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    Summary
    EudraCT Number:2018-003817-16
    Sponsor's Protocol Code Number:KIN001-202
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-12-11
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-003817-16
    A.3Full title of the trial
    A 52 weeks double blind, randomized and placebo controlled trial evaluating the effect of oral KIN001 150 mg plus pioglitazone 10 mg daily on injection frequency of Standard of Care in patients with diagnosed unilateral wet AMD undergoing a treat and extend regimen
    Eine 52-wöchige, doppelblinde, randomisierte und placebokontrollierte Studie zur Bewertung der Wirkung der täglichen oralen Gabe von KIN001 150 mg plus Pioglitazon 10 mg auf das Behandlungsintervall in der Standardtherapie bei Patienten mit diagnostizierter einseitiger feuchter altersbedingter Makuladegeneration (AMD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 52 weeks double blind, randomized and placebo controlled trial evaluating the effect of oral KIN001 150 mg plus pioglitazone 10 mg daily on injection frequency of Standard of Care in patients with diagnosed unilateral wet AMD undergoing a treat and extend regimen
    Eine 52-wöchige, doppelblinde, randomisierte und placebokontrollierte Studie zur Bewertung der Wirkung der täglichen oralen Gabe von KIN001 150 mg plus Pioglitazon 10 mg auf das Behandlungsintervall in der Standardtherapie bei Patienten mit diagnostizierter einseitiger feuchter altersbedingter Makuladegeneration (AMD)
    A.3.2Name or abbreviated title of the trial where available
    Kinarus wet AMD treat and extend study
    A.4.1Sponsor's protocol code numberKIN001-202
    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 SponsorKinarus AG
    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 supportKinarus AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKinarus AG
    B.5.2Functional name of contact pointHead Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressHochbergerstrasse 60C
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4057
    B.5.3.4CountrySwitzerland
    B.5.6E-mailcorinne.peter@kinarus.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 namePioglitazone
    D.3.4Pharmaceutical form Prolonged-release 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 INNnot available
    D.3.9.3Other descriptive namePIOGLITAZONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03834MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.3.2Product code KIN001
    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 INNPAMAPIMOD
    D.3.9.1CAS number 449811-01-2
    D.3.9.2Current sponsor codeKIN001
    D.3.9.4EV Substance CodeSUB32898
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    wet age-related macular degeneration
    feuchte altersbedingte Makuladegeneration
    E.1.1.1Medical condition in easily understood language
    wet age-related macular degeneration
    feuchte altersbedingte Makuladegeneration
    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
    Primary Objectives:
    • To assess the safety and tolerability of oral KIN001 150 mg plus pioglitazone 10 mg daily when given in conjuction with SOC treat and extend regimen in patients with diagnosed unilateral wet AMD
    • To assess the effect of oral KIN001 150 mg plus pioglitazone 10 mg daily on proportion of patients who achieve a successful and confirmed extension of the injection interval of SOC at end of study in patients with diagnosed unilateral wet AMD undergoing a treat and extend regimen (TER)
    Primäres Studienziel
    • Prüfen der Sicherheit und Verträglichkeit der Einnahme von KIN001 150mg plus Pioglitazon 10 mg täglich in Kombination mit der Standardtherapie im Treat-and Extend Behandlungsschema in Patienten mit einseitig diagnostizierter feuchter AMD
    • Prüfen der Wirksamkeit von KIN001 150mg plus Pioglitazon 10mg täglich auf in bezug auf den Anteil der mit einseitiger feuchter AMD diagnostizierter Patienten, die am Ende der Studie eine erfolgreiche und bestätigte Verlängerung des Injektionsintervalls bei der Standardtherapie im Treat-and Extend Behandlungsschema erreichen
    E.2.2Secondary objectives of the trial
    The secondary objectives for this study are:
    • To assess the pharmacokinetics of oral KIN001
    • To assess the effect of oral KIN001 150 mg plus pioglitazone 10 mg daily
    o on visual acuity
    o on retinal morphology and function
    o on patient quality of life
    Die sekundären Ziele der Studie sind folgende:
    - Untersuchung der Pharmkokinetik für orales KIN001
    - Beurteilung der Wirkung von KIN001 150 mg plus Pioglitazon 10 mg täglich auf den Visus, auf die Morphologie sowie die Funktion der Netzhaut sowie auf die Lebensqualität der Patienten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients with confirmed diagnosis of unilateral wet AMD
    2. Patients on SOC treatment for at least 9 months having failed two attempts to extend to a 6-week treatment interval, where failure is defined as having at least one of the following signs of disease activity of the choroidal neovascularization after the 6 week interval
    a. Recurrent or new intra- or subretinal fluid
    b. New macular haemorrhage
    c. New choroidal neovascularization
    3. Patients with Type III choroidal neovascular/retinal angiomatous proliferating (RAP) lesions are allowed for participation in the study. Randomization will be stratified.
    1. Frauen und Männer mit bestätigter Diagnose einer einseitigen feuchten AMD
    2. Patienten mit einer Standardbehandlung seit mindestens 9 Monaten, sowie mit zwei erfolglosen Versuchen zur Verlängerung auf ein 6-wöchiges Behandlungsintervall, wobei das Versagen definiert ist als mindestens eines der folgenden Anzeichen einer krankheitsbedingten choroidalen Neovaskularisierung:
    a. Wiederkehrende oder neue intra- oder subretinale Flüssigkeit
    b. neu auftretende Makula-Blutung
    c. Neue choroidale Neovaskularisierung
    3. Patienten mit Typ III choroidalen neovaskulären/retinalen angiomatösen Proliferations- (RAP) Läsionen sind zur Teilnahme an der Studie zugelassen. Die Randomisierung wird stratifiziert.
    E.4Principal exclusion criteria
    1. Patients ≤ 50 years of age
    2. Advanced fibrosis (more than 50% of the total lesion size on fluorescein angiography)
    3. Fibrosis affecting the fovea as defined by SD-OCT
    4. Subretinal hemorrhage of 50% of the lesion area and atrophy
    5. Retinal pigment epithelium rupture
    6. BCVA letter score < 23 ETDRS letters
    7. Concurrent conditions compromising visual acuity requiring medical or surgical intervention
    8. Ocular media disturbing imaging (significant vitreous opacity or cataract)
    9. Myopia of more than 6 dpt
    10. Surgical intraocular intervention within 3 months prior to baseline
    11. Patients who are being treated or were treated with pioglitazone or rosiglitazone, immunosuppresants (including oral corticosteroids >7.5mg/day) or gemfibrozil and rifampicin within 4 weeks prior randomization
    12. Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria
    13. Any severe, progressive or uncontrolled medical condition at baseline that in the judgment of the investigator prevents the patient from participating in the study
    14. Patients treated with insulin secretagogues
    15. Patients with known hypersensitivities to the active substance or any of the ingredients
    16. Any clinically significant abnormal laboratory tests at screening
    17. Any other investigational treatment for wet AMD in the last 3 months prior to baseline
    1. Patienten ≤ 50 Jahre
    2. Fortgeschrittene Fibrose (mehr als 50% der Gesamtgröße der Läsionen gemäss Fluoreszenzangiographie)
    3. Fibrose, die die Fovea beeinflusst, wie in der Optischen Kohärenztomografie (OCT) definiert
    4. Subretinale Blutung von > 50% des Bereichs mit Läsionen und Atrophie
    5. Retinaler Pigmentepithelbruch
    6. BCVA < 23 ETDRS Buchstaben
    7. Gleichzeitige Verfassung, die die Sehschärfe beeinträchtigt und einen medizinischen oder chirurgischen Eingriff erfordern
    8. Bildgebung-störende Beinträchtigung der Augen (signifikante Glaskörpertrübung oder Katarakt)
    9. Kurzsichtigkeit von mehr als 6 Dioptrien (dpt)
    10. Chirurgischer intraokulärer Eingriff innerhalb von 3 Monaten vor Beginn der Studie
    11. Patienten, die innerhalb von 4 Wochen vor der Randomisierung mit Pioglitazon oder Rosiglitazon, Immunsuppresiva oder Gemfibrozil oder Rifampicin behandelt wurden
    12. Patienten, bei denen die orale Verabreichung von Pioglitazon kontraindiziert ist (d.h. Herzversagen in der Krankengeschichte (NYHA-Stadien I bis IV), Leberfunktionsstörungen, diabetische Ketoazidose, aktueller Blasenkrebs oder eine Vorgeschichte von Blasenkrebs, nicht untersuchte makroskopische Hämaturie
    13. Andere schwere, fortschreitende oder unkontrollierte Erkrankung zu Studienbeginn, die nach Einschätzung des Prüfers den Patienten von der Teilnahme an der Studie ausschliesst
    14. Patienten die mit Insulin-Sekretagogen behandelt sind
    15. Patienten mit bekannter Unverträglichkeit der Studienmedikamente oder deren Hilfsstoffe
    16. Patienten mit auffälligen Laborbefunden beim Screening
    17. Teilnahme an anderen klinischen Prüfungen in feuchter AMD bis zu 3 Monate vor dem Studienstart
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who achieve a successful and confirmed extension of the injection interval of SOC at end treatment
    Anteil der Patienten, die am Ende der Studienbehandlung eine erfolgreiche und bestätigte Verlängerung des Injektionsintervalls bei der Standardtherapie erreichen
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 Wochen
    E.5.2Secondary end point(s)
    • number of injections of SOC at end of treatment
    • proportion of patients who achieve a successful and confirmed extension interval to 8 weeks and above
    • length of the successful interval extension - length of the achieved successful interval extension at end of treatment for each patient
    • number of interval extensions and number of interval reductions per patient
    • time to successful extension per patient and per cohort
    • maximum recurrence-free treatment interval
    • best corrected visual acuity (BCVA) at end of treatment for both the SOC-treated and the fellow eye
    • central retinal thickness (CRT) change from baseline at end of treatment for both the SOC-treated and the fellow eye
    • detailed morphological features as assessed by OCT and FA at end of treatment and at timepoints during the extension phase for both the SOC treated and the fellow eye
    • proportion of patients at each score difference between baseline and end of treatment in the NEI-VFQ-25
    • Anzahl der Injektionen in der Standardtherapie am Ende der Studienbehandlung im Vergleich zur Placebo behandelten Gruppe
    • Anteil der Patienten, die ein erfolgreiches und bestätigtes Verlängerungsintervall von 8 Wochen und mehr erreichen
    • Länge der erfolgreichen Intervallverlängerungen am Ende der Studienbehandlung
    • Anzahl der Behandlungsverlängerungen pro Patient
    • Dauer bis zur erfolgreichen Behandlungsverlängerung pro Patient und pro Kohorte
    • maximales rezidivfreies Behandlungsintervall
    • Best-korrigierte Sehschärfe (BCVA) am Ende der Studienbehandlung im Vergleich zur Placebobehandlung sowohl für das mit Standardtherapie behandelte Auge als auch für das andere Auge
    • detaillierte morphologische Merkmale, die durch die optische Kohärenztomografie und Fluoreszenzangiographie am Ende der Studienbehandlung und zu den Zeitpunkten während der Verlängerungsphase ermittelt wurden, bei beiden Augen im Vergleich zum Placebo-Arm
    • Anteil der Patienten mit höherem Scoreunterschied zwischen Studienbeginn und Studienende in den NEI-VFQ-25
    • Zentrale Netzhautdicke (CRT) und Änderungen gegenüber den Ausgangswerten am Ende der Studie sowohl für das mit Standardtherapie behandelte als auch für das andere Auge
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 Wochen
    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 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    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
    Trial end is defined as last visit of the last subject LVLS
    Studien-Ende ist definiert als die letzte Visite des letzten Studienpatienten
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 100
    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)
    Patients will receive further standard of care treatment.
    Die Patienten werden nach Studienende die Standardbehandlung weiter führen.
    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 Decision2019-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-03-01
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