Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
823
Countries
7
Sites
34
Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, Severe Chronic Plaque Psoriasis, Moderate to severe Chronic Plaque Psoriasis, Juvenile idiopathic Arthritis
To evaluate long term safety as assessed by occurrence of AEs/SAEs
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 22 Dec 2020 → ongoing
- Decision date (initial)
- 2025-11-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Novartis Pharma AG
External identifiers
- EU CT number
- 2023-504417-67-00
- EudraCT number
- 2020-004284-98
- ClinicalTrials.gov
- NCT04638647
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety
To evaluate long term safety as assessed by occurrence of AEs/SAEs
Conditions and MedDRA coding
Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, Severe Chronic Plaque Psoriasis, Moderate to severe Chronic Plaque Psoriasis, Juvenile idiopathic Arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10059176 | Juvenile idiopathic arthritis | 100000004859 |
| 21.0 | LLT | 10037160 | Psoriatic arthritis | 10028395 |
| 20.0 | PT | 10002556 | Ankylosing spondylitis | 100000004859 |
| 20.0 | LLT | 10071117 | Plaque psoriasis | 10040785 |
| 20.0 | SOC | 10028395 | Musculoskeletal and connective tissue disorders | 17 |
| 20.0 | LLT | 10076297 | Non-radiographic axial spondyloarthritis | 10028395 |
| 20.0 | SOC | 10040785 | Skin and subcutaneous tissue disorders | 16 |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2014-005663-32 | A randomized, double-blind, placebo- and active controlled multicenter trial to demonstrate efficacy of subcutaneous secukinumab compared to placebo and etanercept (in a single blinded arm) after twelve weeks of treatment, and to assess the safety, tolerability, and long-term efficacy in subjects from 6 to less than 18 years of age with severe chronic plaque psoriasis, Ensayo multicéntrico, aleatorizado, doble ciego, controlado con placebo y fármaco activo para demostrar la eficacia de secukinumab subcutáneo en comparación con placebo y etanercept (en un brazo simple ciego) después de doce semanas de tratamiento y evaluar la seguridad, la tolerabilidad y la eficacia a largo plazo en pacientes de 6 a menos de 18 años de edad con psoriasis en placas crónica grave, Studio multicentrico, randomizzato, in doppio cieco, con placebo e controllo attivo, per dimostrare l’efficacia di secukinumab per via sottocutanea rispetto a placebo ed etanercept (in un braccio a singolo cieco) dopo dodici settimane di trattamento, e per valutare la sicurezza, tollerabilità ed efficacia a lungo termine in soggetti da 6 a meno di 18 anni di età con psoriasi cronica a placche severa. | |
| 2017-004515-39 | A randomized, open-label, multicenter trial to assess the efficacy of subcutaneous secukinumab after twelve weeks of treatment, and to assess the long-term safety, tolerability and efficacy in subjects from 6 to less than 18 years of age with moderate to severe chronic plaque psoriasis., Ensayo aleatorizado, abierto, multicéntrico para evaluar la eficacia de secukinumab subcutáneo después de doce semanas de tratamiento y evaluar la seguridad, tolerabilidad y eficacia a largo plazo en pacientes de 6 a menos de 18 años de edad con psoriasis crónica en placas de moderada a grave, Randomizované, otevřené, multicentrické klinické hodnocení k posouzení účinnosti subkutánního podání secukinumabu po 12 týdnech léčby a k posouzení dlouhodobé bezpečnosti, snášenlivosti a účinnosti u pacientů ve věku 6 až méně než 18 let se středně závažnou až závažnou chronickou formou ložiskové psoriázy, Randomiseeritud avatud mitmekeskuseline uuring, mis hindab subkutaanselt manustatud sekukinumabi efektiivsust pärast kaksteist nädalat kestnud ravi ning ravimi pikaajalist ohutust, talutavust ja efektiivsust 6 kuni alla 18 aasta vanustel uuritavatel, kellel esineb mõõdukas kuni raske krooniline naastuline psoriaas, Randomiseeritud avatud mitmekeskuseline uuring, mis hindab subkutaanselt manustatud sekukinumabi efektiivsust pärast kaksteist nädalat kestnud ravi ning ravimi pikaajalist ohutust, talutavust ja efektiivsust 6 kuni alla 18 aasta vanustel uuritavatel, kellel esineb mõõdukas kuni raske krooniline naastuline psoriaas, Randomizowane, otwarte, wieloośrodkowe badanie kliniczne oceniające skuteczność terapii sekukinumabem po 12 tygodniach leczenia oraz długoterminowe bezpieczeństwo, tolerancję i skuteczność pacjentów w wieku od 6 do <18 lat z umiarkowaną i ciężką postacią łuszczycy plackowatej, Randomizowane, otwarte, wieloośrodkowe badanie kliniczne oceniające skuteczność terapii sekukinumabem po 12 tygodniach leczenia oraz długoterminowe bezpieczeństwo, tolerancję i skuteczność pacjentów w wieku od 6 do <18 lat z umiarkowaną i ciężką postacią łuszczycy plackowatej | |
| 2019-001176-11 | A randomized, double-blind, placebo-controlled, parallel group, phase III multicenter study of intravenous secukinumab to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Psoriatic Arthritis, Рандомизирано, двойно-сляпо, плацебо-контролирано, паралелно-групово, многоцентрово фаза 3 изпитване със секукинумаб за интравенозно приложение с цел сравняване на ефикасността на 16-та седмица спрямо плацебо и за оценка на безопасността и поносимостта до 52 седмици при пациенти с активен Псориатичен Артит, Рандомизирано, двойно-сляпо, плацебо-контролирано, паралелно-групово, многоцентрово фаза 3 изпитване със секукинумаб за интравенозно приложение с цел сравняване на ефикасността на 16-та седмица спрямо плацебо и за оценка на безопасността и поносимостта до 52 седмици при пациенти с активен Псориатичен Артит, Рандомизирано, двойно-сляпо, плацебо-контролирано, паралелно-групово, многоцентрово фаза 3 изпитване със секукинумаб за интравенозно приложение с цел сравняване на ефикасността на 16-та седмица спрямо плацебо и за оценка на безопасността и поносимостта до 52 седмици при пациенти с активен Псориатичен Артит, Рандомизирано, двойно-сляпо, плацебо-контролирано, паралелно-групово, многоцентрово фаза 3 изпитване със секукинумаб за интравенозно приложение с цел сравняване на ефикасността на 16-та седмица спрямо плацебо и за оценка на безопасността и поносимостта до 52 седмици при пациенти с активен Псориатичен Артит, Τυχαιοποιημένη, διπλά τυφλή, ελεγχόμενη με εικονικό φάρμακο, παράλληλων ομάδων, πολυκεντρική μελέτη φάσης ΙΙΙ του ενδοφλέβιου secukinumab για τη σύγκριση της αποτελεσματικότητας στις 16 εβδομάδες με το εικονικό φάρμακο και την εκτίμηση της ασφάλειας και της ανεκτικότητας έως και τις 52 εβδομάδες σε άτομα με ενεργό ψωριασική αρθρίτιδα, Τυχαιοποιημένη, διπλά τυφλή, ελεγχόμενη με εικονικό φάρμακο, παράλληλων ομάδων, πολυκεντρική μελέτη φάσης ΙΙΙ του ενδοφλέβιου secukinumab για τη σύγκριση της αποτελεσματικότητας στις 16 εβδομάδες με το εικονικό φάρμακο και την εκτίμηση της ασφάλειας και της ανεκτικότητας έως και τις 52 εβδομάδες σε άτομα με ενεργό ψωριασική αρθρίτιδα | |
| 2018-002521-30 | An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis, Estudio de extensión de secukinumab subcutáneo para evaluar la eficacia, seguridad y tolerabilidad a largo plazo hasta un periodo de 4 años en pacientes con los subtipos de artritis idiopática juvenil: artritis psoriásica juvenil y artritis relacionada con entesitis., Przedłużenie badania dotyczącego podskórnie podawanego secukinumabu, mające na celu długoterminową (do 4 lat) ocenę skuteczności, bezpieczeństwa i tolerancji u pacjentów z wybranymi postaciami młodzieńczego idiopatycznego zapalenia stawów: łuszczycowym zapaleniem stawów i zapaleniem stawów z towarzyszącym zapaleniem przyczepów ścięgnistych (enthesitis)., Uno studio di estensione che valuta l’efficacia a lungo termine, la sicurezza e la tollerabilità fino a 4 anni di secukinumab per via sottocutanea in pazienti con Artrite Idiopatica Giovanile, sottotipi Artrite Psoriasica Giovanile e Artrite Entesite Relata | |
| 2015-001106-33 | A randomized, double-blind, placebo-controlled multicenter study of secukinumab 150 mg in patients with active non-radiographic axial spondyloarthritis to evaluate the safety, tolerability and efficacy up to 2 years, followed by an optimal phase of either 150 mg or 300 mg randomized dose escalation for up to another 2 years, Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la seguridad, tolerabilidad y eficacia de secukinumab en pacientes con espondiloartritis axial no radiográfica activa durante un periodo de 2 años, A szekukinumab randomizált, kettősvak, placebo kontrollált multicentrikus vizsgálata a biztonságosság, tolerálhatóság és a hatásosság legfeljebb 2 éves értékelésére aktív, röntgeneltérést nem mutató axiális spondiloartritiszben szenvedő betegeknél, Рандомизирано, двойно сляпо, плацебо контролирано многоцентрово изпитване на секукинумаб за оценка на безопасността, поносимостта и ефикасността до 2 години при пациенти с нерентгенографски активен аксиален спондилоартрит, Étude multicentrique, randomisée, en double aveugle, contrôlée versus placebo, évaluant la sécurité d'emploi, la tolérance et l'efficacité jusqu'à 2 ans du sécukinumab chez des patients atteints d'une spondyloarthrite axiale non radiographique active, Randomizované, dvojitě zaslepené, placebem kontrolované, multicentrické klinické hodnocení bezpečnosti, snášenlivosti a účinnosti secukinumabu 150 mg po dobu až 2 let u pacientů s aktivní neradiografickou axiální spondyloartritidou, následované volitelnou fází s dávkou 150 mg nebo randomizovanou eskalací na dávku 300 mg až po dobu dalších 2 let, Randomizované, dvojitě zaslepené, placebem kontrolované, multicentrické klinické hodnocení bezpečnosti, snášenlivosti a účinnosti secukinumabu 150 mg po dobu až 2 let u pacientů s aktivní neradiografickou axiální spondyloartritidou, následované volitelnou fází s dávkou 150 mg nebo randomizovanou eskalací na dávku 300 mg až po dobu dalších 2 let, Studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo con secukinumab per valutare la sicurezza, la tollerabilit¿ e l¿efficacia fino a 2 anni in pazienti con spondiloartrite assiale attiva non radiografica. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Signed informed consent must be obtained for adult participants before any assessment is performed. Written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. If participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s).
- Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
- Participant has completed treatment per protocol in a Novartis study of secukinumab (unless otherwise specified in a parent study protocol). Participants, who derive benefit from the treatment with secukinumab but have not completed the treatment in certain parent studies, due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (technical / administrative reasons).
- Participant is deriving benefit from secukinumab, investigator believes he/she would continue to derive benefit from secukinumab and the benefit outweighs the risk, based on the investigator’s judgement.
- Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.
Exclusion criteria 3
- Participant has prematurely discontinued study treatment in the parent protocol.
- Use of prohibited medications as listed in the Table 6-2 of the protocol
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks). Contraception methods include: · Total abstinence, when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. · Female sterilization (have had surgical bilateral oophorectomy [with or without hysterectomy], total hysterectomy or bilateral tubal ligation at least six weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. · Male sterilization (at least 6 months before taking study treatment). For female participants on the study, the vasectomized male partner should be the sole partner for that participant. · Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For United Kingdom: with spermicidal foam/gel/film/cream/vaginal suppository. · Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS). In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. In case local regulations deviate from the contraception methods listed above, local regulations apply and will be described in the informed consent form (ICF). Note: Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms). Women are considered not of child bearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks prior to enrollment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Serious adverse events (SAEs), adverse events (AEs), and injection site reactions
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB33242 · Substance
- Active substance
- Secukinumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 8100 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- Yes
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Different secondary packaging site used in comparison to authorized product
SUB33242 · Substance
- Active substance
- Secukinumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 8100 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Different secondary packaging site used in comparison to authorized product
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| S & D Pharma Logistics BG EOOD ORG-100017521
|
Sofia, Bulgaria | Other |
| Eco-Abc Sp. z o. o. ORG-100046253
|
Belchatow, Poland | Other |
| Statmed Sp. z o.o. ORG-100047187
|
Golkow, Poland | Other |
| Sopharma AD ORG-100001020
|
Sofia, Bulgaria | Other |
| Opis S.r.l. ORG-100011127
|
Desio, Italy | Other |
| World Courier Bulgaria Ltd ORL-000001164
|
Sofia, Bulgaria | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other, Interactive response technologies (IRT) |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 12 |
Locations
7 EU/EEA countries · 34 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 16 | 4 |
| Bulgaria | Ongoing, recruiting | 7 | 6 |
| Czechia | Ongoing, recruiting | 72 | 11 |
| Italy | Ended | 5 | 2 |
| Poland | Ongoing, recruiting | 163 | 6 |
| Portugal | Ended | 4 | 1 |
| Spain | Ongoing, recruiting | 56 | 4 |
| Rest of world
South Africa, Mexico, Colombia, Switzerland, Korea, Republic of, Brazil, Russian Federation, India, China, Malaysia, United States, Guatemala, Turkey
|
— | 500 | — |
Investigational sites
CHU Helora
3703; Reumatology, Boulevard President Kennedy 2, 7000, Mons
Reumaclinic
3701; Reumatology, Jaarbeurslaan 21/22, 3600, Genk
Universitair Ziekenhuis Gent
3700; Reumatology, Corneel Heymanslaan 10, 9000, Gent
Az St-Jan Brugge-Oostende A.V.
3702; Reumatology, Ruddershove 10, 8000, Brugge
University Multiprofile Hospital For Active Treatment Kaspela EOOD
#2102: Clinic of rheumatology, Zapaden District, Sofia Str 64, Plovdiv
Military Medical Academy
#2101: Department of rheumatology, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya
Umbal - Prof. D-R Stoyan Kirkovich AD
#2104: Dermatology and Venereology clinic, Ulitsa General Stoletov 2, 6003, Stara Zagora
Medical Centre Synexus Sofia EOOD
#2100: Office of rheoumatology, Mladost, Bul Andrey Saharov 20a, Sofia
ASMC IPSMC Skin And Venereal Diseases
#2103, Ulitsa Persenk 19, Enter B Floor 1 App 13, Sofiya
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
#2105 :Dermatology and Venereology Clinic, Ulitsa Vladimir Vazov 91, 5804, Pleven
Medical Plus s.r.o.
#2204: Revmatologie, Obchodni 1507, 686 01, Uherske Hradiste
Fakultni Nemocnice Hradec Kralove
#2209: Ambulance dětské dermatologie, Sokolska 581, 500 03, Novy Hradec Kralove
Sanatorium profesora Arenbergera
#2210: Dermatologie, Bolzanova 1604/7, 11000, Prague 1
University Hospital Olomouc
2211:III. interni klinika- nefrologicka, revmatologicka, endokrinologicka, Zdravotniku 248/7, 779 00, Olomouc
Revmacentrum MUDr. Mostera s.r.o.
#2202: Revmatologie, Mosnova 2476/8, Zidenice, Brno-Zidenice
Artroscan s.r.o.
#2208: Revmatologie, Trebovicka 5114/106, 722 00, Trebovice
Fakultni Nemocnice Brno
#2205: Revmatologická ambulance, Jihlavska 340/20, Bohunice, Brno
Affidea Praha s.r.o.
#2206: Revmatologie, Sustova 1930/2, Chodov, Prague 11
Fakultni Thomayerova nemocnice
#2207: Klinika revmatologie a rehabilitace 3 LF/UK, Videnska 800, Krc, Prague 4
Revmatologicky Ustav
#2203: Revmatologie, Na Slupi 450/4, Nove Mesto, Prague 2
Fakultni Nemocnice Motol A Homolka
2201:Oddělení revmatologie dětí a dospělých, V Uvalu 84/1, Motol, Prague
Azienda USL IRCCS Di Reggio Emilia
4000:U.O. Reumatologia, Viale Risorgimento 80, 42123, Reggio Emilia
Careggi University Hospital
4001:S.O.D. Reumatologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Malopolskie Badania Kliniczne Sp. z o.o. S.K.
#2308 - Rheumatology, Ul. Pradnicka 12/502, 30-002, Cracow
Pratia S.A.
#2301 - Reumatologia, Ul. Pana Tadeusza 2, 30-727, Cracow
Medicover Integrated Clinical Services Sp. z o.o.
#2306 - Reumatologia, Ul. Stefana Batorego 18/22, 87-100, Torun
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
#2309 - Rheumatology, Ul. Spartanska 1, 02-637, Warsaw
Rcmed Oddzial Sochaczew
#2310 - Rheumatology, Aleja 600-Lecia 45, 96-500, Sochaczew
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
#2316:Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Unidade Local De Saude De Santa Maria E.P.E.
#3800: Serviço de Reumatologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
Complexo Hospitalario Universitario De Santiago
#2503: Rheumatology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario La Paz
#2513:Rheumatology Department, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Y Politecnico La Fe
#2512: Pediatric Rheumatology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital General Universitario Gregorio Maranon
#2514:Rheumatology Department, Calle Del Doctor Esquerdo 46, 28009, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2021-03-24 | 2021-03-24 | |||
| Czechia | 2021-02-02 | 2021-02-02 | |||
| Italy | 2025-01-07 | 2025-12-16 | 2025-01-07 | ||
| Poland | 2021-03-09 | 2021-03-09 | |||
| Portugal | 2024-12-05 | 2026-01-27 | 2024-12-05 | ||
| Spain | 2020-12-22 | 2020-12-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 70 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Benefit Risk Assessment_1_English_NonRed | v02 |
| Protocol (for publication) | D4_Patient-facing document - Diary_1_Italian_NonRed | 02 |
| Protocol (for publication) | Protocol - Protocol Summary in Technical Language_1_Czech_NonRed | v1 |
| Protocol (for publication) | Protocol - Protocol Summary in Technical Language_1_Spanish_NonRed | v01 |
| Protocol (for publication) | Protocol - Signature Page_1_English_Red | v01 |
| Protocol (for publication) | Protocol_1_English_NonRed | v01 |
| Recruitment arrangements (for publication) | Advertisements - Country_1_PL_Polish_NonRed | 1.0 |
| Recruitment arrangements (for publication) | EU CTR_Replacement_document no longer subject to publication | 01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_PT_English_NonRed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitments Arrangements - Country_1_BE_English_NonRed | v00 |
| Recruitment arrangements (for publication) | Recruitment Arrangements - Country_1_BG_Bulgarian_NonRed | 1.0 |
| Recruitment arrangements (for publication) | Recruitment Arrangements - Country_1_CZ_Czech_NonRed | 17Oct2023 |
| Recruitment arrangements (for publication) | Recruitment Arrangements - Country_1_ES_Spanish_NonRed | v4.0 |
| Subject information and informed consent form (for publication) | ICF - Optional treatment beyond treatment disease_1_CZ_Czech_NonRed | V01.00.01 |
| Subject information and informed consent form (for publication) | ICF - Adolescent Assent_1_ES_Spanish_NonRed | v01.00.00 |
| Subject information and informed consent form (for publication) | ICF - Adolescent Assent_1_PL_Polish_NonRed | 01.00.01 |
| Subject information and informed consent form (for publication) | ICF - Child Assent_1_ES_Spanish_NonRed | v01.00.00 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant participant_1_BG_Bulgarian_NonRed | 01.01.02 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant participant_1_BG_English_NonRed | 01.01 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant participant_1_PL_Polish_NonRed | 2 |
| Subject information and informed consent form (for publication) | ICF - Optional treatment beyond disease progression_1_CZ_Czech_NonRed | V01.00.01 |
| Subject information and informed consent form (for publication) | ICF - Pre-Adolescent Assent_1_CZ_Czech_NonRed | V01.00.01 |
| Subject information and informed consent form (for publication) | ICF - Pre-Adolescent Assent_1_PL_Polish_NonRed | 01.00.01 |
| Subject information and informed consent form (for publication) | ICF - Separate Data Protection Consent_1_ES_Spanish_NonRed | v3 |
| Subject information and informed consent form (for publication) | ICF - Separate Data Protection Consent_2_ES_Spanish_NonRed | v3 |
| Subject information and informed consent form (for publication) | ICF Procedure_1_PL_Polish_NonRed | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Adolescent Assent_1_CZ_Czech_NonRed | V01.04.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Adolescent Assent_2_CZ_Czech_NonRed | V01.04.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BE_Dutch_NonRed | v01.02.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BE_English_NonRed | v01.02.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BE_French_NonRed | v01.02.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_CZ_Czech_NonRed | V01.02.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed | v01.02.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_IT_Italian_NonRed | 01.02.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_PT_Portuguese_NonRed | 01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_Dutch_NonRed | 01.04.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_English_NonRed | 01.04.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_French_NonRed | 01.04.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BG_Bulgarian_Red | 01.04.08 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BG_English_NonRed | 01.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_CZ_Czech_Red | V01.04.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_ES_Spanish_NonRed | v01.04.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IT_Italian_Red | 01.04.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PL_Polish_NonRed | 05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PT_Portuguese_NonRed | V03.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_CZ_Czech_Red | V01.04.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_CZ_Czech_NonRed | V01.04.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_IT_Italian_NonRed | 01.01.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_2_CZ_Czech_NonRed | V01.04.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_CZ_Czech_Red | V01.04.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_ES_Spanish_NonRed | v01.02.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_PL_Polish_NonRed | 01.02.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_2_CZ_Czech_Red | V01.04.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_CZ_Czech_NonRed | V01.03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_2_CZ_Czech_NonRed | V01.03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_3_CZ_Czech_NonRed | V01.03.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_4_CZ_Czech_NonRed | V01.03.02 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents Part II - ICF_1_CZ_NonRed | 1 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_BE_English_Red | v2.2 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_PT_English_NonRed | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Reference Label_1_AIN456_1_English_NonRed | v01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_1_Italian_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_1_Portuguese_NonRed | 01.00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-504417-67-00_1_Dutch_NonRed | v00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-504417-67-00_1_French_NonRed | v00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-504417-67-00_1_German_NonRed | v00 |
| Synopsis of the protocol (for publication) | Protocol Summary in Lay Language_1_Bulgarian_NonRed | V01 |
| Synopsis of the protocol (for publication) | Protocol Summary in Lay Language_1_Czech_NonRed | V00 |
| Synopsis of the protocol (for publication) | Protocol Summary in Lay Language_1_English_NonRed | v00 |
| Synopsis of the protocol (for publication) | Protocol Summary in Lay Language_1_Polish_NonRed | v01 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-05 | Poland | Acceptable 2023-08-18
|
2023-08-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-25 | Poland | Acceptable 2023-12-22
|
2024-01-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-21 | Acceptable | 2024-05-20 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-03-26 | Acceptable | 2024-04-17 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-04-19 | Acceptable 2023-12-22
|
2024-07-09 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-04-24 | Acceptable 2023-12-22
|
2024-06-12 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-05 | Acceptable 2025-03-03
|
2025-03-04 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-12 | Poland | Acceptable 2025-03-03
|
2025-03-12 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-31 | Acceptable 2025-05-30
|
2025-05-30 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-06-25 | Acceptable | 2025-07-17 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-06-25 | Acceptable | 2025-08-19 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-06-27 | Acceptable | 2025-07-16 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-04 | Acceptable | 2025-07-22 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-07-04 | Poland | Acceptable | 2025-08-18 |
| 15 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-07-08 | Acceptable | 2025-10-07 | |
| 16 | SUBSEQUENT ADDITION OF MSC | APP-16 | 2025-09-18 | Acceptable 2023-08-18
|
2025-11-19 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-12-19 | Poland | Acceptable 2026-03-02
|
2026-03-02 |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-12 | Acceptable 2026-03-02
|
2026-03-12 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-14 | 2026-03-27 | Acceptable | 2026-04-09 |