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    Summary
    EudraCT Number:2019-002406-43
    Sponsor's Protocol Code Number:V01-118A-401
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-11
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-002406-43
    A.3Full title of the trial
    A Phase 4 (Phase 2 in European Union), Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion in Pediatric Subjects with Moderate to Severe Plaque Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Absorption and effect on defined hormones of IDP-118 lotion, applied on the skin
    A.4.1Sponsor's protocol code numberV01-118A-401
    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 SponsorBausch Health Americas, Inc.(affiliate of Bausch Health US , LLC, formerly known as Dow Pharmaceutical Sciences)
    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 supportBausch Health Americas, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Gerhard Mann chem.-pharm. Fabrik GmbH
    B.5.2Functional name of contact pointLegal Representative
    B.5.3 Address:
    B.5.3.1Street AddressBrunsbütteler Damm 165/173
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13581
    B.5.3.4CountryGermany
    B.5.4Telephone number+493033093318
    B.5.5Fax number+4930330936699
    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 nameDuobrii
    D.3.2Product code IDP-118 lotion
    D.3.4Pharmaceutical form Cutaneous solution
    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 INNTAZAROTENE
    D.3.9.2Current sponsor codeIDP-118
    D.3.9.4EV Substance CodeSUB10844MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.045
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHALOBETASOL PROPIONATE
    D.3.9.2Current sponsor codeIDP-118
    D.3.9.4EV Substance CodeSUB196202
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.01
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis is a long-lasting autoimmune disease characterized by patches of abnormal 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    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
    - Evaluation of the sfatey of IDP-118 (HP 0.01% and Taz 0.045%) Lotion administered topically once daily in pediatric patients(12-16 years 11 months
    of age) for 8 weeks
    - Systemic exposure of HP, Taz and its metabolite, tazarotenic acid after topical application of IDP-118 Lotion once daily in pediatric patients (12-16
    years 11 months of age) for 4 weeks
    - Hypothalamic-pituitary-adrenal (HPA) axis suppression potential for IDP-118 Lotion when applied once daily in pediatric patients (12-16 years 11
    months of age) for 8 weeks
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, of any race, 12 to 16 years 11 months of age at the time of informed consent/assent obtained.
    2. Verbal and written informed consent/assent obtained from the subject and/or parent or legal guardian.
    3. Has a clinical diagnosis of psoriasis at the Screening and Baseline visit with an Investigator’s Global Assessment (IGA) score of 3 or 4.
    4. Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline.
    5. Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation for the duration of the study.
    6. Is in good general adrenal Health.
    7. Is in good general Health.
    8. Pre-menses females (9 and older) and females of childbearing potential, must have a negative urine and serum pregnancy test at Screening and a
    negative urine pregnancy test at the Baseline visit prior to study drug application .
    9. Females of childbearing potential and females who are pre-menses (9 and older) must be willing to practice effective contraception for the duration
    of the study.
    10. Subject is willing to comply with study instructions and return to the clinic for required visits.
    E.4Principal exclusion criteria
    1. Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
    2. Has a history of adrenal disease.
    3. Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the
    investigator.
    4. Is pregnant, nursing an infant, or planning a pregnancy during the study period.
    5. Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to baseline, or
    is concurrently participating in another clinical study with an investigational drug or device.
    6. Received treatment with a topical antipsoriatic drug product other than corticosteroids or Taz-based therapy within 14 days prior to the
    Baseline visit, and/or treatment containing Taz within 28 days prior to the Baseline visit, and/or treatment containing corticosteroids within
    28 days prior to the screening HPA axis stimulation test.
    7. Has used any phototherapy (including laser), photoche motherapy, or systemic non-biologic psoriasis therapy (such as newer oral psoriasis
    medications [eg, Otezla], methotrexate, retinoids or cyclosporine) within 4 weeks prior to the Baseline visit, or systemic corticosteroids
    within 28 days prior to the screening HPA axis stimulation test
    8. Has used immunomodulatory therapy (e.g., biologics) known to affect psoriasis within 3 months of baseline
    9. Has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 4 weeks prior to screening or is intending to have
    exposure during the study thought likely by the investigator to modify the subject’s psoriasis.
    10. Is currently using lithium or Plaquenil.
    11. Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.
    12. Is unable to be compliant with study procedures, study drug administration requirements, study visit schedules, and prohibitions regarding
    the use of concomitant medications/therapies.
    13. Is unable to communicate or cooperate with the investigator.
    14. Has any underlying disease deemed uncontrolled by the investigator that poses a concern for the subject’s safety while participating in the
    study.
    15. Has a history of drug or alcohol abuse as determined by the investigator.
    16. Is considered by the investigator, for any other reason, to be an unsuitable candidate for the study.
    17. Has an abnormal sleep schedule or works at night.
    18. Has a history of an adverse reaction to cosyntropin injection or similar test reagents.
    E.5 End points
    E.5.1Primary end point(s)
    1 Safety of IDP-118 (HP 0.01% and Taz 0.045%) Lotion administered topically once daily
    2 Systemic exposure of HP, Taz and its metabolite, tazarotenic acid after topical application of IDP-118 Lotion once daily
    3 Hypothalamic-pituitary-adrenal (HPA) axis suppression potential for IDP-118 Lotion when applied once daily
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 - after 8 weeks of treatment
    2 - after 4 weeks of treatment
    3 - after 8 weeks of treatment
    E.5.2Secondary end point(s)
    None
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    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 No
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Axis suppression potential of topically applied IDP-118 Lotion
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States No
    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
    Panama
    United States
    Poland
    E.8.7Trial has a data monitoring committee No
    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 years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days29
    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: 45
    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: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    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
    Assent to be given by the minor patient, Consent to be given by parents or legal guardians prior to first study specific assessment
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 45
    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 who have completed the trial will be treated by their physician/dermatologist according to standard of treatment.
    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 Decision2020-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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