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    Summary
    EudraCT Number:2005-005525-63
    Sponsor's Protocol Code Number:C87044
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-29
    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 - PEI
    A.2EudraCT number2005-005525-63
    A.3Full title of the trial
    Follow-up of study C87040 : Multicenter, single blind study to describe the efficacy and safety of re-treatment with CDP870 (certolizumab pegol) subcutaneous at 2 different dose regimens (400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter and 400 mg every 2 weeks) or placebo for 12 weeks, in subjects suffering from moderate-to-severe chronic plaque psoriasis, having responded to treatment in study C87040 and having subsequently relapsed
    A.4.1Sponsor's protocol code numberC87044
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB Pharma S.A.
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameCDP870
    D.3.2Product code CDP870
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCertolizumab pegol (rINN)
    D.3.9.2Current sponsor codeCDP870
    D.3.9.3Other descriptive nameAnti TNF humanized antibody Fab fragment- PEG conjugate
    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 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typePegylated Antibody Fab' fragment
    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
    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
    Psoriasis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10037153
    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 assess difference in PASI scores between week 12 score of the first study C87040 and week 12 score of re-treatment (study C87044).

    E.2.2Secondary objectives of the trial
    The efficacy objectives will be to describe:
    - the evolution of the response during re-treatment using PASI and PGA scales as well as BSA affected by psoriasis,
    - the time to discontinuation from re-treatment due to lack of efficacy
    - the best re-treatment effect
    - the evolution of Health-Related Quality of Life (HRQOL)

    The PK profile of CDP870 as well as the development of anti-CDP870 antibodies will be assessed.

    The safety /tolerance will be described.

    Efficacy, safety and PK data will be analyzed using the data from studies C87040 and C87044 for subjects having participated in both studies
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    To be eligible to participate in this study, all of the following criteria must be met:
    •Subjects having responded to treatment at week 12 in study C87040 (having shown an improvement of ≥ 75% from his/her baseline PASI) and having relapsed during the follow-up period (in the 24 weeks after the end of the study treatment). The relapse is defined as a reduction by more than 50% of the maximal improvement in PASI score from baseline during the treatment period)
    •Subject remaining able to understand the information provided to them and to give written informed consent for C87044;
    •Female subject either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptives; intrauterine device; barrier and spermicide. Abstinence is not an acceptable method). Subjects must agree to continue to use adequate contraception during the study and for 12 weeks after the last dose of CDP870.
    •Subject having a social security system (applicable for France only)
    E.4Principal exclusion criteria
    Subjects must be excluded if they meet any of the following criteria:
    •Erythrodermic, guttate, generalized pustular form of psoriasis;
    •Any recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g. fever, cough);
    •Positive hepatitis B surface antigen test and /or hepatitis C antibody test results;
    •Positive human immunodeficiency virus (HIV) test result;
    •Severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease;
    •Hepatic or renal dysfunction measured by hepatic enzymes (AST and ALT) greater than three times the upper limit of normal or serum creatinine higher than 2 mg/100 ml;
    •Pregnancy;
    •Lactating female;
    •Active malignancy of any type;
    •White blood cell counts less than 4000 per cubic millimeter or more than 20000 per cubic millimeter;
    •New York Heart Association (NYHA) class III-IV congestive heart failure;
    •Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis);
    •Systemic Lupus Erythematosus;
    •History of significant adverse reaction to biological products or polyethylene glycol;
    Tuberculosis positive defined as positive induration ≥ 5 mm PPD skin test (subjects with a positive PPD skin test associated with previous vaccination where there is no clinical or radiographic suspicion of TB maybe enrolled at the discretion of the Investigator);
    •Participation in a clinical study within the past 3 months except study C87040
    •Current or past intake of the following treatments with the here below specified wash out periods before visit 1. These treatments remain also forbidden during the whole trial period i.e. until final visit V9:
    Wash out period = 6 months
    -Infliximab
    -Adalimumab
    -Alefacept
    -Any other antipsoriatic biological agent under investigation other than CDP870

    Wash out period = 3 months
    -Etanercept

    Wash out period = 2 months
    -Efalizumab

    Wash out period = 4 weeks
    -Systemic retinoids
    -Systemic immunosuppressants agents (eg: methotrexate, cyclosporine, azathioprine, thioguanine)
    -Systemic fumarate
    -Systemic corticosteroids
    -Phototherapy or photochemotherapy
    -High potency topical corticosteroids (class I and II)
    -Any other antipsoriatic agent under investigation

    Wash out period = 2 weeks
    -Moderate potency (class III to V) topical corticosteroids (except if applied on the scalp, palms, groin, anal fold and/or soles)
    -Vitamin D analogues and topical retinoïds (except if applied on the scalp, palms, groin, anal fold and/or soles)
    -Keratolitic and coal tar (except if applied on the scalp, palms, groin, anal fold and/or soles)

    •Subjects having experienced a rebound reaction in study C87040
    •Poor compliance with visit schedule or medication intake in study C87040
    •Any other condition, which in the Investigator’s judgment would make the subject unsuitable for inclusion in the study.

    If the investigator has any medically valid reason to doubt the eligibility of a subject, the subject should not be included into the trial. If, however, the Investigator has any other kind of doubts concerning the eligibility, he/she should consult the Sponsor Study Physician for clarification
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable
    Difference in PASI scores between week 12 score of the first study C87040 and week 12 score of re-treatment (study C87044). For patients with a missing PASI score at week 12 of re-treatment, his/her last PASI score under re-treatment will be used.

    Pharmacokinetic variables
    •Samples for the measurement of CDP870 and anti-CDP870 antibodies will be taken at baseline and monthly.

    Safety variables
    •Frequency, severity, nature and duration of adverse events reported by the subjects during the whole duration of the 2 studies (C87040 and C87044).
    •Physical examination abnormalities, evaluated monthly.
    •Vital signs parameters, evaluated monthly.
    •ECG parameters, evaluated during the first and the last visits of the re-treatment period.
    •Blood parameters (hematology, chemistry, CRP and hepatic enzymes), evaluated monthly during the study re-treatment period.
    •Urine test, evaluated monthly during the study re-treatment period .
    •Level of auto-antibodies, evaluated monthly during the study re-treatment period :
    •Level of anti-nuclear antibody (ANA),
    •Level of anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibody,
    •Level of anti-cardiolipin IgG and IgM antibodies
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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.8.3 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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 study is defined as the date of database lock as, at that time, interactions between the Sponsor and the Investigators with possible impact on subject’s data have ended.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-12-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 75
    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 Decision2006-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-06-11
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