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    Summary
    EudraCT Number:2014-004042-96
    Sponsor's Protocol Code Number:32-009
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-19
    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 ConcernedAustria - BASG
    A.2EudraCT number2014-004042-96
    A.3Full title of the trial
    A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects with Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III extension study to evaluate the long-term safety of DE-109 in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in a previous SAKURA study.
    A.4.1Sponsor's protocol code number32-009
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02251938
    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 pointCrystal Browning
    B.5.3 Address:
    B.5.3.1Street Address2100 Powell Street, 16th Floor
    B.5.3.2Town/ cityEmeryville, CA
    B.5.3.3Post code94608
    B.5.3.4CountryUnited States
    B.5.4Telephone number0014152689010
    B.5.5Fax number0015106555687
    B.5.6E-mailCBrowning@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 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.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
    non -infectious Uveitis of the Posterior Segment of the Eye
    E.1.1.1Medical condition in easily understood language
    active, non -infectious 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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10036370
    E.1.2Term Posterior uveitis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.
    E.2.2Secondary objectives of the trial
    The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Day 1, a subject from the SAKURA program must meet all of the following inclusion criteria:
    1. Have a subject number from participation in the SAKURA program
    2. Exited the SAKURA program under Amendment 05
    3. Have received at least two injections of DE-109 in the first five months of the SAKURA program
    4. Received clinical benefit from treatment with DE-109 as determined by the Investigator
    5. Female participants of childbearing potential must not be pregnant or breast-feeding, have a negative pregnancy test at Day 1 and must be willing to undergo pregnancy tests throughout the study
    6. 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
    7. Ability to give informed consent and attend all study visits
    E.4Principal exclusion criteria
    A subject from the SAKURA program with any of the following conditions is not eligible to participate in the study:

    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. Any implantable corticosteroid-eluting device (e.g. Ozurdex, I-vation, Iluvien, fluocinolone acetonide [FA] 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, Iluvien or Retisert has been implanted no less than 3 years and 90 days prior to Day 1, the subject will be eligible
    c. If a Ozurdex implant has been implanted no less than 180 days prior to Day 1, the subject will be eligible
    3. Clinically suspected or confirmed central nervous system or ocular lymphoma
    4. Progressive glaucoma which is unresponsive to treatment.
    5. Intraocular pressure of > 21 mmHg while on medical therapy, or chronic hypotony (< 6 mmHg)
    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 non-proliferative diabetic retinopathy (NPDR) that compromises 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. Any of the following treatments to the study eye:
    a. Intravitreal injections in the past 14 days
    b. Intravitreal injections of DE-109 in the past 60 days
    8. Ocular surgery within the past 30 days
    9. Ocular or periocular infection in either eye
    10. History of or active herpetic infection in the study eye or adnexa
    11. Presence of known active, inactive toxoplasmosis or toxoplasmosis scar in either eye
    12. Presence of any form of ocular malignancy in the either eye including choroidal melanoma
    13. History of vitrectomy in the study eye

    Non-Ocular:
    14. Allergy or hypersensitivity to study drug product or other study related procedures/medications
    15. Participation in other investigational drug (SAKURA is an exception) 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.
    16. Any recent systemic infection within 30 days of Day 1
    17. Known to be immunocompromised
    18. History of cytomegalovirus infection or clinical evidence of active cytomegalovirus infection at Day 1
    19. 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
    20. 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)
    21. 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)
    22. Use of medically prescribed marijuana or other illegal medication
    23. 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)
    24. Therapeutic radiation to the head or neck within 90 days prior to Day 1 and throughout the study.

    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)
    Collection of long term safety data on DE-109 (440 μg) dose

    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months or commercial availability of DE-109, whichever comes first.
    E.5.2Secondary end point(s)
    none
    E.5.2.1Timepoint(s) of evaluation of this end point
    none
    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 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 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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Austria
    France
    Germany
    India
    Italy
    Poland
    Turkey
    United States
    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
    All subjects will exit the study at Month 12, unless terminated early
    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 months12
    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 months12
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 200
    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)
    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 Decision2015-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-01
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