week, or some interference with normal activities) during the preceding 3 months;
    8c. Asthma Control Test (ACT) ≤ 19 (only for subjects with a history of asthma);
    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 baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected COVID-19 infection within 2 weeks before the screening or baseline visit. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods, as described in Section 8.3.5.2.;
    11.Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C [HCV] antibody with positive HCV RNA, or human immunodeficiency virus [HIV] antibody) at the screening visit;
    12. Subjects who, after a full treatment course of 16 weeks with dupilumab, experienced worsening of their AD or failed to achieve minimal improvement (eg, ≤ 10% reduction in EASI or no reduction in IGA);
    13. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for 1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), 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, or
    2) actinic keratoses that have been treated;
    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, if applicable;
    16. Known active or untreated latent tuberculosis (TB) infection;
    17. Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment;
    18. Presence of confounding skin condition that may interfere with study
    assessments;
    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) during the screening period 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 8 weeks before the screening visit (or 5 half-lives of the investigational drug, whichever is longer), 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,
    SPR.118161, SPR.201591, and SPR.201593);
    21. History of alcohol or substance abuse within 6 months 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) throughout the study
    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 200
    - Proportion of subjects with EASI-75 response at each visit through Week 200
    - Change and percent change from baseline in EASI at each visit through
    Week 200
    - Proportion of subjects with low disease activity state (ie, IGA ≤ 2) at each visit through Week 200
    - Change and percent change from baseline in SCORing Atopic Dermatitis
    (SCORAD) score at each visit through Week 200
    - Change and percent change from baseline in subject-reported pruritus
    using 10-cm visual analogue scale (SCORAD sub-component) to Week 200
    - Change and percent change from baseline in subject-reported sleep
    loss using 10-cm visual analogue scale (SCORAD sub-component) to Week 200
    - 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 200
    - 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 200
    - Change from baseline in Dermatology Life Quality Index (DLQI) or Children's DLQI (cDLQI) total score at each visit through Week 200
    - Change from baseline in Patient-Oriented Eczema Measure (POEM) total score at each visit through Week 200
    - Change from baseline in Hospital Anxiety and Depression Scale (HADS) for each subscale (i.e., depression and anxiety) at each visit through Week 200
    - Change from baseline in Work Productivity and Activity Impairment:
    Atopic Dermatitis (WPAI:AD) for each subscale (i.e., work productivity and activity impairment) at each visit through Week 200
    - Change from baseline in EuroQoL 5-Dimension (EQ-5D) at each visit through Week 200
    - Proportion of subjects receiving any rescue therapy by rescue treatment type (e.g., topical, phototherapy, systemic) at any visit during the treatment period
    - Time to first relapse (relapse is defined as: worsening of AD requiring rescue therapy, if judged to be medically necessary by the investigator [i.e, clinically significant worsening of signs and/or symptoms of AD])
    - Duration of remission (time to first relapse in subjects with IGA=0 or 1 at baseline in the LTE)
    - Time to permanent study drug discontinuation
    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 EEA215
    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
    New Zealand
    Singapore
    Australia
    Canada
    Georgia
    Korea, Republic of
    United Kingdom
    United States
    Austria
    Belgium
    Bulgaria
    Czechia
    Estonia
    France
    Germany
    Hungary
    Italy
    Latvia
    Lithuania
    Netherlands
    Poland
    Spain
    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 years6
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days13
    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: 1480
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 69
    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 1010
    F.4.2.2In the whole clinical trial 1749
    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 applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-19
    P. End of Trial
    P.End of Trial StatusOngoing
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