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    Summary
    EudraCT Number:2011-001595-19
    Sponsor's Protocol Code Number:32-007
    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:2011-06-14
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-001595-19
    A.3Full title of the trial
    A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study Assessing the Safety and efficacy of Intravitreal Injections of DE-109 (three doses) for the Treatment of active, Non-Infectious Uveitis of the Posterior Segment of the eye
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see how safe and how well an investigational study drug will work to treat active non-infectious posterior, intermediate or pan-uveitis.
    A.3.2Name or abbreviated title of the trial where available
    n/a
    A.4.1Sponsor's protocol code number32-007
    A.5.4Other Identifiers
    Name:N/ANumber:n/a
    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 SponsorSANTEN INCORPORATED
    B.1.3.4CountryUnited States
    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 supportSANTEN INCORPORATED
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANTEN INCORPORATED
    B.5.2Functional name of contact pointAJ ACKER
    B.5.3 Address:
    B.5.3.1Street Address2100 Powell Street, 16th. Floor
    B.5.3.2Town/ cityEmeryville
    B.5.3.3Post codeCA 94608
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1415 268 9100
    B.5.5Fax number+1510 655 5687
    B.5.6E-mailaacker@Santeninc.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 nameDE-109
    D.3.2Product code DE-109
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRapamycin
    D.3.9.1CAS number 53123-88-9
    D.3.9.2Current sponsor codeDE-109
    D.3.9.3Other descriptive nameRAPA
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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) 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 No
    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 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 nameDE-109
    D.3.2Product code DE-109
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRapamycin
    D.3.9.1CAS number 53123-88-9
    D.3.9.2Current sponsor codeDE-109
    D.3.9.3Other descriptive nameRAPA
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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) 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 No
    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 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 nameDE-109
    D.3.2Product code DE-109
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRapamycin
    D.3.9.1CAS number 53123-88-9
    D.3.9.2Current sponsor codeDE-109
    D.3.9.3Other descriptive nameRAPA
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.0
    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) 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 No
    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
    Uveitis of the Posterior Segment of the Eye.
    E.1.1.1Medical condition in easily understood language
    Active non-infectious posterior, intermediate or pan-uveitis.
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036370
    E.1.2Term Posterior uveitis
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and efficacy of intravitreal injection of three doses of DE-109 (44 μg, 440 μg, 880 μg) for the treatment of active, noninfectious uveitis of the posterior segment of the eye
    E.2.2Secondary objectives of the trial
    To evaluate:
    • The long term safety of multiple intravitreal injections of 880 μg dose of DE-109
    • The durability of effect of 880 μg dose(s) of DE-109.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to give informed consent and attend all study visits
    2. Males or females greater than or equal to 18 years of age
    3. Have diagnosis of active uveitis of the posterior segment determined by the Investigator to be noninfectious based on the subject's medical history, history of present illness, ocular examination, review of systems, physical examination, and any relevant, pertinent laboratory evaluations. If an anterior component is present, it must be less than the posterior component
    4. Have active uveitis defined as a >1+ (excluding 1+) vitreous haze score (SUN scale) in the study eye
    5. Best-corrected ETDRS visual acuity letter score of 19 letters or more (20/400 Snellen equivalent or better) in study eye
    6. Female participants of childbearing potential must not be pregnant or breast-feeding, have a negative pregnancy test at screening and must be willing to undergo pregnancy tests throughout the study
    7. Both female participants of childbearing potential and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, must abstain from intercourse or must agree to practice acceptable methods of contraception throughout the course of the study
    8. Subjects must have vision ≥ 20/200 in the non-study eye
    E.4Principal exclusion criteria
    Ocular:
    1. Active infectious uveitis. However, if the uveitis is the consequence of a previous infectious disease, such as Tuberculosis, the previous infectious disease must be confirmed as no longer active
    2. Clinically suspected or confirmed central nervous system or ocular lymphoma
    3. Primary diagnosis of anterior uveitis
    4. Uncontrolled glaucoma, evidenced by an intraocular pressure of > 21 mmHg while on medical therapy, or chronic hypotony (<6 mmHg)
    5. Any implantable corticosteroid-eluting device (e.g. Ozurdex, I-vation, triamcinolone acetonide [TA] intravitreal implant) in the study eye:
    a. If the Investigator confirms the device has no demonstrable efficacy as indicated in the package insert, the subject will be eligible;
    b. If a Medidur implant or Retisert has, it should have been implanted no less than 3 years and 90 days prior to Day 1, the subject will be eligible
    6. Any significant ocular disease that could compromise vision in the study eye. These include, but are not limited to:
    a. Diabetic retinopathy: proliferative diabetic retinopathy (PDR) or nonproliferative diabetic retinopathy (NPDR) that compromise vision. Subjects with NPDR or PDR that does not compromise vision are not excluded from the study;
    b. Wet age-related macular degeneration;
    c. Myopic degeneration with active subfoveal choroidal neovascularization
    7. Lens opacities or obscured ocular media other than vitreous haze upon enrollment such that reliable evaluations and grading of the posterior segment cannot be performed
    8. Intraocular surgery within 90 days prior to Day 1 in the study eye
    9. Capsulotomy within 30 days prior to Day 1 in the study eye
    10. Any of the following treatments within 90 days prior to Day 1 or anticipated use of any of the following treatments to the study eye:
    a. Intravitreal injections (including but not limited to steroids or antivascular endothelial growth factors);
    b. Posterior subtenon steroids
    11. Ocular or periocular infection in either eye
    12. Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye
    13. Media opacity that would limit clinical visualization, intravenous fluorescein angiography (IVFA), or OCT evaluation in the study eye
    14. History of herpetic infection in the study eye or adnexa
    15. Presence of known active, inactive toxoplasmosis or toxoplasmosis scar in either eye
    16. Presence of any form of ocular malignancy in either eye including choroidal melanoma
    17. History of vitrectomy in the study eye

    Non-Ocular:
    1. Allergy or hypersensitivity to study drug product or fluorescein dye or other study related procedures/medications
    2. Participation in other investigational drug or device clinical trials within 30 days prior to Day 1, or planning to participate in other
    investigational drug or device clinical trials for the entire duration of the study. This includes both ocular and non-ocular clinical trials.
    3. Treatment with a monoclonal antibody or any other biologic therapy (i.e. Etanercept, Tocilizumab, Adalimumab, Rituximab, etc.) within the previous 30 days, or with alemtuzumab within the previous 12 months from Day 1
    4. Immunosuppressive therapy (e.g., methotrexate, cyclosporine, cyclophosphamide, chlorambucil, mycophenolate mofetil, tacrolimus, azathioprine or colchicine) other than prednisone or other corticosteroids for the treatment of uveitis within 30 days of the first study drug administration (Day 1)
    5. Any recent systemic infection within 30 days of Screening
    6. Known to be immunocompromised
    7. History of cytomegalovirus infection or clinical evidence of active cytomegalovirus infection at Screening and/or Day 1
    8. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of an investigational drug, might affect the interpretation of the results of the study, or renders the subject at high risk for treatment complications
    9. Malignancy in remission for less than 5 years prior to study participation (except basal cell or squamous cell skin cancer, or treated melanoma of the skin less than 24 months since last treatment)
    10. Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions (i.e., intrauterine device, oral contraceptives, barrier method, or other contraception deemed adequate by the Investigator)
    11. Use of medically prescribed marijuana or other illegal medication
    12. Active systemic sarcoidosis within the last 30 months (i.e. Subjects with uveitis secondary to sarcoidosis will be eligible as long as systemic sarcoidosis is not active and systemic immunosuppressive therapy has not been given in the last 30 months In addition, the Investigator or Santen Medical Monitor may declare a subject ineligible for any sound reason.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint : Proportion of subjects with a vitreous haze score
    of 0 at Month 5 (SUN scale).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 5
    E.5.2Secondary end point(s)
    The secondary endpoint(s):
    • Proportion of subjects with a vitreous haze score of 0 or a 2 unit improvement from baseline in vitreous haze score at Month 5 (SUN scale)
    • Proportion of subjects with a citreous haze score of 0 or 0.5+ at month 5
    • Time to reach a vitreous haze score of 0 (SUN scale)
    • Mean change from Baseline in vitreous haze score at Month 5 (SUN scale)
    • Proportion of subjects on ≤ 5 mg/day of prednisone (or equivalent dose of another corticosteroid) at Month 5
    • Mean change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) at Month 5
    • Mean change from Baseline in central retina thickness as measured by optical coherence tomography (OCT) at Month 5
    • Change from Baseline in the National Eye Institute (NEI) Visual Functioning Questionnaire-25 (VFQ-25) at Month 5
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 5
    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) 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
    Open label treatment with 880 ug DE-109 after month 5
    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
    Other doses of Sirolimus
    E.8.2.4Number of treatment arms in the trial3
    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 EEA57
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Austria
    Brazil
    Chile
    Colombia
    Dominican Republic
    France
    Germany
    India
    Israel
    Italy
    Mexico
    Peru
    Poland
    Spain
    Turkey
    United Kingdom
    United States
    United States Minor Outlying Islands
    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 visit of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 425
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 500
    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)
    Not different from standard of care
    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 Decision2011-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-30
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