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    Summary
    EudraCT Number:2018-000501-23
    Sponsor's Protocol Code Number:B7451014
    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:2018-07-23
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-000501-23
    A.3Full title of the trial
    A phase 3 randomized withdrawal, double-blind, placebo-controlled, multi-center study investigating the efficacy and safety of PF-04965842 in subjects aged 12 years and over, with moderate to severe atopic dermatitis with the option of rescue treatment in flaring subjects.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The aim of the study is to determine how safe and effective PF-04965842 is when taken as the treatment for moderate to severe atopic dermatitis in patients aged 12 years or older. Patients may also receive topical medications if needed.
    A.4.1Sponsor's protocol code numberB7451014
    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., 235 East 42nd Street, New York, NY 10017
    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+1 800 7181021
    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 Tablets
    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.3.9.3Other descriptive namePF-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 evaluate and compare the maintenance of effect of two doses of PF-04965842 (200 mg and 100 mg once daily [QD]) and placebo in subjects aged 12 and above with moderate to severe atopic dermatitis who respond to an initial open-label run-in treatment of 200 mg PF-04965842 QD.
    E.2.2Secondary objectives of the trial
    • To evaluate and compare the effect of PF-04965842 on additional efficacy endpoints and patient-reported outcomes over time in subjects aged 12 years and older with moderate to severe atopic dermatitis.
    • To assess the efficacy of open-label rescue treatment consisting of 200 mg PF-04965842 in combination with topical therapy per standard of care in cases of flare (per protocol definition).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject or his/her legally acceptable representative/parent(s) or legal guardian if a minor, have been informed of all pertinent aspects of the study.
    2. Male or female subjects of 12 years of age or older, at the time of informed consent and body weight ≥40 kg. Adolescent subjects below the legal age of majority (legal adulthood) in the subject’s country will only be enrolled in this study if instructed by the sponsor and approved by the country’s regulatory/health authority. If these approvals have not been granted, only subjects ≥ the legal age of majority (legal adulthood) in the subject’s country will be enrolled.
    3. Meet all the following atopic dermatitis criteria:
    • Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis at the screening and baseline visits according to Hanifin and Rajka criteria of AD .
    • Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease.
    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 prescription only product).
    • Moderate to severe AD (affected BSA ≥10%, IGA ≥3, EASI ≥16 and pruritus NRS severity ≥4 on the day of the baseline visit).
    4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    5. Female subjects who are of child-bearing potential (which includes adolescents aged 12 years and older regardless of whether they have experienced menarche) must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
    a. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to treatment with investigational product;
    b. Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
    NOTE: Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with study treatments) may obviate the need for contraception ONLY if this is the preferred and usual lifestyle of the subject.
    6. Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
    • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    • Have medically confirmed ovarian failure; or
    • Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state.
    All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
    7. 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.
    E.4Principal exclusion criteria
    1. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    2. Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria:
    • Suicidal ideation associated with actual intent and a method or plan in the past year: “Yes” answers on items 4 or 5 of the Columbia suicide severity rating scale (C-SSRS);
    • Previous history of suicidal behaviors in the past 5 years: “Yes” answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS;
    • Any lifetime history of serious or recurrent suicidal behavior;
    • Suicidal behaviors questionnaire – revised (SBQ-R) total score ≥8;
    • Clinically significant depression: patient health questionnaire – 8 items (PHQ-8) total score ≥15;
    • The presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria;
    • In the opinion of the investigator or Pfizer (or designee) exclusion is required.
    3. A current or past medical history of conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.
    4. Receiving anti-coagulants or medications known to cause thrombocytopenia (unless considered safe to stop and washout for the duration of the study).
    5. Currently have active forms of other inflammatory skin diseases, i.e., not AD or have evidence of skin conditions (e.g., psoriasis, seborrheic dermatitis, Lupus) at the time of Day 1 that would interfere with evaluation of atopic dermatitis or response to treatment.
    6. Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of investigational product, or is expected to be vaccinated or to have household exposure to these vaccines during treatment or during the 6 weeks following discontinuation of investigational product.
    7. Adolescent subjects 12 to <18 years old without 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 (i.e., varicella zoster virus immunoglobulin G antibody [VZV IgG Ab]) at screening.
    8. Subjects who have received prior treatment with any JAK inhibitors.
    Refer to protocol for additional criteria.

    E.5 End points
    E.5.1Primary end point(s)
    Loss of response requiring rescue treatment will be evaluated and compared among groups during the blinded treatment period. Loss of response is denoted as flare and is defined as a loss of at least 50% of the Eczema Area and Severity Index (EASI) response at Week 12 and an Investigator’s Global Assessment (IGA) score of 2 or higher.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through out the blinded treatment period
    E.5.2Secondary end point(s)
    Key Secondary Endpoint
    1. Loss of response based on an IGA score of 2 or higher.

    Clinical Efficacy Assessments
    Treatment:
    1. Response based on the IGA (score of 0 or 1 and a reduction of ≥2 points) at all scheduled time points.
    2. Response based on EASI total score (EASI 50, EASI 75, EASI 90, and EASI 100) at all scheduled time points.
    3. Response based on achieving ≥4 point improvement in the severity of pruritus Numerical Rating Scale (NRS) from baseline at all scheduled time points.
    4. Percentage change from baseline in percent Body Surface Area (BSA) at all scheduled time points.
    5. Percentage change from baseline in SCORing Atopic Dermatitis (SCORAD) subjective assessments of itch and sleep loss at all scheduled time points.
    6. Response based on achieving a ≥50% and ≥75% improvement in SCORAD (SCORAD-50, SCORAD-75) from baseline at all scheduled time points.

    Clinical Efficacy Assessments in Subjects Requiring Rescue Treatment:
    1. Response based on the IGA at the end of rescue therapy.
    2. Response based on the EASI total score at the end of rescue therapy.
    3. Response based on achieving ≥4 point improvement in the severity of pruritus Numerical Rating Scale (NRS) at the end of rescue therapy relative to the start of rescue therapy baseline value.
    4. Percent change in percent Body Surface Area (BSA) at the end of rescue therapy relative to start of rescue therapy baseline value.
    5. Percent change in SCORAD subjective assessments of itch and sleep loss at the end of rescue therapy relative to start of rescue therapy baseline value.
    6. Response based on achieving a ≥50% and ≥75% improvement in SCORAD (SCORAD-50, SCORAD-75) at the end of rescue therapy relative to start of rescue therapy baseline value.

    Patient-Reported Outcomes in All Subjects:
    1. Response based on achieving PtGA score of clear (0) or almost clear (1); and a reduction from baseline of ≥2 points at all scheduled time points (among subjects with a score ≥2 at baseline).
    2. Change from baseline in Dermatology Life Quality Index (DLQI) or Children’s DLQI (CDLQI) at all scheduled time points.
    3. Change from baseline in Hospital Anxiety Depression Scale (HADS) at all scheduled time points.
    4. Change from baseline in Patient Oriented Eczema Measure (POEM) at all scheduled time points.
    5. Change from baseline in the Pruritus and Symptoms Assessment in Atopic Dermatitis (PSAAD) at all scheduled time points.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At all scheduled timepoints; or if rescue therapy is required at the end of the rescue therapy
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Responder enriched
    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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA141
    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
    Argentina
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Czechia
    Germany
    Israel
    Italy
    Latvia
    Mexico
    Netherlands
    Poland
    Russian Federation
    Serbia
    Slovakia
    Spain
    Taiwan
    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
    LSLV
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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 Yes
    F.1.1Number of subjects for this age range: 175
    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: 175
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1050
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 145
    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
    Whenever consent is obtained from a subject's parent(s)/legal guardian, the subject's assent (affirmative agreement) must subsequently be obtained.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state129
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 940
    F.4.2.2In the whole clinical trial 1370
    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)
    Following completion of 40 weeks of blinded treatment, all subjects are to be assessed for eligibility to enter the PF-04965842 LTE study B7451015.
    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 Decision2018-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-07
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