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    Summary
    EudraCT Number:2018-002446-36
    Sponsor's Protocol Code Number:BP40635
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-002446-36
    A.3Full title of the trial
    AN OPEN LABEL PHASE 2A TRIAL ASSESSING THE CLINICAL EFFICACY AND SAFETY OF RO5459072 IN MODERATE TO SEVERE PSORIASIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Assessing the Clinical Efficacy and Safety of RO5459072 in Moderate to Severe Psoriasis
    A.4.1Sponsor's protocol code numberBP40635
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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.3.2Product code RO5459072/F03
    D.3.4Pharmaceutical form Capsule, hard
    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 applicable
    D.3.9.1CAS number 1252637-35-6
    D.3.9.2Current sponsor codeRO5459072
    D.3.9.3Other descriptive nameRO5459072
    D.3.9.4EV Substance CodeSUB168602
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis is an immune-mediated disease that causes raised, red, scaly patches to appear on the skin
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •Assess the efficacy of RO5459072 in clearing psoriatic skin
    E.2.2Secondary objectives of the trial
    •Assess early efficacy of RO5459072 after six weeks of treatment
    •Assess sustained efficacy of RO5459072 after a four week follow-up period
    •Assess the efficacy of RO5459072 in improving the quality of life as measured by the Dermatology Life Quality Index (DLQI)
    •Assess the safety and tolerability of RO5459072 given over twelve weeks
    •Pharmacokinetics (PK) of RO5459072 in psoriatic participants

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants must be between 18 and 75 years of age inclusive, at the time of signing the informed consent
    - Participants must have a >= 6 month history of plaque psoriasis or pustular psoriasis as confirmed by a dermatologist, with a Psoriasis Area and Severity Index (PASI) score > 10, and a body surface area (BSA) involvement > 10%
    - For female participants: Agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method that results in a failure rate of < 1% per year (plus a barrier method in case of hormonal contraception), during the treatment period and for at least 28 days after the last dose of study drug.
    - For male participants: Remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method that results in a failure rate of < 1% per year, plus a barrier method, with partners who are WOCBP, or pregnant female partners, to avoid exposing the embryo, during the treatment period and for at least 28 days after the last dose of the drug

    E.4Principal exclusion criteria
    - Present with clinically significant underlying disease processes, such as: cancer within the past 5 years, chronic systemic autoimmune condition, severe cardiovascular and respiratory disease any other severe condition that requires intensive treatment
    - Any condition, including lab abnormalities, which places the patient at unacceptable risk if the patient were to participate in the study, or may confound the interpretation of trial data
    - Patients who have current erythrodermic or guttate psoriasis
    - Patients who have drug-induced psoriasis
    - Patients treated with any of the following systemic therapies including phototherapy, within 28 days of first study drug dosing, including JAK inhibitors, PDE-4 inhibitors, topical or systemic glucocorticosteriods, retinoids and/or ultraviolet (UV) therapy, and other non-psoriasis prohibited treatments defined in the protocol
    - Patients who received adalimumab, infliximab, tocilizumab, canakinumab, or secukinumab within 4 months of first study drug dosing
    - Patients who received etanercept or anakinra within 56 days of first study drug dosing
    - B cell depleting antibodies are prohibited during the study
    - Patients who received ustekinumab within 6 months of first study drug dosing.
    - Patients who, upon previous exposure to any of the following treatments failed to show any clinical benefit in the investigator's opinion: alefacept, etanercept, efalizumab, infliximab, secukinumab, ustekinumab, or adalimumab
    E.5 End points
    E.5.1Primary end point(s)
    1. The proportion of participants that achieve a psoriasis area and severity index (PASI)75 (PASI75) response after twelve weeks of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 12
    E.5.2Secondary end point(s)
    1. The proportion of participants that achieve a PASI50, PASI75, and PASI90 response after six weeks and twelve weeks of treatment, and four weeks after completion of treatment
    2. Change of PASI from baseline after six weeks and twelve weeks of treatment, and four weeks after completion of treatment
    3. Change of physician’s global assessment score (sIGA) after six weeks and twelve weeks of treatment, and four weeks after completion of treatment
    4. Change of DLQI after six weeks and twelve weeks of treatment, and four weeks after completion of treatment
    5. Incidence of Adverse events
    6. Changes in clinical laboratory values, physical examinations, vital signs, and electrocardiogram (ECG)
    7. AUC (area under the curve) of RO5459072
    8. Cmax (maximum concentration) of RO5459072

    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. At baseline (Day 1), Week 6, Week 12, Week 4 after completion of treatment
    4. At baseline (Day 1), Week 6, Week 12, Week 4 after completion of treatment
    5-6. Up to 20 weeks
    7-8. At baseline (Day 1), Week 6 and Week 12
    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 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
    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) 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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Ukraine
    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
    The end of the study is defined as the date of the last visit of the last participant in the study (LPLV).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 30
    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)
    RO5459072 will not be provided to participants after conclusion of 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 Decision2018-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
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