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    Summary
    EudraCT Number:2021-006498-49
    Sponsor's Protocol Code Number:21103
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-006498-49
    A.3Full title of the trial
    A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Non-infectious, Intermediate-, Posterior- or Pan-uveitis
    Studio cardine di fase 2b per valutare l’efficacia e la sicurezza di izokibep in soggetti affetti da uveite non infettiva, intermedia, posteriore o panuveite
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis
    Studio su izokibep nell' uveite non infettiva, intermedia, posteriore o nella panuveite
    A.3.2Name or abbreviated title of the trial where available
    n/a
    n/a
    A.4.1Sponsor's protocol code number21103
    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 SponsorACELYRIN, 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 supportAcelyrin, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationACELYRIN, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address23371 Mulholland Dr. PMB 417
    B.5.3.2Town/ cityWoodland Hills
    B.5.3.3Post codeCA 91364
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018054564393
    B.5.6E-mailclinicaltrials@acelyrin.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 nameIzokibep
    D.3.2Product code [ABY-035]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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.3.9.4EV 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.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/infusion
    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 non infettiva, intermedia, posteriore o panuveite
    E.1.1.1Medical condition in easily understood language
    Uveitis
    Uveite
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10022557
    E.1.2Term Intermediate uveitis
    E.1.2System Organ Class 100000004853
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10036370
    E.1.2Term Posterior uveitis
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033687
    E.1.2Term Panuveitis
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that 1 or both treatment regimens of izokibep is/are efficacious compared to placebo, as measured by time to treatment failure occurring at or after week 10 and up to week 52
    Dimostrare che 1 o entrambi i regimi di trattamento con izokibep è/sono efficace/i rispetto al placebo, quando misurato/i dal tempo al fallimento della terapia che si verifica alla o dopo la Settimana 10 e fino alla Settimana 52
    E.2.2Secondary objectives of the trial
    - To demonstrate that 1 or both regimens of izokibep is/are efficacious, as measured by:
    • Proportion of subjects that achieve quiescence at week 10
    • Change in BCVA from best state achieved <= week 10 to week 24
    • Change in the NEI VFQ-25 score from best state achieved <= week 10 to week 24
    • Change in central retinal thickness (by SD-OCT) from baseline to week 10
    • Change in central retinal thickness (by SD-OCT) from best state achieved <= week 10 up to week 52
    -To assess the safety and tolerability of izokibep as measured by the incidence of TEAEs, events of special interest, SAEs and clinically significant lab values and vital signs
    - To assess the immunogenicity of izokibep as measured by the presence of treatment-emergent ADAs
    - Dimostrare che 1 o entrambi i regimi con izokibep è/sono efficace/i, quando misurato/i mediante:
    • Percentuale di soggetti che raggiungono la quiescenza alla Settimana 10
    • Variazione della BCVA dallo stato migliore raggiunto da <= Settimana 10 alla Settimana 24
    • Variazione nel punteggio NEI VFQ-25 dallo stato migliore raggiunto da <=Settimana 10 alla Settimana 24
    • Variazione nello spessore centrale della retina (mediante SD-OCT) dal basale alla Settimana 10
    • Variazione dello spessore centrale della retina (mediante SD-OCT) dallo stato migliore raggiunto da <= Settimana 10 fino alla Settimana 52
    - Valutare la sicurezza e la tollerabilità di izokibep misurate in base a incidenza di TEAE, eventi di particolare interesse, SAE e valori di laboratorio e segni vitali clinicamente significativi
    - Valutare l’immunogenicità di izokibep misurata mediante la presenza di ADA emergenti dal trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject (male and female) must be >= 18 and <= 75 years of age
    - Subject is diagnosed with non-infectious intermediate-, posterior- or pan-uveitis
    - Active disease defined by the presence of at least 1 of the following criteria in at least 1 eye despite treatment with stable doses of corticosteroids for at least 2 weeks prior to day 1:
    o Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion by dilated indirect ophthalmoscopy, fundus photography, fluorescein angiography (FA), and Spectral-Domain Optical Coherence Tomography (SD-OCT) to determine whether a lesion is active or inactive (the central reading center assessment using FA, fundus photography and/or SD-OCT is required to confirm eligibility prior to day 1).
    o >= 2+ vitreous haze (National Eye Institute [NEI]/Standardization of Uveitis Nomenclature [SUN] criteria) by digital indirect ophthalmoscope and fundus photography (the central reading center assessment using fundus photography is required to confirm eligibility prior to day 1).
    - Currently receiving treatment with oral corticosteroids (>= 7.5 mg/day to <= 40 mg/day oral prednisone/prednisolone or corticosteroid equivalent) at a stable dose for at least 2 weeks prior to day 1.
    - No known history of active tuberculosis (TB).
    - Subject has a negative TB test at screening,
    - Male and Female participants of childbearing potential must use effective methods of contraception

    For a complete overview of the inclusion criteria refer to the protocol.
    - Il soggetto (di sesso maschile e femminile) deve avere un’età >=18 anni e un’età <= 75 anni
    - Il soggetto presenta una diagnosi di uveite non infettiva intermedia, posteriore o pan-uveite
    - Malattia attiva definita dalla presenza di almeno 1 dei seguenti criteri in almeno 1 occhio nonostante il trattamento con dosaggio stabile di corticosteroidi per almeno 2 settimane prima del giorno 1:
    o Lesione vascolare retinica attiva, infiammatoria, corioretinica e/o infiammatoria mediante oftalmoscopia indiretta dilatata, fotografia del fondo oculare, angiografia con fluoresceina (FA) e tomografia a coerenza ottica del dominio spettrale (SD-OCT) per determinare se una lesione è attiva o inattiva (è necessaria la valutazione del centro di lettura centrale mediante FA, fotografia del fondo oculare e/o SD-OCT per confermare l’idoneità prima del giorno 1).
    o >= 2+ opacizzazione del vitreo (National Eye Institute [NEI]/criteri di Standardizzazione della nomenclatura dell’uveite [SUN]) misurato mediante oftalmoscopio indiretto digitale e fotografia del fondo oculare (è necessaria la valutazione del centro di lettura centrale mediante la fotografia del fondo oculare per confermare l’idoneità prima del giorno 1).
    - Trattamento in corso con corticosteroidi orali (da >=7,5 mg/die a <=40 mg/die di prednisone/prednisolone orale o corticosteroide equivalente) a una dose stabile per almeno 2 settimane prima del giorno 1.
    - Nessuna anamnesi nota di tubercolosi (TB) attiva
    - Il soggetto presenta un test della TB negativo allo screening
    - I partecipanti di sesso maschile e femminile in età fertile devono utilizzare metodi contraccettivi efficaci

    Per una panoramica completa dei criteri di inclusione, si prega di far riferimento al protocollo.
    E.4Principal exclusion criteria
    - Subject with isolated anterior uveitis
    - Subject with serpiginous choroidopathy
    - Subject with confirmed or suspected infectious uveitis
    - Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the study
    - Planned (elective) eye surgery during the course of the study
    - History of prior refractive laser surgery, laser surgery of the macula (including photodynamic therapy or focal laser photocoagulation), retinal laser photocoagulation, or neodymium-doped yttrium aluminum garnet posterior capsulotomy <= 30 days before day 1
    - History of any other prior ocular surgery <= 3 months prior to day 1 except surgery for cosmetic reasons that is not expected to impact vision
    - Subject with intraocular pressure of >= 25 mmHg while on >= 2 glaucoma medications or evidence of glaucomatous optic nerve injury
    - Subject with severe vitreous haze that precludes visualization of the fundus prior to first dose of study intervention
    - Subject has a contraindication for mydriatic eye drops OR subject cannot be dilated sufficiently well to permit good fundus visualization
    - Subject with best corrected visual acuity (BCVA) < 20 letters (Early Treatment Diabetic Retinopathy Study [ETDRS]) in at least 1 eye prior to first dose of study intervention
    - Subject with proliferative or severe non-proliferative retinopathy or clinically significant macular edema due to diabetic retinopathy
    - Subject with neovascular/wet age-related macular degeneration
    - Subject with an abnormality of the vitreo-retinal interface (eg,vitreomacular traction, epiretinal membranes) with the potential for macular structural damage independent of the inflammatory process

    For a complete overview of the exclusion criteria refer to the protocol.
    - Soggetto con uveite anteriore isolata
    - Soggetto con coroidopatia serpiginosa
    - Soggetto con uveite infettiva confermata o sospetta
    - Soggetto con opacità corneale o del cristallino che preclude la visualizzazione del fondo oculare o che probabilmente richiede un intervento chirurgico nel corso della durata dello studio
    - Chirurgia oculare (elettiva) programmata nel corso dello studio
    - Anamnesi di precedente intervento chirurgico al laser refrattivo, intervento chirurgico al laser della macula (compresa la terapia fotodinamica o la fotocoagulazione laser focale), fotocoagulazione laser della retina o capsulotomia posteriore con cristallo di granato di ittrio e alluminio drogato al neodimio <=30 giorni prima del giorno 1
    - Anamnesi di qualsiasi altro intervento chirurgico oculare precedente <=3 mesi prima del giorno 1, tranne un intervento chirurgico per ragioni estetiche che non si prevede influisca sulla vista
    - Soggetto con una pressione intraoculare >=25 mmHg durante il trattamento con >=2 farmaci per il glaucoma o evidenza di lesione del nervo ottico glaucomatoso
    - Soggetto con grave opacizzazione del vitreo che preclude la visualizzazione del fondo oculare prima della prima dose del trattamento dello studio
    - Il soggetto presenta una controindicazione per il collirio midriatico OPPURE il soggetto non può sottoporsi a una dilatazione sufficientemente adeguata da consentire una buona visualizzazione del fondo oculare
    - Soggetto con migliore acuità visiva corretta (BCVA) <20 lettere (Studio sulla retinopatia diabetica in trattamento precoce [ETDRS]) in almeno 1 occhio prima della prima dose del trattamento dello studio
    - Soggetto con retinopatia proliferante o grave non proliferante o edema maculare clinicamente significativo dovuto a retinopatia diabetica
    - Soggetto con degenerazione maculare legata all’età neovascolare/umida
    - Soggetto con un’anomalia dell’interfaccia vitreo-retinica (per es., trazione vitreo-maculare, membrane epiretiniche) con potenziale danno strutturale maculare indipendente dal processo infiammatorio

    Per una panoramica completa dei criteri di esclusione, si prega di far riferimento al protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Time to treatment failure
    Tempo al fallimento della terapia
    E.5.1.1Timepoint(s) of evaluation of this end point
    At any visit /time to treatment failure
    In occasione di qualsiasi visita/tempo al fallimento della terapia
    E.5.2Secondary end point(s)
    - Quiescence
    - BCVA
    - NEI VFQ-25
    - Central retinal thickness
    - TEAEs, events of special interest and SAEs
    - Laboratory values and vital signs
    - ADAs
    - Quiescienza
    - BCVA
    - NEI VFQ-25
    - Spessore centrale della retina
    - TEAE, eventi di particolare interesse e SAE
    - Valori di laboratorio e segni vitali
    - ADA
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Quiescence at week 10
    - BCVA from best state achieved <= week 10 to week 24
    - NEI VFQ-25 score from best state achieved <= week 10 to week 24
    - Central retinal thickness (by SD-OCT) from baseline to week 10
    - Central retinal thickness (by SD-OCT) from best state achieved <= week 10 up to week 52
    From start to end of study:
    - Incidence of TEAEs, events of special interest, SAEs
    - Laboratory values and vital signs at collected timepoints
    - ADAs
    - Quiescienza alla settimana 10
    - BCVA dallo stato migliore raggiunto da <= settimana 10 alla settimana 24
    - Punteggio VFQ-25 dallo stato migliore raggiunto da <= settimana 10 alla settimana 24
    - Spessore centrale della retina (mediante SD-OCT) dal basale alla Settimana 10
    - Spessore centrale della retina (mediante SD-OCT) dallo stato migliore raggiunto da <=Settimana 10 fino alla Settimana 52
    Dall'inizio alla fine dello studio:
    - Incidenza di TEAE, eventi di particolare interesse, SAE
    - valori di laboratorio e segni vitali raccolti nei punti temporali prescelti
    - ADA
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Immunogenicità
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    France
    Spain
    Czechia
    Germany
    Italy
    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
    LVLS
    LVLS
    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 months11
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days21
    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: 110
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 120
    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)
    There is no plan to continue access to study intervention after the end of study. The choice of further therapy for non-infectious, intermediate-, posterior- or pan-uveitis at the end of the clinical study depends on the patient's individual needs and is left at the physician's discretion, based on available therapies approved for such use.
    -
    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 Decision2022-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-05
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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