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    Summary
    EudraCT Number:2010-019293-32
    Sponsor's Protocol Code Number:C33457/3075
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-07-26
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2010-019293-32
    A.3Full title of the trial
    An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus)
    A.3.2Name or abbreviated title of the trial where available
    Celestial 75
    A.4.1Sponsor's protocol code numberC33457/3075
    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 SponsorCephalon, 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 supportCephalon Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointBrian Dove
    B.5.3 Address:
    B.5.3.1Street Address929 North Front Street
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeNC 28401
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 910 558 6797
    B.5.5Fax number+1 919 654 9464
    B.5.6E-mailBrian.Dove@ppdi.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 nameLupuzor
    D.3.2Product code CEP-33457
    D.3.4Pharmaceutical form Powder for injection
    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 INNForigerimod
    D.3.9.1CAS number 1160237-55-7
    D.3.9.2Current sponsor codeCEP-33457
    D.3.9.3Other descriptive nameIPP-201101, P140
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 Yes
    D.3.11.13.1Other medicinal product typeCEP-33457 is a fully synthetic characterised polypeptide (phosphopeptide of 21 amino acids)
    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
    Patients With Systemic Lupus Erythematosus (SLE)
    E.1.1.1Medical condition in easily understood language
    In SLE, the body identifies its own proteins as invaders and attacks itself leading to inflammation. Antibodies are made that recognize normal tissues as foreign resulting in tissue damage.
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective 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 of the study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (sc) CEP 33457 every 4 weeks over 72 weeks in patients with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP-33457.
    Safety will be assessed by evaluating the following:
    •occurrence of adverse events
    •clinical laboratory tests (serum chemistry, hematology, and urinalysis)
    •vital signs (blood pressures, pulse, temperature, and body weight)
    measurements
    •12 lead ECG
    •physical examination findings, including physical examination symptom
    directed findings
    •concomitant medication usage
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are the following:
    •SRI response
    •change in SLEDAI 2K score
    •change in BILAG 2004 score
    •status of disease (PhGA and Patient’s Global Assessment [PtGA] scales)
    •health related QoL (SF 36 Questionnaires)
    •biologic markers of disease activity (eg serology B [autoantibodies, complement components, mmunoglobulins, interleukins]) and immunophenotyping)
    •incidence of disease flares (eg SELENA Flare Index)
    •occurrence of SLE induced organ damage, (eg SLICC/ACR Damage Index)
    •remission of disease (ie SLEDAI 2K score reduction to 0)
    •changes in steroid dose
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are included in the study if all of the following criteria are met:
    (a1) The patient previously participated in and completed at least visit 8 (week 24) in the Cephalon-sponsored clinical study with CEP-33457 (study C33457/2047) and, in the investigator's opinion, would benefit from continued participation in a clinical study.
    (b) The patient is a man or woman between 18 and 70 years of age who has an established diagnosis of SLE as defined by ACR Classification Revised Criteria. The diagnosis is fulfilled provided that at least 4 criteria are met.
    (c) Written informed consent is obtained.
    (d) Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of contraception and must agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug treatment. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
    (e) The patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the final assessment as specified in this protocol.
    E.4Principal exclusion criteria
    Patients are excluded from participating in this study if 1 or more of the following criteria are met:
    (a) The patient has New York Heart Association (NYHA) Class III or IV
    congestive heart failure
    (b) The patient has an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m2 (via Modification of Diet in Renal Disease [MDRD] equation).
    (c) The patient has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 2 times the upper limit of the normal range (ULN) or a total bilirubin value of greater than or equal to 1.5 times the ULN.
    (d) The patient has a planned immunization with a live or live attenuated vaccine within 3 months prior to the 1st dose of study drug and for 3 months after administration of the last dose of study drug is administered.
    (e) The patient has clinically significant abnormalities on the 12 lead EGG that are not related to SLE, as determined by the investigator. Patients with stable ECG changes without evidence of active cardiovascular disease may participate at the discretion of the investigator and medical monitor.
    (f) The patient has an ongoing active systemic infection requiring treatment or a history of severe infection, such as hepatitis or pneumonia, in the 3 months prior to administration of the 1st dose of study drug. Patients with a history of less severe infections in the 3 months prior to administration of the 1st dose of study drug are permitted to participate in the study at the discretion of the investigator and medical monitor.
    (g) The patient has any concomitant medical condition unrelated to SLE that may interfere with his or her safety or with evaluation of the study drug, as determined by the investigator.
    (h1) The patient has a history of a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
    (i) The patient has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease.
    (j) The patient has a history of alcohol or substance dependence or abuse (with the exception of nicotine), according to the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, Fourth Edition, Text Revision (DSM IV TR), within 3 months of the screening visit for study C33457/2047, or current substance abuse.
    (k) The patient has a history of severe allergic reactions to or hypersensitivity to any component of the study drug.
    (l) The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
    (m) The patient has undergone or is undergoing treatment with another investigational drug for the treatment of lupus within 6 months prior to the 1st dose of study drug or has received any other investigational drug for any other condition within 30 days prior to the 1st dose of study drug, except for treatment with CEP-33457 or placebo in study 33457/2047.
    (n1) The patient has a known history of antibodies to CEP-33457.
    (o) The patient is unlikely to comply with the study protocol or is unsuitable for any other reason, as judged by the investigator or medical monitor
    E.5 End points
    E.5.1Primary end point(s)
    Safety is the primary objective of this study and will be assessed by
    evaluating the following:
    • occurrence of adverse events throughout the study
    • clinical laboratory tests (serum chemistry, hematology, and urinalysis) at each visit during the treatment period
    • vital signs (systolic and diastolic blood pressures, pulse, temperature, and body weight) measurements at each visit during the treatment period
    • 12 lead ECG at week 48 and the final assessment (or early termination)
    • physical examination findings, including physical examination symptom directed findings, at selected time points throughout the study
    • concomitant medication usage throughout the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to section E.5.1
    E.5.2Secondary end point(s)
    The efficacy variables and endpoints for this study are to determine the following:
    • proportion of patients achieving a clinical response using the SRI at each visit during the treatment period.
    • change in SLEDAI-2K score at each visit during the treatment period
    • change in BILAG-2004 score at each visit during the treatment period
    • proportion of patients showing no worsening on PhGA scale at each visit during the treatment period
    • proportion of patients showing no worsening on PtGA scale at weeks 12, 24, 36, 48, and 60 and the final assessment (or early termination)
    • changes in SF-36 at weeks 12, 24, 36, 48, and 60 and the final assessment (or early termination)
    • changes in the biomarkers anti-dsDNA Ab and C3 and C4 at each visit during the treatment period
    • changes in the following biomarkers at weeks 12, 24, 36, 48, and 60 and the final assessment (or early termination): anti-U1RNP Ab, anti-Sm Ab, CRP, IgG, IgM, IgE, and ANA
    • SELENA Flare Index at each visit
    • changes in the SLICC/ACR Damage Index score at weeks 24 and 48 and the final assessment (or early termination)
    • remission of disease (ie, reduction of SLEDAI-2K score to 0)
    • proportion of patients with changes in steroid dose over time throughout the study
    The immunogenicity variable and endpoint for this study are as follows: any presence of anti–CEP-33457 Ab at weeks 24 and 48 and the final assessment (or early termination).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to section E.5.2
    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 No
    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
    Quality of Life
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Belgium
    Czech Republic
    Germany
    Hungary
    Poland
    Portugal
    Spain
    Ukraine
    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 patient last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    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 months8
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 126
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 90
    F.4.2.2In the whole clinical trial 130
    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 ended their participation will be treated as per their primary physician's plan of care.
    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 Decision2010-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-06-14
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