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    Summary
    EudraCT Number:2016-003426-16
    Sponsor's Protocol Code Number:PS0013
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-06
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2016-003426-16
    A.3Full title of the trial
    A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study with an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis
    III. fázisú, többközpontú, kettős vak, placebo-kontrollált, egy kezdeti kezelési időszakból és egy randomizált megvonási időszakből álló vizsgálat a Bimekizumab hatásosságának és biztonságosságának értékelésére mérsékelten súlyos-súlyos, krónikus plakkos pikkelysömörben szenvedő felnőtt betegeknél

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study with a initial treatment period followed by a randomized-withdrawal period to evaluate the efficacy and safety of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
    Egy kezdeti kezelési időszakból és egy randomizált megvonási időszakből álló vizsgálat a Bimekizumab hatásosságának és biztonságosságának értékelésére mérsékelten súlyos-súlyos, krónikus plakkos pikkelysömörben szenvedő felnőtt betegeknél
    A.4.1Sponsor's protocol code numberPS0013
    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 SponsorUCB Biopharma SPRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SPRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 nameBimekizumab
    D.3.2Product code UCB4940
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIMEKIZUMAB
    D.3.9.1CAS number 1418205-77-2
    D.3.9.2Current sponsor codeUCB4940
    D.3.9.4EV Substance CodeSUB182636
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous 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 chronic plaque psoriasis
    E.1.1.1Medical condition in easily understood language
    Chronic Plaque Psoriasis is a chronic inflammatory disease characterized by changes in 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 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
    Compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque
    psoriasis (PSO).
    E.2.2Secondary objectives of the trial
    - Evaluate efficacy of bimekizumab compared to placebo at achieving complete clearance (PASI100) after 16 weeks of treatment
    - Evaluate efficacy of bimekizumab compared to placebo after 4 weeks of treatment
    - Evaluate the change in itch, pain, and scaling of bimekizumab compared to placebo after 16 weeks of treatment as reported by subjects using the Patient Symptom Diary
    - Evaluate the change in psoriatic scalp disease of bimekizumab compared to placebo after 16 weeks of treatment in subjects with scalp psoriasis at Baseline
    - Evaluate the efficacy of continuous treatment with bimekizumab versus treatment withdrawal (placebo) as defined by PASI90 at Week 56 for subjects who responded to bimekizumab treatment at Week 16
    - Assess the maintenance of efficacy of bimekizumab dosing 1 versus dosing 2 at Week 56
    - Assess Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Genomic, genetic, epigenetic, proteins, and metabolite biomarkers may be measured in the substudy.
    E.3Principal inclusion criteria
    - Must be at least 18 years of age
    - Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
    - Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator’s Global Assessment (IGA) score >=3 on a 5-point scale
    - Subject is a candidate for systemic PSO therapy
    - Female subject of child bearing potential must be willing to use highly effective method ofcontraception
    E.4Principal exclusion criteria
    - Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections
    - Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
    - Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
    - Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
    - Presence of active suicidal ideation or severe depression
    - Subject has concurrent or a recent history (<5 years) of malignancy
    E.5 End points
    E.5.1Primary end point(s)
    1. Psoriasis Area and Severity Index 90 (PASI90) response at Week 16
    2. Investigator’s Global Assessment (IGA) response at Week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2: Week 16
    E.5.2Secondary end point(s)
    1. PASI100 response at Week 16
    2. PASI75 response at Week 4
    3. Change from Baseline in the Patient Symptom Diary responses for itch at Week 16
    4. Change from Baseline in the Patient Symptom Diary responses for pain at Week 16
    5. Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16
    6. Scalp IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline
    7. PASI90 response at Week 56 among Week 16 PASI90 responders
    8. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment
    9. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment
    10. Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3, 4, 5, 6, 7: Week 16
    2: Week 4
    8-10: From Screening to Safety Follow Up (up to Week 76)
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Australia
    Canada
    Czech Republic
    Germany
    Hungary
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Taiwan
    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
    Last Subject Last Visit (LSLV)
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 182
    F.4.2.2In the whole clinical trial 400
    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)
    Eligible subjects will be allowed to enroll in an open-label 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 Decision2018-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-07
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