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    Summary
    EudraCT Number:2019-000443-28
    Sponsor's Protocol Code Number:C3291035
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-02-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-000443-28
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction with Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 2 Years and Older) with Mild-to-Moderate Atopic Dermatitis, who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment
    Étude de phase 3, randomisée, en double aveugle, contrôlée par placébo, évaluant l’efficacité et la tolérance du traitement d’entretien et de la réduction des poussées par crisaborole, pommade à 2 %, une fois par jour pendant 52 semaines chez l’adulte et l’enfant (à partir de 2 ans) présentant une dermatite atopique légère à modérée, ayant répondu au traitement deux fois par jour par crisaborole, pommade à 2 %
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Evaluating Long-Term Maintenance Treatment and Flare Reduction with Crisaborole Ointment 2% in Pediatric and Adult Participants with Mild-to-Moderate Atopic Dermatitis
    A.3.2Name or abbreviated title of the trial where available
    CrisADe Control
    A.4.1Sponsor's protocol code numberC3291035
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04040192
    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
    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 pointClinicalTrials.gov Call Center
    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 nameCrisaborole
    D.3.2Product code PF-06930164
    D.3.4Pharmaceutical form Ointment
    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 INNCRISABOROLE
    D.3.9.1CAS number 906673-24-3
    D.3.9.2Current sponsor codePF-06930164
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB188740
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboOintment
    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
    Mild-to-Moderate Atopic Dermatitis
    E.1.1.1Medical condition in easily understood language
    Mild-to-Moderate Atopic Dermatitis
    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 10003640
    E.1.2Term Atopic dermatitis and related conditions
    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
    Efficacy: To evaluate the long-term efficacy of crisaborole ointment, 2%, QD for maintenance therapy and flare reduction in pediatric and adult participants ≥2 years of age with mild-to-moderate AD who responded to crisaborole ointment, 2%, BID treatment.
    Safety: To evaluate the safety and local tolerability of crisaborole ointment, 2%, QD for maintenance therapy and flare reduction in pediatric and adult participants ≥2 years of age with mild-to-moderate AD
    E.2.2Secondary objectives of the trial
    - To evaluate other long-term efficacy
    parameters for maintenance therapy
    and flare reduction of crisaborole
    ointment, 2%, QD in pediatric and
    adult participants ≥2 years of age with
    mild-to-moderate AD who responded
    to crisaborole ointment, 2%, BID
    treatment
    - To evaluate the long-term efficacy of
    crisaborole ointment, 2%, QD for
    maintenance therapy and flare
    reduction in participants ≥2 years of
    age with mild-to-moderate AD
    - To evaluate the long-term health
    impact of crisaborole ointment, 2%,
    QD for maintenance therapy and flare
    reduction in participants ≥2 years of
    age with mild-to-moderate AD
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Accelerometry Sub-study
    Objective: The objective of the exploratory sub-study is to quantitatively evaluate night time
    scratch and sleep quantity in response to crisaborole treatment.
    E.3Principal inclusion criteria
    Age
    1. Participant must be 2 years of age or older at the time of signing the informed consent/assent.

    Type of Participant and Disease Characteristics
    2. Participant who meets the following AD criteria:
    a. Confirmed clinical diagnosis of AD according to the criteria of Hanifin and Rajka (see Appendix 6).
    b. AD treatment naïve, prior non-responder to emollient use, or has been previously treated with TCSs or TCIs.
    c. AD involvement of ≥5% Treatable % BSA (excluding the scalp) (see Table 4) at entry into the run-in period.
    d. ISGA score of Mild (2) or Moderate (3) at entry into the open-label run-in period.

    Sex
    3. Male or Female
    Contraceptive 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 contraception methods are required for male participants in this study.
    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 and using an acceptable contraceptive method as described in Appendix 4 during the intervention period (at a minimum until 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 (Appendix 2) pregnancy test (urine or serum as required by local regulations) within 7 days before the first dose of study intervention. 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.
    * Additional requirements for pregnancy testing during and after study intervention are located in Appendix 2.
    * 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
    4. Capable of giving signed informed consent/assent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
    E.4Principal exclusion criteria
    Medical Conditions
    1. Participant has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non-AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant physical examination finding at Screening that in the investigator’s/designee’s opinion may interfere with study objectives (eg, expose participant to unacceptable risk by study participation, confound evaluation of treatment response or AEs, or interfere with participant’s ability to complete the study)
    2. Participant has unstable AD or any consistent requirement for high-potency TCS to manage AD signs and symptoms
    3. Participant has a significant active systemic or localized infection, including known actively infected AD
    4. History of or active suicidal ideation or behavior, or chronic psychiatric abnormality that may increase the risk associated with study participation or study intervention 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 including the following:
    a. For participants 7-11 years of age, suicidal ideation associated with actual
    intent and a method or plan in the past 6 months: “Yes” answers on items 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) (Section 8.2.6) or a previous history of suicidal behaviors in their lifetime:
    “Yes” answer to any of the suicidal behavior items of the C-SSRS.
    b. For participants ≥12 years of age, suicidal ideation associated with actual intent and a method or plan in the past year: “Yes” answers on items 4 or 5 of the C-SSRS (Section 8.2.6) or a 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.
    5. Participant has a history of cancer within 5 years or has undergone treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only).
    6. Participant has a history of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the IPs.
    7. Participant has a known lack of efficacy to crisaborole.

    Prior/Concomitant Therapy
    8. Participant has a history of use of biologic therapy including intravenous immunoglobulin or dupilumab at any time prior to study
    9. Participant has recent or anticipated concomitant use of systemic therapies or therapies that might alter the course of AD, as specified in the protocol
    10. Participant has received any of the prohibited medications/therapies that may alter the course of AD without the required minimum washout period (see Section 6.5.1) or anticipated concomitant use of any of the prohibited medications/therapy (see Section 6.5.2).
    11. Participant has any planned surgical or medical procedure that would overlap with study participation, from Screening through the end of study.

    Prior/Concurrent Clinical Study Experience
    12. Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.

    Diagnostic assessments
    13. 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.

    Other Exclusions
    14. Pregnant female participants, breastfeeding female participants, and female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of study intervention.
    15. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.
    E.5 End points
    E.5.1Primary end point(s)
    - Flare-free maintenance until onset of first flare during the 52-week double-blind period

    - Incidence of treatment emergent adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    E.5.2Secondary end point(s)
    Key secondary endpoints during the 52-week double-blind period:
    - Number of flare-free days
    - Number of flares
    - Pruritus response maintenance until onset of first flare

    Other secondary endpoints during the 52-week double-blind period:
    * ≥50% reduction in Eczema Area and Severity Index (EASI)50 response maintenance
    * Maintenance of Dermatology Quality of Life Assessments
    * Maintenance of Patient Oriented Eczema Measure (POEM)

    The following will be assessed during flare treatment period:
    - Severity of flare on Investigator’s Static Global Assessment (ISGA) and EASI
    - Duration of flare episode

    The following will be assessed as change from baseline of each respective treatment period (run-in, double-blind, and flare treatment):
    - EASI scores
    - ISGA scores
    - Treatable AD %BSA
    - Most commonly affected AD %BSA

    The following patient reported outcomes (PROs) will be assessed:
    - Night Time Itch
    - AD Skin Pain
    - Patient Global Impression of Severity
    - Patient Global Impression of Change
    - Medical Outcomes Study Sleep Scale
    - EuroQoL EQ-5D
    - Work and Classroom Productivity
    - Hospital Anxiety and Depression
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 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 Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Austria
    Canada
    China
    France
    Israel
    Spain
    Turkey
    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
    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 months4
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days20
    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: 420
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 210
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 210
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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
    Children 2 years of age to legal age of adulthood, or adults requiring legal guardians
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 700
    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)
    Study participants will return to their medical care after the end of study. No extended use programme for crisaborole is planned beyond 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 Decision2020-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
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