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    Summary
    EudraCT Number:2020-002931-32
    Sponsor's Protocol Code Number:APL2-GA-305
    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:2021-10-18
    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 number2020-002931-32
    A.3Full title of the trial
    A Phase 3 open-label, multicenter, extension study to evaluate the longterm safety and efficacy of pegcetacoplan in subjects with geographic atrophy secondary to age-related macular degeneration
    Studio di estensione in aperto di fase 3, multicentrico, volto a valutare la sicurezza e l'efficacia a lungo termine di pegcetacoplan in soggetti con atrofia geografica secondaria a degenerazione maculare legata all'età
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical research study involving an intravitreal injection in the eye with pegcetacoplan for the treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration
    Studio di ricerca clinica che prevede un'iniezione intravitreale nell'occhio con pegcetacoplan per il trattamento dell'atrofia geografica secondaria a degenerazione maculare legata all'età
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberAPL2-GA-305
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03525600
    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 SponsorAPELLIS PHARMACEUTCIALS, 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 supportApellis Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationApellis Pharmaceuticals
    B.5.2Functional name of contact pointClin. Development and Med. Affairs
    B.5.3 Address:
    B.5.3.1Street Address100 5th Avenue
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016179775701
    B.5.6E-mailfederico@apellis.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 namePegcetacoplan
    D.3.2Product code [Pegcetacoplan]
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPegcetacoplan
    D.3.9.1CAS number 2019171-69-6
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Geographic Atrophy Secondary to Age-Related Macular Degeneration
    Atrofia Geografica Secondaria a Degenerazione Maculare Legata all'Età
    E.1.1.1Medical condition in easily understood language
    Geographic Atrophy Secondary to Age-Related Macular Degeneration
    Atrofia Geografica Secondaria a Degenerazione Maculare Legata all'Età
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10063947
    E.1.2Term Geographic atrophy
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety of IVT injected pegcetacoplan.
    Valutare la sicurezza a lungo termine di pegcetacoplan iniettato per via IVT
    E.2.2Secondary objectives of the trial
    1. To assess changes in the total area of geographic atrophy (GA) lesion in the study eye measured by fundus autofluorescence (FAF).
    2. To assess changes in visual function as measured by:
    a. Normal-luminance best-corrected visual acuity score (NL-BCVA) in the study eye
    b. Low-luminance best-corrected visual acuity score (LL-BCVA) in the study eye
    c. Low-luminance deficit (LLD) in the study eye
    d. Reading speed in the study eye
    3. To assess the macular functional response as assessed by mesopic microperimetry in the study eye (selected subjects [those who had the assessment performed in the antecedent study] only).
    4. To evaluate changes in subject-reported outcomes as measured by:
    a. National Eye Institute Visual Functioning Questionnaire 25 Item Version (NEI VFQ-25)
    b. Functional Reading Independence (FRI) Index.
    1. Valutare le variazioni dell'area totale di lesione dell'atrofia geografica (GA) nell'occhio in studio misurate mediante autofluorescenza del fondo (FAF).
    2. Valutare le variazioni della funzione visiva misurate mediante:
    a. Punteggio della massima acuità visiva corretta in condizioni di normale luminanza (NLBCVA) nell'occhio in studio
    b. Punteggio della massima acuità visiva corretta in condizioni di bassa luminanza (LLBCVA) nell'occhio in studio
    c. Deficit a bassa luminanza (LLD) nell'occhio in studio
    d. Velocità di lettura nell'occhio in studio
    3. Valutare la risposta funzionale maculare mediante microperimetria mesopica nell'occhio in studio (solo soggetti selezionati [coloro sottoposti alla valutazione nello studio precedente]).
    4. Valutare le variazioni negli esiti segnalati dal soggetto misurate mediante:
    a. Questionario 25-item National Eye Institute Visual Functioning (NEI VFQ-25)
    b. Indice di indipendenza della lettura funzionale (FRI)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Ocular-specific inclusion criteria apply to the study eye only.
    1. Participated in APL2-103 (NCT03777332) or completed the treatment at Month 24 of either APL2-303 (Derby, NCT03525613) or APL2-304 (Oaks, NCT03525600). Specifically, for the APL2-303 and APL2-304 studies, the
    following criterion also applies:
    a. Subjects who did not permanently discontinue treatment but missed the Month 24 visit are also eligible to participate in this extension study; however, to be eligible, these subjects must be screened within 60 daysfrom the last day of the expected Month 24 visit window for the antecedent study.
    2. Clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the investigator.
    3. Female subjects must be:
    a. Women of nonchildbearing potential, or
    b. Women of childbearing potential (WOCBP) with a negative serum pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and 90 days after their last dose of pegcetacoplan, and refrain from breastfeeding for the duration of the study.
    4. Males with female partners of childbearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study and for 90 days after their last dose of pegcetacoplan.
    5. Willing and able to give informed consent and to comply with the study procedures and assessments.
    I criteri di inclusione oculari specifici si applicano solo all'occhio in studio.
    1. Partecipazione ad APL2-103 (NCT03777332) o completamento del trattamento al Mese 24 di APL2-303 (Derby, NCT03525613) o APL2-304 (Oaks, NCT03525600). Nello specifico, per gli studi APL2-303 e APL2-304, si applica anche il seguente criterio:
    a. Sono idonei a partecipare a questo studio di estensione anche i soggetti che non hanno interrotto definitivamente il trattamento, ma non hanno partecipato alla visita al Mese 24; tuttavia, per essere idonei, questi soggetti devono essere sottoposti a screening entro 60 giorni dall'ultimo giorno della finestra della visita al Mese 24 prevista per lo studio precedente.
    2. Adeguata trasparenza dei mezzi oculari, adeguata midriasi e fissazione tali da permettere l'acquisizione di immagini di buona qualità in base al giudizio dello sperimentatore.
    3. I soggetti di sesso femminile devono essere:
    a. Donne in età non fertile oppure
    b. Donne in età fertile con un test di gravidanza sul siero negativo allo screening che devono accettare di utilizzare i metodi contraccettivi definiti dal protocollo per tutta la durata dello studio e fino a 90 giorni dopo l'ultima dose di pegcetacoplan e di astenersi dall'allattamento per tutta la durata dello studio.
    4. Gli uomini con partner di sesso femminile in età fertile devono accettare di usare i metodi contraccettivi definiti dal protocollo e di non donare sperma per l'intera durata dello studio e fino a 90 giorni dopo l'ultima dose di pegcetacoplan.
    5. Disposti e in grado di fornire il consenso informato scritto e di rispettare le procedure e le valutazioni dello studio.
    E.4Principal exclusion criteria
    Ocular-specific exclusion criteria apply to the study eye only.
    1. Subjects who permanently discontinued the study drug prior to Month 24 in the APL2-304 or APL2-304 studies and only for safety assessments. Temporary pause of the study drug is not exclusionary.
    2. Presence of an active ocular disease that, in the opinion of the investigator, compromises or confounds visual function, including, but not limited to, macular hole or other macular diseases (eg, clinically significant epiretinal membrane). Benign conditions in the opinion of the investigator such as peripheral retinal dystrophy are not
    exclusionary.
    3. Any contraindication to IVT injection including current ocular or periocular infection.
    4. Medical or psychiatric condition that, in the opinion of the investigator, is clinically significant and not suitable for study participation or make consistent follow-up over the 36-month treatment period unlikely.
    5. Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to pegcetacoplan or any of the excipients in pegcetacoplan solution.
    6. Pregnancy, breastfeeding, or positive pregnancy test.
    I criteri di esclusione oculari specifici si applicano solo all'occhio in studio, salvo diversamente specificato.
    1. I soggetti che hanno interrotto definitivamente il farmaco dello studio prima del Mese 24 negli studi APL2-303 o APL2-304 e sono rimasti solo per le valutazioni di sicurezza. La sospensione temporanea del farmaco in studio non è motivo di esclusione.
    2. Presenza di una patologia oftalmica attiva che, a giudizio dello sperimentatore, compromette o confonde la funzione visiva, inclusi, a titolo esemplificativo ma non esaustivo, foro maculare o altre malattie maculari (ad es., membrana epiretinica clinicamente significativa). Le condizioni benigne secondo lo sperimentatore, come la
    distrofia retinica periferica, non sono motivo di esclusione.
    3. Eventuali controindicazioni all'iniezione IVT, inclusa infezione oculare o perioculare attiva.
    4. Condizioni mediche o psichiatriche che, a giudizio dello sperimentatore, sono clinicamente significative e non compatibili con la partecipazione allo studio o che renderebbero improbabile il regolare svolgimento delle attività di follow-up nei 36 mesi di trattamento.
    5. Ipersensibilità nota a fluoresceina sodica iniettabile o ipersensibilità a pegcetacoplan o a uno qualsiasi degli eccipienti della soluzione di pegcetacoplan.
    6. Gravidanza, allattamento o test di gravidanza positivo.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence and severity of ocular and systemic AEs
    Incidenza e gravità degli eventi avversi oculari e sistemici (arco temporale: fino a 36 mesi)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Incidence and severity of ocular and systemic AEs (time frame: up to 36 months)
    Incidenza e gravità degli EA oculari e sistemici (periodo di tempo: fino a 36 mesi)
    E.5.2Secondary end point(s)
    • The total area of GA lesion(s) in the study eye (in mm2) as assessed by fundus autofluorescence (FAF)
    • NL-BCVA score (study eye) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart
    • LL-BCVA score (study eye) as assessed by ETDRS chart
    • LLD (study eye)
    • Monocular maximum reading speed (study eye) and monocular critical print size, as assessed by Minnesota Reading (MNRead) charts or Radner
    • Binocular maximum reading speed and binocular critical print size, as assessed by MNRead charts or Radner.
    • The number of absolute scotomatous points (study eye) assessed by mesopic microperimetry (selected subjects [those who had the assessment performed in the antecedent study] only)
    • Macular sensitivity (study eye) as assessed by mesopic microperimetry (selected subjects [those who had the assessment performed in the antecedent study] only)
    • Mean FRI Index score
    • NEI VFQ-25 composite score, near activity subscale score, and distance activity subscale score
    Variazione rispetto al basale dei seguenti parametri:
    - Area totale delle lesioni GA nell'occhio in studio (in mm2) secondo la valutazione FAF al Mese 12, Mese 24 e Mese 36
    - Punteggio NL-BCVA (occhio in studio) valutato in base alla tavola ETDRS (studio trattamento precoce della retinopatia diabetica, Early Treatment Diabetic Retinopathy Study) al Mese 12, Mese 24 e Mese 36
    - Punteggio LL-BCVA (occhio in studio) valutato in base alla tavola ETDRS al Mese 12, Mese 24 e Mese 36
    - LLD (occhio in studio) al Mese 12, Mese 24 e Mese 36
    - Velocità di lettura massima monoculare (occhio in studio) e dimensione critica di stampa monoculare, misurate mediante tavole Minnesota Reading (MNRead) o di Radner al Mese 12, Mese 24 e Mese 36
    - Velocità di lettura massima binoculare e dimensione critica di stampa binoculare, misurate mediante tavole MNRead o di Radner al Mese 12, Mese 24 e Mese 36
    - Numero di punti scotomatosi (occhio in studio) valutati mediante microperimetria mesopica (solo soggetti selezionati [coloro sottoposti alla valutazione nello studio precedente]) al Mese 12, Mese 24 e Mese 36
    - Sensibilità maculare (occhio in studio) valutata mediante microperimetria mesopica (solo soggetti selezionati [coloro sottoposti alla valutazione nello studio precedente]) al Mese 12, Mese 24 e Mese 36
    - Punteggio medio dell'indice di indipendenza della lettura funzionale (FRI) al Mese 12, Mese 24 e Mese 36
    - Punteggio composito del Questionario 25-item National Eye Institute Visual Functioning (NEI VFQ-25), punteggio della sottoscala nelle attività che richiedono una visione da vicino e punteggio della sottoscala nelle attività che richiedono una visione da lontano al Mese 12, Mese 24 e Mese 36
    E.5.2.1Timepoint(s) of evaluation of this end point
    •The total area of GA lesion(s) in the study eye (in mm2) as assessed by FAF at Month 12, 24 and 36.
    • NL-BCVA score (study eye) and LL-BCVA score (study eye) as assessed by ETDRS chart at Month 12, 24 and 36.
    • LLD (study eye) at Month 12, 24 and 36.
    • Monocular maximum reading speed (study eye) and monocular critical print size at Month 12, 24 and 36.
    • Binocular maximum reading speed and binocular critical print size at Month 12, 24 and 36.
    The number of absolute scotomatous points (study eye) at Month 12, 24, and 36.
    • Macular sensitivity (study eye) at Month 12, 24, and 36.
    • Mean FRI Index score at Month 12, 24, and 36
    • NEI VFQ-25 composite score, near activity subscale score, and distance activity subscale score at Month 12, 24, and 36.
    •The total area of GA lesion(s) in the study eye (in mm2) as assessed by FAF at Month 12, 24 and 36.
    • NL-BCVA score (study eye) and LL-BCVA score (study eye) as assessed by ETDRS chart at Month 12, 24 and 36.
    • LLD (study eye) at Month 12, 24 and 36.
    • Monocular maximum reading speed (study eye) and monocular critical print size at Month 12, 24 and 36.
    • Binocular maximum reading speed and binocular critical print size at Month 12, 24 and 36.
    The number of absolute scotomatous points (study eye) at Month 12, 24, and 36.
    • Macular sensitivity (study eye) at Month 12, 24, and 36.
    • Mean FRI Index score at Month 12, 24, and 36
    • NEI VFQ-25 composite score, near activity subscale score, and distance activity subscale score at Month 12, 24, and 36.
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    in aperto
    open
    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.8.2.4Number 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Australia
    Brazil
    Canada
    Israel
    New Zealand
    United States
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    Argentina
    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 years3
    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 years3
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1160
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 206
    F.4.2.2In the whole clinical trial 1200
    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 are no current plans for pegcetacoplan treatment after study completion. Patients will receive the local standard of care for their disease as required after the trial ends.
    There are no current plans for pegcetacoplan treatment after study completion. Patients will receive the local standard of care for their disease as required after the trial ends.
    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 Decision2021-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-15
    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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