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    Summary
    EudraCT Number:2019-000846-37
    Sponsor's Protocol Code Number:INCB18424-306
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-12-18
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-000846-37
    A.3Full title of the trial
    A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo
    Randomizowane badanie fazy III prowadzone metodą podwójnie ślepej próby, z grupa kontrolną otrzymującą podłoże kremu, z okresem przedłużonego leczenia oceniające skuteczność i bezpieczeństwo ruxolitinibu w postaci kremu u osób z bielactwem nabytym.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants with Vitiligo
    Skuteczność i bezpieczeństwo ruxolitinibu w postaci kremu z okresem przedłużonego leczenia u osób z bielactwem nabytym.
    A.3.2Name or abbreviated title of the trial where available
    Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)
    A.4.1Sponsor's protocol code numberINCB18424-306
    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 SponsorIncyte Corporation
    B.1.3.4CountryUnited States
    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 supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post code19803
    B.5.3.4CountryUnited States
    B.5.5Fax number+13024252734
    B.5.6E-mailRA@incyte.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.3.2Product code INCB018424 PHOSPHATE CREAM 1.5%
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNruxolitinib (phosphate)
    D.3.9.1CAS number 1092939-17-7
    D.3.9.2Current sponsor codeINCB018424 phosphate
    D.3.9.3Other descriptive nameRUXOLITINIB PHOSPHATE
    D.3.9.4EV Substance CodeSUB32897
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    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 placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vitiligo
    E.1.1.1Medical condition in easily understood language
    Vitiligo
    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 PT
    E.1.2Classification code 10047642
    E.1.2Term Vitiligo
    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
    To evaluate the efficacy of ruxolitinib cream in participants with vitiligo.
    E.2.2Secondary objectives of the trial
    Key secondary:
    To further assess the efficacy of ruxolitinib cream
    Secondary:
    To evaluate the safety and tolerability of ruxolitinib cream.
    To evaluate the ruxolitinib PK in plasma after treatment of ruxolitinib cream.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adolescents and adults aged ≥ 12 years.
    2. Participants with a clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
    3. Participants who agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
    4. Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of the following:
    a. Females of non-childbearing potential (ie, or surgically sterile with a hysterectomy and/or bilateral oophorectomy OR postmenopausal, ≥ 12 months of amenorrhea without an alternative medical cause).
    b. Prepubescent adolescents.
    Note: Information about specific types of acceptable contraceptive measures and duration of contraceptive use are provided in the protocol.
    5. For adult participant, ability to comprehend and willingness to sign an ICF, for adolescent participant written informed consent of the parent(s) or legal guardian and written assent from the adolescent participant.
    Note: Adolescents, who during the course of the study become legal adults, will be asked for their consent to continue the study, and in the event of lack thereof, will be discontinued from further participation.
    E.4Principal exclusion criteria
    1.Participants who have no pigmented hair within any of the vitiligo areas on the face.
    2.Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
    3. articipants who have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas. Note: Prior use of hydroquinone is not prohibited (as it is a bleaching agent, not a depigmentation treatment).
    4.Participants with concurrent conditions and history of other diseases:
    a.Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
    b.Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster,chicken pox) within 1 week before baseline.
    c.Conditions at baseline that would interfere with evaluation of vitiligo.
    d.Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
    Examples include but are not limited to the following:
    −Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, NY Heart Association Class III/IV congestive heart failure, and arrhythmia requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mmHg) unless approved by the medical monitor/sponsor.
    −History of thrombosis, including deep venous thrombosis and pulmonary embolism.
    −Participants with concurrent malignant disease or a history of that in the 5 years preceding the
    baseline visit except for adequately treated nonmetastatic malignancies.
    −Current and/or history of liver disease, including known hepatitis B or C, with hepatic or biliary abnormalities.
    − Current and/or history of tuberculosis.
    − History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to
    comply with the administration schedule and study assessments.
    − Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
    5.Participants using any of the following treatments within the indicated washout period before baseline:
    a.1 week: Topical drugs when used on the vitiligo areas, for example, corticosteroids,
    calcineurin, and phosphodiesterase type 4 inhibitors or retinoids.
    b.4 weeks:
    −Melanocyte-stimulating agents (eg, afamelanotide).
    −Immunomodulating systemic medications (eg, corticosteroids, methotrexate, cyclosporine).
    − Any other systemic therapies that could increase the skin sensitivity to UV/visible light or
    impact skin pigmentation, for example, tetracyclines, metoxypsoralens.
    − Received live vaccine.
    Note: Live vaccine is prohibited during the course of the study and within 4 weeks after the EOT
    visit.
    c. 8 weeks: Laser or any kind of phototherapy, including tanning bed or intentional UV exposure.
    d. 5 half-lives or 12 weeks, whichever is longer: Biologic agents, investigational or experimental
    therapy or procedures for vitiligo. Investigational biologics should be discussed with the sponsor
    to determine whether a longer period of discontinuation is required.
    6.Participants who have previously received JAK inhibitors, systemic or topical.
    7.Participants with clinically significant abnormal laboratory values at screening:
    a. Hemoglobin (< 10 g/dL).
    b. Liver function tests:
    − AST or ALT ≥ 2 × ULN.
    − Alkaline phosphatase and/or bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
    c. Severe renal disease (with creatinine clearance < 30 ml/min) or renal disease requiring dialysis.
    d. Clinically significant abnormal TSH or free T4 at screening as determined by the investigator.
    e. Positive serology test results at screening for HIV antibody.
    8. Body mass index < 17 or > 40 kg/m2.
    9. Pregnant or lactating participants, or those considering pregnancy during the period of their
    study participation.
    10. Participants who, in the opinion of the investigator, are unable or unlikely to comply with the
    administration schedule and study evaluations.
    11.Employees of the sponsor or investigator or are otherwise dependents of them.
    12.Participants with known allergy or reaction to any component of the study formulation
    13.Participants who live with anyone participating in any current Incyte-
    sponsored ruxolitinib cream study.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants achieving F-VASI75 at Week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    Key secondary:
    • Proportion of participants achieving F-VASI50 at Week 24.
    • Proportion of participants achieving F-VASI90 at Week 24.
    • Proportion of participants achieving T-VASI50 at Week 24.
    • Proportion of participants achieving a VNS of "4 – A lot less noticeable" or "5 – No longer noticeable" at Week 24.
    • Percentage change from baseline in F-BSA at Week 24
    Secondary:
    • The frequency, duration, and severity of AEs; physical examinations; vital signs; and laboratory data for hematology and serum chemistry.
    • Proportion of participants achieving F-VASI25/50/75/90 during the treatment period (double-blind and treatment extension periods).
    • Percentage change from baseline in F-VASI during the treatment period (double-blind and treatment extension periods).
    • Percentage change from baseline in F-BSA during the treatment period (double-blind and treatment extension periods).
    • Percentage change from baseline in T-VASI during the treatment period (double-blind and treatment extension periods).
    • Percentage change from baseline in T-BSA during the treatment period (double-blind and treatment extension periods).
    • Proportion of participants achieving T-VASI25/50/75/90 during the treatment period (double-blind and treatment extension periods).
    • Proportion of participants in each category of VNS during the treatment period (double-blind and treatment extension periods).
    • Population-based (trough) plasma concentrations of ruxolitinib at Weeks 4, 24 and 40.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 24 , 40 and 52 weeks
    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 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
    To determine the participants’ 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Bulgaria
    Canada
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 30
    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: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 240
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 30
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    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)
    Participants who successfully complete the 52-week treatment in this study may be eligible to participate in a separate extension study to evaluate durability of effect and maintenance regimens.
    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 Decision2019-12-20
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-21
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