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    The EU Clinical Trials Register currently displays   35918   clinical trials with a EudraCT protocol, of which   5893   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-003073-97
    Sponsor's Protocol Code Number:M10-060
    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:2007-10-02
    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 number2007-003073-97
    A.3Full title of the trial
    A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination with Topical Treatment (Calcipotriol/Betamethasone) in Subjects with Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)
    A.3.2Name or abbreviated title of the trial where available
    BELIEVE
    A.4.1Sponsor's protocol code numberM10-060
    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 SponsorAbbott GmbH & Co. KG
    B.1.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name Humira 40 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNAdalimumab
    D.3.9.1CAS number 331731-18-1
    D.3.9.3Other descriptive nameABT-Humira
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    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 No
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Humira 40mg solution for injection pre-filled pen
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNAdalimumab
    D.3.9.1CAS number 331731-18-1
    D.3.9.3Other descriptive nameABT-Humira
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    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 No
    D.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Dovobet
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharmaceutical Products
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCalcipotriol
    D.3.9.1CAS number 112828-00-9
    D.3.9.3Other descriptive nameCalcipotriolum; Kalcipotriol; Kalcypotriol; Kalsipotriol; Kalsipotrioli; MC-903
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number52.2 microg/g to (as hydrate)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbetamethasone dipropionate
    D.3.9.1CAS number 22298-29-9
    D.3.9.3Other descriptive nameBenzoato de betametasona; Betametasona, benzoato de; Bétaméthasone, Benzoate de; W-5975
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.643
    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) 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 Information not present in EudraCT
    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 placeboOintment
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    To assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.
    E.2.2Secondary objectives of the trial
    Not applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is ≥ 18 years of age.
    2. Subject has a diagnosis of chronic plaque psoriasis with disease duration of at least 6 months since diagnosis. Subjects with concomitant psoriasis palmaris and plantaris will be permitted into this study.
    3. Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA.
    4. Subject must fulfill at least two of the following three Psoriasis severity criteria:
    ● PASI ≥ 10
    ● Affected Body Surface Area (BSA) ≥ 10%
    ● Dermatology Life Quality Index (DLQI) ≥ 10
    5. Female subject is either not of childbearing potential, defined as postmenopausal (at least one year since last menses) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion.
    ● Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
    ● Contraceptives (oral, parenteral, patch) for three months prior to study drug administration)
    ● A vasectomized partner
    6. Female subjects of childbearing potential must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test at Baseline.
    7. Subject is judged to be in good general health by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, CXR, and 12-lead electrocardiogram (ECG) performed at Screening.
    8. Subject must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections.
    9. Subject has voluntarily signed and dated an informed consent form prior to any study related procedure and is willing to comply with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
    10. Subject has a negative PPD test (or equivalent) and CXR (PA and lateral view) at screening. If the subject had a positive PPD test (or equivalent) and/or CXR (PA and/or lateral view), the subject must have had one of the following:
    ● Prophylactic treatment initiated prior to administration of study drug; however the course of prophylaxis need not be completed prior to the onset of study drug. Prophylactic treatment will be according to Appendix D (United States Centers for Disease Control [CDC] recommended preventive therapy for TB) or per local guidelines as approved by the Abbott Study Physician.
    ● Subject has documented prophylactic treatment for TB in the past and does not need to repeat this treatment or TB prophylaxis is ongoing.
    E.4Principal exclusion criteria
    1. Subject has previous exposure to adalimumab.
    2. Subject has been treated with systemic corticosteroids (oral or parenteral) 4 weeks (28 days) or topical corticosteroids 2 weeks (14 days) prior to Baseline. Inhaled corticosteroids for stable medical conditions are allowed.
    3. Subject received topical treatment with calcipotriol or calcipotriol/betamethasone (Daivobet®) within 2 weeks (14 days) prior to Baseline.
    4. Subject with known overexposure to PUVA or UVB.
    5. Subject received a previous biologic agent within the following washout period:
    ● Etanercept received < 3 weeks (21 days) before Baseline
    ● Infliximab received < 8 weeks (56 days) before Baseline
    ● Efalizumab received < 6 weeks (42 days) before Baseline
    ● Abatacept (Orencia) received < 65 days before Baseline.
    6. Subject has been treated with any investigational drug within one month (30 days) or five half-lives (whichever is longer) prior to Baseline.
    7. Subject has other active skin diseases or skin infections (bacterial, fungal, viral or parasitic) or skin manifestations (rosacea, perioral dermatitis, acne vulgaris, atrophic skin, stria atrophicae, fragiilgtu of skin veins, ichthyosis, ulcers, wounds, perianal and genital pruitus), that may interfere with evaluation of psoriasis.
    8. Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, recent cerebrovascular accidents, and any other condition, which in the opinion of the investigator, would put the subject at risk by participation in the study.
    9. Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia), renal, or liver disease (e.g., fibrosis, cirrhosis, hepatitis B or C), or NYHA class 3 or 4 congestive heart failure.
    10. Subject has history of neurologic symptoms suggestive of CNS demyelinating disease and/or diagnosis of CNS demyelinating disease.
    11. Subject has history of any cancer or lymphoproliferative disease.
    12. Subject has a history of listeriosis, histoplasmosis, untreated or inadequately treated TB, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous (IV) anti-infectives within 30 days or oral anti-infectives within 14 days prior to the 1st adalimumab dose.
    13. Subject is known to have immune deficiency, history of HIV, or is immunocompromised.
    14. Female subject who is pregnant or breast-feeding or has positive serum pregnancy test at screening or positive urine pregnancy test at Baseline or considering becoming pregnant during the study or within 150 days after the last dose of adalimumab.
    15. Subject has a history of clinically significant drug or alcohol usage in the last year.
    16. Known positive Hepatitis B or C serology indicative of previous or current infection.
    17. Screening clinical laboratory analyses show any of the following abnormal hepatic laboratory results:
    ● Aspartate transaminase (AST) or alanine transaminase (ALT) > 2x the upper limit of normal (ULN).
    ● Serum total bilirubin ≥ 1.5 mg/dL (≥ 26 micromol/L)
    18. Subjects with known hypersensitivity to the constituents of study drugs (adalimumab, calcipotriol/betamethasone, or matching vehicle).
    19. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study and not able to comply with the study protocol.
    20. Subject has a calcium metabolism disorder.
    E.5 End points
    E.5.1Primary end point(s)
    The comparison of the proportion of subjects with a PASI75 at Week 16 Arm 1 (adalimumab + calcipotriol/ betamethasone) vs. Arm 2 (adalimumab + vehicle calcipotriol/betamethasone).
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    vehicle-controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA150
    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 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
    The date of the last subject's last scheduled visit or the actual date of follow-up contact, whichever is later.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 630
    F.4.2.2In the whole clinical trial 658
    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)
    No sponsored therapy will be provided at the end of the treatment period. It is expected that EMEA approval for the use of adalimumab in Psoriasis will be granted prior to the first subject completing study participation. If approval has not been granted at the end of study participation, medication will be made available locally until marketing authorization is granted and subjects are able to receive a prescription for adalimumab from their physician.
    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 Decision2007-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-22
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