Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
705
Countries
20
Sites
121
Primary Progressive Multiple Sclerosis (PPMS)
To evaluate the efficacy of orelabrutinib compared to placebo in delaying disability progression in PPMS
Key facts
- Sponsor
- Zenas Biopharma (USA) LLC
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2026-05-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Zenas BioPharma LLC
External identifiers
- EU CT number
- 2025-524316-11-00
- WHO UTN
- U1111-1333-2925
- ClinicalTrials.gov
- NCT07067463
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Pharmacodynamic, Pharmacokinetic, Efficacy
To evaluate the efficacy of orelabrutinib compared to placebo in delaying disability progression in PPMS
Secondary objectives 3
- 1. To evaluate the efficacy of orelabrutinib compared to placebo on disability progression, clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, and quality of life
- 2. To evaluate the safety and tolerability of orelabrutinib
- 3. To assess the pharmacokinetics (PK) of orelabrutinib
Conditions and MedDRA coding
Primary Progressive Multiple Sclerosis (PPMS)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10063401 | Primary progressive multiple sclerosis | 100000004852 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Screening period
|
Not Applicable | None | ||
| 2 | Treatment The treatment period will vary for individual participants. A month is defined as a period of 28 days by convention.
The treatment period consists of double-blinded (DB) and open-label (OL) treatment.
|
Randomised Controlled | Double | [{"id":185713,"code":2,"name":"Investigator"},{"id":185714,"code":3,"name":"Monitor"},{"id":185712,"code":5,"name":"Carer"},{"id":185715,"code":1,"name":"Subject"}] | Double-blinded (DB) treatment: All eligible participants will be randomized at 2:1 ratio to accept orelabrutinib 80mg QD or placebo during the double-blinded treatment period. Open-label treatment (OLT): Open-label treatment period |
| 3 | Safety Follow-up Period The safety follow-up period will begin when the participants discontinue from the treatment before the EOS for any reasons or complete the study but do not enter the long-term safety (LTS) study.
|
Not Applicable | Double | [{"id":185717,"code":5,"name":"Carer"},{"id":185719,"code":1,"name":"Subject"},{"id":185720,"code":3,"name":"Monitor"},{"id":185718,"code":2,"name":"Investigator"}] |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- Zenas may consider giving access to de-identified patient-level data in response to scientifically valid research proposals.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1) 18 to 60 years of age, inclusive, at the time of signing the informed consent.
- 2) Diagnosed with Primary Progressive MS (PPMS) according to McDonald criteria.
- 3) Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before Screening.
- 4) EDSS score between 3.0 to 6.5 points, inclusive, at Screening.
Exclusion criteria 4
- 1. Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
- 2. Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy.
- 3. History or current diagnosis of other neurological disorders that may mimic MS
- 4. History of any other significant active medical condition
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 1. Time to onset of composite confirmed disability progression (cCDP) events, confirmed over at least 12 weeks (12-week cCDP), defined as follows: * Expanded Disability Status Scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is > 5.0, OR
- * ≥ 20% increase in the Timed 25-Foot Walk Test (T25FWT), OR * ≥ 20% increase in the 9-Hole Peg Test (9HPT)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12917102 · Product
- Active substance
- Orelabrutinib
- Substance synonyms
- ICP-022, 6-(1-(1-oxo-2-propen-1-yl)-4-piperidinyl)-2-(4-phenoxyphenyl)-3-pyridinecarboxamide, 2-(4-phenoxyphenyl)-6-(1-(prop-2-enoyl)piperidin-4-yl)pyridine-3-carboxamide
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 134400 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- INNOCARE PHARMA INC
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Zenas Biopharma (USA) LLC
- Sponsor organisation
- Zenas Biopharma (USA) LLC
- Address
- 852 Winter Street Suite 250
- City
- Waltham
- Postcode
- 02451-1439
- Country
- United States
Scientific contact point
- Organisation
- Zenas Biopharma (USA) LLC
- Contact name
- Patient and Medical Information
Public contact point
- Organisation
- Zenas Biopharma (USA) LLC
- Contact name
- Patient and Medical Information
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Neurostatus-UHB AG ORG-100046513
|
Basel, Switzerland | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Millmount Healthcare Limited ORG-100011724
|
Stamullen, Ireland | Code 14 |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Labcorp ORG-100011514
|
Burlington, United States | Laboratory analysis |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | Other |
Locations
20 EU/EEA countries · 121 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 10 | 2 |
| Belgium | Authorised, recruitment pending | 14 | 4 |
| Bulgaria | Authorised, recruitment pending | 27 | 8 |
| Croatia | Authorised, recruitment pending | 10 | 1 |
| Czechia | Authorised, recruitment pending | 13 | 6 |
| Denmark | Authorised, recruitment pending | 9 | 2 |
| Estonia | Authorised, recruitment pending | 10 | 1 |
| Finland | Authorised, recruitment pending | 5 | 1 |
| France | Authorised, recruitment pending | 36 | 15 |
| Germany | Authorised, recruitment pending | 36 | 15 |
| Greece | Authorised, recruitment pending | 21 | 7 |
| Hungary | Not authorised | 10 | 2 |
| Italy | Authorised, recruitment pending | 33 | 10 |
| Netherlands | Authorised, recruitment pending | 10 | 1 |
| Poland | Authorised, recruitment pending | 56 | 24 |
| Portugal | Authorised, recruitment pending | 10 | 4 |
| Romania | Authorised, recruitment pending | 10 | 3 |
| Slovakia | Authorised, recruitment pending | 11 | 4 |
| Spain | Authorised, recruitment pending | 57 | 10 |
| Sweden | Authorised, recruitment pending | 10 | 1 |
| Rest of world
Canada, Serbia, Georgia, Ukraine, Brazil, New Zealand, Argentina, Mexico, Australia, Chile, United States, United Kingdom, China
|
— | 307 | — |
Investigational sites
Medical University Of Vienna
Department of Neurology, Spitalgasse 23, Alsergrund, Vienna
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department of Neurology, Ignaz-Harrer-Strasse 79, 5020, Salzburg
Hopital Erasme
Neurology, Lennikse Baan 808, 1070, Anderlecht
Universitair Ziekenhuis Gent
Neurology, Corneel Heymanslaan 10, 9000, Gent
Noorderhart
Neurology, Boemerangstraat 2, 3900, Pelt
Nationaal Multiple Sclerose Centrum V.Z.W.
Neurology, Vanheylenstraat 16, 1820, Steenokkerzeel
Medical Center Hera EOOD
N/A, Ulitsa Klisura 20, 1510, Sofiya
Diagnostic And Consultative Center Neoclinic EAD
N/A, Bulevard Petko Yu.todorov 20, 1408, Sofiya
Medical Center Medica Plus Ltd.
N/A, Ulitsa Sergey Rumyantsev 63, 5006, Veliko Tirnovo
Diagnostics And Consultation Center Convex Ltd.
N/A, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
Medical Center Nevrocentrum EOOD
N/A, 39 Vasil Aprilov Blvd., 3rd floor office 8; rooms 1, Plovdiv
Multiprofile Hospital For Active Treatment Avis Medika OOD
Department of Nervous Diseases, Ulitsa Kosta Hadzhipakev 7, 5801, Pleven
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD
Clinic of Nervous Diseases, Bulevard Patriarh Evtimiy 37, 1142, Sofiya
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Neurological Clinic, Ulitsa Georgi Kochev 8a, 5803, Pleven
University Hospital Centre Zagreb
Neurology Department, Ulica Mije Kispatica 12, 10000, Zagreb
Fakultni Nemocnice Brno
Neurology Clinic, Jihlavska 340/20, Bohunice, Brno
Neurohk s.r.o.
Neurology Clinic, Smetanova 830, 565 01, Chocen
Krajska zdravotni a.s.
MS Centre – Neurology Department, Duchcovska 53, 415 01, Teplice
Fakultni Nemocnice Hradec Kralove
Neurology Clinic, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
University Hospital Olomouc
Neurology Clinic, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice U Sv Anny V Brne
I.Neurology Clinic, Pekarska 53, Stare Brno, Brno-Stred
Region Midtjylland
Department of Neurology, Heibergs Alle 4, 8800, Viborg
Aalborg University Hospital
Department of Neurology and Neurophysiology, Hospitalsbyen 1, 9260, Gistrup
Groupe Hospitalier Nord Essonne
Service de neurologie, 4 Place Du General Leclerc, 91400, Orsay
Centre Hospitalier Universitaire De Montpellier
Service de neurologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Rennes
Service de neurologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Toulouse
Service de neurologie, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Hospices Civils De Lyon
Service de neurologie, 59 Boulevard Pinel, 69500, Bron
Les Hopitaux Universitaires De Strasbourg
Service de neurologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire Amiens Picardie
Service de neurologie, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire Rouen
Service de neurologie, 1 Rue De Germont, 76000, Rouen
Centre Hospitalier Universitaire Grenoble Alpes
Service de neurologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Assistance Publique Hopitaux De Paris
Service de neurologie, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Centre Hospitalier General
Service de neurologie, 2 Boulevard Du 19 Mars 1962, 95500, Gonesse
Centre Hospitalier Universitaire De Nice
Service de neurologie, 30 Voie Romaine, 06000, Nice
CHRU De Nancy
Service de neurologie, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Fondation A De Rothschild
Service de neurologie, 29 Rue Manin, 75019, Paris
Centre Hospitalier Universitaire De Bordeaux
Service de neurologie, Place Amelie Raba Leon, 33000, Bordeaux
DKD HELIOS Klinik Wiesbaden GmbH
Neurology, Aukammallee 33, Bierstadt, Wiesbaden
Universitaetsklinikum Ulm AöR
Neurology, Oberer Eselsberg 45, Eselsberg, Ulm
Universitaet Leipzig
Neurology, Liebigstrasse 20a, Zentrum-Suedost, Leipzig
Barmherzige Brueder Trier gGmbH
Neurology, Nordallee 1, Trier-Nord, Trier
Universitaetsmedizin Greifswald KöR
Neurology, -, 17475, Greifswald
Neuro Centrum Science GmbH
Neurology, Albert-Schweitzer-Strasse 8, 64711, Erbach
Universitaetsklinikum Jena KöR
Neurology, Am Klinikum 1, Lobeda, Jena
St. Josef-Hospital
Neurology, Allee Nach Sanssouci 7, Brandenburger Vorstadt, Potsdam
Klinikum Bayreuth GmbH
Neurology, Hohe Warte 8, Gruener Baum, Bayreuth
Universitaetsklinikum Essen AöR
Neurology, Hufelandstrasse 55, Holsterhausen, Essen
Gemeinschaftspraxis fuer Neurologie Dr. med. W. Blersch und Dr. med. J. Redelstein
Neurology, Guenzstrasse 1, 93059, Regensburg
Universitaet Muenster
Neurology, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Neurology, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Regensburg AöR
Neurology, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Neurology, Hessenring 121, 61348, Bad Homburg
Eginitio Hospital
1st Department of Neurology, NKUA, Vassilissas Sofias Avenue 74, 115 28, Athens
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
2nd Department of Neurology NKUA, Rimini 1, 124 61, Chaidari
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
3rd Neurology Clinic, Leoforos Mesogeion 264, 155 62, Cholargos
401 General Military Hospital Of Athens
Neurology Department, Panagioti Kanellopoulou Av 1, 115 25, Athens
St. Luke's Hospital S.A.
Multiple Sclerosis Unit - Neurology Department, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
General University Hospital Of Larissa
Department of Neurology, P. O. Box 1425, 411 10, Larissa
Henry Dunant Hospital Center
1st Department of Neurology, 107 Mesogeion Avenue, 115 26, Athens
Clinexpert Kft.
Clinexpert Obuda Egeszsegcentruma, Kaszasdulo Utca 5, 1033, Budapest III
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Neurology, Dozsa Gyorgy Ut 77, 2800, Tatabanya
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
U.O.S. Sclerosi Multipla, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliero-Universitaria Sant Andre
Neurology, Via Di Grottarossa 1035-1039, 00189, Rome
Istituto Neurologico Mediterraneo Neuromed S.p.A.
U.O. di Neurologia 1, Via Atinense N. 18, 86077, Pozzilli
Universita' Degli Studi G. D'Annunzio Di Chieti
Neuroscienze, Via Luigi Polacchi 11, 66100, Chieti Scalo
Azienda Ospedaliera Universitaria Federico II Di Napoli
Centro Sclerosi Multipla, Via Sergio Pansini 5, 80131, Naples
Ospedale San Raffaele S.r.l.
Unità di Neurologia, Via Olgettina 60, 20132, Milan
IRCCS Ospedale Policlinico San Martino
U.O. Clinica Neurologica, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOSD II Clinica Neurologica, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
CReSM - Centro di Riferimento Regionale Sclerosi Multipla, Regione Gonzole 10, 10043, Orbassano
Fondazione Istituto G. Giglio Di Cafalu
U.O. di Neurologia, Contrada Pietra Pollastra Snc, 90015, Cefalu'
Zuyderland Medisch Centrum Stichting
Neurology, Dr. H. Van Der Hoffplein 1, 6162 BG, Geleen
Novo-Med Zielinski I Wspolnicy Sp. j.
N/A, Ul. Brynowska 44, 40-584, Katowice
Centrum Medyczne Intercor Sp. z o.o.
N/A, Ul. Kasztanowa 57, 85-605, Bydgoszcz
Neuro-Medic Sp. z o.o.
N/A, Ul. Zurawia 80, 40-686, Katowice
Centrum Medyczne Neuroprotect
N/A, Ul. Klaudyny 16c, 1 Piętro, Warsaw
Neurokard Sp. z o.o.
ProNeuro Centrum Medyczne, Aleja Zjednoczonej Europy 37, 44-240, Zory
Nmedis Sp. z o.o.
Nmedis, Ul. Kujawska 5, 35-323, Rzeszow
Ilkowski I Partnerzy sp.p. Lekarzy
NZOZ NEURO- KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy, Ul. Wierzbowa 2/2, 61-853, Poznan
Centrum Medyczne Hcp Sp. z o.o.
N/A, Ul. 28 Czerwca 1956 R. 194, 61-485, Poznan
Pratia S.A.
Centrum Medyczne Pratia Katowice, Ul. Dabrowki 13, 40-081, Katowice
Clinirem Sp. z o.o.
Galen Clinic, Ul. Polnocna 24/U1, 20-064, Lublin
Copernicus Podmiot Leczniczy Sp. z o.o.
Szpital im. Mikolaja Kopernika, Oddzial Neurologiczny, Ul. Nowe Ogrody 1/6, 80-803, Gdansk
Clinhouse Sp. z o.o.
ClinHouse Centrum Medyczne, Ul. Tarnopolska 77, 41-807, Zabrze
Linden Sp. z o.o. sp.k.
Centrum Medyczne Linden, Ul. Lipska 8, 30-721, Cracow
Uniwersytecki Szpital Kliniczny W Olsztynie
Klinika Neurologii z Pododdzialem Udarowym, Aleja Warszawska 30, 10-082, Olsztyn
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia PCM, Ul. Marcelinska 92, 60-324, Poznan
Pro Salus Sp. z o.o. sp.k.
Pro Salus, Ul. Julianowska 54b, 91-473, Lodz
Mtz Clinical Research Powered By Pratia
N/A, Ul. Gładka 22, 02-172, Warsaw
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
N/A, Ul. Polnocna 8/3, 20-064, Lublin
Insula Centrum Badan Klinicznych Sp. z o.o.
N/A, Ul. Klobucka 23c/109, 02-699, Warsaw
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Oddzial Neurologii, Ul. Ziolowa 45/47, 40-635, Katowice
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia NCM, Ul. Glowackiego 8d/2, 67-100, Nowa Sol
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej
N/A, ul. Fabianowska 40, 62-064, Plewiska
Euromedis Sp. z o. o.
Centrum Medyczne EuroMedis, Al. Powstancow Wielkopolskich 33A, 70-111, Szczecin
Zana-Med Medical Group Sp. z o.o.
N/A, Ul. Tomasza Zana 32b, 20-601, Lublin
Unidade Local De Saude De Santa Maria E.P.E.
Neurology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local De Saude De Santo Antonio E.P.E.
Neurology, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
Neurology, Rua Doutor Candido Pinho, 4520-211, Santa Maria Da Feira
Unidade Local De Saude De Matosinhos E.P.E.
Neurology, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Spitalul Clinic Judetean De Urgenta Targu Mures
Department of Medical Neurology, Strada Marinescu Gheorghe 50, 540136, Targu Mures
Spitalul Clinic Cai Ferate Constanta
Department of Medical Neurology, Bulevardul 1 Mai 5-7, 900123, Constanta
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Department of Medical Neurology, Strada Prundului 7-9, 500123, Brasov
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov
Oddelenie neurológie, Jana Holleho 5898/14, 080 01, Presov
University Hospital Bratislava
I.neurologická klinika LF UK a UNB, Mickiewiczova 13, Stare Mesto, Bratislava
MUDr. Beata Dupejova neurologicka ambulancia s.r.o.
NA, Nova 21, Foncorda, Banska Bystrica
Univerzitna Nemocnica Martin
Neurologickáklinika JLF UK a UNM, Kollarova 2, 036 01, Martin
Hospital Santa Caterina Ias
Neurology, Calle Del Doctor Castany S/N, 17190, Salt
Hospital Nisa Sevilla Aljarafe
Neurology, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Alvaro Cunqueiro
Neurology, Estrada Clara Campoamor No 341, 36312, Vigo
University Clinical Hospital Virgen De La Arrixaca
Neurology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Universitario De Cruces
Neurology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Puerta De Hierro De Majadahonda
Neurology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Complexo Hospitalario Universitario A Coruna
Neurology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario 12 De Octubre
Neurology, Avenida De Cordoba Sn, 28041, Madrid
Hospital General Universitario Gregorio Maranon
Neurology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Germans Trias I Pujol
Neurology, Carretera Canyet 1a Planta, 08916, Badalona
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 289 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-524316-11-00_Greek_redacted | 5.2-EU |
| Protocol (for publication) | D1_Protocol_2025-524316-11-00_redacted | 5.2-EU |
| Protocol (for publication) | D4_Patient Facing Document_Placeholder document | N/A |
| Recruitment arrangements (for publication) | K1_AT_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_BE_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_BG_Recruitment Procedure_Bulgarian | 1.1 |
| Recruitment arrangements (for publication) | K1_CZ_Recruitment Procedure_Bilingual | 1.0 |
| Recruitment arrangements (for publication) | K1_DE_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_DK_Recruitment Procedure | 1.1 |
| Recruitment arrangements (for publication) | K1_EE_Recruitment Procedure | 1.1 |
| Recruitment arrangements (for publication) | K1_EL_Recruitment Procedure | 1.1 |
| Recruitment arrangements (for publication) | K1_ES_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_FI_Recruitment Procedure_Finnish | 1.1 |
| Recruitment arrangements (for publication) | K1_FR_Recruitment Procedure_Bilingual | 1.0 |
| Recruitment arrangements (for publication) | K1_HR_Recruitment Procedure | 1 |
| Recruitment arrangements (for publication) | K1_IT_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_NL_Recruitment_procedure | 1.1 |
| Recruitment arrangements (for publication) | K1_PL_Recruitment Procedure_Polish | 1.0 |
| Recruitment arrangements (for publication) | K1_PT_Recruitment Procedure | 1 |
| Recruitment arrangements (for publication) | K1_RO_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_SE_Recruitment Procedure_Swedish | 1.0 |
| Recruitment arrangements (for publication) | K1_SK_Recruitment Procedure | 1.1 |
| Recruitment arrangements (for publication) | K2_AT_Recruitment Material_Brochure_German_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_AT_Recruitment Material_ICF Flipbook_German_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_AT_Recruitment Material_Patient Letter_German_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_AT_Recruitment Material_Poster_German | 1.0 |
| Recruitment arrangements (for publication) | K2_BE_Recruitment Material_Brochure_Dutch_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_BE_Recruitment Material_Brochure_French_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_BE_Recruitment Material_HCP Factsheet_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_BE_Recruitment Material_HCP Letter_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_BE_Recruitment Material_Patient Letter_Dutch_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_BE_Recruitment Material_Patient Letter_French_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_BE_Recruitment Material_Poster_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_BE_Recruitment Material_Poster_French | 1.0 |
| Recruitment arrangements (for publication) | K2_BG_Recruitment Material_Brochure_Bulgarian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_BG_Recruitment Material_HCP Factsheet_Bulgarian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_BG_Recruitment Material_HCP Letter_Bulgarian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_BG_Recruitment Material_Patient Letter_Bulgarian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_BG_Recruitment Material_Poster_Bulgarian | 1.0 |
| Recruitment arrangements (for publication) | K2_CZ_Recruitment material_Appointment Reminder Card_Czech | 1.0 |
| Recruitment arrangements (for publication) | K2_CZ_Recruitment material_Brochure_Czech_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_CZ_Recruitment material_ICF Flipbook_Czech_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_CZ_Recruitment material_Patient Letter_Czech_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_CZ_Recruitment material_Poster_Czech | 1.0 |
| Recruitment arrangements (for publication) | K2_CZ_Recruitment material_Study Visit Guide_Czech_redaced | 1.0 |
| Recruitment arrangements (for publication) | K2_DE_Recruitment Material_Appt Reminder Card_German | 1.0 |
| Recruitment arrangements (for publication) | K2_DE_Recruitment Material_Brochure_German_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_DE_Recruitment Material_Patient Letter_German_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_DE_Recruitment Material_Poster_German | 1.1 |
| Recruitment arrangements (for publication) | K2_DE_Recruitment Material_Study Visit Guide_German_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_DK_Recruitment Material_Brochure_Danish_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_DK_Recruitment Material_ICF Flipbook_Danish_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_DK_Recruitment Material_Poster_Danish | 1.1 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_Appt Reminder Card_Estonian | 1.2 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_Appt Reminder Card_Russian | 1.2 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_Brochure_Estonian_redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_Brochure_Russian_redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_HCP Factsheet_Estonian | 1.1 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_HCP Factsheet_Russian | 1.1 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_HCP Letter_Estonian | 1.1 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_HCP Letter_Russian | 1.1 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_ICF Flipbook_Estonian_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_ICF Flipbook_Russian_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_Patient Letter_Estonian_redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_Patient Letter_Russian_redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_Poster_Estonian | 1.3 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_Poster_Russian | 1.3 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_Study Visit Guide_Estonian_redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_EE_Recruitment Material_Study Visit Guide_Russian_redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_EL_Recruitment Material_Appointment Reminder Card_Greek | 1.0 |
| Recruitment arrangements (for publication) | K2_EL_Recruitment Material_Brochure_Greek_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_EL_Recruitment Material_Flipbook_Greek_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_EL_Recruitment Material_HCP Factsheet_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_EL_Recruitment Material_HCP Letter_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_EL_Recruitment Material_Patient Letter_Greek_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_EL_Recruitment Material_Poster_Greek | 1.0 |
| Recruitment arrangements (for publication) | K2_EL_Recruitment Material_Study visit guide_Greek_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_ES_Recruitment Material_Brochure_Spanish_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_ES_Recruitment Material_HCP Factsheet_Spanish_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_ES_Recruitment Material_HCP Letter_Spanish_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_ES_Recruitment Material_ICF Flipbook_Spanish_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_ES_Recruitment Material_Patient Letter_Spanish_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_ES_Recruitment Material_Poster_Spanish | 1.0 |
| Recruitment arrangements (for publication) | K2_FR_Recruitment Material_Additional Document_French_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_FR_Recruitment Material_Brochure_French_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_FR_Recruitment Material_HCP Factsheet_French_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_FR_Recruitment Material_HCP Letter_French_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_FR_Recruitment Material_ICF Flipbook_French_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_FR_Recruitment Material_Patient Letter_French_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_FR_Recruitment Material_Poster_French | 1.1 |
| Recruitment arrangements (for publication) | K2_HR_Recruitment Material_Appt Reminder Card_Croatian | 1.0 |
| Recruitment arrangements (for publication) | K2_HR_Recruitment Material_Brochure_Croatian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HR_Recruitment Material_HCP Factsheet_Croatian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HR_Recruitment Material_HCP Letter_Croatian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HR_Recruitment Material_ICF Flipbook_Croatian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HR_Recruitment Material_Patient Letter_Croatian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HR_Recruitment Material_Poster_Croatian | 1.0 |
| Recruitment arrangements (for publication) | K2_HR_Recruitment Material_Study Visit Guide_Croatian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_Appt_Reminder_Card | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_Appt_Reminder_Card_Hungarian | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_Brochure_Hungarian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_Brochure_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_GP letter_Hungarian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_HCP Factsheet_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_HCP Letter_Hungarian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_HCP Letter_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_HCP_Factsheet_Hungarian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_ICF Flipbook_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_ICF_Flipbook_Hungarian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_Patient Letter_Hungarian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_Patient Letter_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_Poster_Hungarian | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_Study Visit Guide_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_Study_Visit_Guide_Hungarian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_IT_Recruitment Material_Brochure_Italian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_IT_Recruitment Material_ICF Flipbook_Italian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_IT_Recruitment Material_Patient Letter_Italian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_IT_Recruitment Material_Poster_Italian | 1.0 |
| Recruitment arrangements (for publication) | K2_NL_Recruitment Material_Brochure_Dutch_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_NL_Recruitment Material_Patient Letter_Dutch_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_NL_Recruitment Material_Poster_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_PL_Recruitment Material_Brochure_Polish_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_PL_Recruitment Material_ICF Flipbook_Polish_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_PL_Recruitment Material_Patient Letter_Polish_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_PL_Recruitment Material_Poster_Polish | 1.0 |
| Recruitment arrangements (for publication) | K2_PT_Recruitment Material_HCP Factsheet_Portuguese_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_PT_Recruitment Material_HCP Letter_Portuguese_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_PT_Recruitment Material_ICF Flipbook_Portuguese_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_PT_Recruitment Material_Patient Brochure_Portuguese_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_PT_Recruitment Material_Patient Letter_Portuguese_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_PT_Recruitment Material_Poster_Portuguese | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Brochure_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Brochure_Romanian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_ICF FlipBook_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_ICF FlipBook_Romanian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Patient Letter_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Patient Letter_Romanian_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Poster_Romanian | 1.0 |
| Recruitment arrangements (for publication) | K2_SE_Recruitment Material_Brochure_Swedish_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_SE_Recruitment Material_ICF Flipbook_Swedish_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_SE_Recruitment Material_Patient Letter_Swedish_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_SE_Recruitment Material_Poster_Swedish | 1.0 |
| Recruitment arrangements (for publication) | K2_SK_Recruitment Material_Brochure_Slovak_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_SK_Recruitment Material_ICF Flipbook_Slovak_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_SK_Recruitment Material_Patient Letter_Slovak_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_SK_Recruitment Material_Poster_Slovak | 1.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Main_German_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_MRI_German_redacted | 1-2 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Pregnant Participant_German_redacted | 1-2 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Pregnant Partner_German_redacted | 1-2 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_Dutch_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_French_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_MRI Site testing_Dutch_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_MRI Site testing_French_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy_Dutch_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy_French_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main_Bulgarian_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_MRI Site Testing_Bulgarian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_MRI Site Testing_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Pregnancy_Bulgarian_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Pregnancy_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Data Privacy Notice_Czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main_Czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_MRI Site Testing_Czech_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Optional HS_Czech_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Pregnancy Data Collection_Czech_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Travel Reimbursement_Czech_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Adults Main_German_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_MRI site_German_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnancy_German_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Main_Danish_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Right to not know_Danish | 1.1 |
| Subject information and informed consent form (for publication) | L1_EE_SIS-ICF_Main_Estonian_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_EE_SIS-ICF_Main_Russian_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_EE_SIS-ICF_MRI Site Testing_Estonian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_EE_SIS-ICF_MRI Site Testing_Russian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_EE_SIS-ICF_Pregnancy_Estonian | 1.3 |
| Subject information and informed consent form (for publication) | L1_EE_SIS-ICF_Pregnancy_Russian | 1.3 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Main_Greek_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_MRI Testing Healthy Volunteer_Greek_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pregnancy Data_Greek_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main_Spanish_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_MRI Site Testing_Spanish_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnancy_Spanish | 1.1 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Main_Finnish_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_MRI_Finnish_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Partner Pregnancy_Finnish_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_MRI Site Testing_French_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Pregnancy_French_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_HR_SIS-ICF_Main_Croatian_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_HR_SIS-ICF_MRI Site Testing_Croatian_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_HR_SIS-ICF_Optional Accellacare_Croatian | 1.0 |
| Subject information and informed consent form (for publication) | L1_HR_SIS-ICF_Optional Mural Health_Croatian | 1.0 |
| Subject information and informed consent form (for publication) | L1_HR_SIS-ICF_Pregnancy_Croatian | 2.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Main_Hungarian_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_MRI testing_Hungarian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Pregnancy Collection_Hungarian_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Brain MRI Testing_Italian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Data Protection_Italian_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Main_Italian_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Pregnancy Data Collection_Italian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Main_Dutch_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_MRI Site testing_Dutch_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Pregnant partner_Dutch_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Polish_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_MRI Site Testing_Polish_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnancy_Polish_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Main_Portuguese_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_MRI_Portuguese_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_PP_Portuguese_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_Romanian_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_MRI ICF_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_MRI ICF_Romanian_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_PP ICF | 1.1 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_PP ICF_Romanian | 1.1 |
| Subject information and informed consent form (for publication) | L1_SE_SIS-ICF_Main_Swedish_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SE_SIS-ICF_MRI Testing_Swedish_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SE_SIS-ICF_Pregnancy_Swedish_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SK_SIS-ICF_Main_Slovak_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SK_SIS-ICF_MRI Site Testing_Slovak_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SK_SIS-ICF_Pregnancy Information Collection_Slovak_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_BE_Other Subject Material_ICF Flipbook_Dutch_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_BE_Other Subject Material_ICF Flipbook_French_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_BG_Other Subject Material_ICF Flipbook_Bulgarian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other Subject Material_C-SSRS Baseline Screening_Czech | AU5.1 |
| Subject information and informed consent form (for publication) | L2_CZ_Other Subject Material_C-SSRS Since Last Visit_Czech | AU5.1 |
| Subject information and informed consent form (for publication) | L2_CZ_Other Subject Material_Dosing Diary_Czech | 3.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other Subject Material_Participant Emergency Card_Czech | 2.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other Subject Material_Participant Flyer_Czech_redacted | N/A |
| Subject information and informed consent form (for publication) | L2_DE_Other Subject Material_ICF Flipbook_German_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_EL_Other Subject Material_Accellacare Participant Generic Flyer_Greek | N/A |
| Subject information and informed consent form (for publication) | L2_EL_Other Subject Material_Accellacare Video Storyboard_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L2_EL_Other Subject Material_Mural Link Participant App Fun Facts_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L2_EL_Other Subject Material_Mural Link Participant Mobile Web and App Screenshots_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L2_EL_Other Subject Material_Mural Link Patient Travel Reference Guide_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L2_EL_Other Subject Material_Mural LInk Privacy Policy_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L2_EL_Other Subject Material_Mural Link Terms and Conditions_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L2_EL_Other Subject Material_Notifications for Mural Link_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L2_EL_Other Subject Material_Particpant Emergency Card_Greek | 2.0 |
| Subject information and informed consent form (for publication) | L2_HR_Other Subject Material_Dosing Diary_Croatian | 3.0 |
| Subject information and informed consent form (for publication) | L2_HR_Other Subject Material_Mural Link Participant App Fun Facts_Croatian | 1.0 |
| Subject information and informed consent form (for publication) | L2_HR_Other Subject Material_Mural Link Participant Mobile Web and App Screenshots_Croatian | 1.0 |
| Subject information and informed consent form (for publication) | L2_HR_Other Subject Material_Mural Link Participant Reference Guide_Croatian | 2.0 |
| Subject information and informed consent form (for publication) | L2_HR_Other Subject Material_Mural Link Patient Travel Reference Guide_Croatian | 1.0 |
| Subject information and informed consent form (for publication) | L2_HR_Other Subject Material_Mural Link Privacy Policy_Croatian | 1.0 |
| Subject information and informed consent form (for publication) | L2_HR_Other Subject Material_Mural Link Terms and Conditions_Croatian | 1.0 |
| Subject information and informed consent form (for publication) | L2_HR_Other Subject Material_Notifications for Mural Link_Croatian | 1.0 |
| Subject information and informed consent form (for publication) | L2_HR_Other Subject Material_Participant Emergency Card_Croatian | 2.0 |
| Subject information and informed consent form (for publication) | L2_HR_Patient Facing Documents Statement | N/A |
| Subject information and informed consent form (for publication) | L2_HU_Other subject material_AIS Participant Generic Flyer_Hungarian | N/A |
| Subject information and informed consent form (for publication) | L2_HU_Other subject material_C-SSRS-SinceLastVisit_Hungarian_redacted | AU5-1 |
| Subject information and informed consent form (for publication) | L2_HU_Other Subject Material_Dosing Diary_Hungarian | 3.0 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject material_List of submitted documents_bilingual_redacted | N/A |
| Subject information and informed consent form (for publication) | L2_HU_Other Subject Material_Participant Emergency Card_Hungarian | 1.0 |
| Subject information and informed consent form (for publication) | L2_NL_Other Subject Material_ICF Flipbook_Dutch_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_SK_Other Subject Material_Privacy Supplement_Slovak | 1.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Bulgarian_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Czech_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Dutch_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Estonian_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_French_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_German_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Greek_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Hungarian_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Italian_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Polish_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Portuguese_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Romanian_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Russian_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Slovak_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Spanish_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-524316-11-00_Swedish_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524316-11-00_Bulgarian_redacted | 5.2-EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524316-11-00_Czech_redacted | 5.2-EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524316-11-00_French_redacted | 5.2-EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524316-11-00_German-AT_redacted | 5.2-EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524316-11-00_Greek_redacted | 5.2-EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524316-11-00_Hungarian_redacted | 5.2-EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524316-11-00_Italian_redacted | 5.2-EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524316-11-00_Romanian_redacted | 5.2-EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524316-11-00_Slovak_redacted | 5.2-EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524316-11-00_Spanish_redacted | 5.2-EU |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-23 | Germany | Acceptable 2026-05-18
|
2026-05-18 |