Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39185   clinical trials with a EudraCT protocol, of which   6421   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-020002-15
    Sponsor's Protocol Code Number:A3921061
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-16
    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 ConcernedGreece - EOF
    A.2EudraCT number2010-020002-15
    A.3Full title of the trial
    A PHASE 3, MULTI-SITE, OPEN-LABEL STUDY OF THE LONG TERM SAFETY AND TOLERABILITY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a study in a late stage of drug development designed to see what problems people might develop after participating in the study and taking the study medication for a long time. The study is for some people who have been told by a doctor that they have moderate to severe chronic plaque psoriasis, and they will take one of two doses of study medication, called CP690,550, by mouth in the form of a pill.
    A.3.2Name or abbreviated title of the trial where available
    A3921061 Long Term Open Label Extension Study/OPT Extend
    A.4.1Sponsor's protocol code numberA3921061
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01163253
    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 SponsorPfizer Inc, 235 East 42nd Street, New York, NY 10017
    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 organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017, USA
    B.5.4Telephone number+18007181021
    B.5.5Fax number+13037391119
    B.5.6E-mailClinicalTrials.govCallCentre@pfizer.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.3.2Product code CP-690,550
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    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
    Moderate To Severe Chronic Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    To evaluate the long term safety and tolerability of treatment with CP-690,550 (10 mg BID or variable dose 5 and 10 mg BID) in adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
    E.2.2Secondary objectives of the trial
    - To evaluate the durability of efficacy of CP-690,550 (10 mg BID or variable 5 and10 mg BID) in adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

    - To evaluate effects on patient reported outcome (PRO) measures during treatment with CP-690,550 (10 mg BID or variable 5 and 10 mg BID) at various time points in adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria that Apply to All subjects
    1.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study
    2.Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
    3.Be at least 18 years of age at time of consent
    4.Sexually active women of childbearing potential are required to use adequate contraceptive methods during participation in this study
    5.If receiving non-prohibited concomitant medications for any reason, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives prior to first dose of study drug. Subject must be willing to stay on a stable regimen
    6.If received any of the following treatment regimens, for any reason, are eligible providing the following minimum washout criteria are observed:
    -Must be discontinued for at least 12 weeks prior to first dose of study drug
    a. Any investigational or experimental therapy or procedure for psoriasis, psoriatic arthritis or rheumatoid arthritis; Exception: Investigational biologics should be discussed with the Pfizer Medical Monitor to confirm period of discontinuation required. b. Ustekinumab (Stelara)
    -Must be discontinued for at least 8 weeks prior to first dose of study drug
    a. Adalimumab (Humira®) b. Infliximab (Remicade®) c. Alefacept (Amevive®)
    -Must be discontinued for at least 4 weeks prior to first dose of study drug;
    a. Etanercept (Enbrel®) not including potential treatment for subjects entering from qualifying protocol A3921080; Note: For subjects who participated in protocol A3921080, discontinuation from study drug treatment in protocol A3921080, for at least one week from Visit 5/Week 12 is required as washout criteria prior to entry into protocol A3921061. b. Systemic treatments other than biologics that could affect psoriasis, eg, oral or injectable (eg, intraarticular, intramuscular, or intravenous) corticosteroids, retinoids, methotrexate, cyclosporine, fumaric acid derivatives, sulfasalazine,hydroxycarbamide (hydroxyurea), azathioprine, intramuscular gold. c. Psoralens + UVA phototherapy (PUVA)
    -Must be discontinued for at least 2 weeks prior to first dose of study drug:
    a. Topical treatments that could affect psoriasis, eg, corticosteroids, tars,keratolytics, anthralin, vitamin D analogs, and retinoids; Exceptions – the following topical treatments are allowed: non-medicated emollients for use over the whole body; low or least potent (Class 6or7) topical corticosteroids for the palms, soles, face, and intertriginous areas and scalp only; tar and salicylic acid preparations for the scalp only, and shampoos free of corticosteroids for the scalp only. b. UVB (narrowband or broadband) phototherapy
    7.Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study. Note: Per exclusion criterion, prior treatment with efalizumab (Raptiva®) is exclusionary.

    Inclusion Criteria that Apply only to Subjects who participated in Study A3921047
    1.Have previously completed study A3921047 or were withdrawn/discontinued from that study, with the exception that subjects that were withdrawn/discontinued due to a CP-690,550 related serious adverse event are not eligible for this study.
    Inclusion Criteria that Apply only to (i) Subjects who Participated in Study A3921047 and (ii) Subjects who do not Enroll into This Study within a 2-week Window of the End of Study Visit of a Qualifying Phase 3 Study
    1.Subject must have evidence of plaque-type psoriasis (psoriasis vulgaris) and be considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis at screening
    2.No evidence of active, latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by all of the following -A negative QuantiFERON-TB Gold (QFT-G) In-Tube test or if indeterminate upon retest, a Mantoux Purified Protein Derivative (PPD) skin or within the 3 months prior to Screening.
    -Chest radiographs, taken at or within the 3 months prior to a given Screening visit, without changes suggestive of active TB infection as determined by a qualified radiologist
    -No history of either untreated or inadequately treated latent or active TB infection
    For full criteria see section 4.1.3 of the protocol

    Inclusion Criteria that apply only to Subjects who Enroll from a Qualifying Phase 3 Study at any Time Point
    1.Have previously completed participation in a randomized qualifying study of CP-690,550 for the treatment of plaque psoriasis or;
    -Were withdrawn from a randomized qualifying study for worsening of psoriasis or lack of efficacy after compliant participation of 12 weeks or greater
    For full criteria see section 4.1.3 of the protocol
    E.4Principal exclusion criteria
    Exclusion Criteria that Apply to All Subjects
    1.Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed
    2.Have evidence of skin conditions (eg, eczema) at the time of the screening or baseline visit that would interfere with evaluation of psoriasis.
    3.Have current drug-induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium
    4.If planned initiation of, or changes to, concomitant medication that could affect psoriasis (eg, beta blockers, calcium channel blockers, antimalarial drugs or lithium)are to occur within 2 weeks prior to randomization and/or during the study
    5.Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA)
    6.Are taking or require oral or injectable (eg, intramuscular, intravenous, intraarticular) corticosteroids for any condition.
    7.Women who are pregnant or lactating, or planning pregnancy while enrolled in the study.
    8.Have current or recent history of severe, progressive, or uncontrolled renal, hepatic,hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
    9.Have a history of any lymphoproliferative disorder (such as Epstein Barr Virus [EBV]-related lymphoproliferative disorder, as reported in some subjects on other
    immunosuppressive drugs), history of lymphoma, leukemia, or signs and symptoms
    suggestive of current lymphatic disease
    10.Have a history (single episode) of disseminated herpes zoster or disseminated
    herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster
    11.Have a history of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to first dose of study drug
    12.Have a history of infection requiring antimicrobial therapy within 2 weeks prior to
    first dose of study drug
    13.Have been either vaccinated with live or attenuated vaccine within the 6 weeks prior to the first dose of study drug, or expects to be vaccinated with these vaccines during treatment, or within the 6 weeks following discontinuation of study drug
    14.Any prior treatment with non B cell-specific lymphocyte depleting agents/therapies.Subjects who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to first dose of study drug and have normal CD 19/20+ counts by FACS analysis
    15.Have previously been treated with efalizumab (Raptiva®)
    16.Have any condition possibly affecting oral drug absorption, eg, gastrectomy,
    clinically significant diabetic gastroenteropathy, or certain types of bariatric surgerysuch as gastric bypass. Procedures such as gastric banding, that simply divide the stomach into separate chambers, are NOT exclusionary
    17.Have a history of alcohol or substance abuse, unless in full remission for greater than 6 months prior to first dose of study drug
    18.Have a known immunodeficiency disorder or first-degree relative with a hereditary
    immunodeficiency
    19.Have any malignancies or have a history of malignancies with the exception of
    adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ
    20.Have undergone significant trauma or major surgery within 1 month prior to
    Screening
    21. Require treatment with prohibited concomitant medication(s) including prohibited dietary supplements or have received a prohibited concomitant medication/dietary supplement within 7 days or 5 half-lives prior to the first dose of study drug. Note: amiodarone requires discontinuation at least 290 days (5 half-lives) prior to the first dose of study drug
    22. Known to be infected with human immunodeficiency virus (HIV), hepatitis B or
    hepatitis C viruses

    For Exclusion Criteria numbers 23 - 26, please see section 4.2.1 of the protocol.

    For Exclusion Criteria that Apply only to (i) Subjects who Participated in Study A3921047 and (ii) Subjects who do not Enroll into This Study within a 2-week Window of the End of Study Visit of a Qualifying Phase 3 Study see section 4.2.2 of the protocol

    For Exclusion Criteria that Apply only to Subjects who Enroll from a Qualifying Phase 3 Study within a 2-week Window of the End of Study Visit see section 4.2.3 of the protocol
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence and severity of adverse events during treatment.
    - Incidence of clinical laboratory abnormalities and change from baseline (in this
    and/or prior study) in clinical laboratory values during treatment.
    - Incidence of investigator-reported clinically significant changes in physical
    examination from baseline (in this and/or prior study) during treatment.
    - Incidence of vital sign (blood pressure and heart rate) abnormalities and change from
    baseline (in this and/or prior study) in vital sign measures during treatment.
    - Incidence of electrocardiogram (ECG) abnormalities and change from baseline (in
    this and/or prior study) in ECG measurements during treatment.
    - Summary of adjudicated cardiovascular endpoints.
    - Summary of malignancies confirmed by central laboratory pathologist over-read of
    biopsies.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline/Day 1, Months 3, 6, 9, and 12 and thereafter every 3 months. Open-Label ~5 years
    E.5.2Secondary end point(s)
    Physician’s Global Assessment (PGA) response ie, the proportion of subjects achieving a PGA of “clear” or “almost clear” at various time points.
    - Psoriasis Area and Severity Index 75 (PASI75) response ie, the proportion of subjects
    achieving at least a 75% reduction in PASI relative to Baseline/Day 1 (in this and/or
    prior study) at various time points. The actual and change from Baseline/Day 1 (in this and/or prior study) in PASI and PASI component scores at various time points. The proportion of subjects achieving at least a 50% and 90% reduction in PASI relative to Baseline/Day 1 (in this and/or prior study) (ie, PASI50 and PASI90,
    respectively) at various time points. Proportion of subjects with a PASI score ≥125% of the Baseline/Day 1 PASI score (in this and/or prior study) at any time point. The actual and change from Baseline/Day 1 (in this and/or prior study) in the Itch Severity Item (ISI) score at various time points. The actual and change from Baseline/Day 1 (in this and/or prior study) on the Dermatology Life Quality Index (DLQI) score at various time points. Other patient reported outcome (PRO) measures to be assessed at various time points, including: Short Form-36 Health Survey (Version 2, Acute) (SF-36);
    -Patient Global Assessment (PtGA);
    -Euro-Qol 5 Dimensions (EQ-5D);
    - Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessment of secondary endpoints are defined within the protocol
    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 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
    Tolerability - effects on patient reported outcome
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA222
    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
    Argentina
    Australia
    Austria
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Israel
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Portugal
    Serbia
    Singapore
    Slovakia
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United Arab Emirates
    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
    As per protocol section 13.1.
    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 months11
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days26
    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.1.1.2Preterm 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: 2880
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 320
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Legally acceptable representative can give consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1648
    F.4.2.2In the whole clinical trial 3200
    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)
    After the subject has ended his/her participation in the trial, normal treatment is expected to resume based on their health care provider’s standard 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 Decision2011-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA