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    Summary
    EudraCT Number:2018-003359-40
    Sponsor's Protocol Code Number:AE451-G-18-004
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-18
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-003359-40
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of JTE-451 Administered for 16 Weeks in Subjects with Moderate to Severe Plaque Psoriasis (IMPACT-PS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Safety and Efficacy of JTE-451 in Subjects with Moderate to Severe Plaque Psoriasis (IMPACT-PS)
    A.3.2Name or abbreviated title of the trial where available
    IMPACT-PS
    A.4.1Sponsor's protocol code numberAE451-G-18-004
    A.5.4Other Identifiers
    Name:IND Number: Number:129963
    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 SponsorAkros Pharma 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 supportAkros Pharma Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAkros Pharma Inc.
    B.5.2Functional name of contact pointKala Patel
    B.5.3 Address:
    B.5.3.1Street Address302 Carnegie Center, Suite 300
    B.5.3.2Town/ cityPrinceton
    B.5.3.3Post codeNJ 08540
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016099196131
    B.5.5Fax number0016099199575
    B.5.6E-mailpatel@akrospharma.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 nameJTE-451
    D.3.2Product code JTE-451
    D.3.4Pharmaceutical form 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 INNNot availab.
    D.3.9.1CAS number Not availab.
    D.3.9.2Current sponsor codeJTE-451
    D.3.9.3Other descriptive nameJTE-451
    D.3.9.4EV Substance CodeSUB195901
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboTablet
    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 Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    Plaque Psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis compared with placebo.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:

    - To evaluate the safety and tolerability of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis.
    - To evaluate the pharmacokinetics (PK) of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Biopsy Sub-study
    Optional Pharmacokinetic Sub-study
    Optional Photography Sub-study
    E.3Principal inclusion criteria
    1. Male or female, ≥18 and ≤70 years of age at the time of Visit 1 (Screening Visit)
    2. Have a history of moderate to severe plaque psoriasis for at least 6 months prior to Visit 1
    3. Subjects with moderate to severe plaque psoriasis covering ≥10% BSA, with a PASI ≥12 and sPGA score ≥3 at Visit 1 and Visit 2 (baseline)
    4. Body Mass Index (BMI) ≤40 kg/m^2 at Visit 1
    5. Females may participate in the study if they are either surgically sterile, or post-menopausal or if of childbearing potential, use appropriate contraception methods described in the protocol for the duration of the study and for at least 30 days after the last dose of study drug.
    Note: female subjects must not donate eggs for the duration of the study and for at least 12 weeks after the last dose of study drug.
    E.4Principal exclusion criteria
    1. History of the discontinuation of biologic therapies (including marketed and investigational drugs) directly targeting IL-17A, IL-17A/F, IL-17 receptor A, IL-12/IL-23p40 or IL-23p19 due to lack of efficacy, according to the Investigator’s judgement
    Note: If subjects discontinued these therapies due to other reasons (e.g., safety, preference of other medication, cost, insurance coverage, remission), the subjects may participate in the study according to the Investigator’s judgment.
    2. Prior exposure to ROR-γ inhibitors
    3. Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at Visit 1
    Note: Subjects with psoriatic arthritis may participate in the study if criteria for cutaneous severity of psoriasis, as well as all other study restrictions required by the protocol are met.
    4. History or presence of any itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin (e.g., drug-induced pruritus, significant other systemic diseases with itch) within 12 months prior to Visit 1
    5. Does not meet all protocol-specified laboratory test criteria or study restrictions, including previous/concomitant medication restriction criteria
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Parameters:
    Proportion of subjects achieving a minimum 75% improvement from baseline in the PASI (PASI-75) at end of treatment (EOT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and EOT
    E.5.2Secondary end point(s)
    Secondary Efficacy Parameters:
    • Proportion of subjects achieving PASI-50/PASI-75/PASI-90;
    • Percent change from baseline in PASI;
    • Proportion of subjects achieving sPGA score of 0 or 1;
    • Change from baseline in sPGA score;
    • Percent change from baseline in BSA;
    • Change from baseline in Skindex-16;
    • Change from baseline in Itch Numeric Rating Scale (NRS);
    • Change from baseline in each domain score/questionnaire of the Skindex-16.

    Exploratory Efficacy Parameters:
    • Percent change from baseline in psoriasis scalp severity index (PSSI);
    • Change from baseline in Pain NRS for PsA.

    Exploratory Pharmacodynamic Parameters:
    • Change from baseline in levels of cytokines mRNA expression in the biopsy target psoriatic lesions at EOT;
    • Change from baseline in histopathological parameters in the biopsy target psoriatic lesion at EOT.

    Safety Assessments:
    • Number and proportion of subjects with adverse events (AEs), type and severity of AEs, change from baseline in safety laboratory, vital sign and electrocardiogram (ECG) parameters.

    Pharmacokinetic Assessments:
    • Trough plasma levels of JTE-451;
    • Relationship between the JTE-451 dose (exposure) and response may be assessed (exploratory).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Efficacy Parameters: Weeks 2, 4, 8, 12, 16, 20 and EOT, unless otherwise stated
    Exploratory Efficacy Parameters: Weeks 2, 4, 8, 12, 16, 20 and EOT, unless otherwise stated
    Exploratory Pharmacodynamic Parameters: Baseline and EOT
    Safety Assessments: From baseline until Week 16
    Pharmacokinetic Assessments: Trough plasma levels of JTE-451
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned21
    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
    Canada
    Germany
    Poland
    United States
    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 years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 150
    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)
    None, the subjects will return to their standard treatment prior to enrolling in 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 Decision2019-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-26
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