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    The EU Clinical Trials Register currently displays   35495   clinical trials with a EudraCT protocol, of which   5837   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-002086-35
    Sponsor's Protocol Code Number:UP0008
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-002086-35
    A.3Full title of the trial
    A randomized, subject-blind, investigator-blind, placebo-controlled, single-dose, dose escalating study evaluating the safety, pharmacokinetics, and pharmacodynamics of UCB4940 in patients with mild to moderate psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety, pharmacokinetics (the way the
    body absorbs, distributes and eliminates the drug) and pharmacodynamics (effects of drug on the body) of UCB4940 in patients with psoriasis.
    A.4.1Sponsor's protocol code numberUP0008
    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 SponsorUCB Celltech
    B.1.3.4CountryUnited Kingdom
    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 supportUCB Celltech
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointCT Registries & Result Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Straße 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+49217348 1515
    B.5.5Fax number+49217348 1572
    B.5.6E-mailclinicaltrials@ucb.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 nameUCB4940
    D.3.2Product code UCB4940
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number Not availabl
    D.3.9.2Current sponsor codeUCB4940
    D.3.9.3Other descriptive nameCDP4940
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) 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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild to moderate psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis, a skin condition
    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 14.1
    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 safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.
    E.2.2Secondary objectives of the trial
    1. PK of single ascending doses of UCB4940 administered by iv infusion.
    2. Effect of single doses of UCB4940 on clinical features of plaque psoriasis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject prior to the initiation of any study-specific assessment at Screening.
    2. Subject is considered reliable and capable of adhering to the protocol, according to the judgment of the Investigator, and has adequate reading and writing abilities (in his/her native
    language) such that the subject can comprehend and answer the questions on the subject-completed assessments.
    3. Subject is male or female, aged ≥18 years to ≤70 years at Screening. Female subjects must either be postmenopausal (at least 1 year), permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential, must be willing to use at least 2 effective methods of contraception, including a barrier method (eg, male condom,
    female condom, or diaphragm with spermicide) during the study period. Effective methods of contraception are methods of birth control, which result in a low failure rate when used consistently and correctly, such as implants, injectables, oral contraceptives,
    progesterone-releasing intrauterine systems or the TCu 380A intrauterine device, complete sexual abstinence, or vasectomized partner (where post vasectomy testing has demonstrated
    sperm clearance). Male subjects with partners of childbearing potential must be willing to use a condom when sexually active. Both male and female subjects must use the above mentioned contraception for 20 weeks after administration of study drug (anticipated 5 half-lives).
    4. Subject has had a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving ≤5% of BSA (excluding the scalp).
    5. Subject has a body mass index of ≤35kg/m2 at Screening.
    6. Subject has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy.
    7. Subject has adequate venous access on inspection.
    E.4Principal exclusion criteria
    1. Subject has a personal history of polysorbate 80, sorbitol, and/or fructose intolerance.
    2. Subject has donated more than 400mL of blood or blood products within 90 days prior to check-in (Day -2) or plans to donate blood during the study.
    3. Subject is legally institutionalized or has a mental health condition or related care provision (eg, guardianship) that would impede the subject from providing voluntary informed consent to participate in the study.
    4. Subject is an employee or direct relative of an employee of PAREXEL or UCB.
    5. Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method.

    Exclusion criteria related to drugs:
    6. Subject has received systemic nonbiologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening.
    7. Subject has received treatment with biologic agents within 12 months prior to the study.
    8. Subject has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study.
    9. Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to IMP administration.
    10. Subject has a history of drug allergy or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates his/her participation.
    11. Subject requires treatment with a nonsteroidal anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic.

    Exclusion criteria related to concomitant diseases:
    12. Subject has a current or past history of gastrointestinal ulceration.
    13. Subject has cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, stroke, peripheral arterial disease sufficient to cause symptoms and/or require therapy to maintain stable status.
    14. Subject has diabetes mellitus of any type requiring insulin.
    15. Subject has unstable/poorly-controlled Type 2 diabetes mellitus, defined as a glycosylated hemoglobin type A1c (HbA1c) level ≥8.5%.
    16. Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration. When in doubt, the Investigator should confer with the UCB Study Physician.
    17. Subject has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening that cannot be attributed to a prior Bacillus Calmette-Guérin
    inoculation.
    18. Subject has a positive hepatitis B surface antigen or positive hepatitis C antibody result within 3 months prior to Screening.
    19. Subject has a positive test for human immunodeficiency virus (HIV) antibody.
    20. Subject has any of the following hematology values at Screening:
    - For women, hemoglobin <11g/dL; for men, <13g/dL
    - ANC <1.5x109/L (<1500/μL)
    21. Subject has 12-lead ECG with changes considered to be clinically significant, eg, QTc >450ms, bundle branch block, evidence of myocardial ischemia.
    22. Subject has renal or liver impairment, defined as:
    - For women, serum creatinine level ≥125μmol/L; for men, ≥135μmol/L, or
    - ALT and aspartate aminotransferase ≥2x ULN, or
    - Alkaline phosphatase and bilirubin >1.5x ULN (an isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%).
    23. Subject has active neoplastic disease or history of neoplastic disease within 5 years of Screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that
    has been definitively treated with standard of care).
    24. Subject has a history of alcoholism or drug/chemical abuse.
    25. Subject has any other acute or chronic illness which, in the opinion of the Investigator or Study Physician, could pose a threat or harm to the subject.
    E.5 End points
    E.5.1Primary end point(s)
    Safety parameters that will be assessed: adverse events, vital signs including BP measurements, ECG data, and clinical laboratory tests.

    E.5.1.1Timepoint(s) of evaluation of this end point
    The assessments will be made at various timepoints from screnning through to the safety follow up visit.
    E.5.2Secondary end point(s)
    Pharmacokinetic parameters that will be determined from plasma: Cmax, AUC0-∞, AUC0-t, tmax, t1/2, λz,CL, and Vz.

    Pharmacodynamic parameters that will be evaluated: the effect of UCB4940 on psoriatic plaques using the LSS, thickness of the plaque (measured in mm) and keratinocyte layer depth, lesion area, and the overall disease severity using the PGA and the PASI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The assessments will be made at various timepoints from screnning through to the safety follow up visit.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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.1.1.1In 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 39
    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)
    None
    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 Decision2012-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-13
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