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    Summary
    EudraCT Number:2019-004739-22
    Sponsor's Protocol Code Number:DER-201805
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-10-09
    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 - BfArM
    A.2EudraCT number2019-004739-22
    A.3Full title of the trial
    Efficacy of ruxolitinib cream in Prurigo nodularis patients:
    A randomized, placebo-controlled pilot study (PRUX)
    Wirksamkeit von topischer Ruxolitinib-Creme bei Prurigo nodularis Patienten: Eine randomisierte, placebokontrollierte Pilotstudie (PRUX)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of ruxolitinib cream in Prurigo nodularis patients:
    A randomized, placebo-controlled pilot study (PRUX)
    Wirksamkeit von topischer Ruxolitinib-Creme bei Prurigo nodularis Patienten: Eine randomisierte, placebokontrollierte Pilotstudie (PRUX)
    A.4.1Sponsor's protocol code numberDER-201805
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRheinische Friedrich-Wilhelms-Universität Bonn
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIncyte Biosciences International Sàrl (Incyte)
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStudienzentrale Studienzentrum Bonn (SZB)
    B.5.2Functional name of contact pointVerena Proß
    B.5.3 Address:
    B.5.3.1Street AddressVenusberg-Campus 1
    B.5.3.2Town/ cityBonn
    B.5.3.3Post code53127
    B.5.3.4CountryGermany
    B.5.4Telephone number0049228287-13917
    B.5.5Fax number0049228287-16039
    B.5.6E-mailverena.pross@ukbonn.de
    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 nameRuxolitinib
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRUXOLITINIB
    D.3.9.3Other descriptive nameRUXOLITINIB
    D.3.9.4EV Substance CodeSUB32273
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.3Concentration number1,5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 No
    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 placeboCream
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with symptomatic Prurigo nodularis with active skin manifestations
    Patienten mit symptomatischem Prurigo nodularis mit aktiven Hautmanifestationen
    E.1.1.1Medical condition in easily understood language
    Patients with symptomatic Prurigo nodularis with active skin manifestations
    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 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037083
    E.1.2Term Prurigo
    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
    Efficacy of ruxolitinib cream on itching skin lesions in Prurigo nodularis
    Wirksamkeit von topischer Ruxolitinib-Creme bei juckenden Hautläsionen bei Prurigo nodularis
    E.2.2Secondary objectives of the trial
     Reduction of Itching symptoms
     Reduction of inflammatory parameters in skin lesions
     Improvement in quality of life
     Reduzierung von Pruritus-Symptomen
     Reduzierung entzündlicher Parameter in Hautläsionen
     Verbesserung der Lebensqualität
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects will only be included in the study if they meet all of the following criteria:
    1) Age ≥18 years
    2) Written informed consent of the subject for voluntary participation in the study.
    3) Subjects with the ability to follow study instructions and likely to attend and complete all required visits
    4) Patients with clinically confirmed symptomatic Prurigo nodularis
    5) Lesions involve body surface area of at least 4.5% up to a maximum of 36% (according to the “rule of nine”(1), APPENDIX Figure 1)
    6) Numeric Rating Scalevalue for average itch (Itch NRS) of at least 4.0 (4.0-10.0) during the past 24 hours before screening
    E.4Principal exclusion criteria
    Subjects will not be included in the study if any of the following criteria applies:
    1) Patients without legal capacity or unable to understand the nature, scope, significance and consequences of this clinical trial
    2) Patients with a physical or psychiatric condition/ a systemic disease which at the investigator’s discretion may compromise safety of the subject, may confound the trial results, may interfere with the subject’s participation in this clinical trial or may prevent sufficient compliance
    3) Known or persistent abuse of medication, drugs or alcohol within 365 days prior to screening
    4) Change in systemic or topical treatment of prurigo nodularis within the last 14 days before screening (care products and topical immunomodulators excluded, topical immunomodulators have to be stopped 7 days before screening )
    5) Known hypersensitivity to any component of the formulation of the IMP
    6) Chronic or acute infectious disease (including HIV, Hepatitis B or C infection), disease predisposing for infectious disease or recurring infectious diseases in the history, except for patients with stable chronic Hepatitis B or C as long as their liver values are within normal limits (ULN ≤ 3)
    7) Patients with a current diagnosis of a solid malignant tumor or a history of a solid malignant tumor within the last 5 years (patients with heaemato-oncological malignancies can be included, patients with basal-cell-carcinoma of the skin can be included, patients with a history of a solid malignant tumor in remission for > 5 years can be included).
    8) Patients treated within the last 4 weeks before baseline with oral ruxolitinib or any other JAK-specific inhibitor
    9) Women who are pregnant or breast-feeding
    10) Patients with reproductive potential who do not accept to use contraception or to adhere to sexual abstinence during the trial and 30 days thereafter
    11) Prior treatment with an IMP in a different clinical trial either less than 30 days or if not yet reached a minimum of a 5-fold terminal elimination halflife of the respective IMP or one of it's metabolites. The longer of the respective periods shall be applied.
    12) Neutrophil count less than lower limit of normal, hemoglobin concentration < 10 g/dL, and platelet count < 100 G/l
    13) Presence of cytopenia (defined as leucocyte count < 3 G/l) - depending on the physician's assessment
    14) Lymphocyte count < 0.8 G/l - depending on the physician's assessment
    E.5 End points
    E.5.1Primary end point(s)
    Change in numeric rating scale (NRS) for itch from baseline (V1) to EOS (V5) in placebo versus ruxolitinib-treated patients
    E.5.1.1Timepoint(s) of evaluation of this end point
    EOS (V5); Timepoint of evaluation of secondardy end point see E.5.1
    E.5.2Secondary end point(s)
     Change in Prurigo Activity Score (PAS) from baseline (V1) to EOS (V5) in placebo versus ruxolitinib-treated patients
     Change of DQLI from baseline (V1) to EOS (V5) in placebo versus ruxolitinib-treated patients
     Change of IGA-CNPG S/A (V1) to EOS (V5) in placebo versus ruxolitinib-treated patients
     Change of Itch NRS from baseline (V1) to V2, V3, V4, V5/OLE-V1, OLE-V2, OLE-V3, OLE-V4 in placebo and ruxolitinib-treated patients
     Change of PAS from baseline (V1) to V2, V3, V4, V5/OLE-V1, OLE-V2, OLE-V3, OLE-V4 in placebo and ruxolitinib-treated patients
     Change of DPS from baseline (V1) to V2, V3, V4, V5/OLE-V1, OLE-V2, OLE-V3, OLE-V4 in placebo and ruxolitinib-treated patients
     Change of IGA-CNPG S/A from screening (V0) to baseline (V1), V2, V3, V4, V5/OLE-V1, OLE-V2, OLE-V3, OLE-V4 in placebo and ruxolitinib-treated patients
     Change of DLQI from baseline (V1) to V3, V5/OLE-V1, OLE-V2, OLE-V3, OLE-V4 in placebo and ruxolitinib-treated patients
     Change in gene expression profile in serum (V1 vs V5)
     Change in gene expression profile in lesion (V0 vs V5)
     Change in lesional histological acanthosis score (V0 vs V5)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint(s) of evaluation of secondardy end point see E.5.2
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    LVS
    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 months9
    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 months9
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state20
    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)
    No specific post-study arrangements are made and no specific post-study care will be performed after this study. All subjects will return to their standard medical care after the study, as needed. This also applies to subjects who withdraw their consent during the course of the 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 Decision2021-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
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