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    Summary
    EudraCT Number:2019-002821-31
    Sponsor's Protocol Code Number:AKST4290-206
    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:2019-07-15
    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 number2019-002821-31
    A.3Full title of the trial
    The Effect of AKST4290 on Choroidal Blood Flow in Patients with Neovascular Age-Related Macular Degeneration
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the effect of AKST4290 in patients with age-related macular degeneration
    A.3.2Name or abbreviated title of the trial where available
    AMD ChBF
    A.4.1Sponsor's protocol code numberAKST4290-206
    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 SponsorAlkahest, Inc
    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 supportAlkahest, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Vienna
    B.5.2Functional name of contact pointDepartment of Clinical Pharmacology
    B.5.3 Address:
    B.5.3.1Street AddressWaehringer Guertel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+4314040029810
    B.5.6E-mailklin-pharmakologie@meduniwien.ac.at
    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 nameAKST4290
    D.3.2Product code AKST4290
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAKST4290
    D.3.9.1CAS number 1251528-23-0
    D.3.9.2Current sponsor codeAKST4290
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    Age-related macular degeneration
    E.1.1.1Medical condition in easily understood language
    Age-related macular degeneration
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10075568
    E.1.2Term Wet age-related macular degeneration
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effects of a 4-week, oral b.i.d. dosing regimen of AKST4290 on choroidal blood flow (ChBF) in the contralateral eye in subjects with unilateral neovascular age-related macular degeneration (nAMD)
    E.2.2Secondary objectives of the trial
    Secondary Objectives: To assess central retinal thickness (CRT), retinal nerve fiber layer thickness (RNFLT), retinal microcirculation, RVD, ROS, best corrected visual acuity (BCVA), intraocular pressure (IOP), and ocular perfusion pressure (OPP) in both eyes.

    Exploratory Objectives: To assess biomarkers and pharmacokinetics (PK) on blood and plasma samples.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women with active CNV secondary to AMD in 1 eye, as diagnosed by a retinal specialist, with all the following characteristics and ophthalmic inclusion criteria applied to the contralateral eye (study eye), as assessed by a reader.
    a. No active CNV secondary to AMD.
    b. No geographic atrophy.
    c. No previous treatment for AMD.
    d. Ametropy </= 6 diopters.
    2. Patients 50 years of age or older at Screening (Visit 1).
    3. Body mass index (BMI) between 18 and ≤ 40 at Screening (Visit 1).
    4. Female subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening (Visit 1), and the last treatment visit (Visit 3). WOCBP and men must agree to use highly effective contraception (Clinical Trial Facilitation Group 2014) prior to study entry. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menses for at least 2 years without an alternative cause). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in the study, she should inform her treating physician immediately.
    5. Signed informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions.
    6. Must agree to be on stable doses of medications that may impact ChBF (complete listing of these medications will be provided in the Investigator Site File (ISF).
    E.4Principal exclusion criteria
    1. Previous participation in any studies of investigational drugs within 1 month preceding Screening.
    2. Any form of macular degeneration that is not age-related (e.g., Best’s disease, Stargardt’s disease, Sorsby’s disease).
    3. Additional eye disease in either eye that could compromise BCVA (i.e., uncontrolled glaucoma (intraocular pressure > 24) with visual field loss, clinically significant diabetic edema, history of ischemic optic neuropathy or retinal vascular occlusion, vitreomacular traction, monocular vision, high myopia > 8 diopters, or genetic disorders such as retinitis pigmentosa).
    4. Anterior segment and vitreous abnormalities in the either eye that would preclude adequate visualization with fundus photography or SD-OCT.
    5. Intraocular surgery in either eye within 3 months prior to screening.
    6. Aphakia or total absence of the posterior capsule (yttrium-aluminum-garnet laser capsulotomy is permitted in an eye with a posterior chamber intraocular lens if performed a minimum of 1 month prior to enrollment) in the study eye.
    7. Known allergy to fluorescein sodium.
    8. Current or planned use of medications known to be toxic to the retina, lens, or optic nerve. (e.g., desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol).
    9. Medical history or condition:
    a. Uncontrolled diabetes mellitus, with hemoglobin A1c (HbA1c) > 8%.
    b. Myocardial infarction or stroke within 12 months of screening.
    c. Active bleeding disorder.
    d. Concomitant use of Vitamin K antagonists or new oral anticoagulants.
    e. Major surgery within 1 month of screening or planned within the study period.
    f. Hepatic impairment.
    g. Uncontrolled systemic arterial hypertension.
    h. Positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) at Screening (Visit 1).
    10. Prior treatment within 4 weeks of Screening (Visit 1) or planned use of potent cytochrome P450 3A4/5 (CYP3A4/5) or P-glycoprotein (P-gp) inhibitors or inducers during the study.
    11. Planned concomitant use of CYP3A4/5 or P-gp substrates that have a narrow therapeutic index (e.g., digoxin).
    12. Planned concomitant use of CYP3A4/5 sensitive substrates, such as fentanyl.
    13. Planned concomitant use of drugs with a narrow therapeutic window that are metabolized predominantly by CYP2C8 (e.g., carbamazepine), or are CYP2C8 sensitive substrates, such as dasabuvir and repaglinide.
    14. Planned concomitant use of organic anion transporter 3 (OAT3) substrates, such as methotrexate and pravastatin.
    15. Patients with renal impairment (estimated glomerular filtration rate [GFR] ≤ 60) who have planned concomitant use of OCT2 substrates with a narrow therapeutic index or OCT2 inhibitors (e.g. metformin).
    16. Use of any nonselective monoamine oxidase inhibitors (MAOI) (MAOI-B treatment is acceptable).
    17. Use of systemic corticosteroids (> 10 mg prednisone or equivalent/day) within 14 days of first dose of study agent or known diseases which could require the use of systemic corticosteroids within the study period.
    18. Use of intravitreal or implanted corticosteroids:
    a. Dexamethasone (Ozurdex®) or triamcinolone within 6 months prior to screening.
    b. Fluocinolone (Retisert® or Iluvien®) within 48 months prior to screening.
    19. Patients with clinically relevant, abnormal screening hematology, blood chemistry, or urinalysis test results, if the abnormality defines a significant disease as defined in other exclusion criteria (e.g., aspartate aminotransferase [AST] or alanine aminotransferase [ALT] greater than 2.0-fold the upper limit of normal at screening; total bilirubin, or prothrombin time > 1.5 times the upper limit of normal at screening). Laboratory testing may be repeated once during the screening phase.
    20. Significant alcohol or drug abuse within the past 2 years.
    21. Based on 12-lead electrocardiogram (ECG) reading, subjects with a risk of QT prolongation including:
    a. A baseline prolongation of corrected QT interval (QTc) (using Fridericia’s formula: ≥ 450 ms in men and ≥ 470 ms in women) with confirmation on a repeat ECG.
    b. A history of additional risk factors for Torsades de pointes arrhythmia (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
    c. The use of concomitant medications known to prolong the QT/QTc interval.
    22. Significant disease or other medical conditions (as determined by medical history, examination, and clinical investigations at screening) that may, in the opinion of the investigator, result in the any of the following:
    a. Put the patient at risk because of participation in the study.
    b. Influence the results of the study.
    c. Cause concern regarding the patient’s ability to participate in the study.
    23. Patients with malignancy for which the patient has undergone resection, radiation, or chemotherapy within past 5 years. Patients with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in ChBF in the contralateral (study) eye measured using laser Doppler flowmetry (LDF).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before treatment start and after 4 weeks treatment.
    2 weeks after end of treatment
    E.5.2Secondary end point(s)
    o Mean changes in central retinal thickness (CRT) and retinal nerve fiber layer thickness (RNFLT) as measured by SD-OCT.
    o Mean change in best corrected visual acuity (BCVA) as measured by the ETDRS chart method.
    o Mean changes on intraocular pressure (IOP) and ocular perfusion pressure (OPP).
    o Mean changes in retinal vessel diameters (RVD) and retinal oxygen saturation (ROS) as measured by dynamic vessel analyzer (DVA) and fundus photography.
    o Mean change in retinal microcirculation as measured by OCT angiography (OCT-A).
    o Mean changes in systemic hemodynamics including SBP, DBP, and HR.
    o Incidence of AEs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before treatment start and after 4 weeks treatment.
    2 weeks after end of treatment
    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 Yes
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    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 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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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.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)
    None
    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 Decision2019-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-27
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