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    Summary
    EudraCT Number:2006-003252-38
    Sponsor's Protocol Code Number:Hx-Inflam-302
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-08-14
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2006-003252-38
    A.3Full title of the trial
    An open label clinical pilot study with local injection of human antibody (HuMax-Inflam) for the treatment of inflammatory psoriasis
    A.4.1Sponsor's protocol code numberHx-Inflam-302
    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 SponsorGenmab A/S
    B.1.3.4CountryDenmark
    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 nameHuMax-Inflam
    D.3.2Product code HuMax-Inflam
    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 IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 887116-46-3
    D.3.9.2Current sponsor codeHuMax-Inflam
    D.3.9.3Other descriptive nameMDX-018
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Information not present in EudraCT
    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 typehuman 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 placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    inflammatory 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.1.2Term Psoriasis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of the study is to investigate whether treatment with HuMax-Inflam induces regression or reduces progression of inflammatory, progressive psoriasis in comparison with isotonic saline solution.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Diagnosed with inflammatory, progressive psoriasis vulgaris
    2) Man or woman ≥18 years of age
    3) Development of psoriasis on tape-stripped skin within 3 weeks (Koebner-positive patients)
    4) Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study-related activity is carried out
    E.4Principal exclusion criteria
    1) A diagnosis of pustular psoriasis
    2) Koebner-negative patients
    3) Patients previously treated with HuMax-Inflam
    4) Treatment with systemic antipsoriatic drugs: etretinate, methotrexate, salazopyrine or cyclosporine ≤4 weeks prior to treatment start
    5) Local treatment with antipsoriatic drugs and UV radiation within 20 cm of the injection area ≤2 weeks before treatment start
    6) Primary or secondary immunodeficiency
    7) Active autoimmune disease requiring treatment (in addition to psoriasis vulgaris)
    8) Psoriatic rheumatism requiring systemic treatment except for Non-Steroid Antiinflammatoryr Drugs (NSAIDs)
    9) Previous or current malignant disease except:
    a Cervix carcinoma Stage 1B or lower
    b Noninvasive basal cell carcinoma
    c Malignant melanoma with a complete response duration of more than 10 years
    d Other cancer diagnoses with a complete response duration of more than 5 years
    10) Chronic or active infections such as (but not limited to) chronic kidney infection, chronic pulmonary infection with bronchial ectasia, rhinitis, and tuberculosis
    11) Clinically significant heart disease including unstable angina, acute myocardial infarction within 6 months of Visit 1, heart failure, and arrhythmias requiring treatment except for extrasystoles and minor conductivity anomalies
    12) Significant treatment requiring disease; disease conditions of (but not limited to) the kidneys, liver, hematological conditions, gastrointestinal tract, endocrine system, lungs, nervous system – including cerebral conditions, or mental disease
    13) Previous significant cerebrovascular disease
    14) Known or suspected HIV seropositive status
    15) Known or suspected hepatitis B or hepatitis C
    16) Laboratory values at screening:
    Hemoglobin <5.3 mmol/L
    Neutrophil granulocytes < 1.5 x109/L
    Thrombocytes <100 x109/L.
    S- ALT >2 times the upper normal limit
    S- ALP >2 times the upper normal limit
    S-creatinine >133 µmol/L
    17) Known or suspected sensitivity to the ingredients in the investigational product
    18) Patients who have been treated with any non-marketed drug within 4 weeks of Visit 1
    19) Concurrent participation in any other clinical trial
    20) Patients who are known to be or suspected of being incapable of complying with the study protocol (for example, due to alcoholism, substance abuse or psychiatric illness)
    21) Women who breast feed or women with a positive pregnancy test at Visit 1
    22) Women of reproductive potential who are not willing to use a contraceptive, defined as oral contraceptive or a coil during the study or 3 months after the final HuMax-Inflam injection
    E.5 End points
    E.5.1Primary end point(s)
    The Investigator’s overall assessment of disease activity in the treated areas.
    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 No
    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 Yes
    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.8.1.7.1Other trial design description
    Subjects are their own control.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    sterile isotonic saline
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    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 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 state12
    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 Decision2006-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-31
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