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    Summary
    EudraCT Number:2019-004294-13
    Sponsor's Protocol Code Number:RD.06.SPR.202699
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-19
    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 ConcernedGermany - PEI
    A.2EudraCT number2019-004294-13
    A.3Full title of the trial
    A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term study to assess the safety and efficacy of nemolizumab (CD14152) in subjects with prurigo nodularis (PN)

    A.3.2Name or abbreviated title of the trial where available
    A long-term study to assess the safety and efficacy of nemolizumab in subjects with PN
    A.4.1Sponsor's protocol code numberRD.06.SPR.202699
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04204616
    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/119/2020
    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 and solution 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
    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 LLT
    E.1.2Classification code 10037084
    E.1.2Term Prurigo nodularis
    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 subjects with prurigo nodularis (PN).
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the long-term efficacy of nemolizumab (CD14152) in subjects with PN.
    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 participated in a prior nemolizumab study for PN
    including:
    a. Subjects who completed the treatment period in a phase 3 pivotal
    study (RD.06.SPR.202685 or RD.06.SPR.203065) and enroll within 56
    days
    OR
    b. Subjects who were previously randomized in the nemolizumab phase
    2a PN study (RD.03.SPR.115828).
    2. Female subjects of childbearing potential (ie, fertile, following
    menarche and until becoming post-menopausal unless permanently
    sterile) must agree to use an adequate and approved method of
    contraception throughout the study and for 12 weeks after the last study
    drug injection.
    Adequate and approved methods of contraception applicable for the
    subject and/or her partner are defined below:
    • True abstinence, when in line with the preferred and usual lifestyle of
    the subject. Periodic abstinence (eg, calendar, ovulation,
    symptothermal, post-ovulation methods) and withdrawal are not
    acceptable methods of contraception;
    • Progestogen-only oral hormonal contraception
    • Combination of male condom with cap, diaphragm, or sponge with
    spermicide (double barrier methods) (*In Germany only, double barrier
    methods are not considered an adequate and approved method of
    contraception);
    • 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;
    • Vasectomy of partner at least 3 months before the study
    3. 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;
    OR
    • Documented hysterectomy, bilateral salpingectomy, or bilateral
    oophorectomy at least 3 months before the study.
    4. Subject willing and able to comply with all of the time commitments
    and procedural requirements of the clinical study protocol, including
    periodic weekly recordings by the subject using an electronic handheld
    device provided for this study;
    5. Understand and sign an informed consent form before any
    investigational procedure(s) are 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. Body weight < 30 kg;
    3. Having received any of the treatments listed in Table 2 in the protocol
    within the specified timeframe before the baseline visit:
    4. Pregnant women (positive pregnancy test result at screening or
    baseline visit), breastfeeding women, or women planning a pregnancy
    during the clinical study;
    5. Any medical or psychological condition 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);
    6. Planning or expected to have a major surgical procedure during the
    clinical study;
    7. Subjects unwilling to refrain from using prohibited medications during
    the clinical study;
    8. History of alcohol or substance abuse within 6 months of the
    screening visit.
    For subjects who do not rollover within 28 days from a prior
    nemolizumab study or who completed study visits but prematurely
    discontinued study drug, the following exclusion criteria also apply:
    9. Subjects with a history of asthma meeting 1 or more of the following
    criteria:
    a. Had an exacerbation of asthma requiring hospitalization in the
    preceding 12 months;
    b. Reporting asthma that has not been well-controlled (ie, symptoms
    occurring on >2 days per week, nighttime awakenings 2 or more times
    per week, or some interference with normal activities) during the
    preceding 3 months;
    c. Asthma Control Test ≤19 (only for subjects with a history of asthma);
    d. Peak expiratory flow <80% of the predicted value.
    10. Subjects with a current medical history of chronic obstructive
    pulmonary disease and/or chronic bronchitis;
    11. 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 coronavirus disease
    (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 8.4.2 of the protocol.
    12. Positive serology results (hepatitis B surface antigen [HBsAg] or
    hepatitis B core antibody [HBcAb], hepatitis C antibody, or human
    immunodeficiency virus antibody) at screening;
    13. Chronic pruritus resulting from another active condition than PN,
    such as but not limited to scabies, lichen simplex chronicus, psoriasis,
    atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus,
    habitual picking/excoriation disorder, sporotrichosis, bullous
    autoimmune disease, end-stage renal disease, or cholestatic liver
    disease (eg, primary biliary cirrhosis), or diabetes mellitus or thyroid
    disease that is not adequately treated, as per standard of care;
    14. History of or current confounding skin condition (eg, Netherton
    syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary
    syndrome], chronic actinic dermatitis, dermatitis herpetiformis);
    15. Subjects with active atopic dermatitis (signs and symptoms other
    than dry skin) in the last 3 months;
    16. Neuropathic and psychogenic pruritus, such as but not limited to
    notalgia paresthetica, brachioradial pruritus, small fiber neuropathy,
    skin picking syndrome, or delusional parasitosis;
    17. 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
    carcinomas 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;
    18. History of hypersensitivity (including anaphylaxis) to an
    immunoglobulin (plasma-derived or recombinant) product (eg,
    monoclonal antibody) or to any of the study drug excipients;
    19. Known active or latent tuberculosis infection;
    20. Known or suspected immunosuppression or unusually frequent,
    recurrent, severe, or prolonged infections as per investigator judgment;
    21. Any clinically relevant laboratory abnormalities, such as but not
    limited to elevated alanine aminotransferase (ALT) or aspartate
    aminotransferase (AST) (>3 × upper limit of normal [ULN]) in
    combination with elevated bilirubin (>2 × ULN), 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;
    For the complete list of the exclusion criteria please refer to the study
    protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence and severity of adverse events (AEs), including AEs of special interest, treatment-emergent AEs, and serious AEs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    Efficacy Endpoints:
    • Proportion of subjects with an Investigator Global Assessment (IGA) success (defined as IGA of 0 [Clear] or 1 [Almost clear]) at each visit up to Week 52
    • Proportion of subjects with an improvement of ≥4 from baseline in Peak Pruritus numeric rating scale (PP NRS) up to Week 52
    • Proportion of subjects with low disease activity state (ie, IGA ≤2) at each visit up to Week 52
    • Percentage of pruriginous lesions with excoriations/crusts (Prurigo Activity Score [PAS] item 5a) at each visit up to Week 52
    • Percentage of healed prurigo lesions (PAS item 5b) at each visit up to Week 52
    • Change from baseline in number of lesions in representative area (PAS item 4) at each visit up to Week 52
    • Proportion of subjects with PP NRS <2 up to Week 52
    • Absolute and percent change from baseline in PP NRS up to Week 52
    • Proportion of subjects with Average Pruritus (AP) NRS <2 up to Week 52
    • Proportion of subjects with an improvement of ≥4 from baseline in AP NRS up to Week 52
    • Absolute and percent change from baseline in AP NRS up to Week 52
    • Proportion of subjects with an improvement of ≥4 from baseline in Sleep Disturbance (SD) NRS up to Week 52
    • Absolute and percent change from baseline in Sleep Disturbance NRS up to Week 52
    • Change from baseline in PN-associated pain frequency up to Week 52
    • Change from baseline in PN-associated pain intensity up to Week 52
    • Proportion of subjects reporting low disease activity (clear, almost clear, or mild) based on Patient Global Assessment of Disease (PGAD) at each visit up to Week 52
    • Proportion of subjects satisfied with study treatment (good, very good, or excellent) based on Patient Global Assessment of Treatment (PGAT) at each visit up to Week 52
    • Proportion of subjects with an improvement of ≥4 from baseline in Dermatology Life Quality Index (DLQI) up to Week 52
    • Change from baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 52
    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 Yes
    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
    Subject from Ph3 pivotal 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 trial1
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA79
    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
    Austria
    Belgium
    Canada
    Denmark
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Spain
    Sweden
    Switzerland
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days16
    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: 268
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 132
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 400
    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 Decision2020-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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