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    Summary
    EudraCT Number:2021-003928-32
    Sponsor's Protocol Code Number:RD.06.SPR.203890
    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:2021-12-17
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-003928-32
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled, Randomized Study to Assess the Durability of Effect and Safety of Nemolizumab for 24 Weeks 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 durability of effect and safety of nemolizumab (CD14152) in subjects with prurigo nodularis (PN)

    A.4.1Sponsor's protocol code numberRD.06.SPR.203890
    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 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 nameNemolizumab
    D.3.2Product code CD14152
    D.3.4Pharmaceutical form Powder and solvent for 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 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 that binds to human IL-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 solvent for solution 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 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
    To assess the long-term durability of response over a 24-week period following withdrawal of nemolizumab in subjects with prurigo nodularis (PN) who previously responded to treatment in the LTE study RD.06.SPR.202699.
    E.2.2Secondary objectives of the trial
    To assess the safety of nemolizumab compared to placebo over a 24-week period in subjects with PN who previously responded to treatment in the LTE study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Individuals must meet all the following criteria to be included in the study:
    1. Subjects who achieved a clinical response at Week 52 of the LTE study RD.06.SPR.202699, defined as:
    • IGA score of 0 (clear) or 1 (almost clear)
    AND
    • ≥4 point improvement in weekly average of PP NRS score from baseline of the lead-in study;
    Note: Lead-in study baseline is defined as baseline PP NRS score in Phase 3 studies RD.06.SPR.202685 or RD.06.SPR.203065 for subjects who rolled over into the LTE from these studies. For subjects who entered the LTE study from the Phase 2 study RD.03.SPR.115828, the baseline PP NRS score at entry into the LTE study RD.06.SPR.202699 will be used;
    2. Subjects with uninterrupted dosing of nemolizumab in the LTE study RD.06.SPR.202699 for 3 months before the Week 52 visit;
    3. Subjects willing and able to transfer into the study at the time of completion of the Week 52 visit in the LTE study RD.06.SPR.202699;
    4. Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming postmenopausal 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 (e.g., 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),
    Note: “Double barrier methods” refers to simultaneous use of a physical barrier by each partner. Use of a single barrier method (e.g., condom) with a spermicide is not acceptable.
    • 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;
    5. Female subjects of non-childbearing potential must meet one of the following criteria:
    • Absence of menstrual bleeding for 1 year prior to baseline 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 the study,
    Note: Bilateral tubal ligation is not accepted as reason for non-childbearing potential;
    6. 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;
    7. Understand and sign an ICF before any investigational procedure(s) are performed.

    For detailed information on the inclusion criteria please refer to the study protocol.
    E.4Principal exclusion criteria
    Individuals meeting any of the following criteria are ineligible to participate in this study:
    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. Receipt of prohibited medications, including rescue therapy, in the LTE study RD.06.SPR.202699 within 6 months of the Week 52 visit (Section 9.6.3);
    4. Pregnant women (positive pregnancy test result at 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 (e.g., 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 baseline;
    9. Subjects with confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 2 weeks before baseline;
    10. Any condition the Investigator deems incompatible with subject participation in the study.

    For detailed information on the exclusion criteria please refer to the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Time from baseline to relapse, defined as meeting at least 1 of the following criteria:
    • Increase in (weekly average of the) Peak Pruritus Numeric Rating Scale (PP NRS) score ≥4 points from baseline;
    • Increase in Investigator Global Assessment (IGA) score ≥2 points from baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 4 weeks ending with Week 24.
    E.5.2Secondary end point(s)
    Efficacy Endpoints
    The secondary efficacy endpoints include:
    • Proportion of subjects with increase in PP NRS score ≥4 points from baseline at each scheduled visit;
    • Proportion of subjects maintaining IGA success, defined as IGA score of 0 (clear) or 1 (almost clear) at each scheduled visit;
    • Proportion of subjects with increase in IGA ≥2 points from baseline at each scheduled visit;
    • Absolute and percent change from baseline in PP NRS at each scheduled visit;
    • Absolute and percent change from baseline in Sleep Disturbance (SD) NRS at each scheduled visit;
    • Change from baseline in DLQI at Week 16 and Week 24.

    Safety Endpoints
    The safety endpoints of this study are as follows:
    • Incidence and severity of adverse events (AEs), including treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), serious AEs (SAEs), treatment-related AEs, and AEs that lead to discontinuation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study.
    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 No
    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
    Proof of Exposure and 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 Yes
    E.8.1.7.1Other trial design description
    Subjects will continue to receive the same dosing regimen received in the study RD.06.SPR.202699.
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    United States
    Switzerland
    Austria
    France
    Germany
    Poland
    Korea, Republic of
    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
    Last subject's last visit.
    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 months6
    E.8.9.1In the Member State concerned days0
    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 days0
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 40
    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)
    Subjects who complete the study through Week 24 or who exit the study due to relapse may be eligible to re-enroll in the LTE study (RD.06.SPR.202699) and this way will have the option to continue to receive nemolizumab.
    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 Decision2022-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-15
    P. End of Trial
    P.End of Trial StatusOngoing
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