Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
698
Countries
13
Sites
65
Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
To determine if niraparib and AA, plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC provides superior efficacy in improving rPFS
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Oct 2020 → ongoing
- Decision date (initial)
- 2024-03-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Janssen Research & Development, LLC
External identifiers
- EU CT number
- 2023-506365-64-00
- EudraCT number
- 2020-002209-25
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacogenomic, Safety, Pharmacokinetic, Efficacy, Pharmacodynamic
To determine if niraparib and AA, plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC provides superior efficacy in improving rPFS
Conditions and MedDRA coding
Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Pathological diagnosis of prostate adenocarcinoma
- Must have appropriate deleterious homologous recombination repair (HRR) gene alteration
- Metastatic disease as documented by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (for soft tissue lesions) or 99mTc bone scan (for bone lesions). Participants with a single bone lesion on Technetium-99m (99mTc) bone scan with no other non-nodal metastatic disease must have confirmation of bone metastasis by CT or MRI. Participants with lymph node-only disease are not eligible
- Androgen deprivation therapy (either medical or surgical castration) must have been started >=14 days prior to randomization and participants be willing to continue androgen deprivation therapy (ADT) through the treatment phase
Exclusion criteria 4
- Prior treatment with a poly (adenosine diphosphate-ribose) polymerase inhibitor (PARP inhibitor)
- History of adrenal dysfunction
- Long-term use of systemically administered corticosteroids (greater than [>] 5 milligrams [mg] of prednisone or the equivalent) during the study is not allowed. Short-term use (<=4 weeks, including taper) and locally administered steroids (for example, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated
- History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Radiographic progression-free survival (rPFS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
Abiraterone acetate - tablet - 250 mg
PRD589483 · Product
- Active substance
- Abiraterone Acetate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11717535 · Product
- Active substance
- Niraparib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD4369298 · Product
- Active substance
- Niraparib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD8913617 · Product
- Active substance
- Niraparib
- Other product name
- Niraparib tosylate monohydrate + abiraterone acetate
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD8913616 · Product
- Active substance
- Niraparib
- Other product name
- Niraparib tosylate monohydrate + abiraterone acetate
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1100 mg milligram(s)
- Max total dose
- 1100 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 4
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
Placebo for ABIRATERONE ACETATE
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
Placebo for NIRAPARIB / ABIRATERONE ACETATE 50/500 mg FDC
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
Placebo for NIRAPARIB / ABIRATERONE ACETATE 100/500 mg FDC
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
Auxiliary 7
Prednison acis 5 mg, Tabletten
PRD889556 · Product
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- 49572.00.00
- MA holder
- ACIS ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP132446 · ATC
- Active substance
- Abiraterone
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BX03 — ABIRATERONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP56468552 · ATC
- Active substance
- Relugolix
- Substance synonyms
- TAK-385
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BX04 — RELUGOLIX
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP8252543 · ATC
- Active substance
- Degarelix
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BX02 — DEGARELIX
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP9645195 · ATC
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- V09IA0X — TECHNETIUM (99MTC) COMPOUNDS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
L02AE · Product
- Pharmaceutical form
- PHF00243MIG
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE — GONADOTROPIN RELEASING HORMONE ANALOGUES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP16881830 · ATC
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- D07AA03 — PREDNISOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| PPD Global Limited ORG-100007533
|
Cambridge, United Kingdom | Data management |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Interactive response technologies (IRT) |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| SGS Belgium ORG-100007917
|
Mechelen, Belgium | Data management |
| Foundation Medicine Inc. ORG-100040457
|
Cambridge, United States | Laboratory analysis |
Locations
13 EU/EEA countries · 65 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 9 | 5 |
| Bulgaria | Ongoing, recruitment ended | 5 | 1 |
| Czechia | Ongoing, recruitment ended | 6 | 2 |
| Denmark | Ongoing, recruitment ended | 10 | 4 |
| France | Ongoing, recruitment ended | 32 | 10 |
| Germany | Ongoing, recruitment ended | 12 | 3 |
| Hungary | Ongoing, recruitment ended | 7 | 4 |
| Italy | Ongoing, recruitment ended | 56 | 14 |
| Netherlands | Ongoing, recruitment ended | 3 | 1 |
| Poland | Ongoing, recruitment ended | 25 | 6 |
| Portugal | Ongoing, recruitment ended | 2 | 1 |
| Spain | Ongoing, recruitment ended | 39 | 12 |
| Sweden | Ongoing, recruitment ended | 5 | 2 |
| Rest of world
South Africa, Thailand, Israel, United Kingdom, Malaysia, Russian Federation, Argentina, Taiwan, China, Ukraine, Brazil, Australia, Korea, Republic of, Turkey, Belarus, New Zealand, Mexico, Canada, United States
|
— | 487 | — |
Investigational sites
Clinique Saint-Pierre
Oncology, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve
Algemeen Ziekenhuis Delta
Oncology, Deltalaan 1, 8800, Roeselare
CHC MontLegia
Oncology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Oncology, Place Louise Godin 15, 5000, Namur
Ziekenhuis Aan De Stroom
Oncology, Oosterveldlaan 24, 2610, Antwerp
Complex Oncological Center Plovdiv EOOD
Department of Medical Oncology and Oncological Diseases in Gastroenterology, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv
Krajska nemocnice Liberec a.s.
Urologie, Husova 357/10, Liberec I-Stare Mesto, Liberec (neclenene Mesto)
Fakultni Nemocnice Hradec Kralove
Urologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Sygehus Lillebaelt Vejle Sygehus
Department of Oncology, Kabbeltoft 25, 7100, Vejle
Næstved Hospital
Department of Oncology, Ringstedgade 61, 4700, Næstved
Aalborg University Hospital
Department of Oncology, Hobrovej 18/22, 9000, Aalborg
Institut Bergonie
Service Oncologie, 229 Cours De L Argonne, 33000, Bordeaux
Centre Oscar Lambret
Pôle d'Oncologie Médicale, 3 Rue Frederic Combemale, 59000, Lille
Institut Sainte Catherine
Oncologie, 250 Chemin De Baigne Pieds, 84000, Avignon
Groupe Hospitalier Saint Vincent
Service d'oncologie Libérale, 182 Route De La Wantzenau, 67000, Strasbourg
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Unite De Recherche Clinique HIA Begin
Oncologie médicale, 69 Avenue De Paris, 94160, Saint-Mande
Besancon University Hospital Center
Service Oncologie Médicale, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Intercommunal De Cornouaille
Oncologie, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Hospital Foch
Oncologie Médicale, 40 Rue Worth, 92150, Suresnes
Centr Georges Francois Leclerc
Service d'Oncologie Médicale, 1 Rue Professeur Marion, 21000, Dijon
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
not applicable, Steinengrabenstrasse 17, 72622, Nuertingen
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik für Urologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Staedtisches Klinikum Braunschweig gGmbH
Klinik fuer Urologie und Uroonkologie, Salzdahlumer Str. 90, 38126 Braunschweig, Freisestrasse 9-10, 38118, Brunswick
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Onkologiai Osztaly, Dozsa Gyorgy Ut 77, 2800, Tatabanya
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Klinikai Onkologiai es Sugarterapias Centrum, Szentpeteri Kapu 72-76, 3526, Miskolc
University Of Debrecen
Onkologiai Klinika, Nagyerdei Korut 98, 4032, Debrecen
University Of Szeged
Onkoterapias Klinika, Koranyi Fasor 12, 6720, Szeged
Ospedale San Raffaele S.r.l.
Oncologia Medica, Via Olgettina 60, 20132, Milan
Azienda Unita Locale Socio Sanitaria N 8 Berica
Oncologia Medica, Viale Ferdinando Rodolfi 37, 36100, Vicenza
European Institute Of Oncology S.r.l.
Urologia, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Oncologia Medica, Strada Provinciale 142 Km 3,95, 10060, Candiolo
Azienda Ospedaliero Universitaria Pisana
Oncologia Medica, Via Roma 67, 56126, Pisa
Istituto Oncologico Veneto
Oncologia Medica 1, Via Gattamelata 64, 35128, Padova
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Uro-ginecologica, Via Piero Maroncelli 40, 47014, Meldola
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica Genito-urinaria, Via Giacomo Venezian 1, 20133, Milan
Azienda Socio Sanitaria Territoriale Di Cremona
Oncologia Medica, Viale Concordia 1, 26100, Cremona
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncologia Medica Uro-Ginecologica, Via Mariano Semmola 52, 80131, Naples
Azienda Sanitaria Locale Napoli 2 Nord
Oncologia, Via Michelangelo Lupoli 27, 80027, Frattamaggiore
Azienda USL Toscana Sud Est
UO Oncologia Medica, Ospedale Area Aretina Nord, Via Pietro Nenni 20/22, Arezzo
Casa Sollievo Della Sofferenza
Onco-Ematologia, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Azienda Sanitaria Universitaria Integrata Del Trentino
Oncologia Medica, Largo Medaglie D' Oro 9, 38122, Trento
Stichting Elisabeth-Tweesteden Ziekenhuis
internal medecine, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
Oncology, Ul. Grenadierow 51/59, 04-073, Warsaw
Specjalistyczne Gabinety Sp. z o.o.
Oncology, Pl. Lasoty 4, 30-539, Cracow
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Oncology, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Polimed Specjalistyczna Przychodnia Lekarska
Oncology, Pl. Powstancow Slaskich 1/116, 53-329, Wroclaw
In Vivo Sp. z o.o.
Oncology, Ul. Kaszubska 17h, 85-048, Bydgoszcz
Szpitale Pomorskie Sp. z o.o.
Radiotherapy, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Hospital De Jerez De La Frontera
Urology, Carretera De La Ronda Circunvalacion S/n, 11408, Jerez De La Frontera
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Clinic De Barcelona
Urology, Calle Villarroel 170, 08036, Barcelona
Hospital General Universitario De Castellon
Urology, Avenida De Benicasim S/n, 12004, Castello De La Plana
Complexo Hospitalario Universitario A Coruna
Urology, Lugar Jubias De Arriba 84, 15006, A Coruna
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Hospital Universitario De La Princesa
Oncology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Institut Catala D'oncologia
Oncology, Avinguda De Franca S/n, 17007, Girona
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario 12 De Octubre
Urology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Hm Monteprincipe
Urology, Avenida De Monteprincipe 25, 28668, Boadilla Del Monte
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 | 2020-10-16 | 2020-10-16 | 2022-07-20 | ||
| Bulgaria | 2021-04-29 | 2021-04-29 | 2023-02-21 | ||
| Czechia | 2021-01-29 | 2021-01-29 | 2022-12-22 | ||
| Denmark | 2021-04-22 | 2021-04-22 | 2023-03-29 | ||
| France | 2021-04-01 | 2021-04-01 | 2023-03-22 | ||
| Germany | 2021-11-12 | 2021-11-12 | 2023-03-23 | ||
| Hungary | 2021-01-28 | 2021-01-28 | 2022-12-01 | ||
| Italy | 2021-02-05 | 2021-02-05 | 2023-05-09 | ||
| Netherlands | 2021-03-16 | 2021-03-16 | 2022-10-17 | ||
| Poland | 2020-11-09 | 2020-11-09 | 2023-04-12 | ||
| Portugal | 2021-05-06 | 2021-05-06 | 2022-12-21 | ||
| Spain | 2020-11-19 | 2020-11-19 | 2023-04-25 | ||
| Sweden | 2021-02-03 | 2021-02-03 | 2022-04-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 140 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | Procedure Number Clarification_2023-506365-64-00 | 1 |
| Clinical study report (for publication) | REDACTED_CSR_2023-506365-64-00 | 1 |
| Clinical study report (for publication) | REDACTED_Patient Narratives_2023-506365-64-00_Part 1_1 of 3 | 1 |
| Clinical study report (for publication) | REDACTED_Patient Narratives_2023-506365-64-00_Part 1_2 of 3 | 1 |
| Clinical study report (for publication) | REDACTED_Patient Narratives_2023-506365-64-00_Part 1_3 of 3 | 1 |
| Clinical study report (for publication) | REDACTED_Patient Narratives_2023-506365-64-00_Part 2_1 of 3 | 1 |
| Clinical study report (for publication) | REDACTED_Patient Narratives_2023-506365-64-00_Part 2_2 of 3 | 1 |
| Clinical study report (for publication) | REDACTED_Patient Narratives_2023-506365-64-00_Part 2_3 of 3 | 1 |
| Clinical study report (for publication) | Study Anonymization Report_2023-506365-64-00 | 1.1 |
| Protocol (for publication) | D1_REDACTED Protocol 2023-506365-64 | Am5 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangement_DK_eng_67652000PCR3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangement_SE_eng_67652000PCR3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements _BE_Eng_67652000PCR3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_BG_Eng_67652000PCR3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_CZ_ENG_67652000PCR3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_DE_ENG_67652000PCR3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_ES_EN_67652000PCR3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_FR_EN_67652000PCR3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_HU_Eng_67652000PCR3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_IT_Eng_67652000PCR3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment arrangements_NL_Eng_67652000PCR3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_PT_EN_67652000PCR3002 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Placeholder_PL_EN_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Follow up OLE_DE_GER_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Follow up OLE_PL_POL_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Follow up OLE_PT_POR_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Follow up OLE_SE_SWE_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum _PL_PL_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 1_BE_Dut_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 1_BE_Fre_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 1_NL_Dut_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical LTE_ES_SPA_2023-506365-64 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical OLE_ES_SPA_2023-506365-64 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical PTFU OLE_ES_SPA_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_DK_dan_67652000PCR3002 | 12 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Follow up OLE_DK_DAN_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Follow up OLE_FR_FRE_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF FU OLE_CZ_cze_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE _HU_HUN_2023-506365-64 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE_BE_Dut_2023-506365-64 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE_BE_Fre_2023-506365-64 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE_CZ_cze_2023-506365-64 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE_DE_GER_2023-506365-64 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE_DK_dan_67652000PCR3002 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE_FR_FRE_2023-506365-64 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE_IT_ita_2023-506365-64 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE_NL_Dut_2023-506365-64 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE_PL_POL_2023-506365-64 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE_SE_SWE_2023-506365-64 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main _HU_HUN_2023-506365-64 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main _PL_PL_67652000PCR3002 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main ICF Highlighted_CZ_cze_2023-506365-64 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main ICF_CZ_CZE_67652000PCR3002 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_ES_ES_67652000PCR3002 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_PT_PT_67652000PCR3002 | 11 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_SE_SWE_67652000PCR3002 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OLE _HU_HUN_2023-506365-64 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OLE_BE_Dut_2023-506365-64 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OLE_BE_Fre_2023-506365-64 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OLE_CZ_cze_2023-506365-64 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OLE_DE_GER_2023-506365-64 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OLE_DK_dan_67652000PCR3002 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OLE_FR_FRE_2023-506365-64 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OLE_IT_ita_2023-506365-64 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OLE_NL_Dut_2023-506365-64 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OLE_PL_POL_2023-506365-64 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OLE_SE_SWE_2023-506365-64 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Exit Interview_ES_ES_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Future Research_DK_dan_67652000PCR3002 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy _PL_PL_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_DK_dan_2023-506365-64 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_ES_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PT_PT_67652000PCR3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Family_IT_ITA_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Language to ICF_CZ_CZE_67652000PCR3002 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF PTFU OLE_BE_dut_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF PTFU OLE_BE_fre_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF PTFU OLE_IT_ita_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF PTFU OLE_NL_dut_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF PTFU_OLE _HU_HUN_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Right to Reject Knowledge_DK_dan_2023-506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal _PL_PL_67652000PCR3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_ES_67652000PCR3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum Main ICF_IT_ITA_67652000PCR3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_BE_DUB_67652000PCR3002 | 7.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_BE_FRB_67652000PCR3002 | 7.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Long-Term Extension ICF_HU_HUN_67652000PCR3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_LTE ICF_BG_bul_2023 506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_LTE ICF_BG_eng_2023 506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main ICF_IT_ITA_67652000PCR3002 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main Study_DE_GER_67652000PCR3002 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_Addendum_FR_FR_67652000PCR3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_FR_FR_67652000PCR3002 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_MAIN_NL_Dut_67652000PCR3002 | 7.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Clinical ICF _HU_HUN_67652000PCR3002 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Clinical ICF_BG_bul_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Clinical ICF_BG_eng_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Pregnant Partner ICF_BG_bul_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Pregnant Partner ICF_BG_eng_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Pregnant Partner ICF_HU_HUN_67652000PCR3002 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Withdrawal ICF_BG_bul_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Withdrawal ICF_BG_eng_67652000PCR3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Withdrawal ICF_HU_HUN_67652000PCR3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_OLE ICF_BG_bul_2023 506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_OLE ICF_BG_eng_2023 506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Open-Label Extension ICF_HU_HUN_67652000PCR3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Optional Research_DE_GER_67652000PCR3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Optional Substudy_DE_GER_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner ICF_HU_HUN_2023-506365-64-00 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_DE_GER_67652000PCR3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_FR_FR_67652000PCR3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_PTFU OLE ICF_BG_bul_2023 506365-64 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_PTFU OLE ICF_BG_eng_2023 506365-64 | 1 |
| Subject information and informed consent form (for publication) | Redacted_L1_SIS and ICF_Withdrawal ICF_HU_HUN_2023-506365-64-00 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal ICF_IT_ITA_67652000PCR3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal_FR_FR_67652000PCR3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal_PT_PT_67652000PCR3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BG_bul_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_CZ_cze_2023-506365-64 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DE_GER_67652000PCR3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DK_dan_2023-506365-64 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_fre_2023-506365-64 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_HU_HUN_67652000PCR3002 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_IT_ITA_67652000PCR3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_PL_67652000PCR3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_SE_swe_2023-506365-64 | 2 |
| Synopsis of the protocol (for publication) | D1_REDACTED Protocol synopsis EN 2023-506365-64 | AM4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _ES_SPA_2023-506365-64 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _PL_POL_2023-506365-64 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _PT_POR_2023-506365-64 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _SE_SWE_2023-506365-64 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_Dut_2023-506365-64 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_Fre_2023-506365-64 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_Ger_2023-506365-64 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BG_bul_2023 506365-64 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_CZ_cze_2023-506365-64 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_FR_FRE_2023-506365-64 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_HU_HUN_2023-506365-64 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_IT_ita_2023-506365-64 | Am5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_NL_Dut_2023-506365-64 | Am5 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-02 | Poland | Acceptable 2024-03-28
|
2024-03-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-22 | Poland | Acceptable 2024-03-28
|
2024-08-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-30 | Poland | Acceptable 2024-12-09
|
2024-12-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-10 | Acceptable | 2025-01-28 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-01-10 | Acceptable | 2025-02-20 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-14 | Acceptable | 2025-02-25 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-23 | Acceptable | 2025-03-10 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-29 | Poland | Acceptable 2026-01-04
|
2026-01-05 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-12 | Poland | Acceptable 2026-05-15
|
2026-05-18 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-05-26 | Acceptable | 2026-06-02 |