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    The EU Clinical Trials Register currently displays   35419   clinical trials with a EudraCT protocol, of which   5814   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-003481-42
    Sponsor's Protocol Code Number:291-417
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-11-28
    Trial 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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2005-003481-42
    A.3Full title of the trial
    A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
    A.3.2Name or abbreviated title of the trial where available
    RESTORE™ R
    A.4.1Sponsor's protocol code number291-417
    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 SponsorPDL BioPharma, 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 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 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 nameVisilizumab (Nuvion)
    D.3.2Product code HuM291
    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 IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVisilizumab
    D.3.9.1CAS number 219716-33-3
    D.3.9.2Current sponsor codeHuM291
    D.3.9.3Other descriptive nameanti-CD3 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.3.11.8Extractive medicinal product No
    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 typeHumanized monoclonal antibody
    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 placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary: To assess the efficacy of visilizumab compared with placebo in retreated subjects.

    E.2.2Secondary objectives of the trial
    Secondary:
    1) To compare the safety of visilizumab to placebo in retreated subjects.
    2) To compare the pharmacokinetics and immunogenicity of visilizumab to placebo in retreated subjects.
    3) To compare health-related quality of life (HRQoL) and pharmacoeconomic outcomes of visilizumab to placebo in retreated IVSR-UC subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
    1) Males and females, 18 years of age or older
    2) Only 1 prior treatment course with visilizumab (or placebo in a blinded visilizumab study)
    3) Response (as defined in parent protocol) of IVSR-UC disease to visilizumab or placebo
    4) Symptomatic worsening (ie, an increase of ≥3 points in MTWSI score) from the subject’s best response on the parent study, a score of ≥9, sustained for at least 2 assessments performed at least 1 week apart; and a confirmatory MTWSI of ≥8 within 1 day prior to randomization
    5) CD4+ T-cell count ≥ 200 cells/mcL at screening for this protocol, or ≥80% of the subject’s screening baseline count prior to enrollment on the parent study
    6) Mayo assessment (including flexible sigmoidoscopy) performed by a trained, blinded evaluating physician within 2 weeks prior to randomization
    7) Agreement to use adequate contraception by male or female subjects of reproductive potential throughout the study and for 3 months after receiving the last dose of study drug
    8) Negative serum pregnancy test at screening in female subjects of childbearing potential
    9) Negative Clostridium difficile test within 10 days prior to the first dose of study drug
    10) Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
    E.4Principal exclusion criteria
    Subjects will be ineligible for this study if they meet any one of the following criteria:
    1) UC requiring immediate surgical, endoscopic, or radiologic interventions, including massive hemorrhage, perforation and sepsis, suppurative complications (intra-abdominal or perianal abscesses), or toxic megacolon requiring imminent intervention
    2) White blood cell (WBC) count less than 2.5 x 10(E3)/mcL; platelet count less than 150 x 10(E3)/mcL; or hemoglobin level less than 8 g/dL. Note: For subjects currently taking a stable dose of 6-MP, AZA, or MTX (for 60 days or more), a WBC count <2.0 x 10(E3)/mcL. Platelet count and hemoglobin level are as stated above.
    3) Active medically significant infections, particularly those of viral etiology, eg, known CMV colitis. This includes any incidence of medically significant, opportunistic infections (see Definitions) within the past 12 months
    4) Live vaccination within 6 weeks prior to randomization. (Subjects may not receive any vaccine for 60 days after randomization)
    5) Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality (eg, creatinine ≥1.6 mg/dL; ALT or AST ≥2X the upper limit of normal [ULN]; alkaline phosphatase ≥1.5X ULN); history of myocardial infarction, coronary artery disease, congestive heart failure, or arrhythmias within 6 months prior to consent
    6) History or treatment of lymphoproliferative disorder (LPD) or malignancy within the past 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix).
    7) Seropositive for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV)
    8) Pregnant women or nursing mothers
    9) Treatment with any other UC salvage drugs (including but not limited to infliximab or another anti-TNF- α drug, cyclosporine, tacrolimus [FK506], adalimumab, thalidomide, or another experimental agent), or therapies (surgery, pheresis, affinity columns) since the first course of treatment with study drug in the parent visilizumab study
    10) Treatment with any other investigational drug or therapy within 60 days prior to randomization
    11) Nontherapeutic levels of chronic antiseizure medications in subjects with a history of seizures, as tested within 4 days prior to randomization
    12) Any condition that, in the investigator’s opinion, makes the subject unsuitable for study participation
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the comparison of the proportion of subjects who respond to retreatment on Day 45 (± 4days) in the visilizumab and placebo groups for the first retreatment course. A subject is defined as a retreatment responder if he/she has a ≥ 3-point (or ≥30%) reduction in the Mayo score from baseline, with the rectal bleeding subscore reduced by at least 1 point, or an actual rectal bleeding subscore of 0 to 1.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, 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) 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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Please refer to section "Duration of Treatment and Study Period" in the protocol study synopsis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 Yes
    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 2005-11-28. Yes
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 80
    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 Opinion2005-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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