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    Summary
    EudraCT Number:2004-003972-12
    Sponsor's Protocol Code Number:CAEB071A2201
    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:2007-12-03
    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 number2004-003972-12
    A.3Full title of the trial
    A 2 week multiple ascending dose, double-blind placebo controlled study to evaluate the safety, tolerability and pharmacokinetics (PK) of twice daily administration of oral AEB071 and to explore the pharmacodynamics (PD) of oral AEB071 in moderate to severe psoriasis patients.
    A.4.1Sponsor's protocol code numberCAEB071A2201
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot applicable
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 nameAEB071
    D.3.2Product code AEB071A
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 425637-18
    D.3.9.2Current sponsor codeAEB071
    D.3.9.3Other descriptive nameAEB071 drug substance, mono acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 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 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 nameAEB071
    D.3.2Product code AEB071A
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 425637-18
    D.3.9.2Current sponsor codeAEB071
    D.3.9.3Other descriptive nameAEB071 drug substance, mono acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral 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 chronic plaque psoriasis patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version M15
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Overall safety and tolerability of multiple dose twice daily oral administration of AEB071.
    E.2.2Secondary objectives of the trial
    Pharmacodynamics of oral AEB071versus AEB071 matching placebo:
    Skin: Change in histological score as assessed by number of T cells (dermal and epidermal), activation status of T cells, epidermal thickening, Ki67 and K16 expression in keratinocytes.
    Clinical assessment: Evaluated using PASI score and digital photography.
    •Pharmacokinetics of AEB071 in:
    •Blood & skin to determine the levels of AEB071 and AEE800.
    •Pharmacogenomics
    •To conduct exploratory genomic studies to identify gene expression patterns of blood and tissue that are associated with treatment response to AEB071, or that possibly correlate with the severity or progression of psoriasis
    •Exploratory Biomarker Assessments
    •The effect of AEB071 on:
    1. Monitor Macrophage migration inhibitory factor (MIF) in serum, as a function of time.
    2. sIL-2R and TNF-α expression in serum will be assayed (if there is sufficient level of expression).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female patients from 18-65 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
    2. Female patients must be postmenopausal (i.e. must have had no regular menstrual bleeding for at least 2 years prior to inclusion) or must have been surgically sterilized (bilateral oophorectomy) or hysterectomized at least 6 months prior to screening. Menopause will be confirmed by a plasma 17β-estradiol concentration of <20 pg/mL and a plasma FSH level of >40 IU/L. Surgical sterilization procedures or hysterectomy must be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF
    3. Body weight must be between 50 and 100kg (inclusive).
    4. Moderate/severe chronic plaque psoriasis.
    5. Able to provide written informed consent prior to study participation.
    Subject information and consent forms generated by the investigator must be approved by the sponsor prior to submission to the Ethics Committee (EC)/Institutional Review Board (IRB). A copy of the subject information and consent forms approved by the EC/IRB must be forwarded to the sponsor prior to study initiation.
    6. Able to communicate well with the investigator and comply with the requirements of the study.
    Additional criteria for cohort 4:
    Male patients must agree to use double barrier methods of contraception (condoms and spermicide) for the duration of the study and until one month after receiving the last dose of study medication. Also, male patients should not donate sperm for the duration of the study until one month after receiving the last dose of study medication.
    E.4Principal exclusion criteria
    1. Use of any prescription drug or over-the-counter (OTC) medication (including herbal remedies) within 2 weeks prior to dosing. Paracetamol is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the eCRF
    Concomitant medication/ other therapies or medication for psoriasis:
    • Topical therapy for psoriasis (eg, tar, corticosteroids, anthralin (dithranol), vitamin D analogues, retinoids) within 2 weeks prior to first administration of study medication with the exception of indifferent topical substances (eg, Vaseline), topical formulations containing salicylic acid (not more than 10%) or tar shampoos.
    • Immunosuppressive agents, radiation therapy, chemotherapy or any specific systemic therapy for psoriasis (eg, methotrexate, cyclosporine, tacrolimus, steroids, retinoids, fumaric acid, biologicals) within 4 weeks (8 weeks for biologicals with a half-life longer than 2 days) prior to first administration of study drug OR the anticipated use of these therapies at any time during the study.
    • Who are currently receiving or have received photochemotherapy/phototherapy (eg, PUVA, UVB, etc.) within 4 weeks prior to first administration of study drug.
    2. Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
    3. Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
    4. Significant illness within the two weeks prior to dosing.
    5. 5. A past medical history or family history of a prolonged QT-interval syndrome; clinically significant ECG findings including QTcB > 450 for males and > 470 for females, PR > 220, QRS > 110; hypokalemia or hypomagnesemia; history of heart failure or known left ventricular dysfunction (EF < 45%); history of clinically significant atrial arrhythmias eg atrial fibrillation, atrial flutter, supraventricular tachycardia) or ventricular arrhythmias; history of clinically significant atherosclerotic cardiovascular disease (eg, angina, coronary artery disease, history of MI or CVA).
    6. History of autonomic dysfunction.
    7. History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
    8. History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
    9. History of malignancies including skin cancer or lymphoproliferative disorders
    10. Who have hypertension (systolic BP >150 mmHg or diastolic BP >95 mmHg after 5 minutes in sitting or supine position) and who have other cardiovascular diseases requiring medical intervention. Subjects with drug-controlled hypertension are also excluded.
    11. Other forms of psoriasis:
    • Guttate, generalized erythrodermic, local or generalized pustular, or drug-associated (eg, beta-blockers, lithium) psoriasis.
    • Psoriasis is limited to palmar/plantar areas.
    12. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study. The investigator should be guided by evidence of any of the following:
    • history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding;
    • history of major gastrointestinal tract surgery such as gastrectomy, gastroentero-stomy, or bowel resection;
    • history or clinical evidence of pancreatic injury or pancreatitis;
    • clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin.
    • history or presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria);
    • evidence of urinary obstruction or difficulty in voiding at screening;
    • polymorphonuclears <1500/µL or platelets <109/L at inclusion.
    13. History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.
    14. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
    15. A positive Pregnancy test result at screening or baseline.
    16. History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
    E.5 End points
    E.5.1Primary end point(s)
    no specified primary end point; the study is focussed on the safety and tolerability of AEB1071 as monotherapy in psoriasis patients exposed to 2 weeks of treatment. The exploratory aspects of the study also allow the evaluation of efficacy and patient biomarkers in psoriatic patients.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    double-blind, sequential cohort , randomised, multiple ascending dose, placebo controlled design
    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.8.5The 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 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 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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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) No
    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 No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    The last scheduled assessment is planned for Day 28 but, with regards to patient care after the study has finished, any onging AEs at Day 28 should be followed by the investigator until resolution.
    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 Decision2005-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-12-04
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