Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
640
Countries
7
Sites
52
Parkinson's Disease
To evaluate the efficacy of BIIB122 225 mg compared with placebo.
Key facts
- Sponsor
- Biogen Idec Research Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 28 Nov 2022 → 9 Mar 2026
- Decision date (initial)
- 2024-06-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Biogen Idec Research Limited
External identifiers
- EU CT number
- 2023-505645-12-00
- EudraCT number
- 2021-004849-20
- ClinicalTrials.gov
- NCT05348785
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Pharmacokinetic, Safety, Efficacy, Pharmacogenetic
To evaluate the efficacy of BIIB122 225 mg compared with placebo.
Secondary objectives 1
- To evaluate the efficacy, safety and tolerability and of BIIB122 225 mg compared with placebo
Conditions and MedDRA coding
Parkinson's Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061536 | Parkinson's disease | 100000004852 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Period Once informed consent is obtained, screening assessments can occur.
|
Not Applicable | None | Patients receiving BIIB122: Experimental: BIIB122 225 mg Participants will receive BIIB122, 225 mg tablets, by mouth, once daily (QD) for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received BIIB122 and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122, 225 mg tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Placebo Comparator: BIIB122 Matching Placebo: Participants will receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received placebo and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. |
|
| 2 | Double-blind, placebo-controlled treatment period -week minimum to 144-week maximum (when the total number of events for the
primary endpoint reaches 330) double-blind, placebo-controlled treatment period.
|
Randomised Controlled | Double | [{"id":165191,"code":4,"name":"Analyst"},{"id":165188,"code":1,"name":"Subject"},{"id":165189,"code":5,"name":"Carer"},{"id":165190,"code":2,"name":"Investigator"},{"id":165192,"code":3,"name":"Monitor"}] | Patients receiving BIIB122: Experimental: BIIB122 225 mg Participants will receive BIIB122, 225 mg tablets, by mouth, once daily (QD) for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received BIIB122 and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122, 225 mg tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Placebo Comparator: BIIB122 Matching Placebo: Participants will receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received placebo and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. |
| 3 | Follow up period 2 week Subject Follow Up period
|
Randomised Controlled | Double | [{"id":165195,"code":5,"name":"Carer"},{"id":165197,"code":4,"name":"Analyst"},{"id":165194,"code":3,"name":"Monitor"},{"id":165196,"code":1,"name":"Subject"},{"id":165198,"code":2,"name":"Investigator"}] | Patients receiving BIIB122: Experimental: BIIB122 225 mg Participants will receive BIIB122, 225 mg tablets, by mouth, once daily (QD) for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received BIIB122 and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122, 225 mg tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Placebo Comparator: BIIB122 Matching Placebo: Participants will receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received placebo and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 2 years of the screening visit, inclusive, and at least 30 years of age at the time of diagnosis
- Modified Hoehn and Yahr scale, stages 1 to 2 (in OFF state), inclusive
- MDS-UPDRS Parts II and III (in OFF state) combined score less than or equal to (≤)40 at screening
- Screening genetic test results verifying the absence of a pathogenic leucine-rich repeat kinase 2 (LRRK2) variant (i.e., G2019S, N1437H, R1441G, R1441C, R1441H, Y1699C, or I2020T). Participants with additional LRRK2 variants may be excluded if data emerge to convincingly support an association of the variants with LRRK2-PD pathogenicity. Confirmation of this eligibility requirement may come from an accredited genetic test that includes all exclusionary LRRK2 genetic variants.
- Other protocol defined Inclusion criteria may apply. See Protocol section 6.1
Exclusion criteria 4
- Clinically significant neurological disorder other than PD, including but not limited to stroke, dementia, or seizure, within 5 years of screening visit, in the opinion of the Investigator
- Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.
- Montreal Cognitive Assessment (MoCA) score <24 at the screening visit
- Other protocol defined Exclusion criteria may apply. See Protocol section 6.2
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to confirmed worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score over the treatment period.
Secondary endpoints 5
- Incidence of AEs and SAEs during the treatment period
- Time to confirmed worsening in MDS-UPDRS Part II score over the treatment period
- Change in MDS-UPDRS Parts II and III combined score
- Time to confirmed worsening in Schwab and England Activities of Daily Living Scale (SEADL) over the treatment period
- Change in MDS-UPDRS Parts I, II, and III combined score
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10968886 · Product
- Active substance
- N2-3-2-2H-123-TRIAZOL-2-YLPROPAN-2-YL-1-CYCLOPROPYL-1H-PYRAZOL-5-YL-N4-ETHYL-5-TRIFLUOROMETHYLPYRIMIDINE-24-DIAMINE
- Substance synonyms
- DNL151, BIIB122
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 225 mg milligram(s)
- Max total dose
- 225 mg milligram(s)
- Max treatment duration
- 144 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIOGEN IDEC RESEARCH LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Matching Placebo tablets without active substance
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
Biogen Idec Research Limited
- Sponsor organisation
- Biogen Idec Research Limited
- Address
- Building 5 Foundation Park, Roxborough Way Roxborough Way
- City
- Maidenhead
- Postcode
- SL6 3UD
- Country
- United Kingdom
Scientific contact point
- Organisation
- Biogen Idec Research Limited
- Contact name
- Clinical Trials Information Desk
Public contact point
- Organisation
- Biogen Idec Research Limited
- Contact name
- Clinical Trials Information Desk
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Code 2, Code 5 |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Other |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Other |
| Preventiongenetics LLC ORG-100043377
|
Marshfield, United States | Other |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Madison, United States | Other |
| eResearchTechnology GmbH ORG-100044103
|
Estenfeld, Germany | Other |
| Invicro LLC ORG-100046990
|
New Haven, United States | Other |
| PPD Global Limited ORG-100007533
|
Cambridge, United Kingdom | Code 8 |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
Locations
7 EU/EEA countries · 52 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 7 | 2 |
| France | Ended | 65 | 9 |
| Germany | Ended | 55 | 11 |
| Italy | Ended | 36 | 11 |
| Netherlands | Ended | 17 | 3 |
| Poland | Ended | 56 | 5 |
| Spain | Ended | 75 | 11 |
| Rest of world
United Kingdom, Japan, United States, Israel, China, Canada
|
— | 329 | — |
Investigational sites
Medizinische Universitaet Innsbruck
Neurology, Anichstrasse 35, 6020, Innsbruck
Stadt Wien Wiener Gesundheitsverbund
Neurology, Montleartstrasse 37, Ottakring, Vienna
Hospices Civils De Lyon
Neurologist, 59 Boulevard Pinel, 69500, Bron
Assistance Publique Hopitaux De Paris
Neurologist, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Centre Hospitalier Universitaire De Nantes
Neurologist, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Rennes
Neurologist, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Montpellier
Neurologist, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Toulouse
Neurologist, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Assistance Publique Hopitaux De Marseille
Neurologist, 264 Rue Saint Pierre, 13005, Marseille
Assistance Publique Hopitaux De Paris
Neurologist, 43 Boulevard De L Hopital, 75013, Paris
University Hospital Of Clermont-Ferrand
Neurologist, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Universitaetsklinikum Giessen und Marburg GmbH
Klinik für Neurologie, Baldingerstrasse 1, 35043, Marburg
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Neurologie, Haus D6, Ratzeburger Allee 160, Luebeck
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA
Studienabteilung, Klinikstrasse 16, Harleshausen, Kassel
Katholisches Klinikum Bochum gGmbH
Forschungszentrum für Neurodegeneration, Gudrunstrasse 56, Grumme, Bochum
Universitaetsklinikum Duesseldorf AöR
Center for Movement Disorders and Neuromodulation, Moorenstrasse 5, Bilk, Duesseldorf
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik für Neurologie - Studienambulanz, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Medizinische Hochschule Hannover
Neurologische Klinik, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Klinikum der Universitaet Muenchen AöR
Neurologische Klinik und Poliklinik, Marchioninistrasse 15, Hadern, Munich
Klinikum rechts der Isar der TU Muenchen AöR
Klinikum rechts der Isar, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Wuerzburg AöR
Neurologische Klinik und Poliklinik, Josef-Schneider-Strasse 11, Grombuehl, Wuerzburg
Universitaetsklinikum Ulm AöR
Neurologisches Studienzentrum im RKU, Oberer Eselsberg 45, Eselsberg, Ulm
Azienda Unita Sanitaria Locale Di Bologna
Neurology, Via Altura 3, 40139, Bologna
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Neurology, Piazza Luigi Miraglia 2, 80138, Naples
Azienda Ospedale-Universita Padova
Neurology, Via Nicolo' Giustiniani 2, 35128, Padova
Irccs San Raffaele Roma S.r.l.
Research Facility, Via Della Pisana 235, 00163, Rome
Ospedale San Raffaele S.r.l.
Neurology, Via Olgettina 60, 20132, Milan
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Neurology, Via Atinense N. 18, 86077, Pozzilli
Universita' Degli Studi G. D'annunzio Di Chieti
Neurology, Via Luigi Polacchi 11, 66100, Chieti Scalo
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Neurology, Via Santa Sofia 78, 95123, Catania
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Neurology, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero Universitaria Pisana
Neurology, Via Roma 67, 56126, Pisa
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Research Facility, Via Francesco Sforza 35, 20122, Milan
Radboud universitair medisch centrum / RADBOUDUMC
-, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Brain Research Center Amsterdam B.V.
Neurology, Cronenburg 2, 1081 GN, Amsterdam
Brain Research Center Zwolle B.V.
-, Dokter Stolteweg 90, 8025 AZ, Zwolle
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
N/A, Ul. Gen. Jaroslawa Dabrowskiego 4, 32-600, Oswiecim
Centrum Medyczne Neuroprotect
N/A, Ul. Klaudyny 16c, 1 Piętro, Warsaw
Novo-Med Zielinski I Wspolnicy Sp. j.
NZOZ Novo-Med, Ul. Brynowska 44, 40-584, Katowice
Centrum Medyczne Neuromed Sp. z o.o.
Centrum Medyczne Neuromed Sp.z o.o, Ul. Jana Biziela 14, 85-163, Bydgoszcz
Md Clinic Praga Sp. z o.o.
MD Clinic Praga, Ul. Sw. Wincentego 14 U1, 03-505, Warsaw
Hospital Universitari General De Catalunya
Servicio de Neurología, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Clinica Universidad De Navarra
Neurología, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario De Cruces
Neurología, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario De La Princesa
Neurología, Calle De Diego De Leon 62, 28006, Madrid
Hospital De La Santa Creu I Sant Pau
Neurología, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Clinic De Barcelona
Servicio de Neurología, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Servicio de Neurología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Complexo Hospitalario Universitario A Coruna
Servicio de Neurología Pediátrica, Lugar Jubias De Arriba 84, 15006, A Coruna
University Hospital Virgen Del Rocio S.L.
Neurología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Marques De Valdecilla
Neurología, Avenida Valdecilla Sn, 39008, Santander
Policlinica Gipuzkoa S.A.
Neurología, Paseo Miramon 174, 20009, Donostia
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 |
|---|---|---|---|---|---|
| Austria | 2023-07-03 | 2026-03-03 | 2023-09-12 | 2025-05-01 | |
| France | 2023-04-03 | 2026-03-02 | 2023-04-03 | 2025-05-01 | |
| Germany | 2023-03-06 | 2026-03-06 | 2023-04-18 | 2025-05-01 | |
| Italy | 2023-06-21 | 2026-03-09 | 2023-06-21 | 2025-05-01 | |
| Netherlands | 2022-12-22 | 2026-02-26 | 2023-04-11 | 2025-05-01 | |
| Poland | 2022-12-02 | 2026-03-05 | 2023-01-11 | 2025-05-01 | |
| Spain | 2022-11-28 | 2026-03-04 | 2023-02-15 | 2025-05-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 104 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_ 2023-505645-12-00_red_san | 8.0 |
| Protocol (for publication) | D4_ Patient facing documents - 283PD201 LUMA Statement | 1 |
| Protocol (for publication) | D5_Justification for Gender Selection_red_san | 1 |
| Protocol (for publication) | D5_Justification for inclusion of vulnerable population_red_san | 1 |
| Protocol (for publication) | D5_Justification for Placebo_red_san | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_2023-505645-12_Recruitment and Informed Consent Procedure_memo | V1.0 |
| Recruitment arrangements (for publication) | K1_283PD201_Recruitment and Informed Consent Procedure_Clean | V1.0 |
| Recruitment arrangements (for publication) | K1_Blank placeholder created for Val RFI Response | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_blank | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_blank | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_Blank placeholder | n/a |
| Recruitment arrangements (for publication) | K10_2023-505645-12_Appreciation item_FRAfr | 1 |
| Recruitment arrangements (for publication) | K11_2023-505645-12_Retention item_FRAfr | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Biogen Generic_Lumbar Puncture Booklet | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Generic_Lumbar Puncture Animation | N/A |
| Recruitment arrangements (for publication) | K2_ Recruitment material_ICF Summary Brochure | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Local Digital Ad Templates | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Patient Brochure Insert | 1 |
| Recruitment arrangements (for publication) | K2_2023-505645-12_LP Brochure_FRAfr | 1 |
| Recruitment arrangements (for publication) | K2_283PD201_Advertising text_Brain Research Center_NLD | V2.0 |
| Recruitment arrangements (for publication) | K2_283PD201_ICF Summary Brochure_NL | V2 |
| Recruitment arrangements (for publication) | K2_283PD201_Local Digital Ad Templates Copy_NL | V1 |
| Recruitment arrangements (for publication) | K2_283PD201_Local Digital Ad Templates_NL | V1 |
| Recruitment arrangements (for publication) | K2_283PD201_Patient Brochure Insert_NL | V1 |
| Recruitment arrangements (for publication) | K2_283PD201_Patient Brochure_NL | V3 |
| Recruitment arrangements (for publication) | K2_283PD201_Patient Flyer_NL | V2 |
| Recruitment arrangements (for publication) | K2_283PD201_Patient Poster_NL | V2 |
| Recruitment arrangements (for publication) | K2_Recruiment material_Paid Search Ads | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Adult Supplemental Privacy Notice | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ ICF Summary Brochure | V2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Patient Brochure Insert_san | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_About Clinical Trial Animation_PL_san | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_About Clinical Trial Animation_san | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Biogen Generic_About Clinical Trial Animation | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Cookie Policy_san | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Facebook Family Ads _san | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_san | V2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ICF Summary Brochure_PL_san | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Local Digital Ad Templates_PL_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Lumbar Puncture Animation_PL_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Lumbar Puncture Animation_san | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Lumbar Puncture Booklet_PL_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Lumbar Puncture Booklet_san | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Online Prescreener_san | V2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure Insert_PL_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_PL_san | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_san | V3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_PL_san | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_PL_san | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_san | V2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Confirmation Email_san | V2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website_san | v1 |
| Recruitment arrangements (for publication) | K3_2023-505645-12_Patient Brochure_FRAfr | 3 |
| Recruitment arrangements (for publication) | K4_2023-505645-12_Patient Poster_FRAfr | 2 |
| Recruitment arrangements (for publication) | K5_2023-505645-12_Flyer_FRAfr | 2 |
| Recruitment arrangements (for publication) | K6_2023-505645-12_Local Digital Ad Templates_FRAfr | 1 |
| Recruitment arrangements (for publication) | K7_2023-505645-12_ICF Summary Brochure_FRAfr | 2 |
| Recruitment arrangements (for publication) | K8_2023-505645-12_Patient Brochure Insert_FRAfr | 1 |
| Recruitment arrangements (for publication) | K9_2023-505645-12_CT animation_FRAfr | NA |
| Subject information and informed consent form (for publication) | L1_2023-505645-12_SIS and ICF Main_FRA_Red-San | V6.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_283PD201_Main ICF_ITA_red | V6.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_283PD201_Main ICF_red_san | V6.0NLD3.0 |
| Subject information and informed consent form (for publication) | L1_283PD201_Main wOptional_ICF_ITA_red | V6.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_283PD201_Privacy ICF_ITA_red | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_FSR ICF_red_san | V4.0DEUde1 |
| Subject information and informed consent form (for publication) | L1_ICF Additional I_red | V4.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Additional II_red | V5.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult_red | V6.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_List of sites and contact details for ICF_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF without BFS_red_san | V6.0DEUde1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_red_san | V6.0DEUde1 |
| Subject information and informed consent form (for publication) | L1_Opt Biofluid subst ICF_red_san | V5.0DEUde1 |
| Subject information and informed consent form (for publication) | L1_Opt PGX ICF_red_san | V4.0DEUde1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FSR_Austria_redacted | V4.0AUTde1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FSR_PL_redacted | V4.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire_PL_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult_PL_redacted | V6.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Austria_redacted | V6.0AUTde2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biofluid_Austria_redacted | V5.0AUTde1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biofluid_PL_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PGx_Austria_redacted | V4.0AUTde1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PGx_PL_redacted | V4.0POL1.0 |
| Subject information and informed consent form (for publication) | L2_2023-505645-12_SIS and Optional ICF 1_FRA_Red-San | V5.0FRA1.0 |
| Subject information and informed consent form (for publication) | L2_283PD201_Additional I ICF_ITA_red | V4.0ITA1.0 |
| Subject information and informed consent form (for publication) | L2_283PD201_Additional II ICF_ITA_red | V5.0ITA1.0 |
| Subject information and informed consent form (for publication) | L2_283PD201_FSR ICF_ITA_red | V4.0ITA1.0 |
| Subject information and informed consent form (for publication) | L3_2023-505645-12_SIS and Optional ICF 2_FRA_Red-San | V4.0FRA1.0 |
| Synopsis of the protocol (for publication) | D1_Full Protocol Synopsis_AT_2023-505645-12-00_red_san | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Layman Synopsis_AT_2023-505645-12-00 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol Layman Synopsis_EN_2023-505645-12-00 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Layman Synopsis_ES_2023-505645-12-00 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Layman Synopsis_ES_2023-505645-12-00_TC | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Layman Synopsis_FR_2023-505645-12-00 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Layman Synopsis_IT_2023-505645-12-00 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Layman Synopsis_NL_2023-505645-12-00 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Layman Synopsis_PL_2023-505645-12-00 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-505645-12-00_Full_red_san | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-505645-12-00_Full_red_san FR | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-505645-12-00_Full_red_san ITA | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2023-505645-12-00_Full_red_san ES | 5.0 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-03 | Germany | Acceptable 2024-06-12
|
2024-06-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-11 | Acceptable 2024-06-12
|
2024-07-11 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-08 | Germany | Acceptable | 2024-08-19 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-17 | Acceptable | 2024-09-17 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-10 | Acceptable | 2024-11-15 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-11 | Germany | Acceptable | 2024-11-08 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-10-30 | Acceptable | 2024-11-29 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-31 | Acceptable | 2024-12-03 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-20 | Germany | Acceptable | 2025-01-20 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-03-07 | Germany | Acceptable 2025-05-08
|
2025-05-08 |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-07-14 | Acceptable | 2025-09-09 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-09-23 | Germany | Acceptable 2025-11-14
|
2025-11-17 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-01-09 | Germany | Acceptable 2025-11-14
|
2026-01-09 |