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    Summary
    EudraCT Number:2019-004293-25
    Sponsor's Protocol Code Number:RD.06.SPR.202685
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-07
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2019-004293-25
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety 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 study to assess the efficacy and safety of nemolizumab (CD14152) in subjects with prurigo nodularis (PN)
    A.3.2Name or abbreviated title of the trial where available
    A study to assess the efficacy and safety of nemolizumab in subjects with prurigo nodularis
    A.4.1Sponsor's protocol code numberRD.06.SPR.202685
    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 efficacy of nemolizumab (CD14152) compared to placebo in subjects ≥ 18 years of age with prurigo nodularis (PN) after a 16 week treatment period.

    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the safety, pharmacokinetics, and immunogenicity of nemolizumab (CD14152) compared to placebo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional biopsy sampling, optional Pharmacogenomic testing and optional Clinical Photography assessment
    E.3Principal inclusion criteria
    1. Male or female and aged ≥18 years at the time of screening;
    2. Clinical diagnosis of PN for at least 6 months with:
    • Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs;
    • At least 20 nodules on the entire body with a bilateral distribution
    • 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;
    3. Severe pruritus defined as follows on the PP NRS:
    • At the screening visit (Visit 1): PP NRS score is ≥ 7.0 for the 24-hour period immediately preceding the screening visit;
    • At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score is ≥ 7.0 over the previous week;
    4. 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 a highly effective 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 male partner at least 3 months before the study
    5. Female subjects of non-childbearing potential must meet 1 of the following criteria:
    • Absence of menstrual bleeding for 1 year prior to screening without any other medical reason;
    • Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before the study;
    6. Subject is willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the subject using an electronic handheld device provided for this study.
    7. Read, understood and signed an informed consent form (ICF) before any investigational procedure(s) are performed.
    E.4Principal exclusion criteria
    1. Body weight < 30 kg;
    2. Chronic pruritus resulting from another active condition other 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;
    3. Unilateral lesions of prurigo (eg, only one arm affected);
    4. History of or current confounding skin condition (eg, Netherton syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis)
    5. Subjects meeting 1 or more of the following criteria at screening or baseline:
    - Had an exacerbation of asthma requiring hospitalization in the preceding 12 months;
    - 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;
    - Asthma Control Test ≤ 19 (only for subjects with a history of asthma)
    - Peak expiratory flow < 80% of the predicted value.
    6. Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis;
    7. 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;
    8. Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C antibody, or human immunodeficiency virus antibody) at the screening visit;
    9. Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit;
    10. Subjects with active atopic dermatitis (signs and symptoms other than dry skin) in the last 3 months;
    11. Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis;
    12. Having received any of the treatments in the table reported in the protocol within the specified timeframe before the baseline visit;
    13. Previous participation in a clinical study with nemolizumab;
    14. Pregnant women (positive serum pregnancy test result at the screening visit or positive urine pregnancy test at the baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study;
    15. 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), 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;
    - Actinic keratoses that have been treated
    16. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients;
    17. Known active or latent tuberculosis infection;
    18. Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment;
    19. Any medical or psychological condition or 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, or may interfere with study assessments (eg, poor venous access or needle-phobia);
    20. History of alcohol or substance abuse within 6 months of the screening visit;
    21. Planned or expected major surgical procedure during the clinical study;
    22. Subject is unwilling to refrain from using prohibited medications during the clinical study;
    23. Currently participating or participated in any other study of a drug or device, within the past 8 weeks before the screening visit, or is in an exclusion period (if verifiable) from a previous study.

    See the full list of exclusion criteria in the protocol Section 8.2
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of subjects with an improvement of ≥ 4 from baseline in Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16

    • Proportion of subjects with an Investigator Global Assessment (IGA) success (defined as an IGA of 0 [Clear] or 1 [Almost clear] and a ≥ 2-point improvement from baseline) at Week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoints:

    - Proportion of subjects with an improvement of ≥ 4 from baseline in PP NRS at Week 4;
    - Proportion of subjects with PP NRS < 2 at Week 16
    - Proportion of subjects with an improvement of ≥ 4 from baseline in SD NRS at Week 16;
    - Proportion of subjects with an improvement of ≥ 4 from baseline in SD NRS at Week 4;
    - Proportion of subjects with PP NRS < 2 at Week 4

    Secondary Efficacy Endpoints:

    - IGA success rate at each visit through Week 24;
    - Percentage of pruriginous lesions with excoriations/crusts (Prurigo Activity Score [PAS] item 5a) at each visit through Week 24;
    - Percentage of healed prurigo lesions (PAS item 5b) at each visit through Week 24;
    - Change from baseline in number of lesions in representative area (PAS item 4) at each visit through Week 24;
    - Proportion of subjects with an improvement of ≥ 4 from baseline in PP NRS through Week 24;
    - Proportion of subjects with PP NRS < 2 from baseline through Week 24;
    - Proportion of subjects with PP NRS < 3 from baseline through Week 24;
    - Absolute change from baseline in PP NRS through Week 24;
    - Percent change from baseline in PP NRS through Week 24;
    - Proportion of subjects with an improvement of ≥ 4 from baseline in AP NRS through Week 24;
    - Proportion of subjects with AP NRS < 2 from baseline through Week 24;
    - Absolute change from baseline in AP NRS through Week 24;
    - Percent change from baseline in AP NRS through Week 24;
    - Proportion of subjects with an improvement of ≥ 4 from baseline in SD NRS through Week 24;
    - Absolute change from baseline in SD NRS through Week 24;
    - Percent change from baseline in SD NRS through Week 24;
    - Change from baseline in sleep diary endpoints (sleep onset latency, wakefulness
    after sleep onset [WASO], total awake time, total sleep time, sleep efficiency,
    WASO related to PN, number of WASO related to PN) based on recordings from
    subject sleep diary through Week 24;
    - Change from baseline in PN-associated pain frequency through Week 24:
    - Change from baseline in PN-associated pain intensity through Week 24;
    - Proportion of subjects reporting low disease activity (clear, almost clear, or mild) based on Patient Global Assessment of Disease (PGAD) at Week 24;
    - Proportion of subjects satisfied with study treatment (good, very good, or
    excellent) based on Patient Global Assessment of Treatment (PGAT) at Week 24;
    Proportion of subjects with an improvement of ≥ 4 in DLQI through Week 24;
    - Change from baseline in DLQI through Week 24;
    - Change from baseline in Hospital Anxiety and Depression Scale (HADS) for each
    subscale (ie, depression and anxiety) at Week 24;
    - Change from baseline in EuroQoL 5-Dimension (EQ-5D) at Week 24;

    Safety Endpoints:

    - The safety endpoints of this study are the incidence and severity of AEs, including TEAEs, AESIs, and SAEs.
    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 Yes
    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 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Denmark
    Germany
    Hungary
    Italy
    Sweden
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days7
    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: 223
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 47
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 238
    F.4.2.2In the whole clinical trial 270
    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)
    Long term open label extension study planned for subjects who complete this phase 3 pivotal study.
    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 Decision2020-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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