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    Summary
    EudraCT Number:2018-001043-31
    Sponsor's Protocol Code Number:C3291037
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-001043-31
    A.3Full title of the trial
    A PHASE 3B/4, MULTICENTER, RANDOMIZED, ASSESSOR BLINDED, VEHICLE AND ACTIVE (TOPICAL CORTICOSTEROID AND CALCINEURIN INHIBITOR) CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY, SAFETY, AND LOCAL TOLERABILITY OF CRISABOROLE OINTMENT, 2% IN PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PHASE 3B/4 STUDY OF THE EFFICACY, SAFETY, AND LOCAL TOLERABILITY OF CRISABOROLE OINTMENT, 2% IN PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
    A.4.1Sponsor's protocol code numberC3291037
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/101/2018
    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 pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street, New York, NY 10017, USA
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1800 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 namecrisaborole ointment, 2%
    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 IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCRISABOROLE
    D.3.9.2Current sponsor codePF-06930164
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name LOCOID Cream, 0.1%
    D.2.1.1.2Name of the Marketing Authorisation holder Leo Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical 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 INNHYDROCORTISONE BUTYRATE
    D.3.9.1CAS number 13609-67-1
    D.3.9.4EV Substance CodeSUB02563MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Elidel 10 mg/g cream
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Products Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameElidel
    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 INNpimecrolimus
    D.3.9.1CAS number 137071-32-0
    D.3.9.3Other descriptive namePIMECROLIMUS
    D.3.9.4EV Substance CodeSUB16457MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    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 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 compare the efficacy of crisaborole ointment, 2% applied BID versus vehicle in pediatric and adult subjects, aged 2 years and older, with mild to moderate AD.
    To evaluate the safety and local tolerability of crisaborole ointment 2% applied BID versus vehicle in pediatric and adult subjects (ages 2 years and older) with mild to moderate AD.
    To evaluate the safety and local tolerability of hydrocortisone butyrate cream 0.1% and pimecrolimus cream 1% applied BID in pediatric and adult subjects (ages 2 years and older) with mild to moderate AD.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of crisaborole ointment, 2% applied BID versus vehicle, hydrocorotisone butycrate cream 0.1% applied BID on additional efficacy endpoints over time in pediatric and adult subjects (ages 2 years and older) with mild to moderate AD .
    To evaluate the efficacy of crisaborole ointment, 2% BID versus hydrocortisone butyrate cream 0.1% and pimecrolimus cream 1% applied BID in pediatric and adult subjects (ages 2 years and older) with mild to moderate AD.
    To evaluate the effect of crisaborole ointment, 2% applied BID versus vehicle on patient/observer reported outcomes over time in pediatric and adult subjects (ages 2 years and older) 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
    Optical Coherence Tomography Sub-Study – A Study of Optical
    Coherence Tomography and Biomarkers in Subjects ages 2 to <18 years old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID.
    The primary objective of this sub-study is to evaluate the differences in atrophic changes in epidermal thickness by structural OCT after
    treatment with crisaborole ointment, 2% or crisaborole vehicle
    ointment, or hydrocortisone butyrate 0.1% cream applied BID for 28
    days.
    The secondary objectives of this sub-study are to evaluate the
    differences in atrophic change in epidermal thickness, skin biomarkers of AD, and TEWL during the course of treatment and following treatment with crisaborole ointment, 2% or crisaborole vehicle ointment, or hydrocortisone butyrate 0.1% cream applied BID for 28 days.
    This sub-study is expected to provide OCT, TEWL, and skin biomarker
    evidence of the effects of crisaborole ointment and vehicle ointment
    compared to TCS.
    This sub-study is planned to be conducted at selected sites in Germany, United Kingdom and the United States only.
    E.3Principal inclusion criteria
    1. Is male or female 2 years and older at the Screening visit/time of informed consent/assent.
    2. Has a clinical diagnosis of AD according to the criteria of Hanifin and Rajka (See Appendix 2).
    3. Has AD involvement of ≥ 5% Treatable %BSA (excluding the scalp) at Baseline/Day 1.
    4. Has an ISGA score of Mild (2) or Moderate (3) (excluding the scalp) at Baseline/Day 1.
    5. Female subjects of childbearing potential who have a negative urine pregnancy test at the screening visit and negative urine pregnancy test at the baseline visit prior to randomization. A female is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children (includes any female who has experienced menarche and does not meet the criteria for females not of childbearing potential).
    6. Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
    a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
    b. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    c. Have medically confirmed ovarian failure.
    All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
    7. Evidence of a personally signed and dated informed consent/assent document indicating that the subject [or parent(s)/legal guardian] has been informed of all pertinent aspects of the study.
    8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    Additional Inclusion Criteria for Cohort 1 and Cohort 2 and can be found in the Protocol.
    E.4Principal exclusion criteria
    1. 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 that in the PI’s or designee’s opinion may interfere with study objectives (eg, expose subject to unacceptable risk by study participation, confound evaluation of treatment response or AEs, or interfere with subject’s ability to complete the study).
    2. Has unstable AD or a history of requirement for high/strong potency or very high/very strong potency topical corticosteroids to manage AD signs and symptoms (See Appendix 3).
    3. 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 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 including the following:
    For subjects 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 Children’s Columbia suicide severity rating scale (C-SSRS) or a previous history of suicidal behaviors in their lifetime: “Yes” answer to any of the suicidal behavior items of the Children’s C-SSRS.
    For subjects >=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 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. Pregnant female subjects; breastfeeding female subjects; and female 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 investigational product.
    6. Has received any of the prohibited medications/therapies that may alter the course of AD without the required minimum washout period (see Section 5.8.1) or anticipated concomitant use of any of the prohibited medications/therapy (see Section 5.8.2).
    7. Has any planned surgical or medical procedure that would overlap with study participation, from Screening through the end of study.
    8. 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).
    9. Has a history of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the investigational products.
    10. Has a known lack of efficacy to crisaborole.
    11. Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.
    12. Other acute or chronic medical 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.
    13. 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 subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
    Aditional exclusion criteria for Cohort 1 and Cohort 2 and can be found in the Protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from Baseline in the Eczema Area and Severity Index (EASI) total score at Day 29.
    AEs, SAEs, local tolerability, discontinuations and clinically significant changes in vital signs and clinical laboratory parameters.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy endpoint at Day 29.
    Safety endpoints along the study.
    E.5.2Secondary end point(s)
    Efficacy endpoints:
    -Percent change from Baseline in EASI total score by scheduled time points except Day 29.
    -Achieving success in the Investigator’s Static Global Assessment (ISGA) (defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from Baseline) by scheduled time points.
    -Achievement of ISGA score of clear (0) or almost clear (1) by scheduled time points.
    -Achievement of EASI75 (>=75% improvement from Baseline) by scheduled time points.
    -Time to EASI75.
    -Change from Baseline in % BSA by scheduled time points.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Schedule time points
    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 Yes
    E.6.13.1Other scope of the trial description
    Local tolerability
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    pimecrolimus and hydrocortisone butyrate cream
    E.8.2.4Number of treatment arms in the trial6
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Belgium
    Germany
    Italy
    Netherlands
    Poland
    Sweden
    Switzerland
    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
    End of trial in all participating countries is defined as last subject last visit (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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 410
    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: 290
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 120
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 82
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 from 2 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 368
    F.4.2.2In the whole clinical trial 600
    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)
    The End of Treatment visit (Day 29), investigators will assess the subject’s condition and initiate an appropriate treatment plan according to their usual standard of care, and in collaboration with the subject’s own physician, where applicable. An open-label extension study is not available for those subjects who complete Study C3291037.
    For the treatment of mild to moderate atopic dermatitis there are many commercially available products.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation INCiPiT
    G.4.3.4Network Country Italy
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation NIHR
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-12-20
    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 trial2020-12-11
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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