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    Summary
    EudraCT Number:2005-003530-17
    Sponsor's Protocol Code Number:C0743T09
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-21
    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 ConcernedAustria - BASG
    A.2EudraCT number2005-003530-17
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
    A.3.2Name or abbreviated title of the trial where available
    PHOENIX 2
    A.4.1Sponsor's protocol code numberC0743T09
    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 SponsorCentocor B.V.
    B.1.3.4CountryNetherlands
    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 nameCNTO 1275
    D.3.2Product code CNTO 1275
    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 INNNot available yet
    D.3.9.1CAS number ---
    D.3.9.2Current sponsor codeCNTO 1275
    D.3.9.3Other descriptive nameHuman monoclonal antibody (CNTO 1275) to interleukin-12p40, Anti-IL-12; Human anti-IL-12 Mab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40 and to 90
    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 typeMonoclonal 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 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 plaque psoriasis
    MedDRA Classification
    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 this study is to evaluate the efficacy and safety of CNTO 1275 in the treatment of subjects with moderate to severe plaque psoriasis.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to:
    1 Evaluate dosing interval adjustment in subjects who inadequately respond to their starting dose regimen and
    2 Evaluate the impact of CNTO 1275 on quality of life.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Be 18 years of age or older at time of consent; may be male or female.
    2. Have had a diagnosis of plaque-type psoriasis at least 6 months prior to first administration of study agent (subjects with concurrent psoriatic arthritis [PsA] may be enrolled).
    3. Have plaque-type psoriasis covering at least 10% of total BSA at screening and at the time of the first administration of study agent.
    4. Have a PASI score of 12 or greater at screening and at the time of the first administration of study agent.
    5. Be candidates for phototherapy or systemic treatment of psoriasis (either naive or history of previous treatment).
    6. Women of childbearing potential and all men must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue to use such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last injection of study agent.
    7. Able to adhere to the study visit schedule and other protocol requirements.
    8. Capable of giving informed consent and the consent must be obtained prior to any study related procedures.
    9. Must avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study.
    10. Must agree not to receive a live virus or live bacterial vaccination during the study or up to 12 months after the last injection.
    11. Must agree not to receive a BCG vaccination during the study or up to 12 months after the last injection.
    12. Have screening laboratory test results within the following parameters:
    a. Hemoglobin ≥ 10 g/dL
    b. White blood cells ≥ 3.5 x 1.000.000.000/L
    c. Neutrophils ≥ 1.5 x 1.000.000.000/L
    d. Platelets e 100 ≥ 1.000.000.000/L
    e. Serum creatinine < 1.5 mg/dL (or < 133 µmol/L)
    f. AST, ALT, and alkaline phosphatase levels must be within 1.5 times the upper limit of normal range for the laboratory conducting the test.
    13. Be considered eligible according to the following TB screening criteria:
    a. Have no history of latent or active TB prior to screening.
    b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    c. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent.
    d. Within 1 month prior to the first administration of study agent, either have a negative tuberculin skin test, as outlined in Appendix C, or have a newly identified positive tuberculin skin test during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent.
    e. Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.
    E.4Principal exclusion criteria
    1. Currently have nonplaque forms of psoriasis.
    2. Have current drug-induced psoriasis.
    3. Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study.
    4. Have used any therapeutic agent targeted at reducing IL-12 or IL-23, including but not limited to CNTO 1275 and ABT-874.
    5. Have used any investigational drug within the previous 4 weeks or 5 times the half-life of the investigational agent, whichever is longer.
    6. Have used any biologic within the previous 3 months or 5 times the half-life of the biologic, whichever is longer.
    7. Have ever received natalizumab or other agents that target alpha-4-integrin.
    8. Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PASI evaluation (including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of the first administration of study agent.
    9. Have used topical medications/treatments that could affect psoriasis or PASI evaluation within 2 weeks of the first administration of study agent.
    10. Have used any systemic immunosuppressants within 4 weeks of the first administration of study agent.
    11. Are currently receiving lithium, antimalarials, or intramuscular gold or have received lithium, antimalarials, or intramuscular gold within 4 weeks of the first administration of study agent.
    12. Have received within 3 months prior to the first injection a live virus or bacterial vaccination. Subjects must agree not to receive a live virus or bacterial vaccination during the study or up to 12 months after the last study agent injection.
    13. Have had a BCG vaccination within 12 months of screening. Subject must agree not to receive a BCG vaccination during the study or up to 12 months after the last study agent injection.
    14. Have a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers.
    15. Have or have had a serious infection, or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening.
    16. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
    17. Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB or fibrosis.
    18. Have or ever have had a nontuberculous mycobacterial infection or opportunistic infection.
    19. Have or have had a herpes zoster infection within 2 months of the first administration of study agent.
    20. Are known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C.
    21. Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
    22. Have a transplanted organ (with exception of a corneal transplant > 3 months prior to the first administration of study agent).
    23. Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
    24. Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, cervical carcinoma in situ that has been treated with no evidence of recurrence, orrecurrence within 5 years prior to the first administration of study agent).
    25. Have been hospitalized in the past 3 years for asthma, ever required intubation for treatment of asthma, currently require oral corticosteroids for the treatment of asthma, or required more than one short-term (≤ 2 weeks) course of oral corticosteroids for asthma within the previous year.
    26. Have undergone allergy immunotherapy previously for prevention of anaphylactic reactions.
    27. Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product.
    28. Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
    29. Are known to have had a substance abuse (drug or alcohol) problem within the previous 12 months.
    30. Are participating in another study using an investigational agent or procedure during participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects who achieve ≥ 75% improvement in PASI from baseline at 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 Information not present in EudraCT
    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 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 Yes
    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.8.6 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 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
    NA
    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 months10
    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 months10
    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 2006-02-21. 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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 1200
    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 Decision2006-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-07
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