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    Summary
    EudraCT Number:2018-003804-37
    Sponsor's Protocol Code Number:B7451036
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-003804-37
    A.3Full title of the trial
    A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTI CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF 04965842 CO ADMINISTERED WITH BACKGROUND MEDICATED TOPICAL THERAPY IN ADOLESCENT PARTICIPANTS 12 TO <18 YEARS OF AGE WITH MODERATE TO SEVERE ATOPIC DERMATITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating PF 04965842 in adolescents with moderate to severe atopic dermatitis on background medicated topical therapy
    A.3.2Name or abbreviated title of the trial where available
    JADE TEEN
    A.4.1Sponsor's protocol code numberB7451036
    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 SponsorPfizer Inc.
    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 supportPfizer Inc, 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street,
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 namePF-04965842
    D.3.2Product code PF-04965842
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-04965842
    D.3.9.2Current sponsor codePF-04965842
    D.3.9.4EV Substance CodeSUB177174
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis is also known as atopic eczema. It is a type of inflammation of the skin that results in itchy, red, swollen, and cracked Skin.
    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 LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    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 efficacy of PF 04965842 compared with placebo when co administered with background medicated topical therapy in adolescent participants 12 to <18 years of age with moderate-to-severe AD.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of PF 04965842 co administered with background medicated topical therapy on additional efficacy endpoints and patient reported outcomes over time in adolescent participants 12 to <18 years of age with moderate to severe AD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age
    1. Participant must be 12 to < 18 years of age, inclusive, at the time of signing the informed consent.
    Type of Participant and Disease Characteristics
    2. Participants who meet the following AD criteria:
    • Confirmed diagnosis of AD at the screening and baseline visits according to Hanafin and Rajka criteria for AD.
    • Documentation of any of the following:
    • Inadequate response to treatment with medicated topical therapy for AD for at least 4 consecutive weeks, within 6 months before the screening visit; or
    • Treatment with systemic therapy for AD within 6 months before the screening visit; or
    • Participant is a candidate for systemic therapy for AD.

    NOTE: Medicated topical therapy is defined as a topical product that contains an active pharmaceutical ingredient indicated for the treatment of AD (irrespective of whether it is an over-the-counter [OTC] or prescribed product).
    • Moderate to severe AD (must fulfil all of the following criteria: affected BSA greater than or equal 10%, IGA greater than or equal 3, EASI greater than or equal16, and Peak Pruritus NRS greater than or equal 4 at the baseline visit).
    3. During the last 7 days prior to Day 1, for the treatment of AD, the subject must have used only non-medicated topical therapy (ie, emollient) at least twice daily, without other active ingredients indicated to treat AD, or other additives which could affect AD (eg, hyaluronic acid, urea, ceramide or filaggrin degradation products), with response to treatment remaining inadequate at baseline. The participant must also be willing and able to comply with standardized background topical therapy, as per protocol guidelines, throughout the remainder of the study.
    4. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
    5. If receiving concomitant medications for any reason other than AD, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half lives (whichever is longer) prior to Day 1 and through the duration of the study.
    Weight
    6. Body weight greated or equal 25 kg.
    Sex
    7. Male or Female
    Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    a. Male participants:
    No contraceptive measures required.
    b. Female participants:
    A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    • Is not a woman of childbearing potential (WOCBP)
    OR
    • Is a WOCBP (all female participants, regardless of whether or not they have experienced/reported menarche, are considered WOCBP unless they are permanently sterile or confirmed infertile). A WOCBP who is sexually active must use a contraceptive method that is highly effective, with a failure rate of <1%, as described in Appendix 4 during the intervention period and for at least 28 days after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
    • A WOCBP must have a negative highly sensitive serum pregnancy test at the screening visit. A urine pregnancy test with a sensitivity of at least 25 mIU/mL, will be performed before the first dose of study intervention and at every site visit including the EOT and follow up visits to confirm the subject has not become pregnant. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
    • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
    Informed Consent
    8. Capable of giving signed informed consent/assent as described Appendix in which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    9. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    E.4Principal exclusion criteria
    Medical Conditions
    1. Other acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
    2. Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the criteria listed in the study protocol.
    3. A current or past medical history of conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.
    4. Currently have active forms of other inflammatory skin diseases, ie, not AD or have evidence of skin conditions at the time of Day 1 that would interfere with evaluation of AD or response to treatment.
    5. Have a history of any lymphoproliferative disorder such as Epstein Barr virus (EBV)-related lymphoproliferative disorder, history of lymphoma, leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
    6. Infection History as indicated in the study protocol:
    7. Have a history of alcohol or substance abuse within 6 months prior to Day 1 that in the opinion of the investigator will preclude participation in the study.
    8. Have a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
    9. Have any malignancies or have a history of malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
    10. Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as evidenced by any of the listed in the protocol.
    Prior/Concomitant Therapy
    11. Require treatment with prohibited concomitant medication(s) or have received a prohibited concomitant medication within the specified time frame prior to the first dose of study medication.
    12. Receiving anti coagulants or medications known to cause thrombocytopenia, (unless considered safe to stop and washout for the duration of the study).
    13. Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of study intervention, or is expected to be vaccinated or to have household exposure to these vaccines during treatment or during the 6 weeks following discontinuation of study intervention.
    14. Participants without documentation confirming prior varicella-zoster infection (chickenpox) or documented evidence of having received at least one dose of the varicella vaccine in countries where the vaccine is approved and standard of care or those who do not have evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, varicella zoster virus immunoglobulin G antibody [VZV IgG Ab]) at screening.
    15. Participants who have received prior treatment with systemic JAK inhibitors.
    16. Have received any of the following treatment regimens specified in the timeframes outlined below:
    Within 1 year of first dose of study intervention:
    • As indicated in the protocol
    Within 12 weeks of first dose of study intervention:
    • As indicated in the protocol
    Within 4 weeks of first dose of study intervention:
    • As indicated in the protocol
    Within 1 week of first dose of study intervention:
    • As indicated in the protocol
    Prior/Concurrent Clinical Study Experience
    17. Participation in other studies involving investigational drug(s) within 8 weeks or within 5 half lives (if known) whichever is longer, prior to study entry and/or during study participation.
    Note: Any investigational or experimental therapy taken or procedure performed for AD, psoriasis, psoriatic arthritis or rheumatoid arthritis in the previous 1 year should be discussed with the Pfizer clinician (or designee). Participants cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study.
    Diagnostic assessments
    18. ANY of the abnormalities listed in the protocol in the clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat, if deemed necessary
    For details and other exclusion criteria please see the protocol.

    E.5 End points
    E.5.1Primary end point(s)
    • Response based on the Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5 point scale) and a reduction from baseline of greater or equel 2 points at Week 12;
    • Response based on the Eczema Area and Severity Index greater or equel 75% improvement from baseline (EASI 75) response at Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    Key Secondary Endpoints
    • Response based on at least 4 points improvement in the Peak Pruritus NRS from baseline at Weeks 2, 4, and 12;
    • Change from baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) total score at Week 12.
    Secondary Efficacy Endpoints
    • Response based on at least 4 points improvement in the Peak Pruritus NRS from baseline at all scheduled time points other than Weeks 2, 4 and 12;
    • Time to achieve at least 4 points improvement in the Peak Pruritus NRS from baseline by Day 15;
    • Response based on the EASI 75 at all scheduled time points except Week 12;
    • Response based on the IGA of clear (0) or almost clear (1) and 2 point reduction from baseline at all scheduled time points except Week 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 2, 4, and 12 and day 15
    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
    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 trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Australia
    Canada
    China
    Czech Republic
    Germany
    Hungary
    Italy
    Japan
    Latvia
    Mexico
    Poland
    Spain
    Taiwan
    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
    The end of the study is defined as the date of the last study visit shown in the Schedule of Activities for the last participant in the study globally.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days18
    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: 225
    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: 225
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients are minors between 12 and 18 years therefore incapable of giving consent personally.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 225
    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 should be treated by their physicians with appropriate standard of care management and medications when required after the end of the study.
    Qualified participants completing 12 week treatment with study intervention will have the option to enter the long-term extension (LTE) study B7451015. Participants discontinuing early from the study will undergo a 4 week follow up.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-08
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