Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
517
Countries
15
Sites
83
Relapsing-remitting Multiple Sclerosis
- Demonstrate PK similarity between ABP 692 and ocrelizumab (US), and ABP 692 and ocrelizumab (EU). - Demonstrate PD similarity between ABP 692 and ocrelizumab RP based on assessment of the suppression of new active brain lesions over 24 weeks.
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 12 Sep 2025 → ongoing
- Decision date (initial)
- 2025-03-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Amgen Inc.
External identifiers
- EU CT number
- 2024-512914-16-00
- WHO UTN
- U1111-1305-9272
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety, Pharmacodynamic
- Demonstrate PK similarity between ABP 692 and ocrelizumab (US), and ABP 692 and ocrelizumab (EU).
- Demonstrate PD similarity between ABP 692 and ocrelizumab RP based on assessment of the suppression of new active brain lesions over 24 weeks.
Secondary objectives 13
- Compare PK between ocrelizumab (US) and ocrelizumab (EU), ABP 692 and ocrelizumab (US), and ABP 692 and ocrelizumab (EU), following the initial dose
- Descriptively compare PK between ocrelizumab (US) and ocrelizumab (EU), ABP 692 and ocrelizumab (US), and ABP 692 and ocrelizumab (EU)
- Descriptively compare the total number of new or enlarging T2 hyperintense lesions between ABP 692 and ocrelizumab RP over 24 weeks
- Descriptively compare the total number of new or enlarging T2 hyperintense lesions between ABP 692/ABP 692, ocrelizumab (EU)/ocrelizumab (EU), and ocrelizumab (US)/ABP 692 treatment sequences over 48 weeks
- Descriptively compare the total number of GdE T1-weighted lesions between ABP 692 and ocrelizumab RP treatment groups over 24 weeks
- Descriptively compare the total number of GdE T1-weighted lesions between ABP 692/ABP 692, ocrelizumab (EU)/ocrelizumab (EU), and ocrelizumab (US)/ABP 692 treatment sequences over 48 weeks
- Descriptively compare the total number of combined unique active (CUA) brain MRI lesions between ABP 692 and ocrelizumab RP treatment groups over 24 weeks
- Descriptively compare the total number of CUA MRI lesions between ABP 692/ABP 692, ocrelizumab (EU)/ocrelizumab (EU), and ocrelizumab (US)/ABP 692 treatment sequences over 48 weeks.
- Descriptively compare the proportion of subjects achieving a CD19+ B-cell level ˂ 5 cells/μL, and level ˂ 10 cells/μL between ABP 692 and ocrelizumab RP treatment groups at week 24
- Descriptively compare the proportion of subjects achieving a CD19+ B-cell level ˂ 5 cells/μL, and level ˂ 10 cells/μL between ABP 692/ABP 692, ocrelizumab (EU)/ocrelizumab (EU), and ocrelizumab (US)/ABP 692 treatment sequences at week 48
- Descriptively compare the proportion of subjects with relapse-free status at week 24 between ABP 692 and ocrelizumab (US) and ABP 692 and ocrelizumab (EU)
- Descriptively compare the proportion of subjects with relapse-free status at week 48 between ABP 692/ABP 692, ocrelizumab (EU)/ocrelizumab (EU), and ocrelizumab (US)/ABP 692 treatment sequences
- Assess safety and immunogenicity of ABP 692 compared with ocrelizumab (US) and ocrelizumab (EU)
Conditions and MedDRA coding
Relapsing-remitting Multiple Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10063399 | Relapsing-remitting multiple sclerosis | 100000004852 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomized (1:1:1) to receive ABP 692, FDA-licensed or EU-approved ocrelizumab (same dose) This is a randomized, double-blind, parallel-group study to in 18- to 60-year-old subjects with relapsing-remitting multiple sclerosis. Approximately 444 eligible subjects (148 subjects per treatment group) will be randomized in a 1:1:1 ratio to receive either ABP 692, ocrelizumab (US)/ABP 692, or ocrelizumab (EU).
The overall study is composed of two groups, the PK group and the main study group.
|
Randomised Controlled | Double | [{"id":187865,"code":4,"name":"Analyst"},{"id":187867,"code":2,"name":"Investigator"},{"id":187868,"code":3,"name":"Monitor"},{"id":187866,"code":1,"name":"Subject"},{"id":187869,"code":5,"name":"Carer"}] | ABP 692: Randomized (1:1:1) to receive ABP 692, FDA-licensed or EU-approved ocrelizumab (same dose) FDA-licensed ocrelizumab: Randomized (1:1:1) to receive ABP 692, FDA-licensed or EU-approved ocrelizumab (same dose) EU-approved ocrelizumab: Randomized (1:1:1) to receive ABP 692, FDA-licensed or EU-approved ocrelizumab (same dose) |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- The decision is subject to final internal confirmation.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017.
- Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive.
- Evidence of recent MS activity as defined by the study protocol.
- Neurologically stable subject, with no relapse for ≤ 28 days before randomization.
Exclusion criteria 7
- Diagnosis of PPMS according to the 2017 revision of the McDonald diagnostic criteria or with secondary progressive MS (Thompson et al, 2018).
- Multiple sclerosis disease duration of ≥ 10 years in subjects with EDSS score of ≤ 2.5 at screening.
- Any contraindications to study procedures or medications as outlined in the study protocol.
- Any prohibited medication as defined in the study protocol.
- Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study.
- Current or history of any medical conditions described in the study protocol.
- Any abnormal laboratory blood values as defined in the study protocol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Area under the serum concentration-time curve (AUC) from time 0 to day 15 (AUC0-d15) following infusion 1 of the initial dose
- AUC from time 0 extrapolated to infinity (AUC0-inf) of the entire initial dose
- Total number of new GdE T1-weighted lesions (assessed by brain MRI) over weeks 4, 8, 12, 16, 20, and 24
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11253913 · Product
- Active substance
- Ocrelizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- AMGEN INC
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
PRD11423822 · Product
- Active substance
- Ocrelizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- AMGEN INC
- Paediatric formulation
- No
- Orphan designation
- No
Ocrevus 300 mg concentrate for solution for infusion
PRD5771848 · Product
- Active substance
- Ocrelizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA36 — -
- Marketing authorisation
- EU/1/17/1231/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- only limited to over-labeling and secondary packaging
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1730
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| ICON Clinical Research Limited Ireland Filial ORG-100030826
|
Lund, Sweden | Other |
| Meeting Protocol Worldwide LP ORG-100049471
|
Dallas, United States | Other |
| Accellacare Limited ORG-100044508
|
Dublin 18, Ireland | Other |
| CSI Clinical Services International GmbH ORG-100046704
|
Berlin, Germany | Code 14 |
| Arup Laboratories Inc. ORG-100041750
|
Salt Lake City, United States | Other |
| Trulab Inc. ORG-100054545
|
Raleigh, United States | Other |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Almac Clinical Services LLC ORG-100041692
|
Souderton, United States | Other, Interactive response technologies (IRT) |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Other |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 14, Code 2, Code 5, Data management, E-data capture, Code 8, Code 9 |
| Advarra Inc. ORG-100045827
|
Columbia, United States | Other |
Locations
15 EU/EEA countries · 83 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Temporarily halted | 23 | 3 |
| Bulgaria | Ongoing, recruitment ended | 14 | 6 |
| Croatia | Ongoing, recruitment ended | 11 | 2 |
| Czechia | Ongoing, recruitment ended | 16 | 5 |
| Denmark | Ongoing, recruitment ended | 11 | 3 |
| France | Ended | 9 | 2 |
| Germany | Ongoing, recruitment ended | 41 | 13 |
| Italy | Ended | 28 | 9 |
| Lithuania | Temporarily halted | 11 | 2 |
| Poland | Ongoing, recruitment ended | 150 | 14 |
| Romania | Ongoing, recruitment ended | 5 | 4 |
| Slovakia | Ongoing, recruitment ended | 9 | 3 |
| Slovenia | Ended | 6 | 2 |
| Spain | Ongoing, recruitment ended | 32 | 13 |
| Sweden | Temporarily halted | 9 | 2 |
| Rest of world
United States, Switzerland, Georgia, Turkey, United Kingdom, Canada, Serbia
|
— | 142 | — |
Investigational sites
Algemeen Ziekenhuis Delta
Neurology, Deltalaan 1, 8800, Roeselare
Noorderhart
Neurology, Boemerangstraat 2, 3900, Pelt
Universitair Ziekenhuis Antwerpen
Neurology, Drie Eikenstraat 655, 2650, Edegem
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Neurology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Clinic of Neurology, Krasno Selo, Bulevard Gen Totleben 21, Sofiya
Medical Center Hera EOOD
N/A, Ulitsa Klisura 20, 1510, Sofiya
Diagnostics And Consultation Center Convex Ltd.
N/A, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Neurology, Ulitsa Dr Lyuben Rusev 1, 1113, Sofia
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Neurological Clinic, Ulitsa Georgi Kochev 8a, 5803, Pleven
Klinicki bolnicki centar Sestre milosrdnice
Neurology Department, Vinogradska Cesta 29, Zagreb, Grad Zagreb
University Hospital Centre Zagreb
Neurology Department, Ulica Mije Kispatica 12, 10000, Zagreb
Neurologie Rs Centrum s.r.o.
Nestatni zdravotnicke zarizeni, Privatni ordinace neurologie, Placelova 1257, 500 03, Hradec Kralove
Fakultni Nemocnice Hradec Kralove
Neurologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Nemocnice Jihlava prispevkova organizace
Neurologicke oddeleni, Vrchlickeho 4630/59, 586 01, Jihlava 1
Fakultni Nemocnice U Sv Anny V Brne
I. neurologicka klinika, Pekarska 53, Stare Brno, Brno-Stred
Krajska zdravotni a.s.
MS centrum pri neurologickem oddeleni, Duchcovska 53, 415 01, Teplice
Esbjerg Og Grindsted Sygehus
Danish Multiple Sclerosis Center, Finsensgade 35, 6700, Esbjerg
Aarhus University Hospital
Department of Neurology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Rigshospitalet
Danish Multiple Sclerosis Center, Valdemar Hansens Vej 13, 2600, Glostrup
Centre Hospitalier Universitaire De Nimes
Service Neurologie, Place Du Professeur Robert Debre, 30029, Nimes Cedex 9
Centre Hospitalier Universitaire Reims
Service de Neurologie, 45 Rue Cognacq Jay, 51092, Reims Cedex
Gemeinschaftpraxis Dres. Med Blersch/Redelstein
Centre for Neurology, Guenzstrasse 1, 93059, Regensburg
Universitaetsklinikum Leipzig AöR
Department of Neurology, Liebigstrasse 18, Zentrum-Suedost, Leipzig
Universitaetsklinikum Essen AöR
Clinic for Neurology, Hufelandstrasse 55, Holsterhausen, Essen
MultipEL Studies
Institut für klinische Studien GbR, Bengelsdorfstrasse 5, 22179, Hamburg
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Centre for Neurology, Hessenring 121, 61348, Bad Homburg
curiositas ad sanum Studien und Beratungs GmbH
Centre for Neurology, Alpenstrasse 9, 85560, Ebersberg
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department of Neurology MS Center, Fetscherstrasse 74, Johannstadt-Nord, Dresden
ZNS GmbH Zentrum fuer Neuro-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen
Department of Neurology, Weidenauer Str.120, 57076, Siegen
Studienzentrum Dr. Bischof GmbH
Department of Neurology, Konrad-Zuse-Strasse 14, West, Boeblingen
Universitaetsklinikum Heidelberg AöR
Department of Neurology, Im Neuenheimer Feld 400, Neuenheim, Heidelberg
Neuropraxis Muenchen Sued
Department of Neurology, Hauptstrasse 2, 82008, Unterhaching
Klinische Forschung Hamburg GmbH
Center for Neurology, Hoheluftchaussee 18, Hoheluft-Ost, Hamburg
Universitaetsklinikum Giessen und Marburg GmbH
Neurologie, Klinikstrasse 33, 35392, Giessen
Azienda Ospedaliero-Universitaria Sant Andre
Neurologia Azienda Ospedaliero-Universitaria Sant Andrea, Via Di Grottarossa 1035-1039, 00189, Rome
Careggi University Hospital
SOD Neurologia II Largo Piero Palagi 1, 50139 Firenze, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Casa Di Cura Igea S.p.A.
Dipartimento di Riabilitazione Igea, Via Giuseppe Dezza 48, 20144, Milan
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Centro Sclerosi Multipla – Ambulatorio di Neuroriabilitazione, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliera Universitaria Senese
UOC Clinica Neurologica e Malattie Neurometaboliche, Strada Delle Scotte 14, 53100, Siena
Azienda Ospedaliera Policlinico Universitario Tor Vergata
UOSD Multiple Sclerosis Clinical and Research Center, Viale Oxford 81, 00133, Rome
Fondazione Istituto G. Giglio Di Cafalu
Division of Neurology, Contrada Pietra Pollastra Snc, 90015, Cefalu'
Azienda Unita Sanitaria Locale Di Bologna
UO Riabilitazione Sclerosi Multipla Via Altura 3, 40139 Bologna (Italy), Via Castiglione 29, 40124, Bologna
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Clinica Neurologica,Dip.to Scienze Mediche e Chirurgiche Avanzate-P.za L.Miraglia 2,80138,Napoli,IT, Via Santa Maria Di Costantinopoli 104, 80138, Naples
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Neurology department, Eiveniu G. 2, Kauno M. Sav., Kaunas
Klaipedos universiteto ligonine VšĮ
Neurology center, Liepojos G. 41, Klaipedos M. Sav., Klaipeda
Vitamed Galaj I Cichomski Sp. j.
NA/ND, Ul. Tadeusza Kosciuszki 35, 85-079, Bydgoszcz
Neuro-Medic Sp. z o.o.
Neuro-Medic Poradnia Wielospecjalistyczna, Ul. Zurawia 80, 40-686, Katowice
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
NA/ND, Ul. Polnocna 8/3, 20-064, Lublin
Ilkowski I Partnerzy sp.p. Lekarzy
NZOZ NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy, Ul. Wierzbowa 2/2, 61-853, Poznan
Neurocentrum Bydgoszcz Sp. z o.o.
NA / ND, Ul. Aleje Prof. Sylwestra Kaliskiego 28/U1, 85-796, Bydgoszcz
Ma-Lek Clinical Sp. z o.o.
Centrum Terapii SM, Ul. Zaleska 9, 40-571, Katowice
Krakowska Akademia Neurologii Sp. z o.o.
Centrum Neurologii Klinicznej, Ul. Arianska 7/3, 31-505, Cracow
Centrum Neurologii Krzysztof Selmaj
NA/ND, ul. Tylna 12, 90-324, Łódź
Mtz Clinical Research Powered By Pratia
NA/ND, Ul. Gładka 22, 02-172, Warsaw
Neuro-Care Sp. z o.o. sp.k.
NA/ND, Ul. Pawla Kolodzieja 8, 40-749, Katowice
Centrum Medyczne Neuroprotect
NA/ND, Ul. Klaudyny 16c, 1 Piętro, Warsaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
SU w Krakowie, Zespol Poradni Specjalistycznych - Botaniczna 3, Poradnia Neurologiczna, Ul. Botaniczna 3, 31-503, Cracow
Resmedica Sp. z o.o.
Resmedica, Ul. Romualda Mielczarskiego 105/3-4, 25-726, Kielce
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej
NA/ND, ul. Fabianowska 40, 62-064, Plewiska
Spitalul Clinic Judetean De Urgenta Cluj
Neurologie, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Arensia Clinics S.R.L.
Neurologie, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Brainaxy Clinic S.R.L.
Neurologie, Strada Muresanu Andrei No. 8, 900348, Constanta
Spitalul Clinic Cai Ferate Constanta
Neurologie, Bulevardul 1 Mai 5-7, 900123, Constanta
University Hospital Bratislava
Neurologická klinika SZU Nemocnica Ružinov Ružinovská 6 826 06 Bratislava, Ruzinovska 6, Ruzinov, Bratislava
EMPATHY s. r. o.
Neurologická ambulancia EMPATHY s. r. o. Švabinského 17 85101 Bratislava, Belinského 11, 85101, Bratislava
Fakultna Nemocnica Trnava
Neurologická klinika, Andreja Zarnova 11, 917 02, Trnava
Univerzitetni Klinicni Center Maribor
Department of neurology, Ljubljanska Ulica 5, 2000, Maribor
University Medical Center Ljubljana
Department of neurology, Zaloska Cesta 2, 1000, Ljubljana
Hospital Alvaro Cunqueiro
Neurology, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Universitario Fundacion Alcorcon
Neurology, Calle Budapest 1, 28922, Alcorcon
Hospital Santa Caterina Ias
Neurology, Calle Del Doctor Castany S/N, 17190, Salt
Hospital Universitario Dr Peset Aleixandre
Neurology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital Clinic De Barcelona
Neurology, Calle Villarroel 170, 08036, Barcelona
Hospital Nisa Sevilla Aljarafe
Neurology, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Universitario Regional De Malaga
Neurology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Virgen De La Macarena
Neurology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Vithas Parque San Antonio
Neurology, Avenida Del Pintor Joaquin Sorolla 2, 29016, Malaga
Hospital Universitario De Torrejon
Servicio de Neurología, Calle De Mateo Inurria 1, 28850, Torrejon De Ardoz
Hospital Universitario Y Politecnico La Fe
Neurology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital De Denia
Servicio de Neurología, Calle Beniala S/n, 03700, Denia
Hospital General Universitario Gregorio Maranon
Neurology, Calle Del Doctor Esquerdo 46, 28007, 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 |
|---|---|---|---|---|---|
| Belgium | 2025-10-02 | 2026-03-05 | 2026-03-10 | ||
| Bulgaria | 2025-09-18 | 2025-12-02 | 2026-04-20 | ||
| Croatia | 2025-09-30 | 2025-10-22 | 2026-02-23 | ||
| Czechia | 2025-10-01 | 2025-11-18 | 2026-04-17 | ||
| Denmark | 2025-09-30 | 2026-01-06 | 2026-03-04 | ||
| France | 2025-11-07 | ||||
| Germany | 2025-09-17 | 2025-11-19 | 2026-04-17 | ||
| Italy | 2025-10-16 | ||||
| Lithuania | 2025-10-07 | 2025-10-21 | 2026-03-10 | ||
| Poland | 2025-09-12 | 2025-10-14 | 2026-04-20 | ||
| Romania | 2026-02-23 | 2026-02-26 | 2026-04-17 | ||
| Slovakia | 2025-10-29 | 2025-11-24 | 2026-04-20 | ||
| Slovenia | 2026-02-24 | ||||
| Spain | 2025-09-18 | 2025-11-19 | 2026-03-10 | ||
| Sweden | 2025-09-16 | 2026-02-04 | 2026-03-10 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 11 · Art. 38 CTR
Temporary halt TH-124891
- Halt date
- 2026-03-10
- Member states concerned
- Belgium
- Publication date
- 2026-03-24
- Reason
- Study management related
- Explanation
- Temporary Halt of Screening due to IMP supply constraints
- Follow-up measures
- N/A
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-124963
- Halt date
- 2026-03-11
- Member states concerned
- Slovenia
- Publication date
- 2026-03-25
- Reason
- Study management related
- Explanation
- Temporary Halt of Screening due to IMP supply constraints
- Follow-up measures
- N/A
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-124900
- Halt date
- 2026-03-10
- Member states concerned
- Sweden
- Publication date
- 2026-03-25
- Reason
- Study management related
- Explanation
- Temporary Halt of Screening due to IMP supply constraints
- Follow-up measures
- N/A
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-124901
- Halt date
- 2026-03-11
- Member states concerned
- Romania
- Publication date
- 2026-03-25
- Reason
- Study management related
- Explanation
- Temporary Halt of Screening due to IMP supply constraints
- Follow-up measures
- N/A
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-124899
- Halt date
- 2026-03-10
- Member states concerned
- Lithuania
- Publication date
- 2026-03-25
- Reason
- Study management related
- Explanation
- Temporary Halt of Screening due to IMP supply constraints
- Follow-up measures
- N/A
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-124902
- Halt date
- 2026-03-11
- Member states concerned
- Slovakia
- Publication date
- 2026-03-25
- Reason
- Study management related
- Explanation
- Temporary Halt of Screening due to IMP supply constraints
- Follow-up measures
- N/A
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-124903
- Halt date
- 2026-03-16
- Member states concerned
- Germany
- Publication date
- 2026-03-25
- Reason
- Study management related
- Explanation
- Temporary Halt of Screening due to IMP supply constraints
- Follow-up measures
- N/A
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-124898
- Halt date
- 2026-03-10
- Member states concerned
- Italy
- Publication date
- 2026-03-25
- Reason
- Study management related
- Explanation
- Temporary Halt of Screening due to IMP supply constraints
- Follow-up measures
- N/A
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-124904
- Halt date
- 2026-03-18
- Member states concerned
- Czechia
- Publication date
- 2026-03-25
- Reason
- Study management related
- Explanation
- Temporary Halt of Screening due to IMP supply constraints
- Follow-up measures
- N/A
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-124897
- Halt date
- 2026-03-10
- Member states concerned
- France
- Publication date
- 2026-03-25
- Reason
- Study management related
- Explanation
- Temporary Halt of Screening due to IMP supply constraints
- Follow-up measures
- N/A
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-124895
- Halt date
- 2026-03-10
- Member states concerned
- Croatia
- Publication date
- 2026-03-24
- Reason
- Study management related
- Explanation
- Temporary Halt of Screening due to IMP supply constraints
- Follow-up measures
- N/A
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 291 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-512914-16_FP | 4.0 |
| Protocol (for publication) | D1_Protocol_Scientific Justification_IT_2024-512914-16_FP | N/A |
| Recruitment arrangements (for publication) | K1_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Flyer_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_ICF and Patient Recruitment Procedure_FP | N/A |
| Recruitment arrangements (for publication) | K1_ICF and patient recruitment_FP | N/A |
| Recruitment arrangements (for publication) | K1_ICF Flipbook_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_IT_Recruitment Procedure | N/A |
| Recruitment arrangements (for publication) | K1_Patient Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruit arrang_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruit Arrang_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit ICF process_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF Process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF Process_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment ICF process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recuitment ICF process_FP | N/A |
| Recruitment arrangements (for publication) | K1_RO_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_SI_Recruitment Procedure | N/A |
| Recruitment arrangements (for publication) | K1_Site Biosimilar Infographic_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_SVG_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Flyer_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Flyer_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Flyer_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Flyer_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Flyer_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Flyer_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Flyer_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Flyer_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_HCP Factsheet_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_HCP Factsheet_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_HCP Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_HCP Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 2.1 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_LT_Recruitment material_Flyer_Lit | 1.1 |
| Recruitment arrangements (for publication) | K2_LT_Recruitment material_Site Biosimilar Infographic_Lit_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruit Arrang_Advertising Statement_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruit mat_Brochure_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Brochure_fr_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Brochure_nl_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Flyer_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Flyer_fr_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Flyer_nl_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_ICF Flipbook_en_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_ICF Flipbook_fr_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_ICF Flipbook_nl_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Patient Letter_en_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Patient Letter_fr_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Patient Letter_nl_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Poster_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Poster_fr_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Poster_nl_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Site Biosimilar Infographic_en_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Site Biosimilar Infographic_fr_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_Site Biosimilar Infographic_nl_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_SVG_en_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_SVG_fr_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruit mat_SVG_nl_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruiting Advertising Statement_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruiting Advertising Statement_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruiting Advertising Statement_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruiting Advertising Statement_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruiting Advertising Statement_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruiting Advertising Statement_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material statement_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material statement_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_FP | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ICF Flipbook_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Site Biosimilar Infographic_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_SVG_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials Statement_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment_Statement_FP | N/A |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Biosimilat Infographic_Romanian | 2.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Brochure_Romanian_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Flipbook_Romanian_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Flyer_Romanian | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Patient Letter_Romanian_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Poster_Romaian | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_StudyGuide_Romanian_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Subject Card | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Subject Card_Romanian | 1.0 |
| Recruitment arrangements (for publication) | K2_Scout Clinical Study Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_SI_Recruitment Material_Flyer_Slovenian | 1.0 |
| Recruitment arrangements (for publication) | K2_SI_Recruitment Material_ICF Flipbook_Slovenian | 2.0 |
| Recruitment arrangements (for publication) | K2_SI_Recruitment Material_Patient Brochure_Slovenian | 1.0 |
| Recruitment arrangements (for publication) | K2_SI_Recruitment Material_Patient Letter_Slovenian | 2.0 |
| Recruitment arrangements (for publication) | K2_SI_Recruitment Material_Visit Guide_Slovenian | 2.0 |
| Recruitment arrangements (for publication) | K2_Site Biosimilar Infographic_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Site Biosimilar Infographic_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Site Biosimilar Infographic_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Site Biosimilar Infographic_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Site Biosimilar Infographic_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Site Biosimilar Infographic_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_SVG_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_SVG_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_SVG_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_SVG_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_SVG_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_SVG_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_SVG_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_dut_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS ICF_PK Group ICF_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main-Group_Czech_redacted_enrolled | 4.1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_PK-Group_Czech_redacted_enrolled | 2.1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main Group_Catalan_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main Group_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_PK Group_Catalan_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_PK Group_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_HR_SIS-ICF_Main group_hr_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_HR_SIS-ICF_PK group_hr_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_LT_SIS-ICF_EU Main Group ICF_Lit_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_LT_SIS-ICF_EU PK Group ICF_Lit_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main PK_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main PK_Romanian_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_Romanian_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnancy_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnancy_Romanian_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Scout | 1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Scout_Romanian | 1.0 |
| Subject information and informed consent form (for publication) | L1_SI_SIS-ICF_Main_Slovenian_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SI_SIS-ICF_PK_Slovenian_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SI_SIS-ICF_Pregnant Participant_Slovenian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SI_SIS-ICF_Pregnant Partner_Slovenian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS ICF_PK Group_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF PK_en_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF PK_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF PK_fr_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF PK_nl_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF PP_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Country Main_bg_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Country Main_en_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Country Pregnancy Follow-up_bg_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Country Pregnancy Follow-up_en_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_GDPR_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Global Main_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Global Pregnancy Follow-up_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main Group_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main Privacy_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_en_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_fr_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Newborn_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PK Group_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PK_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PK_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PK_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PK_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PK_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PK_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PK_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PP_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PP_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Preg Participant_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Preg Partner_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnancy FU_en_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnancy FU_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnancy FU_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnancy FU_fr_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnancy FU_nl_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnancy_FP | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnancy_spa_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Participant_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Patient_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Privacy Supp PK_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Privacy Supp_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_SC_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Scout Clinical_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Scout IC_bg_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Scout IC_en_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Scout ICF_en_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Scout ICF_fr_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Scout ICF_nl_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Scout_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Scout_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Scout_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Sponsor statement_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SK_SIS-ICF_Pregnant Participant_Slovak_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SK_SIS-ICF_Pregnant Partner_Slovak_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_BG_Other Subject Material_Subject Card_bg | 1.0 |
| Subject information and informed consent form (for publication) | L2_DK_Other Subject Material_Leaflet_Danish | N/A |
| Subject information and informed consent form (for publication) | L2_GP Letter_FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_FP | N/A |
| Subject information and informed consent form (for publication) | L2_ID Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Emergency Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient ID Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_PT Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_SC PFD Email Comm_bg_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_SC PFD Email Comm_en_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_SC PFD Study Brochure_bg_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_SC PFD Study Brochure_en_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_SC_Email Comm_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_SC_PFD_Email Comm_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_SC_PFD_Reloadable ScoutPass Brochure_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_SC_PFD_Reloadable ScoutPass Mailer_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_SC_PFD_Study Brochure_FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_SC_PFD_Taxable Payments Letter_Template_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_SC_Reloadable ScoutPass Brochure_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_SC_Reloadable ScoutPass Mailer_FP | N/A |
| Subject information and informed consent form (for publication) | L2_SC_Study Brochure_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_SC_Taxable Payments Letter_Template_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Scout Clinical Email Communication_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Scout Clinical Taxable Payments Letter_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Scout_SIS-ICF_FP | 1.1 |
| Subject information and informed consent form (for publication) | L2_SI_Other subject material_Subject Card_Slovenian | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Card Template study Level_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Card_FP | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ocrevus 300 mg solution for infusion_FP | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_USPI_Ocrevus 300 mg Intravenous_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2024-512914-16_Romanian_redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2024-512914-16_Slovenian_redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_BE_de_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_BE_fr_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_BE_nl_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_BG_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_CZ_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_ES_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_FR_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_IT_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_LT_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_PL_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_SE_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Laymen Protocol Synopsis_SK_2024-512914-16_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_full_CZ_cs_2024-512914-16_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_full_ES_es_2024-512914-16_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_full_LT_lt_2024-512914-16_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_full_SK_sk_2024-512914-16_FP | 4.0 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-07 | Poland | Acceptable with conditions 2025-03-17
|
2025-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-06 | Poland | Acceptable 2025-08-04
|
2025-08-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-19 | Acceptable | 2025-10-06 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-19 | Acceptable | 2025-11-18 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-25 | Acceptable | 2025-10-09 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-09-26 | Acceptable 2025-08-04
|
2025-11-13 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-03 | Acceptable | 2025-12-01 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2025-10-29 | Acceptable 2025-08-04
|
2026-02-09 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-17 | Poland | Acceptable 2026-04-20
|
2026-04-20 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-25 | Acceptable 2026-04-20
|
2026-05-25 |