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    Summary
    EudraCT Number:2017-004227-75
    Sponsor's Protocol Code Number:ALK4290-201
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-01-04
    Trial 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-004227-75
    A.3Full title of the trial
    A Single Arm Open-Label Study to Evaluate the Therapeutic Effects and Safety of a 6-Week Treatment Regimen of ALK4290 in Patients with Newly Diagnosed Wet Age-Related Macular Degeneration (wAMD).
    Jednoramienne, otwarte badanie oceniające skutki terapeutyczne oraz bezpieczeństwo 6-tygodniowego okresu leczenia preparatem ALK4290 wśród pacjentów z nowo zdiagnozowaną wysiękową postacią zwyrodnienia plamki związaną z wiekiem (wAMD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Single Arm Open-Label Study to Evaluate the Therapeutic Effects and Safety of a 6-Week Treatment Regimen of ALK4290 in Patients with Newly Diagnosed Wet Age-Related Macular Degeneration (wAMD).
    Jednoramienne, otwarte badanie oceniające skutki terapeutyczne oraz bezpieczeństwo 6-tygodniowego okresu leczenia preparatem ALK4290 wśród pacjentów z nowo zdiagnozowaną wysiękową postacią zwyrodnienia plamki związaną z wiekiem (wAMD)
    A.4.1Sponsor's protocol code numberALK4290-201
    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 organisationAlkahest, Inc.
    B.5.2Functional name of contact pointJonas Hannestad,
    B.5.3 Address:
    B.5.3.1Street Address75 Shoreway Road, Suite D
    B.5.3.2Town/ citySan Carlos
    B.5.3.3Post codeCA 94070
    B.5.3.4CountryUnited States
    B.5.4Telephone number6508010469
    B.5.5Fax number6508010480
    B.5.6E-mailjhannestad@alkahest.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 nameALK4290
    D.3.2Product code ALK4290
    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 INN ALK4290
    D.3.9.1CAS number 1251528-23-0
    D.3.9.2Current sponsor code ALK4290
    D.3.9.3Other descriptive name2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB191358
    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
    Newly Diagnosed Wet Age-Related Macular Degeneration (wAMD)
    Nowo zdiagnozowana wysiękowa postać zwyrodnienia plamki związana z wiekiem (wAMD)
    E.1.1.1Medical condition in easily understood language
    Newly Diagnosed Wet Age-Related Macular Degeneration (wAMD)
    Nowo zdiagnozowana wysiękowa postać zwyrodnienia plamki związana z wiekiem (wAMD)
    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
    The primary objective of the study is to investigate the potential therapeutic effects of a 6-week, twice daily oral dosing regimen of ALK4290 on BCVA in newly diagnosed (treatment naïve) patients with wAMD as measured by ETDRS.
    E.2.2Secondary objectives of the trial
    As a secondary objective, the study will assess the safety of the proposed dosing regimen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible for inclusion, all subjects must meet the following criteria:
    • Men and women with newly diagnosed active CNV secondary to AMD, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye:
    • No prior treatment for wAMD in the study eye
    and no current or planned concomitant intravitreal anti-VEGF
    treatment in the fellow eye
    • Central subfield retinal thickness ≥ 250 microns on SD-OCT
    (exclusive of subretinal pigment epithelial fluid, inclusive of
    SRF)
    • Presence of SRF and/or IRF on SD-OCT
    • Any active CNV with subfoveal leakage as determined by FA
    • Total lesion size not greater than 12 disc areas on FA
    • If present, subretinal hemorrhage must comprise < 50% of the total lesion area on FA
    • No subfoveal fibrosis or atrophy on FA
    • BCVA letter score, as measured by ETDRS in the study eye, between 70 and 24 letters, inclusive, at screening
    • Patients 50 years of age or older at screening visit 1
    • Body mass index (BMI) between18 and ≤ 40 at screening visit 1
    • Female subjects must not be pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry. 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
    • Signed informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in
    the trial, which includes medication washout and restrictions
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion if any of the following criteria apply:
    • Previous participation in any studies of investigational drugs within 1 month preceding screening visit (Visit1)
    • Any form of macular degeneration that is not age-related (e.g., Best’s disease, Stargardt’s disease, Sorsby’s disease, etc.)
    • Additional eye disease in the study eye that could compromise BCVA (i.e., uncontrolled glaucoma (intraocular pressure > 24) with visual field loss, clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinal vascular occlusion, vitreomacular traction, monocular vision, or genetic disorders such as retinitis pigmentosa; high myopia > 8 diopters)
    • The presence of polypoidal choroidal vasculopathy (PCV) or retinal angiomatous proliferation (RAP) in the study eye
    • Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with fundus photography/FA or SD-OCT
    • Intraocular surgery in the study eye within 3 months prior to screening
    • Aphakia or total absence of the posterior capsule (yttrium aluminum garnet (YAG) laser capsulotomy
    permitted, a minimum of 1 month prior to enrollment) in the study eye
    • Known allergy to fluorescein sodium for injection in FA
    • 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)
    • Medical history or condition:
    • Uncontrolled diabetes mellitus, with hemoglobin
    A1c (HbA1c) > 8%
    • Myocardial infarction or stroke within 12 months
    of screening
    • Active bleeding disorder
    • Concomitant use of warfarin or anticoagulation therapy
    • Major surgery within 1 month of screening or
    planned within the study period
    • Hepatic impairment
    • Uncontrolled hypertension
    • Positive screening for Hepatitis B, Hepatitis C, or
    Human Immunodeficiency Virus (HIV)
    • Planned concomitant use of cytochrome P450 3A4 (CYP3A4) or P-glycoprotein (P-gp) inhibitors or inducers during the study
    • Planned concomitant use of P-gp substrates that are narrow therapeutic index drugs (e.g., digoxin)
    • Use of systemic steroids (>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 steroids within the study period
    • Use of intravitreal steroids:
    • Dexamethasone (Ozurdex) or triamcinolone within
    6 months prior to screening
    • Flucinolon (Retisert or Iluvien) within 48 months prior
    to screening
    • Patients with a clinically relevant abnormal screening hematology, blood chemistry, or urinalysis, 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 (TB) or prothrombin time (INR) > 1.5 times the upper limit of normal at screening). Laboratory testing may be repeated once during the screening phase
    • Patients with impaired renal function defined as calculated glomerular filtration rate (GFR) < 30 mL/min
    • Significant alcohol or drug abuse within past 2 years
    • Based on ECG reading, patients with a risk of prolonged QT interval effects including:
    • A marked baseline prolongation of QTc
    (using Bazett’s formula: ≥ 430 ms in men
    and ≥ 450 ms in women) with confirmation
    on a repeat ECG)
    • A history of additional risk factors for
    Torsade de Pointes (TdP) (e.g., heart failure,
    hypokalemia, family, history of Long QT Syndrome, etc.)
    • The use of concomitant medications known to prolong
    the QT/QTc interval
    • 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:
    • Put the patient at risk because of participation in the study
    • Influence the results of the study
    • Cause concern regarding the patient’s ability to
    participate in the study
    • 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)
    The primary endpoint is mean changes in BCVA as measured by the ETDRS testing method.
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 week
    E.5.2Secondary end point(s)
    The secondary endpoint is safety as assessed by incidence, seriousness, and severity of adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 week
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 25
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 Decision2018-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-21
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