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    Summary
    EudraCT Number:2008-004862-24
    Sponsor's Protocol Code Number:ESBA105CRD04
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-10-02
    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 ConcernedGermany - PEI
    A.2EudraCT number2008-004862-24
    A.3Full title of the trial
    An open-label exploratory study to assess the safety, tolerability and clinical activity of topically applied ESBA105 in patients with acute anterior uveitis
    A.4.1Sponsor's protocol code numberESBA105CRD04
    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 SponsorESBATech, an Alcon Biomedical Research Unit LLC
    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 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 nameESBA105
    D.3.2Product code ESBA105 10 mg/ml
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeESBA105 10 mg/ml
    D.3.9.3Other descriptive namehumanised single-chain (scFv) antibody fragment directed against human TNF-alpha
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number9.0 to 11.0
    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.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
    Acute, unilateral anterior uveitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10002709
    E.1.2Term Anterior uveitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Evaluation of safety and local tolerability of topical ESBA105 (first data in disease population).
    - Evaluation of systemic exposure to ESBA105 following topical application to the eye (first data in disease population).
    - Exploratory evaluation of clinical activity of topical ESBA105 in inflammatory ocular disease (human leukocyte antigen [HLA]-B27 positive acute anterior uveitis [AAU]).
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed and dated informed consent.
    - Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).
    - 2+ anterior chamber cells according to the Standardization of Uveitis Nomenclature (SUN) Working Group criteria, as assessed by slit lamp biomicroscopy.
    - Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.
    - Male or female of any race and ≥18 years.
    - Negative pregnancy test for women of childbearing potential (pre-menopausal, <2 years post-menopausal or not surgically sterile).
    - Patients with a negative QuantiFERON TB Gold test result.
    - Patients who currently have no clinically apparent symptoms of a HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.
    - Patients who are willing and able to cooperate with study requirements.
    E.4Principal exclusion criteria
    If any of the following criteria are met, the patient will not be eligible to participate in the study:
    - Glaucoma.
    - IOP elevation requiring therapy.
    - Uncontrolled diabetes mellitus and/or diabetic retinopathy.
    - Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.
    - Patients with 1+ or less anterior chamber cells.
    - Patients with 3+ or 4+ anterior chamber cells or hypopyon.
    - Patients known as HLA-B27 negative, based on results of previous HLA antigen testing or with any other known cause for their anterior uveitis other than HLA-B27-associated AAU.
    - Patients in which the time of the beginning of the current attack can not be determined.
    - Patients exhibiting corneal ulceration or a history of recurrent herpetic keratinitis or clinical evidence of herpetic dermatitis.
    - Patients currently treated with topical corticosteroids.
    - Patients treated with stable doses >10 mg daily systemic prednisone (or comparable corticosteroids) within the last 2 months.
    - Patients treated with systemic immunosuppressive therapy within the last 2 months.
    - Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.
    - Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.
    (Primary forms of contraception include intrauterine devices, oral contraceptive agents that the patient has already been using for at least 90 days before screening, and injectable/implantable/insertable hormonal birth control products. Secondary forms of contraception include diaphragms, latex condoms, and cervical caps.)
    - Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.
    - Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.
    - Patients with history of recurrent infections, or a clinical presentation suggestive of a chronic infection requiring antimicrobial therapy (e.g. syphilis) including active episodes of serious viral infections by, e.g. herpes simplex, herpes zoster, cytomegalic or hepatitis viruses or clinical signs of fungal infections, such as histoplasmosis, aspergillosis or coccidiomycosis. In particular, patients have to be excluded if they present with granulomaous precipitates or plaque-like lesions on the corneal endothelium interpreted by the investigator as indicative for infectious origin of the uveitis attack.
    - patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.
    - Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.
    - Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.
    - Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.
    - Patients with known coexisting malignancy.
    - Patients with congestive heart failure New York Heart Association Grade III or IV.
    - Patients with uncontrolled hypertension (≥160/100 millimetres of mercury [mmHg]).
    - Patients with significant haematological disease (total white cell count below 2 x 109/litre [L]).
    - Patients who participated in a clinical study with investigational medicinal products (IMPs) within 3 months prior to Screening.
    - Non-ability to comply with the study requirements.
    - Patients with known, severely impaired hepatic or renal function, or laboratory values reflecting inadequate hepatic or renal function (above 3 x upper limit of normal for alanine aminotransferase (ALT) or aspartate aminotransferase (AST); presence of chronic renal failure defined by a calculated creatinine clearance (CrCl) of <60 mL/minute, using the Cockcroft-Gault estimate for glomerular filtration rate as follows:
    CrCl=((140-age [years]) x weight [kg]) / (serum creatinine [mg/decilitre] x 72), with female gender adjustment (CrCl female = CrCl x 0.85)).
    - Patients suffering from any concomitant disease that in the investigator’s opinion may interfere with study-related procedures or clinical data assessment.
    E.5 End points
    E.5.1Primary end point(s)
    There are exploratory endpoints only.
    Safety and Tolerability:
    - The nature and incidence of adverse events (AEs), changes in vital signs, electrocardiogram (ECG), physical and ophthalmological examination findings and laboratory test results.
    Systemic Exposure:
    - Systemic exposure to topical ESBA105 will be monitored at each visit by analysis of ESBA105 levels in the patient’s serum.
    Clinical Activity:
    - Changes in the level of ocular inflammation observed at each visit in the treatment period with study medication.
    According to the SUN Working Group criteria, “improved activity” is defined as reduction of anterior chamber cells by two levels.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 No
    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.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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) 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 25
    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)
    It is not intended to continue therapy with ESBA105 after patients have completed the study. Patients should return to standard care, as recommended by the investigator.
    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 Decision2009-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-12-14
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