Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
325
Countries
13
Sites
92
Treatment naïve patients with MF
Primary: To evaluate the efficacy of selinexor + ruxolitinib compared to placebo + ruxolitinib in patients with MF.
Key facts
- Sponsor
- Karyopharm Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 4 Jan 2024 → ongoing
- Decision date (initial)
- 2024-03-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Karyopharm Therapeutics Inc.
External identifiers
- EU CT number
- 2023-506139-13-00
- WHO UTN
- U1111-1295-4110
- ClinicalTrials.gov
- NCT04562389
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Primary: To evaluate the efficacy of selinexor + ruxolitinib compared to placebo + ruxolitinib in patients with MF.
Secondary objectives 3
- To evaluate additional measures of efficacy of selinexor + ruxolitinib compared to placebo + ruxolitinib in patients with MF
- To characterize pharmacokinetics (PK) of selinexor in patients with MF
- To evaluate the safety of selinexor + ruxolitinib compared to placebo + ruxolitinib in patients with MF
Conditions and MedDRA coding
Treatment naïve patients with MF
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10028537 | Myelofibrosis | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Double-blind, randomized, placebo-controlled, Phase 3 part of the study Phase 3 is the double-blind, randomized, and placebo
controlled part of the study comparing the combination of selinexor + ruxolitinib with the
combination of placebo + ruxolitinib.
|
Randomised Controlled | Double | [{"id":183066,"code":3,"name":"Monitor"},{"id":183068,"code":1,"name":"Subject"},{"id":183070,"code":4,"name":"Analyst"},{"id":183067,"code":5,"name":"Carer"},{"id":183069,"code":2,"name":"Investigator"}] | Selinexor 60 mg QW (RP2D) + Ruxolitinib* BID: BID = twice daily; QW = once weekly; RP2D=Recommended Phase 2 Dose *Ruxolitinib dose is based on the patient’s baseline platelet count (per local product label): • >200 × 109/L: 20 mg BID • 100 to 200 × 109/L: 15 mg BID Placebo QW + Ruxolitinib* BID: BID = twice daily; QW = once weekly. *Ruxolitinib dose is based on the patient’s baseline platelet count (per local product label): • >200 × 109/L: 20 mg BID • 100 to 200 × 109/L: 15 mg BID |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Spleen volume of ≥450 cm3 by MRI or CT scan.
- DIPSS risk category of intermediate-1, or intermediate-2, or high-risk.
- ECOG Performance Status ≤2.
- Platelet count ≥100 × 109/L without platelet transfusion.
- Active symptoms of MF as determined by presence of at least 2 symptoms with a score ≥3 or total score of ≥10 at screening using the MFSAF V4.0.
Exclusion criteria 2
- Previous treatment with JAK inhibitors for MF.
- More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Proportion of patients with spleen volume reduction (SVR) of ≥35% (SVR35) at Week 24 as measured by MRI or CT scan by Investigator assessment
- Absolute mean change in TSS (Abs-TSS) from baseline to Week 24 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0a
Secondary endpoints 9
- Proportion of patients with SVR35 at Week 48 as measured by MRI or CT scan by Investigator assessment
- Overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause.
- PFS as defined in the statistical analysis plan (SAP)
- Proportion of patients with SVR35 at any time point in the study as measured by MRI or CT scan.
- Absolute mean change in TSS (Abs-TSS) from baseline to Week 48 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0a
- Incidence and severity of TEAEs including treatment-related adverse events (TRAEs), SAEs.
- PK endpoints including but not limited to AUC, Cmax, and Tmax.
- Proportion of patients with at least a 1-grade decrease in bone marrow fibrosis at any point in the study.
- Progression-free survival (PFS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD3949619 · Product
- Active substance
- Ruxolitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 29.4 g gram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/008
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3949611 · Product
- Active substance
- Ruxolitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 29.4 g gram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/015
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3949635 · Product
- Active substance
- Ruxolitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 29.4 g gram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3949627 · Product
- Active substance
- Ruxolitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 29.4 g gram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/011
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB177942 · Substance
- Active substance
- Selinexor
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 6.3 g gram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMA/OD/0000095946
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- supplies are specific for clinical studies only
Placebo 1
Selinexor placebo for 20 mg tablets formulated for oral administration.
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 6
EMEND 125 mg+80 mg hard capsules
PRD6279072 · Product
- Active substance
- Aprepitant
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 29.92 g gram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- A04AD12 — -
- Marketing authorisation
- EU/1/03/262/006
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09445MIG · Substance
- Active substance
- Ondansetron
- Pharmaceutical form
- ORODISPERSIBLE TABLET
- Route of administration
- ORAL
- Max daily dose
- 24 mg milligram(s)
- Max total dose
- 3.36 g gram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ONDANSETRON ZYDUS 8 mg, comprimé orodispersible
PRD1165245 · Product
- Active substance
- Ondansetron
- Pharmaceutical form
- ORODISPERSIBLE TABLET
- Route of administration
- ORAL
- Max daily dose
- 24 mg milligram(s)
- Max total dose
- 3.36 g gram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- A04AA01 — ONDANSETRON
- Marketing authorisation
- 34009 382 385 4 9
- MA holder
- ZYDUS FRANCE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Akynzeo 300 mg/0.5 mg hard capsules
PRD2825038 · Product
- Active substance
- Palonosetron
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300.5 mg milligram(s)
- Max total dose
- 31.55 g gram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- A04AA55 — -
- Marketing authorisation
- EU/1/15/1001/001
- MA holder
- HELSINN BIREX PHARMACEUTICALS LTD.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09593MIG · Substance
- Active substance
- Palonosetron
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.5 mg milligram(s)
- Max total dose
- 52.5 mg milligram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB130488 · Substance
- Active substance
- Netupitant
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 31.5 g gram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karyopharm Therapeutics Inc.
- Sponsor organisation
- Karyopharm Therapeutics Inc.
- Address
- 85 Wells Avenue
- City
- Newton
- Postcode
- 02459-3298
- Country
- United States
Scientific contact point
- Organisation
- Karyopharm Therapeutics Inc.
- Contact name
- Clinical Trials Information Desk
Public contact point
- Organisation
- Karyopharm Therapeutics Inc.
- Contact name
- Clinical Trials Information Desk
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 12, Code 5, Data management, Code 8 |
| Almac Clinical Services Limited ORG-100017464
|
Craigavon, United Kingdom (Northern Ireland) | Other |
| Geneuity Clinical Research Services ORG-100046072
|
Maryville, United States | Other |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Other, Laboratory analysis |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | On site monitoring, Code 12, Code 5, Data management |
| Eclinical Solutions LLC ORG-100044778
|
Mansfield, United States | Data management |
| PPD Global Limited ORG-100007533
|
Cambridge, United Kingdom | Code 12, Other |
Locations
13 EU/EEA countries · 92 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 10 | 5 |
| Bulgaria | Ongoing, recruitment ended | 8 | 5 |
| Czechia | Ongoing, recruitment ended | 13 | 3 |
| Denmark | Ongoing, recruitment ended | 8 | 2 |
| France | Ongoing, recruitment ended | 40 | 14 |
| Germany | Ongoing, recruitment ended | 14 | 5 |
| Greece | Ongoing, recruitment ended | 6 | 6 |
| Hungary | Ongoing, recruitment ended | 12 | 2 |
| Italy | Ongoing, recruitment ended | 31 | 18 |
| Netherlands | Ongoing, recruitment ended | 7 | 2 |
| Poland | Ongoing, recruitment ended | 17 | 8 |
| Romania | Ongoing, recruitment ended | 5 | 6 |
| Spain | Ongoing, recruitment ended | 24 | 16 |
| Rest of world
United States, Korea, Democratic People's Republic of, Israel, United Kingdom, Taiwan, Canada
|
— | 130 | — |
Investigational sites
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
Az St-Jan Brugge-Oostende A.V.
Hematology, Ruddershove 10, 8000, Brugge
Het Ziekenhuisnetwerk Antwerpen
Hematology, Kempenstraat 100, 2030, Antwerp
Het Ziekenhuisnetwerk Antwerpen
Hematology, Lindendreef 1, 2020, Antwerp
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
First Department of Clinical Hematology at Clinic of Clinical Hematology, Bulevard Kliment Ohridski 1a, 1797, Sofiya
Umbal - Prof. D-R Stoyan Kirkovich AD
Department of Clinical Hematology, Ulitsa General Stoletov 2, 6003, Stara Zagora
Alexandrovska University Hospital
Clinic of Clinical Hematology, Georgy Sofiiski Str 1, 1431, Sofia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of Clinical Hematology, Bulevard Vasil Aprilov 15a, 4002, Plovdiv
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department of Clinical Hematology at Clinic of Clinical Hematology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
Vseobecna Fakultni Nemocnice V Praze
I. internal clinic - hematology clinic, Karlovo Namesti 554/32, Nove Mesto, Prague 2
University Hospital Olomouc
Hematooncology clinic, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Hradec Kralove
IV. internal hematology clinic, Sokolska 581, 500 03, Novy Hradec Kralove
Region Midtjylland
Department of Haematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Aalborg University Hospital
Hæmatologisk afdeling, Moelleparkvej 4, 9000, Aalborg
Institut Bergonie
Hématologie, 229 Cours De L Argonne, 33000, Bordeaux
Centre Hospitalier Universitaire De Lille
Hématologie, Rue Michel Polonowski, 59000, Lille
Assistance Publique Hopitaux De Paris
Hématologie, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Universitaire De Saint Etienne
Hématologie Clinique et Thérapie Cellulaire, St Priest En Jarez, 25 Boulevard Pasteur, St Etienne Cedex 2
Assistance Publique Hopitaux De Paris
Hématologie Clinique, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire De Nimes
Hématologie Clinique, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Hopital Saint Louis
Centre d’investigation Clinique – CIC 1427, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Regional Et Universitaire De Brest
Hématologie, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier Regional Universitaire De Tours
Hématologie et thérapie cellulaire, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
University Hospital Of Clermont-Ferrand
Service d'Hématologie Clinique Adultes et Thérapie Cellulaire, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier Universitaire D'Angers
Maladies du Sang, 4 Rue Larrey, 49100, Angers
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Hématologie, 20 Avenue Du Docteur Rene Laennec, 68100, Mulhouse
Hospices Civils De Lyon
Hématologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Universitaire De Nice
Hématologie, 151 Route De Saint Antoine, 06200, Nice
Universitaetsklinikum Jena KöR
Klinik für Innere Medizin, Am Klinikum 1, Lobeda, Jena
Staedtisches Krankenhaus Kiel GmbH
2. Medizinische Klinik, Chemnitzstrasse 33, Schreventeich, Kiel
Martin-Luther-Universitaet Halle-Wittenberg
Clinic for Internal Medicine IV, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Marien Hospital Duesseldorf GmbH
Klinik für Onkologie, Hämatologie, und Palliativmedizin, Rochusstrasse 2, Pempelfort, Duesseldorf
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts
Internal Medicine, Wetzgauer Strasse 85, 73557, Mutlangen
Laiko General Hospital Of Athens
Hematology Clinic and BMT Unit Medical School, National and Kapodistrian University of Athens, Sevastoupoleos 16, 115 26, Athens
Alexandra Hospital
Hematology/Oncology Unit, Vassilissas Sofias Avenue 80, 115 28, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology Department, Exochi, 570 10, Thessaloniki
University General Hospital Of Ioannina
Department of Hematology, Faculty of Medicine, School of Health Sciences, Niarchou Stavrou Avenue, 455 00, Ioannina
University General Hospital Attikon
2nd Propaedeutic Internal Medicine Clinic, Hematology Unit, Rimini Street 1, 124 62, Athens
General University Hospital Of Larissa
1st Internal Medicine Sector, Hematology Clinic, P. O. Box 1425, 411 10, Larissa
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
II.Belgyagyaszat - Haematologia, Vasvari Pal Utca 2-4, 9024, Gyor
Semmelweis University
Belgyogyaszati és Hematologiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
U.O. Ematologia con TMO, Via Santa Sofia 78, 95123, Catania
IRCCS Ospedale Policlinico San Martino
UO Clinica Ematologica, Largo Rosanna Benzi 10, 16132, Genoa
IRCCS Centro Di Riferimento Oncologico Della Basilicata
UO Ematologia e Trapianto di Cellule Staminali, Via Padre Pio 1, 85028, Rionero In Vulture
Azienda Ospedaliera Ordine Mauriziano Di Torino
SCDU Ematologia e Terapie Cellulari, Via Ferdinando Magellano 1, 10128, Turin
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Dipartimento Area Medica, Ematologia, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU Ematologia, Corso Giuseppe Mazzini 18, 28100, Novara
Fondazione Policlinico Universitario Campus Bio-Medico
Ematologia, Via Alvaro Del Portillo N 200, 00128, Rome
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Fondazione IRCCS Policlinico San Matteo
UOC Ematologia I, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
U.O.C Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Fondazione IRCCS San Gerardo Dei Tintori
Ematologia Adulti, Via Giovanni Battista Pergolesi 33, 20900, Monza
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Servizio e DH Ematologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Dipartimento Ematologia, Viale Del Policlinico 155, 00161, Rome
European Institute Of Oncology S.r.l.
Divisione di Oncoloematologia, Via Giuseppe Ripamonti 435, 20141, Milan
Careggi University Hospital
SOD Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
SC Ematologia U, Corso Bramante 88, 10126, Turin
ASST Grande Ospedale Metropolitano Niguarda
Hematology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Centro Ricerche Cliniche Di Verona S.r.l.
Dpt. of Engineering for Innovation Medicine, Biomedicine Section, Hematology Area, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Spaarne Gasthuis
Department of Internal Medicine, Spaarnepoort 1, 2134 TM, Hoofddorp
Universitair Medisch Centrum Groningen
Department of hematology, Hanzeplein 1, 9713 GZ, Groningen
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Centrum Hematologiczno-Transplantacyjne, Ul. Grabiszynska 105, 53-439, Wroclaw
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Oddział Hematologii Onkologicznej z Pododdziałem Transplantologii Klinicznej, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Aidport Sp. z o.o.
N/A, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Centrum Innowacyjnych Terapii/ Centrum Wsparcia Badań Klinicznych Uniwersytetu Medycznego w Lublinie, Ul. Dr. K. Jaczewskiego 8, 20-954, Lublin
Medicover Integrated Clinical Services Sp. z o.o.
N/A, Ul. Stefana Batorego 18/22, 87-100, Torun
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Pratia Hematologia Sp. z o.o.
Hematologia, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Oddział Hematologii, Ul. Alfreda Sokolowskiego 4, 58-309, Walbrzych
Spitalul Clinic Municipal Filantropia Craiova
Hematology, Strada Filantropiei No 1, 200143, Craiova
Institutul Regional De Oncologie Iasi
Hematology, Strada G-Ral Berthelot 2-4, 700483, Iasi
Spitalul Clinic Coltea
Hematology, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
Spitalul Clinic Colentina Bucuresti
Hematology, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Hematology, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul Clinic Judetean De Urgenta Targu Mures
Clinical department of internal medicine I, hematology compartmen, Strada Marinescu Gheorghe 50, 540136, Targu Mures
Hospital San Pedro De Alcantara
Hematology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Virgen De La Victoria
Hematology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Clinico Universitario De Valencia
Hematology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Central De Asturias
Hematology, Avenida De Roma S/n, 33011, Oviedo
Hospital Quironsalud Zaragoza
Hematology, Paseo Renovales S/n, 50006, Zaragoza
Hospital Universitario Lucus Augusti
Hematology and Hemotherapy, Rua Dr. Ulises Romero 1, 27003, Lugo
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Clinical Hospital Virgen De La Arrixaca
Hematology and Hemotherapy, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
El Hospital Universitario De Gran Canaria Dr. Negrin
Hematology, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Institut Catala D'oncologia
Hematology, Avinguda De Franca S/n, 17007, Girona
Hospital General Universitario Gregorio Maranon
Hematology and Hemotherapy, Calle Del Doctor Esquerdo 46, 28009, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-04-22 | 2024-06-21 | 2025-07-15 | ||
| Bulgaria | 2024-04-02 | 2024-04-18 | 2025-08-21 | ||
| Czechia | 2024-04-23 | 2024-05-17 | 2025-05-29 | ||
| Denmark | 2024-05-28 | 2024-11-18 | 2025-04-28 | ||
| France | 2024-01-15 | 2024-02-29 | 2025-07-02 | ||
| Germany | 2024-04-10 | 2024-06-26 | 2025-06-16 | ||
| Greece | 2024-06-04 | 2024-08-08 | 2025-07-15 | ||
| Hungary | 2024-06-28 | 2024-10-30 | 2025-05-26 | ||
| Italy | 2024-03-19 | 2024-04-18 | 2025-09-03 | ||
| Netherlands | 2024-06-25 | 2025-02-07 | 2025-07-14 | ||
| Poland | 2024-04-12 | 2024-04-17 | 2025-08-27 | ||
| Romania | 2024-03-29 | 2024-04-11 | 2025-06-02 | ||
| Spain | 2024-01-04 | 2024-04-19 | 2025-08-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 199 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol_2023-506139-13-00_Justification of placebo_For Publication | NA |
| Protocol (for publication) | D1_ Protocol_2023-506139-13-00_redacted | 6 |
| Protocol (for publication) | D1_ Protocol_2023-506139-13-00_summary of changes | 6 |
| Protocol (for publication) | D1_034_Protocol Clarification Memo_24Jan2025_Redacted | 1 |
| Protocol (for publication) | D1_Protocol_2023-506139-13-00_Greek_redacted | 6 |
| Protocol (for publication) | D4_BE_Patient Facing Document_MF-PGIS Single Item_Dutch_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_BE_Patient Facing Document_MF-PGIS Single Item_French_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_BG_Patient Facing Document_MF PGIS Single Item_Bulgarian_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_CZ_Patient Facing Document_MF PGIS Single Item_Czech_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_CZ_Patient Facing Document_MF PGIS Single Item_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_DE_Patient Facing Document_MF-PGIS Single Item_German_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_DK_Patient Facing Document_MF PGIS Singel Item_Danish_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_EL_Patient Facing Document_MF PGIS Single Item_Greek_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_ES_Patient Facing Document_MF PGIS Single Item_Spanish_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_FR_Patient Facing Document_MF PGIS Single Item_French_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_HU_Patient Facing Document_MF PGIS Single Item_Hungarian_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_IT_Patient Facing Document_MF PGIS Single Item_Italian_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_NL_Patient Facing Document_MF-PGIS Single Item_Dutch_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_BE_Dutch | 1.2 |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_BE_French | NA |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_BG_Bulgarian | NA |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_CZ_Czech | NA |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_DE_German | NA |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_DK_PL_English | 1.2 |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_ES_Spanish | NA |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_FR_French | 1.2 |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_GR_Greek | NA |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_HU_Hungarian | 1.3 |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_IT_Italian | 1.1 |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_NL_Dutch | 1.1 |
| Protocol (for publication) | D4_Patient Facing Document_EQ-5D-5L_RO_Romanian | NA |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_BE_Dutch | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_BE_French | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_BG_Bulgarian | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_CZ_Czech | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_DE_German | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_DK_PL_English | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_ES_Spanish | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_FR_French | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_GR_Greek | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_HU_Hungarian | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_IT_Italian | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_NL_Dutch | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF 7-Day Recall_RO_Romanian | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_BE_Dutch | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_BE_French | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_BG_Bulgarian | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_CZ_Czech | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_DE_German | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_DK_PL_English | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_ES_Spanish | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_FR_French | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_GR_Greek | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_HU_Hungarian | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_IT_Italian | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_NL_Dutch | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_MFSAF Diary_RO_Romanian | 4.0 |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_BE_Dutch_vTS1-0 | NA |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_BE_French_vTS1-0 | NA |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_BG_Bulgarian_vTS1-0 | NA |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_CZ_Czech | NA |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_DE_German_vTS1-0 | NA |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_DK_PL_English_TS1-0 | NA |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_ES_Spanish_vTS1-0 | NA |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_FR_French_vTS1-0 | NA |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_GR_Greek_vTS1-0 | NA |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_HU_Hungarian_vTS1-0 | NA |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_IT_Italian_vTS1-0 | NA |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_NL_Dutch_vTS1-0 | NA |
| Protocol (for publication) | D4_Patient Facing Document_PGI-C_RO_Romanian_vTS1-0 | NA |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_BE_Dutch | 3.0 |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_BE_French | 3.0 |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_BG_Bulgarian | 3.0 |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_CZ_Czech | 3.0 |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_DE_German | 3.0 |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_DK_PL_EN | 3.0 |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_ES_Spanish | 3.0 |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_FR_French | 3.0 |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_GR_Greek | 3.0 |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_HU_Hungarian | 3.0 |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_IT_Italian | 3.00 |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_NL_Dutch | 3.0 |
| Protocol (for publication) | D4_Patient Facing Document_PSDD_RO_Romanian | 3.0 |
| Protocol (for publication) | D4_PL_Patient Facing Document_MF PGIS Single Item_Polish_v1-0_27Nov2024 | 1 |
| Protocol (for publication) | D4_RO_Patient Facing Document_MF PGIS Single Item_Romanian_v1-0_27Nov2024 | 1 |
| Recruitment arrangements (for publication) | K1_BE_Recruitment Procedure | 1.1 |
| Recruitment arrangements (for publication) | K1_BG_Recruitment Procedure_Bulgarian | 1.0 |
| Recruitment arrangements (for publication) | K1_CZ_Recruitment Procedure_Bilingual | 1 |
| Recruitment arrangements (for publication) | K1_DE_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_DK_Recruitment Procedure | 1.1 |
| Recruitment arrangements (for publication) | K1_EL_ Recruitment procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_ES_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_FR_Recruitment Procedure_Bilingual | 1.0 |
| Recruitment arrangements (for publication) | K1_HU_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_IT_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_NL_Recruitment Procedure | 1.1 |
| Recruitment arrangements (for publication) | K1_PL_Recruitment Procedure | 1.1 |
| Recruitment arrangements (for publication) | K1_RO_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K2_BG_Recruitment Material_HCP Referral Email Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_BG_Recruitment Material_HCP Referral Email Letter_Bulgarian | 1.0 |
| Recruitment arrangements (for publication) | K2_EL_Recruitment material_HCP Referral Email Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_ES_Recruitment material_HCP Referral Email Letter_Spanish | 1.0 |
| Recruitment arrangements (for publication) | K2_FR_Recruitment material_HCP Referral Email Letter_French | 1.0 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment Material_HCP Referral Email Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_HCP Referral Email Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_HCP Referral Email Letter_Romanian | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_Dutch_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_French_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy Data Collection_Dutch | 1.2 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy Data Collection_French | 1.2 |
| Subject information and informed consent form (for publication) | L1_BE_Sponsor Statement on Main ICF_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main | 4.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main_Bulgarian | 4.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main_Global | 2.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Optional Future testing and extensive PK-PD | 1.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Optional Future testing and extensive PK-PD_Bulgarian | 1.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Optional Future testing and extensive PK-PD_Global | 2.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Pregnant Partner_Bulgarian | 1 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Pregnant Partner_Global | 1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Data Privacy_Czech_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Data Privacy_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main | 3.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main_Czech | 4.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main_Czech_hl | 4.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main_hl | 3.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Optional Extensive PK and PD | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Optional Extensive PK and PD_Czech | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Optional Future Research | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Optional Future Research_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Pregnant Partner_Czech_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Main_German_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Optional Future testing and extensive PKPD_German_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnant Partner ICF_German_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Main_Danish | 4.0 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Optional Future Research and Extensive PK-PD_Danish | 1.0 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Pregnant Partner_Danish | 1.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Main_Greek_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Optional Future testing and extensive PKPD_Greek_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pregnant Partner_Greek_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main_Spanish_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Optional Future testing_Spanish_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnant Partner_Spanish_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Optional Blood Samples for PK PDN analysis_French | 2.2 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Optional Future testing and extensive PKPD_French | 2.1 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Pregnant Partner_French | 1.1 |
| Subject information and informed consent form (for publication) | L1_HU_Description and summary of patient documents ToC_Hungarian | 1.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Optional Future Genetic testing and extensive PK PDn_Hungarian | 1.1 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Optional Future Genetic testing and extensive PK PDn_Hungarian_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Main_Hungarian_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Pregnant Partner_Hungarian | 1.1 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Data Protection Form_Italian | 1.1 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Main_Italian_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Optional Future Testing and extensive PKPD_Italian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Pregnancy_Italian | 1.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Main and future research_Dutch_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Pregnant Partner ICF_Dutch_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Polish_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Optional Future testing _Polish | 1.1 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnant Partner_Polish_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main | 4.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_Romanian | 4.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Optional Future testing and extensive PK PD_Romanian | 1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnant Partner_Romanian | 1.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_patient card_Czech | 2.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other Subject Material_Visit Calendar_Czech | 1.1 |
| Subject information and informed consent form (for publication) | L2_DE_Other Subject Material_Visit Calendar_German | 1.1 |
| Subject information and informed consent form (for publication) | L2_EL_Other subject material_C2R reimbursement form_Greek_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_EL_Other subject material_Patient card_Greek | 2.0 |
| Subject information and informed consent form (for publication) | L2_EL_Other subject Material_Visit calendar_Greek | 1.1 |
| Subject information and informed consent form (for publication) | L2_FR_Other subject material_Patient Card_French | 1.1 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject material_Patient card_Hungarian | 1.0 |
| Subject information and informed consent form (for publication) | L2_PL_Other Subject Material_Data processing declaration_Polish | 8.0 |
| Subject information and informed consent form (for publication) | L2_PL_Other Subject Material_Reimbursement form_Polish | 8.0 |
| Subject information and informed consent form (for publication) | L2_PL_Other Subject Material_Statement of reimbursement_Polish | 5.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_blank page | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Jakavi | NA |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-506139-13-00_Czech | 6 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-506139-13-00_Dutch | 6 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-506139-13-00_French | 6 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-506139-13-00_Greek | 6 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-506139-13-00_Italian | 6 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-506139-13-00_Polish | 6 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-506139-13-00_Spanish | 6 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_20235061391300_Bulgarian | 6 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_20235061391300_German | 6 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_20235061391300_Hungarian | 6 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_20235061391300_Romanian | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506139-13-00_Bulgarian | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506139-13-00_Czech | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506139-13-00_France | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506139-13-00_German | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506139-13-00_Greek | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506139-13-00_Hungarian | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506139-13-00_Italian | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506139-13-00_Polish | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506139-13-00_Romanian | 6 |
Application history
18 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-02 | Spain | Acceptable 2023-11-27
|
2023-11-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-05 | Acceptable | 2024-05-30 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-05 | Acceptable | 2024-06-10 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-10 | Acceptable | 2024-06-26 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-10 | Spain | Acceptable | 2024-04-25 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-05-08 | Acceptable | 2024-06-19 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-05 | Acceptable | 2024-07-05 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-09-13 | Spain | Acceptable 2024-12-10
|
2024-12-10 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-02-04 | Spain | Acceptable 2025-05-08
|
2025-05-08 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-15 | Spain | Acceptable 2025-05-08
|
2025-05-15 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-02 | Acceptable 2025-05-08
|
2025-06-02 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-06-02 | Acceptable | 2025-06-25 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-08-22 | Spain | Acceptable | 2025-08-22 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-09-11 | Spain | Acceptable | 2025-09-11 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-09-19 | Spain | Acceptable | 2025-09-19 |
| 16 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-09-23 | Acceptable | 2025-10-09 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-03-11 | Spain | Acceptable 2026-04-07
|
2026-04-07 |
| 18 | SUBSTANTIAL MODIFICATION | SM-12 | 2026-04-27 | Acceptable | 2026-05-21 |