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    Summary
    EudraCT Number:2020-004964-25
    Sponsor's Protocol Code Number:ABY-035-203
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-10-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-004964-25
    A.3Full title of the trial
    A phase 2 trial of the efficacy and safety of the interleukin-17A inhibitor ABY-035 in the treatment and prevention of relapse/recurrence of non-infectious intermediate, posterior or pan-uveitis, including an initial pilot phase (LINNAEA)
    Studio clinico di fase 2 sull'efficacia e la sicurezza dell'inibitore ABY-035 dell'interleuchina-17A nel trattamento e nella prevenzione di ricaduta / recidiva di uveite non infettiva intermedia, posteriore o pan-uveite, compresa una fase pilota iniziale (LINNAEA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multinational, multicenter, phase 2 study of the efficacy and safety of ABY-035 in treating and preventing relapse/recurrence of disease activity in subjects with non-infectious intermediate, posterior or pan-uveitis.
    Studio clinico multinazionale, multicentrico di fase 2 sull'efficacia e la sicurezza di ABY-035 nel trattamento e nella prevenzione della malattia attiva in soggetti con uveite non infettiva intermedia, posteriore o pan-uveite
    A.3.2Name or abbreviated title of the trial where available
    LINNAEA
    LINNAEA
    A.4.1Sponsor's protocol code numberABY-035-203
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04706741
    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 SponsorAffibody AB
    B.1.3.4CountrySweden
    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 supportAffibody AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAffibody AB
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressScheeles väg 2
    B.5.3.2Town/ citySolna
    B.5.3.3Post codeSE-17165
    B.5.3.4CountrySweden
    B.5.4Telephone number+46763495849
    B.5.5Fax number+46859883801
    B.5.6E-mailcamilla.sandell@affibody.se
    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 nameABY-035
    D.3.2Product code [ABY-035]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIzokibep
    D.3.9.1CAS number 2226130-02-3
    D.3.9.2Current sponsor codeABY-035
    D.3.9.3Other descriptive nameRecombinant protein comprising two IL-17A binding domains and an albumin binding domain
    D.3.9.4EV Substance CodeSUB201240
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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 Yes
    D.2.1.1.1Trade name Decortin H
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDecortin H
    D.3.2Product code [ICRS0391]
    D.3.4Pharmaceutical form 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 INNPrednisolone
    D.3.9.1CAS number 50-24-8
    D.3.9.2Current sponsor codeDecortin H
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    non-infectious intermediate, posterior, or pan-uveitis
    uveite intermedia, posteriore o panuveite, non infettiva
    E.1.1.1Medical condition in easily understood language
    non-infectious intermediate, posterior, or pan-uveitis
    uveite intermedia, posteriore o panuveite, non infettiva
    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 PT
    E.1.2Classification code 10046851
    E.1.2Term Uveitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A: To evaluate the efficacy of ABY-035 in treating active uveitis from Baseline (BL) up to week 10 (W10) with subsequent possible adaptation of the design in Part B
    Part B: To investigate the efficacy of ABY-035 in preventing relapse/recurrence in inactive uveitis from trial beyond W10 up to W5
    Parte A: valutare l'efficacia di ABY-035 nel trattamento dell'uveite attiva dal basale (BL) fino alla Settimana 10 (S10), con possibile successivo adattamento del disegno nella Parte B
    Parte B: studiare l'efficacia di ABY-035 nella prevenzione delle recidive/ricorrenze nell'uveite inattiva dalla S10 alla S50
    E.2.2Secondary objectives of the trial
    To evaluate the safety of ABY-035
    To characterize the exposure of ABY-035 in plasma
    To assess the immunogenicity of ABY-035
    To investigate the efficacy of ABY-035 in treating active uveitis from BL up to W10
    Valutare la sicurezza di ABY-035
    Caratterizzare l'esposizione di ABY-035 nel plasma
    Valutare l'immunogenicità di ABY-035
    Studiare l'efficacia di ABY-035 nel trattamento dell'uveite attiva dal basale (BL) alla S10
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1] Signed informed consent and signed data protection declaration
    2] >=18 years of age at SCR
    3] Previously documented medical history with diagnosed unilateral or bilateral NIIPPU
    4] Active disease at BL defined by the presence of at least 1 of the following criteria in at least one eye despite treatment with stable doses of corticosteroids for at least 2 weeks:
    a) active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion by dilated indirect ophthalmoscopy (DIO), fundus photography, and fluorescein angiography (FA), Spectral-Domain Optical Coherence Tomography (SD-OCT) to determine whether a lesion is active or inactive (the central reader's assessment using FA, fundus photography and/or SD-OCT is required to confirm eligibility).
    b) >=2+ vitreous haze ( NEI/SUN criteria) by DIO and Fundus Photography (the central reader's assessment using Fundus Photography is required to confirm eligibility).
    5] On treatment with oral corticosteroids (>=7 to <=40 mg/day oral prednisolone/pre dnisone or equivalent) at a stable dose for at least 2 weeks before BL
    6] For females of non-childbearing potential: Post-menopausal or surgically sterile 7] For females of childbearing potential: Negative human chorionic gonadotropin (hCG) test at SCR visit AND practicing adequate contraception (see section 7.1.7) from SCR to FUpreg (section 6.2.6)
    8] For males: if having a female partner, the partner should be of nonchildbearing potential (see inclusion criteria 6) OR using an adequate method of contraception (see section 7.1.7) from SCR to FUpreg (see 6.2.6)
    9] Able and willing to comply with the trial directives (as per the investigator's judgment)
    1. Sottoscrizione del consenso informato e della dichiarazione sulla protezione dei dati
    2. Età >=18 anni allo SCR
    3. Anamnesi medica precedentemente documentata con diagnosi di NIIPPU unilaterale o bilaterale
    4. Malattia attiva al BL, definita dalla presenza di almeno 1 dei seguenti criteri in almeno un occhio nonostante il trattamento con dosi stabili di corticosteroidi per almeno 2 settimane:
    a. Lesione corioretinica infiammatoria attiva e/o lesione vascolare retinica infiammatoria valutata mediante oftalmoscopia indiretta con dilatazione (Dilated Indirect Ophthalmoscopy, DIO), fotografia del fondo oculare, angiografia con fluoresceina (Fluorescein Angiography, FA), tomografia a coerenza ottica nel dominio spettrale (Spectral-Domain Optical Coherence Tomography, SD-OCT) al fine di determinare se una lesione è attiva o inattiva (è necessaria la valutazione del lettore centrale mediante FA, fotografia del fondo oculare e/o SD-OCT per confermare l'idoneità)
    b. Annebbiamento del corpo vitreo di grado >=2+ (criteri SUN/del National Eye Institue [NEI]) valutato mediante DIO e fotografia del fondo oculare (è necessaria la valutazione del lettore centrale mediante fotografia del fondo oculare per confermare l'idoneità)
    5. Trattamento con corticosteroidi orali (da >=7 a <=40 mg/die di prednisolone/prednisone orale o equivalente) a una dose stabile per almeno 2 settimane prima del BL
    6. Donne non potenzialmente fertili: post-menopausa o chirurgicamente sterili
    7. Per le donne potenzialmente fertili: test della gonadotropina corionica umana (hCG) negativo alla visita di SCR E uso di un metodo contraccettivo adeguato (vedere la sezione 7.1.7) dallo SCR al FUpreg (vedere la sezione 6.2.6)
    8. Per gli uomini: se aventi una partner di sesso femminile, la partner deve essere non potenzialmente fertile (vedere il criterio di inclusione 6) O è necessario l'uso di un metodo contraccettivo adeguato (vedere la sezione 7.1.7) dallo SCR al FUpreg (vedere la sezione 6.2.6)
    9. Capacità e volontà di rispettare le indicazioni dello studio (secondo il giudizio dello sperimentatore)
    E.4Principal exclusion criteria
    1] History of hypersensitivity or allergy to ABY-035 or its excipients
    2] History of hypersensitivity or allergy to fluorescein dye
    3] Previous enrollment or randomization in the trial
    4] Participation in another interventional clinical trial within 30 days before SCR or administration of another IMP within 5 half-lives (for experimental biologics: 6 months or 5 half-lives, whichever is longer) before BL
    5] Evidence or suspicion of social drug and/or alcohol abuse or dependence, according to the judgment of the investigator
    6] Females who are currently pregnant, who intend to become pregnant during the trial, or who are breastfeeding
    7] The subject is an investigator or belongs to the personnel of the trial site, the sponsor or involved service providers and/or their immediate families (partner, spouse, parent, child, or sibling, whether biological or legally adopted)
    8] Subject with any medical or psychiatric condition which, in the investigator's opinion, would preclude the subject from adhering to the protocol or completing the clinical trial per protocol
    9] The subject is considered to belong to a vulnerable population (e.g. placed under guardianship, imprisoned, other)
    Criteria that relate to ocular conditions (and the etiology thereof)
    10] Subject with isolated anterior uveitis
    11] Subject with Occlusive Behçet's disease, Acute Posterior Multifocal Placoid Pigment Epitheliopathy, Acute Posterior Pigment Epithelitis, Multiple Evanescent White Dot Syndrome, Punctate Inner Choroiditis or serpiginous choroidopathy
    12] Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, syphilis, cytomegalovirus, Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 infection, Whipple's disease, herpes zoster virus, and herpes simplex virus
    13] Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
    14] Planned (elective) eye surgery within 80 weeks after BL
    15] History of prior refractive laser surgery, retinal laser photocoagulation, or neodymium-doped yttrium aluminium garnet posterior capsulotomy within 30 days before BL
    16] History of any other prior ocular surgery within 90 days before BL
    17] Subject with intraocular pressure (IOP) of >=25 mmHg while on >=2 glaucoma medications or evidence of glaucomatous optic nerve injury
    18] Subject with severe vitreous haze that precludes visualization of the fundus at BL
    19] Subject has a contraindication for mydriatic eye drops OR subject cannot be dilatated sufficiently well to permit good fundus visualization
    20] Subject with BCVA <20 letters (ETDRS) in at least one eye at BL
    21] Subject with intermediate uveitis or panuveitis who has presence or history of whitish exudates on the inferior pars plana (snowbanking) or vitreal inflammatory aggregates (snowballs) in combination with a medical history or signs or symptoms suggestive of a demyelinating disease such as multiple sclerosis
    …
    PLEASE REFER TO THE STUDY PROTOCOL FOR THE COMPLETE LIST OF EXCLUSION CRITERIA
    1. Anamnesi di ipersensibilità o allergia ad ABY-035 o ai suoi eccipienti
    2. Anamnesi di ipersensibilità o allergia alla fluoresceina
    3. Precedente arruolamento o randomizzazione nella sperimentazione
    4. Partecipazione a un altro studio clinico interventistico nei 30 giorni precedenti allo SCR o somministrazione di un altro medicinale sperimentale (Investigational Medicinal Product, IMP) entro 5 emivite (per prodotti biologici sperimentali: 6 mesi o 5 emivite, a seconda di quale periodo è più lungo) prima del BL
    5. Evidenza o sospetto di abuso o dipendenza da droghe sociali e/o alcol, secondo il parere dello sperimentatore
    6. Soggetti di sesso femminile in stato di gravidanza, che intendono avviare una gravidanza nel corso della sperimentazione o in allattamento
    7. Soggetto che è uno sperimentatore o fa parte del personale del centro di sperimentazione, dello sponsor o di fornitori di servizi coinvolti nello studio e/o sono loro familiari stretti (partner, coniuge, genitore, fratello o sorella, sia biologico/a che legalmente adottato/a)
    8. Qualsiasi condizione medica o psichiatrica che, secondo il giudizio dello sperimentatore, impedirebbe al soggetto di rispettare il protocollo o completare la sperimentazione clinica secondo il protocollo stesso
    9. Soggetto considerato come appartenente a una popolazione vulnerabile (ad es. soggetto sotto tutela legale, detenuto, altro)
    Criteri relativi alle condizioni oculari (e alla loro eziologia)
    10. Soggetto con uveite anteriore isolata
    11. Soggetto affetto da malattia di Behçet occlusiva, epiteliopatia acuta multifocale posteriore a placche di pigmento, epitelite acuta posteriore del pigmento, sindrome da punti bianchi evanescenti, coroidite puntata interna o coroidopatia serpiginosa
    12. Soggetto con uveite infettiva confermata o sospetta, tra cui, a titolo esemplificativo, uveite infettiva da tubercolosi (TB), sifilide, citomegalovirus, malattia di Lyme, toxoplasmosi, infezione da virus umano linfotropo delle cellule T di tipo 1, malattia di Whipple, virus dell'herpes zoster e virus dell'herpes simplex
    13. Soggetto con opacità corneale o del cristallino che impedisce la visualizzazione del fondo oculare o che probabilmente richiederà un intervento chirurgico di cataratta durante lo studio
    14. Intervento chirurgico oculare programmato (elettivo) entro 80 settimane dopo il BL
    15. Anamnesi di precedente intervento chirurgico laser refrattivo, fotocoagulazione laser della retina o capsulotomia posteriore con neodimio:ittrio-alluminio:granato nei 30 giorni precedenti al BL
    16. Anamnesi di qualsiasi altro intervento chirurgico oculare precedente entro 90 giorni prima del BL
    17. Soggetto con pressione intraoculare (Intraocular Pressure, IOP) >=25 mmHg, durante il trattamento farmacologico del glaucoma di grado >=2 o evidenza di lesione del nervo ottico da glaucoma
    18. Soggetto con grave annebbiamento del corpo vitreo che impedisce la visualizzazione del fondo oculare al BL
    19. Soggetto con controindicazione per l'uso di colliri midriatici O soggetto per il quale non può essere ottenuta una dilatazione sufficiente per consentire una buona visualizzazione del fondo oculare
    20. Soggetti con migliore acuità visiva corretta (Best Corrected Visual Acuity, BCVA) <20 lettere (Early Treatment Diabetic Retinopathy Study, ETDRS) in almeno un occhio al BL
    21. Soggetto con uveite intermedia o panuveite che presenta o ha un'anamnesi di essudati biancastri sulla pars plana inferiore (snowbanking) o aggregati infiammatori vitreali (snowball) in associazione ad un'anamnesi medica o a segni o sintomi che suggeriscono una malattia demielinizzante, come ad esempio la sclerosi multipla
    ...
    PER L'ELENCO COMPLETO DEI CRITERI DI ESCLUSIONE, SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO DI STUDIO
    E.5 End points
    E.5.1Primary end point(s)
    Part A: Numero e percentuale di soggetti con risposta completa alla S10
    Part B: "tempo al fallimento del trattamento" (Time to Treatment Failure, TTF) dopo la S10)
    Parte A: number and proportion of subjects with complete response at
    week 10
    Parte B: "Time to Treatment Failure" (TTF) beyond week 10
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A: week 10
    Part B: after week 10
    Parte A: Settimana 10
    Parte B: dopo la Settimana 10
    E.5.2Secondary end point(s)
    Secondary endpoints supporting the primary objectives for Part B
    (Efficacy) related to the preventive part (>W10):
    • Change in ACC grade from best state achieved =W10 up to W50 or up
    to discontinuation due to Treatment Failure, if earlier
    • Change in vitreous haze grade (NEI/SUN criteria) from best state
    achieved =W10 up to W50 or up to discontinuation due to Treatment
    Failure, if earlier
    • Change in BCVA using logarithm of the minimum angle of resolution
    (logMAR) calculation from best state achieved =W10 up to W50 or up to
    discontinuation due to Treatment Failure, if earlier
    • Change in central retinal thickness (by SD-OCT) from best state
    achieved =W10 up to W50 or up to discontinuation due to Treatment
    Failure, if earlier
    • In subjects with excess CST (by SD-OCT) at BL: Change in the
    reduction of BL excess CST from best state achieved =W10 up to W50 or
    up to discontinuation due to Treatment Failure, if earlier
    • Change in the NEI VFQ-25 score from best state achieved =W10 up to
    W50 or up to discontinuation due to Treatment Failure, if earlier
    • Change in the EQ-5D-3L score from from best state achieved =W10 up
    to W50 or up to discontinuation due to Treatment Failure, if earlier
    Secondary endpoints (Efficacy) related to the treatment of active disease
    (=W10):
    • Change in ACC grade from BL to W10 or up to discontinuation due to
    Early Lack of Response, if earlier
    • Change in vitreous haze grade (NEI/SUN criteria) from BL to W10 or
    up to discontinuation due to Early Lack of Response, if earlier
    • Change in BCVA using logMAR calculation from BL to W10 or up to
    discontinuation due to Early Lack of Response, if earlier
    • Change in central retinal thickness (by SD-OCT) from BL to W10 or up
    to discontinuation due to Early Lack of Response, if earlier
    • Change of excess CST from BL to W10 or up to discontinuation due to
    Early Lack of Response, if earlier
    • Change in the NEI VFQ-25 score from BL over time (at least up to W10
    or up to discontinuation due to Early Lack of Response, if earlier)
    • Change in the EQ-5D-3L score from BL over time (at least up to W10 or
    up to discontinuation due to Early Lack of Response, if earlier)
    Endpoint secondari a sostegno degli obiettivi primari per la Parte B (efficacia) correlati alla parte preventiva (>S10):
    • Variazione del grado dell'ACC dal migliore stato ottenuto =S10 alla S50 o all'interruzione a causa del fallimento del trattamento, se precedente
    • Variazione del grado di annebbiamento del corpo vitreo (criteri NEI/SUN) dal migliore stato ottenuto =S10 alla S50 o all'interruzione a causa del fallimento del trattamento, se precedente
    • Variazione nella BCVA calcolata mediante il logaritmo del minimo angolo di risoluzione (Logarithm Of The Minimum Angle Of Resolution, logMAR) dal migliore stato ottenuto =S10 alla S50 o all'interruzione a causa del fallimento del trattamento, se precedente
    • Variazione dello spessore retinico centrale (mediante SD-OCT) dal migliore stato ottenuto =S10 alla S50 o all'interruzione a causa del fallimento del trattamento, se precedente
    • In soggetti con spessore del sottocampo centrale (CST) in eccesso (mediante SD-OCT) al BL: variazione della riduzione del CST in eccesso al BL dal migliore stato ottenuto =S10 alla S50 o all'interruzione a causa del fallimento del trattamento, se precedente
    • Variazione del punteggio NEI VFQ-25 dal migliore stato ottenuto =S10 alla S50 o all'interruzione a causa del fallimento del trattamento, se precedente
    • Variazione del punteggio del questionario EuroQOL-5D-3L dal migliore stato ottenuto =S10 alla S50 o all'interruzione a causa del fallimento del trattamento, se precedente
    Endpoint secondari (efficacia) correlati al trattamento della malattia attiva (=S10):
    • Variazione del grado dell'ACC dal BL alla S10 o all'interruzione a causa dell'assenza di risposta precoce, se precedente
    • Variazione del grado di annebbiamento del corpo vitreo (criteri di NEI/SUN) dal BL alla S10 o all'interruzione a causa dell'assenza di risposta precoce, se precedente
    • Variazione della BCVA calcolata mediante il logMAR dal BL alla S10 o all'interruzione a causa dell'assenza di risposta precoce, se precedente
    • Variazione dello spessore retinico centrale (mediante SD-OCT) dal BL alla S10 o all'interruzione a causa dell'assenza di risposta precoce, se precedente
    • Variazione del CST in eccesso dal BL alla S10 o all'interruzione a causa dell'assenza di risposta precoce, se precedente
    • Variazione del punteggio NEI VFQ-25 dal BL nel corso del tempo (almeno fino alla S10 o all'interruzione a causa dell'assenza di risposta precoce, se precedente)
    • Variazione del punteggio del questionario EuroQOL-5D-3L dal BL nel corso del tempo (almeno fino alla S10 o all'interruzione a causa dell'assenza di risposta precoce, se precedente)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A: BL to W10
    Part B: >W10 to W50
    Parte A: BL a S10
    Parte B: da S10 a S50
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity of ABY-035
    immunogenicità di ABY-035
    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 trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Austria
    Germany
    Italy
    Spain
    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
    Last Subject Last Visit (LSLV)
    Last Subject Last Visit (LSLV)
    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: 100
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 110
    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)
    When subjects complete the study, continuing treatment according to clinical routine will be provided as judged by the Investigator or treating physician.
    Quando i soggetti completeranno lo studio, sarà previsto il proseguimento del trattamento in accordo alla pratica clinica secondo il giudizio dello Sperimentatore o del medico curante.
    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 Decision2021-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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