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    Summary
    EudraCT Number:2021-006538-38
    Sponsor's Protocol Code Number:C3291032
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2022-02-02
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2021-006538-38
    A.3Full title of the trial
    A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CRISABOROLE OINTMENT, 2% IN CHINESE AND JAPANESE 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 STUDY TO EVALUATE IF CRISABOROLE OINTMENT 2% WORKS WELL AND SAFE IN 2 YEARS AND OLDER CHINESE AND JAPANESE ECZEMA PATIENTS
    A.4.1Sponsor's protocol code numberC3291032
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04360187
    A.5.4Other Identifiers
    Name:ClinicalTrials.govNumber:NCT04360187
    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.
    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 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    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
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCrisaborole
    D.3.9.1CAS number 906672-24-3
    D.3.9.4EV Substance CodeSUB188740
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    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
    Eczema
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    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 crisaborole ointment, 2% applied BID versus Vehicle in Chinese and Japanese pediatric and adult subjects (ages 2 years and older) with mild to moderate Atopic Dermatitis (AD);

    - To evaluate the safety and tolerability of crisaborole ointment, 2% applied twice daily (BID) versus Vehicle in Chinese and Japanese 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 on additional efficacy endpoints in Chinese and Japanese 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 Chinese and Japanese pediatric and adult subjects (ages 2 years and older) with mild and moderate AD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Is male or female 2 years and older at the Screening visit/time of informed consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at least 5% BSA and ISGA≥2 at baseline(Day1)
    E.4Principal exclusion criteria
    - 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 PI’s or designee’s opinion may interfere with study objectives.

    -Has unstable AD or any consistent requirement for high/strong potency or very high/very strong potency topical corticosteroids to manage AD signs and symptoms.

    - Has participated in a previous crisaborole clinical study.
    E.5 End points
    E.5.1Primary end point(s)
    - Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Daxiii;
    - Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs);
    - Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters;
    - Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Baseline, Day 29
    - Baseline up to Day 60
    - Baseline up to Day 29
    - Baseline up to Day 29
    E.5.2Secondary end point(s)
    - Percentage of Participants Achieving Improvement in Investigator’s Static Global Assessment (ISGA) at Day 29;
    - Percentage of Participants Achieving Success in ISGA at Day 29;
    - Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants ≥12 years;
    - Percentage of Participants Achieving Success in ISGA Over Time;
    - Percentage of Participants Achieving Improvement in ISGA Over Time;
    - Percent Change From Baseline in EASI Total Score Over Time;
    - Change from Baseline in Percent Body Surface Area (%BSA) Over Time;
    - Percentage of Participants Achieving EASI-50 Over Time;
    - Percentage of Participants Achieving EASI-75 Over Time;
    - Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥ 12 Years;
    - Change from Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years;
    - Change from Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years;
    - Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time;
    - Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time;
    - Change From Infants’ Dermatitis Quality of Life Index (IDQOL) Total Score Over Time;
    - Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time;
    - Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 years;
    - Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years;
    - Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score;
    - Patient Global Impression of Change (PGIC) Score;
    - Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score;
    - Observer Reported Global Impression of Change (OGIC) Score.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Baseline, Day 29
    - Baseline, Day 29
    - Baseline, Week 4
    - Baseline, Day 8, Day 15, Day 22, Day 29
    - Baseline, Day 8, Day 15, Day 22, Day 29
    - Baseline, Day 8, Day 15, Day 22, Day 29
    - Baseline, Day 8, Day 15, Day 22, Day 29
    - Baseline, Day 8, Day 15, Day 22, Day 29
    - Baseline, Day 8, Day 15, Day 22, Day 29
    - Baseline, Week 1, Week 2, Week 3, Week 4
    - Baseline, Week 1, Week 2, Week 3, Week 4
    - Baseline, Week 1, Week 2, Week 3, Week 4
    - Baseline, Day 15, Day 29
    - Baseline, Day 15, Day 29
    - Baseline, Day 15, Day 29
    - Baseline, Day 15, Day 29
    - Baseline, Day 15, Day 29
    - Baseline, Day 15, Day 29
    - Baseline, Week 1, Week 2, Week 3, Week 4
    - Day 8, Day 15, Day 22, Day 29
    - Baseline, Week 1, Week 2, Week 3, Week 4
    - Day 8, Day 15, Day 22, Day 29
    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 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 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 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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    China
    Japan
    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.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days13
    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: 232
    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: 192
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 154
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 391
    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)
    crisaborole ointment 2% or vehicle BID for AD lesions except for scalp
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: China
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